Basaglar is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood.

Basaglar is used to improve blood sugar control in adults and children with diabetes mellitus.

Basaglar, is for use in adults with type 1 or 2 diabetes and in children at least 6 years old with type 1 diabetes (not type 2).

For type 1 diabetes, Basaglar KwikPen is used together with a short-acting insulin given before meals.

Warnings

Never share a Basaglar KwikPen with another person, even if the needle has been changed.

You should not use Basaglar if you are having an episode of hypoglycemia (low blood sugar), or if you are in a state of diabetic ketoacidosis (call your doctor for treatment).

Basaglar is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Never share an injection pen, even if you changed the needle.

Basaglar KwikPen side effects

Get emergency medical help if you have any signs of an allergic reaction to Basaglar: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• rapid weight gain, swelling in your feet or ankles;
• shortness of breath; or
• low blood potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Basaglar side effects may include:

• low blood sugar;
• swelling, weight gain;
• allergic reaction, itching, rash; or
• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Before taking this medicine

You should not use Basaglar KwikPen if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar) or diabetic ketoacidosis (call your doctor for treatment).

Basaglar KwikPen is not approved for use by anyone younger than 6 years old, and some brands are for use only in adults. Do not use this medicine to treat type 2 diabetes in a child of any age.

To make sure Basaglar is safe for you, tell your doctor if you have:

• liver or kidney disease; or
• heart failure or other heart problems.

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

How should I use Basaglar KwikPen?

Use Basaglar exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use Basaglar in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

The Toujeo brand of insulin glargine contains 3 times as much insulin per milliliter (mL) as the Basaglar brand. There are 300 units of insulin in 1 mL of Toujeo, and 100 units in 1 mL of Basaglar.

If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change.

Basaglar is injected under the skin. You will be shown how to use injections at home. Do not give yourself Basaglar if you do not understand how to use the injection and properly dispose of used needles and pens.

Basaglar must not be given with an insulin pump, or mixed with other insulins. Do not inject Basaglar into a vein or a muscle.

Do not inject this medicine into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

Basaglar is usually injected once per day at the same time each day. You will be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and pens.

Your care provider will show you the best places on your body to inject Basaglar. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Use only the injection pen that comes with Basaglar KwikPen. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

Never share an injection pen with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles. Use a puncture-proof “sharps” disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your insulin dose or schedule.

Basaglar is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Keep Basaglar in its original container protected from heat and light. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) Basaglar KwikPen:

• Refrigerate and use until the expiration date; or
• if stored at room temperature (below 86 degrees Fahrenheit) , use within 28 days.

Storing opened (in use) Basaglar KwikPen:

• Store the injection pen at room temperature (do not refrigerate) and use within 28 days.

Do not use the medicine if it looks cloudy, has changed colors, or has any particles in it. Call your pharmacist for new medicine.

Wear a diabetes medical alert tag (or carry an ID card) in case of emergency. Any medical care provider who treats you should know that you have diabetes.

Do not store an injection pen with the needle attached. Do not reuse a needle or syringe. Place them in a puncture-proof “sharps” container and dispose of it following state or local laws. Keep out of the reach of children and pets.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose. Do not use more than one dose in a 24-hour period unless your doctor tells you to.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Insulin overdose can cause severe hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using Basaglar KwikPen?

Avoid driving or hazardous activity until you know how Basaglar KwikPen will affect you. Your reactions could be impaired.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol or using medicines that contain alcohol. It may interfere with your diabetes treatment.

What other drugs will affect Basaglar KwikPen?

Many drugs can affect your blood sugar and may also affect Basaglar. Some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use. Not all possible interactions are listed here.

What is Humalog?

Humalog is a fast-acting insulin that starts to work about 15 minutes after injection, peaks in about 1 hour, and keeps working for 2 to 4 hours. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood.

Humalog is used to improve blood sugar control in adults and children with diabetes mellitus.

Humalog is used to treat type 2 diabetes in adults.

Humalog is also used to treat type 1 diabetes in adults and children who are at least 3 years old.

Warnings

Humalog is a fast-acting insulin that begins to work very quickly. If you use this medication with meal, use it within 15 minutes before or just after you eat.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed.

You should not use Humalog if you are having an episode of hypoglycemia (low blood sugar).

Humalog is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Humalog side effects

Get emergency medical help if you have signs of insulin allergy to Humalog: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• weight gain, swelling in your hands or feet, feeling short of breath;
• low blood sugar – headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or
• low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Humalog side effects may include:

• low blood sugar;
• weight gain;
• swelling in your hands or feet;
• itching; or
• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Before taking this medicine

You should not use Humalog if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Humalog should not be given to a child younger than 3 years old. Humalog should not be used to treat type 2 diabetes in a child of any age.

To make sure Humalog is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;
• heart problems; or
• low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using Humalog if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use Humalog?

Use Humalog exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Humalog is injected under the skin using a syringe and needle, an injection pen, or with an infusion pump. A healthcare provider will teach you how to properly use this medicine by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors or has particles in it. Call your pharmacist for new medicine.

Humalog is to be used within 15 minutes before a meal, or right after eating.

Your healthcare provider will show you where on your body to inject insulin lispro. Use a different place each time you give an injection. Do not inject into the same place two times in a row. Do not inject into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

Concentrated Humalog (200 units) must not be given with an insulin pump, or mixed with other insulins. Do not transfer insulin lispro from an injection pen to a syringe or a severe overdose could occur.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Keep this medicine in its original container protected from heat and light. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) insulin lispro:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within 28 days.

Storing opened (in use) Humalog:

• Store the vial in a refrigerator or at room temperature and use within 28 days.
• Store the cartridge or injection pen (without a needle attached) at room temperature and use within 28 days.

Use a needle and syringe only once and place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

Since Humalog is used before meals, you may not be on a timed dosing schedule. Whenever you use Humalog, be sure to eat a meal within 15 minutes. Do not use two doses at one time.

Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using Humalog?

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.

What other drugs will affect Humalog?

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines,  vitamins, and herbal products.

Buy vitamins and supplements

Humalog Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 3 for Humalog.Admelog (insulin lispro) – Sanofi-Aventis U.S. LLC

What is Humulin N?

Humulin N is a man-made form of a hormone that is produced in the body. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin isophane is an intermediate-acting insulin that starts to work within 2 to 4 hours after injection, peaks in 4 to 12 hours, and keeps working for 12 to 18 hours.

Humulin N is used to improve blood sugar control in adults and children with diabetes mellitus.

Humulin N may also be used for purposes not listed in this medication guide.

Warnings

You should not use Humulin N if you are having an episode of low blood sugar.

Never share an injection pen or syringe with another person, even if the needle has been changed.

Hypoglycemia, or low blood sugar, is the most common side effect of Humulin N. Symptoms of low blood sugar may include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating. Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Humulin N side effects

Get emergency medical help if you have any signs of an allergic reaction to Humulin N: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, chest tightness, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• fluid retention – weight gain, swelling in your hands or feet, feeling short of breath; or
• low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Humulin N side effects may include:

• low blood sugar;
• weight gain, swelling in your hands or feet;
• itching, mild skin rash; or
• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Before taking this medicine

You should not use Humulin N if you are allergic to insulin isophane, or if you are having an episode of hypoglycemia (low blood sugar).

Do not give Humulin N to a child without a doctor’s advice.

To make sure Humulin N is safe for you, tell your doctor if you have ever had:

• liver or kidney disease; or
• low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using Humulin N if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use Humulin N?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Humulin N is injected under the skin. A healthcare provider can teach you how to properly use the medication by yourself.

Do not give Humulin N with an insulin pump.

Humulin N must not be given with an insulin pump, or mixed with other insulins. Do not inject into a vein or a muscle.

Do not inject this medicine into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use Humulin N if you don’t understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Humulin N should look cloudy after mixing. Do not use the mixture if it looks clear or has particles in it. Call your pharmacist for new medicine.

Your care provider will show you where on your body to inject Humulin N. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

If you use an injection pen, use only the injection pen that comes with Humulin N. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

Never share an injection pen or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, and feeling shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Humulin N is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Keep this medicine in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) Humulin N:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within the number of days specified in the Instructions for Use provided with your medicine.

Storing opened (in use) Humulin N:

• Store in a refrigerator or at room temperature as directed in the Instructions for Use provided with your medicine. Do not refrigerate an in-use injection pen.
• In-use Humulin N is stable for only a certain number of days. Throw away any medicine not used within that time. Follow all storage directions provided with your medicine.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

In case of emergency, wear or carry medical identification to let others know you have diabetes.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Get your Humulin N prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using Humulin N?

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin. Some brands of insulin isophane and syringes are interchangeable, while others are not. Your doctor and/or pharmacist know which brands can be substituted for one another.

Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.

What other drugs will affect Humulin N?

Humulin N may not work as well when you use other medicines at the same time. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low.

What is Humulin R?

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Humulin R is a short-acting insulin that starts to work within 30 minutes after injection, peaks in 2 to 3 hours, and keeps working for up to 8 hours.

Humulin R is used to improve blood sugar control in adults and children with diabetes mellitus.

Humulin R may be used for type 1 or type 2 diabetes.

Warnings

You should not use insulin if you are having an episode of hypoglycemia (low blood sugar).

Before taking this medicine

You should not use Humulin R if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Humulin R is not approved for use by anyone younger than 2 years old. Humulin R should not be used to treat type 2 diabetes in a child of any age.

To make sure Humulin R is safe for you, tell your doctor if you have ever had:

• liver or kidney disease; or
• heart failure.

Taking certain oral diabetes medicines while using Humulin R may increase your risk of serious heart problems. Tell your doctor if you also take medicine that contains pioglitazone or rosiglitazone.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using Humulin R if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use Humulin R?

Use Humulin R exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Humulin R is injected under the skin. A healthcare provider can teach you how to properly use the medication by yourself. Humulin R must not be given with an insulin pump. Do not inject Humulin R into a vein or a muscle.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Prepare a Humulin R injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Your care provider will show you where on your body to inject insulin. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Do not inject this medicine into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

After using Humulin R, you should eat a meal within 30 minutes.

Never share a syringe with another person, even if the needle has been changed. Sharing syringes can allow infections or disease to pass from one person to another.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Insulin is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

In case of emergency, wear or carry medical identification to let others know you have diabetes.

Keep Humulin R in its original container protected from heat and light. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) Humulin R:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within the number of days shown in your Instructions for Use.

Storing opened (in use) Humulin R:

• Store at room temperature and use within the number of days shown in your Instructions for Use.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using Humulin R?

Do not change the brand of insulin or syringe you are using without first talking to your doctor or pharmacist. Some brands of insulin and syringes are interchangeable, while others are not. Your doctor and/or pharmacist know which brands can be substituted for one another.

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how Humulin R will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol. It can interfere with your diabetes treatment.

Humulin R side effects

Get emergency medical help if you have signs of an allergy to Humulin R: redness, swelling, sweating, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Humulin R side effects may include:

• low blood sugar;
• swelling in your hands or feet;
• weight gain; or
• thickening or hollowing of the skin where you injected the medicine.

What is concentrated (U-500) insulin?

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Concentrated (U-500) insulin is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours. U-500 insulin is five times more concentrated than regular U-100 insulin.

U-500 insulin is used to improve blood sugar control in adults and children with diabetes mellitus who have significant daily insulin needs (more than 200 units per day).

U-500 insulin may also be used for purposes not listed in this medication guide.

U-500 insulin side effects

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Humulin R (Concentrated) may cause serious side effects. Call your doctor at once if you have:

• fluid retention–weight gain, swelling in your hands or feet, feeling short of breath; or
• low potassium–leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects of Humulin R (Concentrated) may include:

• low blood sugar;
• itching, mild skin rash; or
• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed.

Before taking this medicine

You should not use Humulin R (Concentrated) if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Tell your doctor if you have ever had:

• liver or kidney disease; or
• low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using insulin if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use U-500 insulin?

U-500 insulin is concentrated and contains 500 units of insulin in each milliliter (mL). This is five times more concentrated than regular U-100 insulin, which contains 100 units per mL. Measure each dose of U-500 insulin carefully. Using too much insulin can lead to insulin shock or death. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Insulin is injected under the skin. A healthcare provider can teach you how to properly use the medication by yourself.

U-500 insulin must not be given with an insulin pump, or mixed with other insulins. Do not inject U-500 insulin into a vein or a muscle.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Your healthcare provider will show you where on your body to inject U-500 insulin. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Do not inject this medicine into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

After using U-500 insulin, you should eat a meal within 30 minutes.

If you use an injection pen, use only the injection pen that comes with U-500 insulin. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe. The injection pen has a dial on it that allows you to set your correct doses of U-500 insulin.

If you use U-500 insulin from a vial (bottle), use only a U-500 insulin syringe to inject the medicine. Do not use any other type of syringe.

Do not convert your dose when using a U-500 injection pen or U-500 insulin syringe.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

U-500 insulin is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Keep this medicine in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) U-500 insulin:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within 28 days.

Storing opened (in use) U-500 insulin:

• Store the vial in a refrigerator or at room temperature and use within 40 days. Do not shake the vial.
• Store the injection pen at room temperature (do not refrigerate) and use within 28 days. Do not store the injection pen with a needle attached.

In case of emergency, wear or carry medical identification to let others know you have diabetes.

What happens if I miss a dose?

Follow your doctor’s directions if you miss a dose. To prevent missed doses, keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

What is insulin aspart?

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin aspart is a fast-acting insulin that starts to work about 15 minutes after injection, peaks in about 1 hour, and keeps working for 2 to 4 hours.

Insulin aspart is used to improve blood sugar control in adults and children with diabetes mellitus. insulin aspart is sometimes used together with a long-acting or intermediate-acting insulin.

Insulin aspart may also be used for purposes not listed in this medication guide.

Insulin aspart side effects

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Insulin aspart may cause serious side effects. Call your doctor at once if you have:

• heart problems–swelling, rapid weight gain, feeling short of breath; or
• low potassium–leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects of insulin aspart may include:

• low blood sugar;
• weight gain;
• low potassium;
• swelling in your hands and feet;
• skin rash, itching, redness, or swelling; or
• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed.

Before taking this medicine

You should not use insulin aspart if you are allergic to it, or if you are having an episode of hypoglycemia (low blood sugar).

Insulin aspart is not approved for use by anyone younger than 2 years old, and should not be used to treat type 2 diabetes in a child of any age. Fiasp is for use only in adults.

Tell your doctor if you have ever had:

• liver or kidney disease; or
• low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using insulin if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use insulin aspart?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Insulin aspart is injected under the skin, or as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Your healthcare provider will show you where on your body to inject insulin aspart. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Do not inject insulin aspart into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

After using Novolog, you should eat a meal within 5 to 10 minutes. Fiasp should be given at the start of a meal or within 20 minutes after starting a meal.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Prepare an injection only when you are ready to give it. This medicine should be clear and colorless. Do not use the medicine if it has changed colors or has particles in it. Call your pharmacist for new medicine.

If you use an injection pen, use only the pen provided with your medicine. If you use this medicine with an insulin pump, do not mix or dilute insulin aspart with any other insulin. Change the medicine in the reservoir at least every 6 days.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Insulin aspart is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Keep this medicine in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) insulin aspart:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within 28 days.

Storing opened (in use) insulin aspart:

• Store the vial in a refrigerator or at room temperature and use within 28 days.
• Store the cartridge or injection pen at room temperature (do not refrigerate) and use within 28 days. Do not store the injection pen with a needle attached.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

In case of emergency, wear or carry medical identification to let others know you have diabetes.

What happens if I miss a dose?

Since insulin aspart is used before meals, you may not be on a timed dosing schedule. Whenever you use insulin aspart, be sure to eat a meal within 5 to 10 minutes. Do not use extra insulin aspart to make up a missed dose.

Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using insulin aspart?

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how insulin aspart will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol or using medicines that contain alcohol. Alcohol can cause low blood sugar and may interfere with your diabetes treatment.

What other drugs will affect insulin aspart?

Insulin may not work as well when you use other medicines at the same time. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all medicines you start or stop using.

Insulin aspart Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for insulin aspart.Fiasp (insulin aspart) – Novo Nordisk Inc.

What is insulin degludec?

Insulin degludec is a long-acting basal human insulin analog that is used to improve glycemic control in people with diabetes.

Insulin is a hormone produced by your body that helps you to lower your blood glucose (blood sugar) levels.

People with type 1 diabetes and some people with type 2 diabetes need to administer man-made forms of insulin. This is because they don’t produce enough insulin themselves or their body doesn’t respond well enough to the insulin they produce.

Basal insulin analogs like insulin degludec, work to keep your blood glucose levels stable during times when you’re fasting, such as at night when you’re asleep. Insulin degludec provides a ‘background’, slow-acting supply of insulin.

Insulin degludec was approved by the US Food and Drug Administration (FDA) in 2015. The Tresiba brand of insulin degludec is the only version of this medication currently available.

What is insulin degludec used for?

• Insulin degludec is used to control high blood sugar in adults and children who are 1 year of age and older with diabetes mellitus.
• Insulin degludec is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).
• It is not known if insulin degludec is safe and effective in children under 1 year of age.
• Insulin degludec is available in 2 concentrations (U-100 and U-200):
  • U-100 concentration is available in pen and vial
    • The 100 units/mL pen can be injected from 1 to 80 units in a single injection, in increments of 1 unit.
    • The 100 units/mL vial should be used with a U-100 insulin syringe only.
  • U-200 concentration is only available in pen
    • The 200 units/mL pen can be injected from 2 to 160 units in a single injection, in increments of 2 units.

Important information

Do not share your insulin degludec FlexTouch insulin delivery device (pen) with other people, even if the needle has changed. Do not share needles or syringes with another person. You may give other people a serious infection, or get a serious infection from them.

Who should not take insulin degludec?

Do not take insulin degludec if you:

• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to insulin degludec or any of the ingredients in insulin degludec. See below for a complete list of ingredients.

What should I tell my doctor before taking insulin degludec?

Before taking insulin degludec, tell your healthcare provider about all your medical conditions including, if you are:

• pregnant, planning to become pregnant, or are breastfeeding.
• taking new prescription or over-the-counter medicines, vitamins, or herbal supplements.

Before you start taking insulin degludec, talk to your healthcare provider about low blood sugar and how to manage it.

How should I take insulin degludec?

• Read the Instructions for Use that come with your insulin degludec.
• Take insulin degludec exactly as your healthcare provider tells you to.
• Do not do any conversion of your dose. The dose counter always shows the selected dose in units. Both the 100 units/mL and 200 units/mL insulin degludec FlexTouch pens are made to deliver your insulin dose in units.
• Know the type and strength of insulin you take. Do not change the type of insulin you take unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you take different types of insulin.
• For children who need less than 5 units of insulin degludec each day, use a insulin degludec U-100 vial.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.
• Do not reuse or share your needles with other people. You may give other people a serious infection or get a serious infection from them.
• Never inject insulin degludec into a vein or muscle.
• Never use a syringe to remove insulin degludec from the FlexTouch pen.
• Insulin degludec can be injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).
• Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
  • Do not use the exact same spot for each injection.
  • Do not inject where the skin has pits, is thickened, or has lumps.
  • Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

What happens if I miss a dose?

• Adults: If you miss or are delayed in taking your dose of insulin degludec:
  • Take your dose as soon as you remember then continue with your regular dosing schedule.
  • Make sure there are at least 8 hours between your doses.
• If children miss a dose of insulin degludec:
  • Call the healthcare provider for information and instructions about checking blood sugar levels more often until the next scheduled dose of insulin degludec.

What should I avoid while taking insulin degludec?

While taking insulin degludec do not:

• Drive or operate heavy machinery, until you know how insulin degludec affects you.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

Dosing information

• Inject insulin degludec subcutaneously into the thigh, upper arm, or abdomen.
• Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis.
• For pediatric patients requiring less than 5 units of insulin degludec each day, use a U-100 vial.
• In adults, inject subcutaneously once daily at any time of day.
• In pediatric patients inject subcutaneously once daily at the same time every day.
• Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal.
• The recommended days between dose increases are 3 to 4 days.

Starting dose in patients who are not taking insulin:

• Type 1 diabetes
  The recommended starting dose of insulin degludec in insulin naive patients with type 1 diabetes is approximately one-third to one-half of the total daily insulin dose. The remainder of the total daily insulin dose should be administered as a short-acting insulin and divided between each daily meal. As a general rule, 0.2 to 0.4 units of insulin per kilogram of body weight can be used to calculate the initial total daily insulin dose in insulin naive patients with type 1 diabetes.
• Type 2 diabetes
  The recommended starting dose of insulin degludec in insulin naïve patients with type 2 diabetes mellitus is 10 units once daily.

Starting dose in patients already taking insulin:

• Adults with type 1 or type 2 diabetes
  Start insulin degludec at the same unit dose as the total daily long or intermediate-acting insulin unit dose.
• Pediatric patients (≥ 1 year of age) with type 1 or type 2 diabetes
  Start insulin degludec at 80 percent of the total daily long or intermediate-acting insulin unit dose to minimize the risk of hypoglycemia

See full prescribing information for additional important information about insulin degludec dosing.

What are the side effects of insulin degludec?

Insulin degludec may cause serious side effects that can lead to death, including:

• Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
  • dizziness or light-headedness
  • blurred vision
  • anxiety, irritability, or mood changes
  • sweating
  • slurred speech
  • hunger
  • confusion
  • shakiness
  • headache
  • fast heartbeat
• Low potassium in your blood (hypokalemia).
• Heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with insulin degludec may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure, it may get worse while you take TZDs with insulin degludec. Your healthcare provider should monitor you closely while you are taking TZDs with insulin degludec. Tell your healthcare provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet and sudden weight gain. Treatment with TZDs and insulin degludec may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

Your insulin dose may need to change because of:

• change in level of physical activity or exercise
• weight gain or loss
• increased stress
• illness
• change in diet

Common side effects of insulin degludec may include:

• serious allergic reactions (whole body reactions)
• reactions at the injection site
• skin thickening or pits at the injection site (lipodystrophy)
• itching
• rash
• swelling of your hands and feet
• weight gain

Get emergency medical help if you have:

• trouble breathing
• shortness of breath
• fast heartbeat
• swelling of your face, tongue, or throat
• sweating
• extreme drowsiness
• dizziness
• confusion

These are not all the possible side effects of insulin degludec. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Interactions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take medications that may:

• increase your risk of hypoglycemia (low blood sugar)
• increase or decrease how well insulin degludec works
• make it hard to tell if your blood sugar is getting too low

Ask your healthcare provider or pharmacist if you are not sure if you take one of these medications.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. There is a risk to mother and fetus associated with poorly controlled diabetes in pregnancy. However, there is a lack of data available to determine whether insulin degludec is safe in pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed. There is a lack of data available to determine whether insulin degludec is safe to use while breastfeeding. Talk to your doctor about whether the benefits of taking insulin degludec while breastfeeding outweigh any possible risks. Talk to your doctor about the best way to feed your baby while taking insulin degludec.

Storage

Vials before use:

• Store unopened insulin degludec vials in the refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.
• Do not freeze insulin degludec. Do not use insulin degludec if it has been frozen.
• Unused insulin degludec vials may be used until the expiration date printed on the label, if they are kept in the refrigerator.
• After 56 days, throw away insulin degludec vials that have been kept at room temperature (below 86°F (30°C)).

Vials in use:

• Store the insulin degludec vial you are currently using in the refrigerator between 36°F to 46°F (2°C to 8°C) or keep at room temperature below 86°F (30°C) in the original carton to protect from light.
• Keep insulin degludec away from direct heat or light.
• The insulin degludec vial you are using should be thrown away after 56 days, even if it still has insulin left in it and the expiration date has not passed.

Pen before use:

• Store unused insulin degludec FlexTouch Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Do not freeze insulin degludec. Do not use insulin degludec if it has been frozen.
• Unused Pens may be used until the expiration date printed on the label, if kept in the refrigerator.

Pen in use:

• Store the Pen you are currently using in the refrigerator between 36°F to 46°F (2°C to 8°C) or keep at room temperature below 86°F (30°C).
• Keep insulin degludec away from heat or light.
• The insulin degludec FlexTouch Pen you are using should be thrown away after 56 days if it is refrigerated or kept at room temperature, even if it still has insulin left in it and the expiration date has not passed.

What are the ingredients in insulin degludec?

Active Ingredient: insulin degludec

Inactive Ingredients: glycerol, metacresol, phenol, water for injection, and zinc. Hydrochloric acid or sodium hydroxide may be added.

Insulin degludec is manufactured under the brand name Tresiba by Novo Nordisk A/S, DK-2880 Bagsværd, Denmark.

Insulin degludec Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for insulin degludec.Tresiba (insulin degludec) – Novo Nordisk Inc.

V

What is insulin detemir?

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin detemir is a man-made long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours.

Insulin detemir is used to improve blood sugar control in people with diabetes mellitus.

Insulin detemir is for use in adults and children at least 2 years old.

Insulin detemir is not to be used to treat diabetic ketoacidosis.

Warnings

Never share an injection pen or syringe with another person, even if the needle has been changed.

Before taking this medicine

You should not use insulin detemir if you are allergic to it. Do not use during an episode of hypoglycemia (low blood sugar) or diabetic ketoacidosis (call your doctor for treatment).

To make sure insulin detemir is safe for you, tell your doctor if you have ever had:

• low levels of potassium in your blood (hypokalemia); or
• liver or kidney disease.

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin detemir may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using insulin detemir if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use insulin detemir?

Use insulin detemir exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Insulin detemir is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Prepare an insulin detemir injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Your healthcare provider will show you where on your body to inject insulin detemir. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Do not inject insulin detemir into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

If you use insulin detemir once daily, use the injection at your evening meal or at bedtime. If you use the medicine twice daily, use your evening dose at least 12 hours after your morning dose.

Your doctor may want you to also use a short-acting insulin. Always inject your insulins separately. Insulin detemir must not be given with an insulin pump, or mixed with other insulins. Do not inject into a vein or a muscle.

If you use an injection pen, use only the injection pen that comes with insulin detemir. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

Never share an injection pen or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Insulin detemir is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Keep insulin detemir in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) insulin detemir:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within 42 days.

Storing opened (in use) insulin detemir:

• Store the vial in a refrigerator or at room temperature and use within 42 days.
• Store the injection pen at room temperature (do not refrigerate) and use within 42 days. Do not store the injection pen with a needle attached.

In case of emergency, wear or carry medical identification to let others know you have diabetes.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose. Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using insulin detemir?

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how insulin detemir will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol.

Insulin detemir side effects

Get emergency medical help if you have signs of an allergy to insulin detemir: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• fluid retention – weight gain, swelling in your hands or feet, feeling short of breath; or
• low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common insulin detemir side effects may include:

• low blood sugar;
• weight gain;
• swelling in your hands and feet;
• rash, itching; or
• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect insulin detemir?

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Insulin detemir Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for insulin detemir.Levemir (insulin detemir) – Novo Nordisk Inc.

What is insulin glargine?

Insulin glargine is a long-acting insulin used to treat type 1 and type 2 diabetes in certain patients to improve and maintain blood glucose levels. Insulin glargine is a man-made form of human insulin that is used once daily to provide a base level of insulin that keeps working for 24 hours or longer.

Insulin glargine is available under the brand names Lantus, Basaglar, Toujeo, Semglee, and Rezvoglar.

Rezvoglar, Lantus, Semglee, and Toujeo are FDA-approved to be used for use in adult and pediatric patients with type 1 and type 2 diabetes. Basasglar is FDA-approved to be used by adults for type 2 diabetes and also for adults and pediatric patients with type 1 diabetes. In patients with type 1 diabetes, insulin glargine must be used together with a short-acting insulin.

Insulin glargine side effects

Common insulin glargine side effects may include low blood sugar, swelling, weight gain, allergic reaction, itching, rash, or thickening or hollowing of the skin where you injected the medicine (lipodystrophy).

Serious insulin glargine side effects

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Insulin glargine may cause other serious side effects. Call your doctor at once if you have:

• rapid weight gain, swelling in your feet or ankles;
• shortness of breath; or
• low blood potassium–leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Warnings

Never share an injection pen, even if you changed the needle.

Before taking this medicine

You should not use insulin glargine if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar) or diabetic ketoacidosis (call your doctor for treatment).

Different brands of insulin glargine are specifically approved for different age groups and different diabetes types. The safety and effectiveness of insulin glargine in pediatric patients younger than 6 years of age with type 1 diabetes and pediatric patients with type 2 diabetes has not been established.

Tell your doctor if you have ever had:

• liver or kidney disease; or
• heart failure or other heart problems.

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant, as it is not known if insulin glargine will harm your unborn baby. Follow your doctor’s instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or are planning to breastfeed, as it is not known if insulin glargine may harm your breastfeeding baby.

How should I use insulin glargine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Ask your doctor or pharmacist if you don’t understand how to use an injection.

Prepare an injection only when you are ready to give it. Do not use it if the medicine looks cloudy, has changed colors, or has particles in it.

Insulin glargine is injected under the skin, using a syringe or insulin pen, once per day at the same time of day.

Insulin can be injected into your upper legs (thighs), upper arms, or stomach area (abdomen). Do not inject into the same place two times in a row. Avoid injecting into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

When treating type 1 diabetes, use your short-acting insulin before meals as directed by your doctor.

Insulin glargine must not be given with an insulin pump or mixed with other insulins. Do not inject insulin glargine into a vein or a muscle.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes.

If you use an injection pen, use only the injection pen that comes with insulin glargine. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

Never share an injection pen, even if you changed the needle. Sharing these devices can pass infections from person to person.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injections in case of severe hypoglycemia.

Tell your doctor if you have frequent symptoms of high blood sugar (hyperglycemia), such as increased thirst or urination. Ask your doctor before changing your medication dosage.

Wear a medical alert tag or carry an ID card to let others know you have diabetes.

Insulin glargine is available as:

Basaglar 100 units/mL is available as Basaglar KwikPen 3 mL, BasaglarTempo Pen

3 mL

Lantus 100 units/mL is available as a Lantus multiple-dose vial 10 mL, Lantus SoloStar prefilled pen 3 mL

Rezvoglar 100 units/mL available as Rezvoglar KwikPen prefilled pen 3 mL

Semglee 100 units/mL available as Semglee multiple-dose vial 10 mL, Semgleeprefilled pen 3 mL

Toujeo 300 units/mL available as Toujeo SoloStar prefilled pen 1.5 ml, Toujeo Max SoloStar 3 mL prefilled pen

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose. Do not use more than one dose in a 24-hour period unless your doctor tells you to.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Insulin overdose can cause severe hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using insulin glargine?

Avoid driving or hazardous activity until you know how insulin glargine will affect you. Your reactions could be impaired.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol or using medicines that contain alcohol. It may interfere with your diabetes treatment.

What other drugs will affect insulin glargine?

Many drugs can affect your blood sugar and may also affect insulin glargine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use. Not all possible interactions are listed here.

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Storage

Storing unopened (not in use) insulin glargine:

• Refrigerate at 36°F–46°F (2°C–8°C )
• Do NOT use after the expiration date.

Storing opened (in use) insulin glargine:

• Storage once in use varies for different brands of insulin glargine. For storage information for the different brands of insulin glargine while in use, check prescribing information.

General storage information

• Keep this medicine in its original container protected from heat and light.
• Do not store an injection pen with the needle attached. Do not reuse a needle or syringe. Place them in a puncture-proof “sharps” container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Company

Basaglar manufactured by: Eli Lilly and Company, Indianapolis, IN 46285 USA.

Lantus manufactured by: sanofi-aventis U.S. LLC, Bridgewater, NJ 08807, A SANOFI COMPANY.

Rezvoglar manufactured by: Eli Lilly and Company, Indianapolis, IN 46285, USA.

Semglee manufactured by: Biocon Biologics Inc. 245 Main St, 2nd Floor, Cambridge, MA 02142 USA.

Toujeo manufactured by: sanofi-aventis U.S. LLC, Bridgewater, NJ 08807, A SANOFI COMPANY.

Insulin glargine Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 4 for insulin glargine.Basaglar (insulin glargine) – Eli Lilly and Company

What is insulin lispro?

Insulin Lispro is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin lispro is a fast-acting insulin that starts to work about 15 minutes after injection, peaks in about 1 hour, and keeps working for 2 to 4 hours.

Insulin lispro is used to improve blood sugar control in adults and children with diabetes mellitus.

Admelog and HumaLOG are used to treat type 2 diabetes in adults, or type 1 diabetes in adults and children who are at least 3 years old.

Lyumjev is not approved for use by anyone younger than 18 years old.

Warnings

Do not share your Insulin lispro with another person. This includes any pens, cartridge devices, needles, or syringes, even if the needle has been changed. Sharing may pass infections from one person to another. This includes infections you may not know you have.

Low blood sugar may happen with insulin lispro. Very low blood sugar can lead to seizures, passing out, long lasting brain damage, and sometimes death.

Low blood potassium may also happen with insulin lispro. If not treated, this can lead to a heartbeat that is not normal, very bad breathing problems, and sometimes death.

It may be harder to control blood sugar during times of stress such as fever, infection, injury, or surgery. A change in physical activity, exercise, or diet may also affect blood sugar.

Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.

Talk with your doctor before you drink alcohol or take products that have alcohol in them.

Before taking this medicine

You should not use insulin lispro if you are allergic to it, or if you are having an episode of hypoglycemia (low blood sugar).

Insulin lispro should not be given to a child younger than 3 years old. Insulin lispro should not be used to treat type 2 diabetes in a child of any age.

To make sure Insulin lispro is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;
• heart problems; or
• low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take medicine that contains pioglitazone or rosiglitazone. Taking certain oral diabetes medicines while you are using insulin lispro may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using insulin lispro if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use insulin lispro?

Use Insulin lispro exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Insulin lispro is injected under the skin with a syringe and needle, an injection pen, or with an infusion pump. A healthcare provider will teach you how to properly use insulin lispro by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors or has particles in it. Call your pharmacist for new medicine.

Admelog or HumaLOG are given within 15 minutes before a meal, or right after eating. Lyumjev is given at the start of a meal or within 20 minutes after eating.

Your healthcare provider will show you where on your body to inject insulin lispro. Use a different place each time you give an injection. Do not inject into the same place two times in a row. Do not inject into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

Concentrated insulin lispro (200 units) must not be given with an insulin pump, or mixed with other insulins. Do not transfer insulin lispro from an injection pen to a syringe or a severe overdose could occur.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Keep insulin lispro in its original container protected from heat and light. Do not freeze insulin lispro or store it near the cooling element in a refrigerator. Throw away any insulin lispro that has been frozen.

Storing unopened (not in use) insulin lispro:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within 28 days.

Storing opened (in use) insulin lispro:

• Store the vial in a refrigerator or at room temperature and use within 28 days.
• Store the cartridge or injection pen (without a needle attached) at room temperature and use within 28 days.

Use a needle and syringe only once and place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

Since insulin lispro is used with meals, you may not be on a timed dosing schedule. Whenever you use insulin lispro, follow the directions for your specific brand about whether to use the medicine before of after you eat. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using insulin lispro?

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how insulin lispro will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin lispro.

Avoid drinking alcohol.

Insulin lispro side effects

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• weight gain, swelling in your hands or feet, feeling short of breath;
• low blood sugar – headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or
• low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Insulin lispro side effects may include:

• low blood sugar;
• weight gain;
• swelling in your hands or feet;
• itching; or
• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA

What other drugs will affect insulin lispro?

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Insulin lispro Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 3 for insulin lispro.Admelog (insulin lispro) – Sanofi-Aventis U.S. LLC

What is regular insulin?

Insulin is a hormone that is produced naturally in our bodies. Its main role is to allow cells throughout the body to uptake glucose (sugar) and convert it into a form that can be used by these cells for energy. Naturally occurring human insulin is made by beta cells within the pancreas, but people with diabetes have little or no natural insulin release.

Regular insulin is a short-acting insulin that takes 30 minutes to 1 hour to start working, peaks in 2 to 5 hours, and lasts for up to 6 hours. It may be used to improve blood sugar control in adults and children with diabetes mellitus and is usually always used in combination with an intermediate or long-acting insulin. Regular insulins are available in the U.S. without a prescription.

Insulin is mostly used to treat type 1 diabetes but can be used in people with type 2 diabetes if insulin levels remain low despite the use of other types of medications. Insulin may also be given to pregnant women who develop a type of diabetes during pregnancy called gestational diabetes.

Warnings

You should not use insulin if you are having an episode of hypoglycemia (low blood sugar).

Hypoglycemia, or low blood sugar, is the most common side effect of insulin. Symptoms include headache, hunger, dizziness, sweating, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose tablets with you in case you have low blood sugar.

Before taking this medicine

You should not use insulin regular if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Regular insulin is not approved for use by anyone younger than 2 years old. This medicine should not be used to treat type 2 diabetes in a child of any age.

Tell your doctor if you have ever had:

• liver or kidney disease; or
• heart failure.

Taking certain oral diabetes medicines while using insulin may increase your risk of serious heart problems. Tell your doctor if you also take medicine that contains pioglitazone or rosiglitazone.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using regular insulin if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use regular insulin?

Use insulin exactly as directed. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Regular insulin is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself. Regular insulin must not be given with a pump. Do not inject this medicine into a vein or a muscle.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use insulin if you don’t understand all instructions for proper use. Ask your doctor or pharmacist if you don’t understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Your care provider will show you where on your body to inject this medicine. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Do not inject this medicine into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

After using regular insulin, you should eat a meal within 30 minutes.

Never share a syringe with another person, even if the needle has been changed. Sharing syringes can allow infections or disease to pass from one person to another.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, medications, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Insulin is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

In case of emergency, wear or carry medical identification to let others know you have diabetes.

Keep this medicine in its original container protected from heat and light. Do not freeze or store near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) pens of vials:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within the number of days shown in your Instructions for Use.

Storing opened (in use) pens or vials:

• Store at room temperature and use within the number of days shown in your Instructions for Use.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using regular insulin?

Do not change the brand of insulin or syringe you are using without first talking to your doctor or pharmacist. Some brands are interchangeable, while others are not. Your doctor and/or pharmacist know which brands can be substituted for one another.

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid medication errors by always checking the medicine label before injecting your dose.

Avoid drinking alcohol. It can interfere with your diabetes treatment.

Regular insulin side effects

Get emergency medical help if you have signs of insulin allergy: redness, swelling, sweating, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common insulin side effects may include:

• low blood sugar;
• swelling in your hands or feet;
• weight gain; or
• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA

What is Lantus?

Lantus is a man-made form of a hormone (insulin) that is produced in the body. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin glargine is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours.

Lantus is used to improve blood sugar control in adults and children with diabetes mellitus.

Lantus is for use in adults with type 1 or type 2 diabetes, and in children at least 6 years old with type 1 diabetes.

For type 1 diabetes, Lantus is used together with a short-acting insulin given before meals.

Some brands of insulin glargine are for use only in adults. Carefully follow all instructions for the brand of insulin glargine you are using.

Warnings

You should not use Lantus if you are having an episode of hypoglycemia (low blood sugar), or if you are in a state of diabetic ketoacidosis (call your doctor for treatment).

Never share a Lantus SoloStar pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Not all insulin glargine brands are equal in dosing. Follow your doctor’s instructions when changing from one brand to another. If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change.

Lantus is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Before taking this medicine

You should not use Lantus if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar) or diabetic ketoacidosis (call your doctor for treatment).

Lantus is not approved for use by anyone younger than 6 years old, and some brands are for use only in adults. Do not use this medicine to treat type 2 diabetes in a child of any age.

To make sure Lantus is safe for you, tell your doctor if you have:

• liver or kidney disease; or
• heart failure or other heart problems.

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

How should I use Lantus?

Use Lantus exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Lantus is injected under the skin, usually once per day at the same time of day.

When treating type 1 diabetes, use your short-acting insulin before meals as directed by your doctor.

Lantus must not be given with an insulin pump, or mixed with other insulins. Do not inject Lantus into a vein or a muscle.

Ask your doctor or pharmacist if you don’t understand how to use an injection.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Your healthcare provider will show you where to inject Lantus. Do not inject into the same place two times in a row.

Avoid injecting into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes.

If you use a Lantus SoloStar injection pen, use only the injection pen that comes with Lantus. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

Never share an injection pen, even if you changed the needle. Sharing these devices can pass infections from person to person.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.

Tell your doctor if you have frequent symptoms of high blood sugar (hyperglycemia) such as increased thirst or urination. Ask your doctor before changing your medication dosage.

Keep this medicine in its original container protected from heat and light. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) Lantus:

• Refrigerate and use until expiration date; or
• Store at room temperature (below 86 degrees Fahrenheit) and use within 28 days.

Storing opened (in use) Lantus:

• Store the vial in a refrigerator or at room temperature and use within 28 days.
• Store the Lantus SoloStar injection pen at room temperature (do not refrigerate) and use within 28 days.

Do not store an injection pen with the needle attached. Do not reuse a needle or syringe. Place them in a puncture-proof “sharps” container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Wear a medical alert tag or carry an ID card to let others know you have diabetes.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose. Do not use more than one dose in a 24-hour period unless your doctor tells you to.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Insulin overdose can cause severe hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using Lantus?

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol or using medicines that contain alcohol. It may interfere with your diabetes treatment.

Lantus side effects

Get emergency medical help if you have any signs of an allergic reaction to Lantus: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• rapid weight gain, swelling in your feet or ankles;
• shortness of breath; or
• low blood potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Lantus side effects may include:

• low blood sugar;
• swelling, weight gain;
• allergic reaction, itching, rash; or
• thickening or hollowing of the skin where you injected the medicine.

What is Levemir?

Levemir is a man-made form of insulin, a hormone that is produced in the body. Insulin works by lowering levels of glucose (sugar) in the blood.

Levemir is a long-acting insulin that starts to work several hours after injection and keeps working evenly for up to 24 hours.

Levemir is used to improve blood sugar control in people with diabetes mellitus. This medicine is for use in adults and children at least 2 years old.

Warnings

You should not use Levemir if you are allergic to insulin detemir, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with a short-acting insulin).

Never share a Levemir injection pen or syringe with another person, even if the needle has been changed.

Many other drugs can potentially interfere with the effects of Levemir. It is extremely important that you tell your doctor about all the prescription and over-the-counter medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. An insulin overdose can cause life-threatening hypoglycemia. Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Be sure your family and close friends know how to help you in an emergency.

Before taking this medicine

You should not use Levemir if you are allergic to iinsulin detemir. Do not use during an episode of hypoglycemia (low blood sugar) or diabetic ketoacidosis (call your doctor for treatment).

To make sure Levemir is safe for you, tell your doctor if you have ever had:

• low levels of potassium in your blood (hypokalemia); or
• liver or kidney disease.

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using Levemir may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using Levemirif you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use Levemir?

Use Levemir exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Levemir is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Your healthcare provider will show you where on your body to inject Levemir. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Do not inject this medicine into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

If you use this medicine once daily, use the injection at your evening meal or at bedtime. If you use the medicine twice daily, use your evening dose at least 12 hours after your morning dose.

Your doctor may want you to also use a short-acting insulin. Always inject your insulins separately. Levemir must not be given with an insulin pump, or mixed with other insulins. Do not inject into a vein or a muscle.

If you use an injection pen, use only the injection pen that comes with Levemir. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

Never share a Levemir injection pen or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Levemir is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Keep this medicine in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) Levemir:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within 42 days.

Storing opened (in use) Levemir:

• Store the vial in a refrigerator or at room temperature and use within 42 days.
• Store the injection pen at room temperature (do not refrigerate) and use within 42 days. Do not store the injection pen with a needle attached.

In case of emergency, wear or carry medical identification to let others know you have diabetes.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose. Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line. Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using Levemir?

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol.

Levemir side effects

Get emergency medical help if you have signs of an allergic reaction to Levemir: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• fluid retention – weight gain, swelling in your hands or feet, feeling short of breath; or
• low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Levemir side effects include:

• low blood sugar;
• weight gain;
• swelling in your hands and feet;
• rash, itching; or
• thickening or hollowing of the skin where you injected the medicine.

What is Novolin N?

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Novolin N is an intermediate-acting insulin that starts to work within 2 to 4 hours after injection, peaks in 4 to 12 hours, and keeps working for 12 to 18 hours.

Novolin N is used to improve blood sugar control in adults and children with diabetes mellitus.

Novolin N may also be used for purposes not listed in this medication guide.

Novolin N side effects

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, chest tightness, feeling like you might pass out, or swelling in your tongue or throat.

Novolin N may cause serious side effects. Call your doctor at once if you have:

• fluid retention–weight gain, swelling in your hands or feet, feeling short of breath; or
• low potassium–leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects of Novolin N may include:

• low blood sugar;
• weight gain, swelling in your hands or feet;
• itching, mild skin rash; or
• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

You should not use Novolin N if you are having an episode of low blood sugar.

Never share an injection pen or syringe with another person, even if the needle has been changed.

Before taking this medicine

You should not use Novolin N if you are allergic to it, or if you are having an episode of hypoglycemia (low blood sugar).

Do not give Novolin N to a child without a doctor’s advice.

Tell your doctor if you have ever had:

• liver or kidney disease; or
• low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using insulin if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use Novolin N?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Novolin N is injected under the skin. A healthcare provider can teach you how to properly use the medication by yourself.

Novolin N must not be given with an insulin pump, or mixed with other insulins. Do not inject into a vein or a muscle.

Do not inject Novolin N into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Novolin N should look cloudy after mixing. Do not use the mixture if it looks clear or has particles in it. Call your pharmacist for new medicine.

Your care provider will show you where on your body to inject Novolin N. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

If you use an injection pen, use only the injection pen that comes with Novolin N. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

Never share an injection pen or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Novolin N is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Keep this medicine in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) Novolin N:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within the number of days specified in the Instructions for Use provided with your medicine.

Storing opened (in use) Novolin N:

• Store in a refrigerator or at room temperature as directed in the Instructions for Use provided with your medicine. Do not refrigerate an in-use injection pen.
• In-use Novolin N is stable for only a certain number of days. Throw away any medicine not used within that time. Follow all storage directions provided with your medicine.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

In case of emergency, wear or carry medical identification to let others know you have diabetes.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using Novolin N?

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how Novolin N will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin. Some brands of insulin isophane and syringes are interchangeable, while others are not. Your doctor and/or pharmacist know which brands can be substituted for one another.

Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.

What other drugs will affect Novolin N?

Novolin N may not work as well when you use other medicines at the same time. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Not all possible interactions are listed here. Tell your doctor about all medicines you start or stop using.

What is NovoLog?

NovoLog is a fast-acting insulin that starts to work about 15 minutes after injection, peaks in about 1 hour, and keeps working for 2 to 4 hours. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood.

NovoLog is used to improve blood sugar control in adults and children with diabetes mellitus.

This medicine is sometimes used together with a long-acting or intermediate-acting insulin.

Novolog is available as:

• NovoLog 10‑mL vial
• NovoLog FlexPen
• NovoPen Echo

NovoLog side effects

Get emergency medical help if you have signs of an allergic reaction to NovoLog: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• heart problems – swelling, rapid weight gain, feeling short of breath; or
• low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common NovoLog side effects may include:

• low blood sugar;
• weight gain;
• low potassium;
• swelling in your hands and feet;
• skin rash, itching, redness, or swelling; or
• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

NovoLog is a fast-acting insulin that begins to work very quickly. After using it, you should eat a meal within 5 to 10 minutes.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

You should not use NovoLog if you are having an episode of hypoglycemia (low blood sugar).

Before taking this medicine

You should not use NovoLog if you are allergic to insulin aspart, or if you are having an episode of hypoglycemia (low blood sugar).

To make sure NovoLog is safe for you, tell your doctor if you have:

• liver or kidney disease; or
• low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using insulin if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use NovoLog?

Use NovoLog exactly as it was prescribed for you. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

NovoLog is injected under the skin, or into a vein through an IV. You will be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Your care provider will show you the best places on your body to inject NovoLog. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Do not inject this medicine into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

After using NovoLog, you should eat a meal within 5 to 10 minutes.

If you use an injection pen, use only the injection pen that comes with NovoLog. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe or infusion pump.

If you use this medicine with an insulin pump, do not mix or dilute NovoLog with any other insulin. Infusion pump tubing, catheters, and the needle location on your skin should be changed every 3 days. Change the medicine in the reservoir every 6 days.

Prepare an injection only when you are ready to give it. This medicine should be clear and colorless. Do not use the medicine if it has changed colors or has particles in it. Call your pharmacist for new medicine.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Use a disposable needle or syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof “sharps” disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Low blood sugar (hypoglycemia) can happen to anyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, medications, or skipping meals. Ask your doctor before changing your insulin dose or medication schedule.

NovoLog is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Wear a diabetes medical alert tag in case of emergency. Any medical care provider who treats you should know that you have diabetes.

What happens if I miss a dose?

Since NovoLog is used before meals, you may not be on a timed dosing schedule. Whenever you use NovoLog, be sure to eat a meal within 5 to 10 minutes. Do not use extra insulin to make up a missed dose.

Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using NovoLog?

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol or using medicines that contain alcohol. Alcohol can cause low blood sugar and may interfere with your diabetes treatment.

What other drugs will affect NovoLog?

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

NovoLog and Medicare

Because of the prescription drug law, known as the Inflation Reduction Act, Medicare is able to negotiate directly with drug companies to improve access to some of the costliest single-source brand-name Medicare Part B and Part D drugs.

NovoLog is one of 10 drugs covered under Medicare Part D that were selected in 2024 for the first cycle of negotiation based on Total Expenditures under Part D and other criteria as required by the law. Negotiations with participating drug companies are ongoing, and any negotiated prices for the first cycle of negotiation is effective from 2026.

Storage

Dispense in the original sealed carton with the enclosed Instructions for Use. Store unused insulin in a refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze insulin and do not use insulin if it has been frozen. Do not expose insulin to excessive heat or light. Do not withdraw insulin into a syringe and store for later use.

Always remove and discard the needle after each injection from the NovoLog FlexPen or NovoLog FlexTouch and store without a needle attached.

The storage conditions are summarized in the following table:

Storage Conditions for vial, PenFill cartridges, NovoLog FlexPen, and NovoLog FlexTouch

*For insulin pump use, the total in-use time is 19 days, including 7 days pump in-use time.

Storage in External Insulin Pump:

Change the Novolog in the pump reservoir at least every 7 days or according to the pump user manual, whichever is shorter, or after exposure to temperatures that exceed 37°C (98.6°F).

Company

Manufactured by: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536

Novolog Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Novolog.Fiasp (insulin aspart) – Novo Nordisk Inc.

What is Lyumjev?

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Lyumjev is a man-made fast-acting insulin that starts to work about 15 minutes after injection, peaks in about 1 hour, and keeps working for 2 to 4 hours.

Lyumjev is used to improve blood sugar control in adults and children with diabetes mellitus.

Warnings

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed.

Before taking this medicine

You should not use Lyumjev if you are allergic to insulin lispro, or if you are having an episode of hypoglycemia (low blood sugar).

To make sure Lyumjev is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;
• heart problems; or
• low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take medicine that contains pioglitazone or rosiglitazone. Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using Lyumjev if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use Lyumjev?

Use Lyumjev exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Read the Instructions for Use leaflet that comes with your prescription.

Lyumjev starts acting fast. Inject Lyumjev at the beginning of a meal or within 20 minutes after you start eating a meal.

Lyumjev is injected under the skin with a syringe and needle or an injection pen (KwikPen, Junior KwikPen or Tempo Pen).

Know the type and strength of insulin you take. Do not change the type or amount of insulin you take unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you take different types of insulin.

Check your insulin label each time you give your injection to make sure you are using the correct insulin.

Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar level.

Lyumjev comes in U-100 (100 units/mL) and U-200 (200 units/mL) insulin strengths. Lyumjev U-200 contains 2 times as much insulin (200 units/mL) in 1 mL as Lyumjev U-100 (100 units/mL).

Lyumjev U-100 and Lyumjev U-200 can be injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs, or upper arms.

Lyumjev U-100 can be given by continuous infusion under the skin (subcutaneously) through an insulin pump into an area of your body recommended in the instructions that come with your insulin pump. Lyumjev U-200 cannot be given through an insulin pump.

Lyumjev U-100 can also be given in your vein (intravenously) by your healthcare provider. Lyumjev U-200 cannot be given in your vein.

The Lyumjev Tempo Pen contains a component that allows for data connectivity when used with a compatible transmitter. A healthcare provider will teach you how to properly use Lyumjev by yourself.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors or has particles in it. Call your pharmacist for new medicine.

Your healthcare provider will show you where on your body to inject Lyumjev. Use a different place each time you give an injection. Do not inject into the same place two times in a row. Do not inject into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

Do not transfer Lyumjev U-200 from the KwikPen to a syringe as overdosage and severe hypoglycemia can result.

Never share a Lyumjev injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Keep Lyumjev in its original container protected from heat and light. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) Lyumjev:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within 28 days.

Storing opened (in use) Lyumjev:

• Store the vial in a refrigerator or at room temperature and use within 28 days.
• Store the cartridge or injection pen (without a needle attached) at room temperature and use within 28 days.

Use a needle and syringe only once and place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

Since Lyumjev is used with meals, you may not be on a timed dosing schedule. Whenever you use Lyumjev, follow the directions for your specific brand about whether to use the medicine before of after you eat. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using Lyumjev?

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how Lyumjev will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol.

Lyumjev side effects

Get emergency medical help if you have signs of an allergy to Lyumjev: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• weight gain, swelling in your hands or feet, feeling short of breath;
• low blood sugar – headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or
• low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Lyumjev side effects may include:

• low blood sugar (hypoglycemia);
• allergic reactions;
• rash.
• weight gain;
• swelling in your hands or feet;
• itching (pruritus); or
• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA

What other drugs will affect Lyumjev?

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Lyumjev Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 3 for Lyumjev.Admelog (insulin lispro) – Sanofi-Aventis U.S. LLC