Cequa is an immunosuppressant. Cequa can increase tear production that has been reduced by inflammation in the eye(s). Cequa is used to treat chronic dry eye that may be caused by inflammation.

Cequa eye drops are packaged in sterile, preservative-free, single-use vials.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Cequa if you are allergic to cyclosporine.

Tell your doctor if you are pregnant or breastfeeding.

Cequa is not approved for use by anyone younger than 16 years old.

How should I use Cequa?

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

Use the medicine about every 12 hours. Remove contact lenses first.

Wash your hands before using eye medication.

To apply the eye drops: Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye and squeeze a drop into this pocket. Close your eyes for 1 or 2 minutes.

Use only the number of drops your doctor has prescribed.

Wait at least 15 minutes before inserting contact lenses or using artificial tears.

Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Cequa eye drops should be clear and colorless.

Each single-use bottle is for one use only (in both eyes). Throw the bottle away after one use, even if there is still medicine left inside.

Store at room temperature. Store Cequa single-use vials in their original foil pouch.

Dosing information

Usual Adult Dose for Keratoconjunctivitis Sicca:

1 drop 2 times a day in each eye approximately 12 hours apart

Comments:
– This drug can be used concomitantly with artificial tears, allowing a 15 minute interval between products.

Use: To increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca

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.

What happens if I overdose?

An overdose of Cequa is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

What should I avoid while using Cequa eye drops?

It may be best not to wear contact lenses if you have dry eyes. Talk with your doctor about your own risk.

Cequa side effects

Get emergency medical help if you have signs of an allergic reaction to Cequa: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Cequa and call your doctor at once if you have:

• severe eye pain, burning, or stinging after putting in the drops;
• swollen eyelids; or
• signs of eye infection – swelling, redness, severe discomfort, crusting or drainage.

Common Cequa side effects may include:

• mild eye pain, redness, or other irritation;
• watery eyes;
• blurred vision; or
• feeling like something is in your eye.

Betaseron is used for relapsing forms of multiple sclerosis (MS), including relapsing-remitting multiple sclerosis (RRMS), isolated syndrome, and active secondary progressive disease in adults. Betaseron (interferon beta-1b) helps to reduce the number of flare-ups and clinical symptoms in relapsing forms of multiple sclerosis, but it will not cure MS. Betaseron injection works as it is similar to a protein in the body called interferon, which is involved in inflammation.

Betaseron is given as an injection under the skin every other day.

Betaseron injection received FDA approval on July 23, 1993, and can now be used to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. This includes people who have had their first symptoms of multiple sclerosis and have an MRI consistent with multiple sclerosis.

Betaseron side effects

Common Betaseron side effects may include:

• low white blood cell counts;
• abnormal liver function tests;
• headache, weakness;
• sleep problems (insomnia);
• stomach pain;
• muscle pain, stiffness, or weakness;
• rash;
• flu symptoms; or
• a skin reaction where the medicine was injected.

Serious Betaseron side effects
Allergic reactions Get emergency medical help if you have signs of an allergic reaction to Betaseron injection: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Liver problems including liver failure Symptoms of liver problems include yellowing of eyes, itchy skin, nausea or vomiting, feeling very tired, flu-like symptoms, and bruising easily or bleeding problems.

Depression Some patients using interferon medicines have become very depressed or had thoughts of suicide. Report any new or worsening symptoms of depression to your doctor, such as mood or behavior changes, anxiety, trouble sleeping, hallucinations, or if you feel impulsive, hostile, aggressive, depressed, or have thoughts about suicide or hurting yourself.

Other serious side effects Stop using Betaseron injection and call your doctor at once if you have:

• fever, chills, sweating, tiredness, body aches;
• a seizure;
• pain, swelling, redness, or skin changes where an injection was given;
• heart problems – chest tightness, swelling, rapid weight gain, trouble lying flat in bed, feeling short of breath;
• liver problems – nausea, vomiting, itching, easy bruising, unusual bleeding, dark urine, jaundice (yellowing of your skin or eyes); or
• new or worsening symptoms of lupus – joint pain and a skin rash on your cheeks or arms that worsens in sunlight.

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

Warnings

Betaseron may be harmful to an unborn baby or may cause a miscarriage. Do not use Betaseron if you are pregnant. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Before using Betaseron, tell your doctor if you are allergic to any drugs, or if you have liver disease, a thyroid disorder, epilepsy or other seizure disorder, a bleeding or blood-clotting disorder, anemia (low red blood cells), or a history of depression or suicidal behavior.

Serious allergic reactions can happen quickly and may happen after your first dose of Betaseron or after you have taken Betaseron many times. Symptoms may include difficulty breathing or swallowing, swelling of the mouth or tongue, rash, itching, or skin bumps.

Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using Betaseron if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself.

Interferon beta-1b can harm your liver. Call your doctor at once if you have nausea, vomiting, itching, bruising or bleeding, or yellowing of your skin or eyes.

To be sure Betaseron is not causing harmful effects, your blood and liver function will need to be tested on a regular basis. Your thyroid function may also need to be tested. Do not miss any scheduled appointments.

Before taking this medicine

You should not use Betaseron if you are allergic to interferon beta, albumin, or mannitol.

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

• liver disease;
• heart problems;
• a seizure;
• depression, anxiety, or sleep problems;
• a bleeding or blood-clotting disorder;
• low white blood cell (WBC) counts;
• anemia (lack of red blood cells); or
• an allergy to latex.

Tell your doctor if you are pregnant or breastfeeding.

How should I use Betaseron?

Use Betaseron exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Betaseron is injected under the skin, usually every other day. 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 Betaseron. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

You will need frequent medical tests.

Store unmixed Betaseron and the diluent at cool room temperature away from moisture and heat.

After mixing, store the medicine in the refrigerator and use within 3 hours. Do not freeze.

Each single-use vial (bottle) or prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside. Throw away any Betaseron that is not used within 3 months.

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.

Betaseron Dosing information

Usual Betaseron Adult Dose for Multiple Sclerosis:

Initial dose: 0.0625 mg subcutaneously every other day, and increased (in 25% increments) every 2 weeks, over a 6 week period, to maintenance dose
Maintenance dose: 0.25 mg subcutaneously every other day

Schedule for dose titration:
Weeks 1 and 2: 0.0625 mg subcutaneously every other day (25% of recommended dose)
Weeks 3 and 4: 0.125 mg subcutaneously every other day (50% of recommended dose)
Weeks 5 and 6: 0.1875 mg subcutaneously every other day (75% of recommended dose)
Week 7 and beyond: 0.25 mg subcutaneously every other day (100% of recommended dose)

Betaseron Use: For the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Then wait at least 48 hours (2 days) before using another injection, and restart your dosing schedule at that time. Do not use more than one injection every 48 hours.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Betaseron?

Avoid injecting this medicine into skin that is sore, red, or infected.

Avoid drinking alcohol. It may increase your risk of liver problems.

What other drugs will affect Betaseron?

Other drugs may interact with interferon beta-1b, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Ingredients

Active ingredient: interferon beta-1b

Inactive ingredients: albumin (human), mannitol Diluent contains sodium chloride solution.

Company

Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981

Betaseron 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 Betaseron.Betaseron (interferon beta-1b) – Bayer HealthCare Pharmaceuticals Inc.

Bactroban is an antibiotic that prevents bacteria from growing on your skin.

Bactroban topical (for use on the skin) is used to treat skin infections such as impetigo or a “Staph” infection of the skin.

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

Warnings

Use Bactroban cream or ointment for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed. Avoid your eyes, nose, mouth, and lips when applying Bactroban. If medication gets in any of these areas, wash with water.

Watch for signs of improvement in 3 to 5 days. If your condition gets worse or does not improve, see your doctor.

A separate formulation, Bactroban nasal ointment, is available for nasal use.

Before taking this medicine

You should not use Bactroban cream or ointment if you are allergic to mupirocin.

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

• kidney disease.

Do not use Bactroban on a child without medical advice. The cream should not be used on a child younger than 3 months old. The ointment may be used on a child as young as 2 months old.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether mupirocin topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. If you apply this medicine to your breast or nipple, wash the areas thoroughly before nursing your baby.

How should I use Bactroban?

Use Bactroban cream or ointment exactly as directed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Bactroban is for use only on the skin. If this medicine gets in your eyes, nose, or mouth, rinse with water.

Wash your hands before and after applying Bactroban.

Clean and dry the affected skin area. Use a cotton swab or gauze pad to apply a small amount of Bactroban cream or ointment as directed.

Do not spread Bactroban over large areas of skin.

Bactroban is usually applied 3 times per day for 10 days. Use only a small amount of the cream or ointment.

Use only a sterile gauze pad to cover the treated skin. Do not cover treated areas with a bandage, plastic wrap, or other covering that does not allow air to circulate.

Call your doctor if your symptoms do not improve within 3 to 5 days, or if your skin condition gets worse.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

Store at room temperature away from moisture and heat. Do not freeze. Keep the medicine tube tightly closed when not in use.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

An overdose of Bactroban cream or ointment is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line if anyone has accidentally swallowed the medication.

What should I avoid while using Bactroban?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid getting this medicine in your eyes, mouth, or nose. A separate product called Bactroban nasal is made for use in the nose. Bactroban topical is for use only on the skin.

Avoid using other medications on the areas you treat with Bactroban unless your doctor tells you to.

Bactroban side effects

Get emergency medical help if you have signs of an allergic reaction to Bactroban: hives; dizziness, fast or pounding heartbeats; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;
• severe itching, rash, or other irritation of treated skin;
• unusual skin blistering or peeling; or
• any signs of a new skin infection.

Common Bactroban side effects may include:

• burning, stinging;
• itching; or
• pain.

What is Azulfidine?

Azulfidine is used to treat ulcerative colitis (UC), and to decrease the frequency of UC attacks. This medicine will not cure ulcerative colitis, but it can reduce the number of attacks you have.

Azulfidine is also used to treat rheumatoid arthritis in children and adults who have used other arthritis medicines that did not work or have stopped working.

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

Azulfidine side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, sore throat;
• mouth sores, red or swollen gums;
• pale skin, easy bruising, unusual bleeding; or
• chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Also call your doctor at once if you have:

• fever with headache, rash, and vomiting;
• a skin rash, no matter how mild;
• severe nausea or vomiting when you first start taking Azulfidine;
• little or no urination, urine that looks foamy;
• puffy eyes, swelling in your ankles or feet, weight gain; or
• liver problems–loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of Azulfidine may include:

• nausea, vomiting, upset stomach, loss of appetite;
• headache;
• rash; or
• low sperm count in men.

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 Azulfidine if you have porphyria, a blockage in your bladder or intestines, or if you are allergic to sulfa drugs, aspirin, or similar medicines called salicylates.

Before taking this medicine

You should not use Azulfidine if you are allergic to it, or if you have:

• a blockage in your bladder or intestines;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• an allergy to sulfa drugs; or
• an allergy to aspirin or other salicylates (such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others).

Tell your doctor if you have ever had:

• frequent infections;
• asthma;
• low blood cell counts; or
• liver or kidney disease.

Tell your doctor if you are pregnant. Taking Azulfidine can make it harder for your body to absorb folic acid, and folic acid helps prevent major birth defects of the baby’s brain or spine. You may need to take folic acid supplements if you take this medicine during pregnancy. Follow your doctor’s instructions.

Sulfasalazine can pass into breast milk and may cause diarrhea or bloody stools in a nursing baby. Tell your doctor if you are breast-feeding.

Azulfidine is not approved for use by anyone younger than 2 years old.

How should I take Azulfidine?

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

Take Azulfidine after a meal.

Swallow the tablet whole and do not crush, chew, or break it.

You will need frequent medical tests.

Drink plenty of liquids to keep your kidneys working properly while you are taking Azulfidine.

Azulfidine can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Azulfidine may cause your skin or urine to appear orange-yellow in color. Call your doctor if you also have yellowing of your eyes, brown urine, or stomach pain. These may be signs of liver problems.

If you are treating arthritis, do not stop using any of your other arthritis medicines until your doctor tells you to. Azulfidine may not improve your symptoms right away, and you may still need your other medicines for awhile.

Azulfidine is only part of a complete treatment for rheumatoid arthritis that may also include rest and physical therapy. Follow your doctor’s instructions very closely.

What is azathioprine?

Azathioprine weakens your body’s immune system, to help keep it from “rejecting” a transplanted organ such as a kidney. Organ rejection happens when the immune system treats the new organ as an invader and attacks it.

Azathioprine is used to prevent your body from rejecting a transplanted kidney. Azathioprine is also used to treat symptoms of rheumatoid arthritis.

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

Azathioprine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Azathioprine may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Stop using azathioprine and call your doctor right away if you have any of these symptoms of lymphoma:

• fever, swollen glands, body aches, night sweats, not feeling well;
• pale skin, rash, easy bruising or bleeding;
• cold hands and feet, feeling light-headed or short of breath;
• pain in your upper stomach that may spread to your shoulder; or
• feeling full after eating only a small amount, weight loss.

Also call your doctor at once if you have:

• signs of infection (fever, chills, weakness, flu symptoms, sore throat, cough, pain or burning when you urinate);
• severe nausea, vomiting, or diarrhea;
• easy bruising, unusual bleeding;
• rapid heartbeats, shortness of breath;
• pale skin, cold hands and feet; or
• dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of azathioprine may include:

• nausea, diarrhea, stomach pain;
• hair loss; or
• skin rash.

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

Warnings

Azathioprine may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn’s disease or ulcerative colitis.

Before taking this medicine

You should not take azathioprine if you are allergic to azathioprine.

You should not use azathioprine to treat rheumatoid arthritis if you are pregnant. This medicine can harm an unborn baby. Use effective birth control to prevent pregnancy while using this medicine.

Azathioprine may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn’s disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

While taking azathioprine, you may have a higher risk of developing skin cancer. Ask your doctor about skin symptoms to watch for.

Tell your doctor if you have ever had:

• kidney disease, or a kidney transplant (if you are using azathioprine for rheumatoid arthritis);
• any type of viral, bacterial, or fungal infection;
• liver disease; or
• chemotherapy with medications like cyclophosphamide, chlorambucil, melphalan, busulfan, and others.

You should not breast-feed while you are using azathioprine.

How should I take azathioprine?

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using azathioprine.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

When given for kidney transplant, azathioprine is usually given right before or on the day of transplant. For rheumatoid arthritis, azathioprine is taken on a daily basis.

It may take up to 8 weeks before your symptoms improve. Keep using azathioprine as directed and tell your doctor if your symptoms have not improved after 12 weeks of use.

Take with food if azathioprine upsets your stomach.

You may not be able to continue taking other arthritis medications together with azathioprine. Do not change your dose or dosing schedule without your doctor’s advice.

Azathioprine affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking azathioprine?

Avoid sunlight or tanning beds. Azathioprine can increase your risk of developing skin cancer. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

What is Aubagio?

Aubagio is used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease). Aubagio may help reduce the relapse rate, slow disability progression, and also slow lesion size growth, compared to placebo treatment. Aubagio tablets are taken once daily with or without food.

Aubagio affects the immune system and reduces swelling and inflammation in the nervous system. Aubagio works by lowering the number of lymphocytes that cause inflammation and damage to the nerves. This helps to slow the progression of RRMS and reduce the relapse rate.

In RRMS, a type of white blood cell called lymphocytes mistakenly attacks the protective coating (myelin) that surrounds your neurons, which causes inflammation of the neurons and loss of myelin. The neurons are unable to work properly, causing the symptoms of RRMS.

Aubagio is not a cure for MS; it helps slow disease progression and reduces relapse rate.

Aubagio received FDA approval on September 12, 2012. The generic for Aubagio is called teriflunomide and is also now available.

Aubagio side effects

Common Aubagio side effects may include:

• headache;
• nausea, diarrhea;
• thinning hair; or
• abnormal liver function tests.

Serious Abagio side effects

Get emergency medical help if you have signs of an allergic reaction to Aubagio (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using this medicine and call your doctor at once if you have:

• numbness or tingling in your hands or feet that feels different from your MS symptoms;
• trouble breathing, new or worsening cough with or without fever;
• signs of infection – fever, chills, body aches, nausea, vomiting, feeling tired, or
• liver problems – upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).

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

Warnings

Do not use Aubagio if you are pregnant or may become pregnant. You will need to have a negative pregnancy test before starting this treatment. Tell your doctor right away if you become pregnant during treatment or within 2 years after your treatment ends.

Teriflunomide can cause severe liver problems. You should not use this medicine if you have severe liver disease or if you are also taking leflunomide (Arava). Tell your doctor if you have a history of liver disease.

Call your doctor at once if you have signs of liver problems: upper stomach pain, loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

Your doctor may need to test your liver function up to 6 months before you start taking Aubagio and then every month when you first start taking this medicine.

Teriflunomide can lower blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. While using Aubagio, you may need blood tests every 6 months. Your blood pressure will also need to be checked often.

After you stop taking Aubagio, the drug could stay in your body for up to 2 years. You may need to be treated with other medications to help your body eliminate teriflunomide quickly. Follow your doctor’s instructions.

Before taking this medicine

You should not use Aubagio if you are allergic to teriflunomide or leflunomide, or if:

• you have severe liver disease or
• you are also taking leflunomide (Arava).

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

• liver or kidney disease;
• high blood sugar;
• high blood pressure;
• skin problems when taking medicines;
• a fever, or uncontrolled infections;
• breathing problems;
• tuberculosis; or
• nerve problems, such as neuropathy.

Pregnancy

Do not use Aubagio if you are pregnant or may become pregnant You will need to have a negative pregnancy test before starting this treatment. Use birth control to prevent pregnancy while you are taking this medicine. After you stop taking Aubagio, continue using birth control until you have received blood tests to make sure the drug has been eliminated from your body.

Avoid getting pregnant until after you stop taking this medicine and undergo a “drug elimination” procedure to help rid your body of this medicine. Stop taking Aubagio and call your doctor right away if you miss a period or think you might be pregnant. If you inadvertently become pregnant while receiving Aubagio or within 2 years of stopping it, there is a pregnancy surveillance program for Aubagio. You or your healthcare provider can report the pregnancy by calling 1-800-745- 4447. This is to track the outcome of the pregnancy and to evaluate any effects of teriflunomide on the baby.

If you are a man, use effective birth control to prevent pregnancy if your sex partner is able to get pregnant. After your treatment ends, keep using birth control until you have received the medications to help your body eliminate teriflunomide.

Breastfeeding

You should not breastfeed while using this medicine.

How should I take Aubagio?

Before you start treatment with Aubagio, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take Aubagio with or without food.

Your blood pressure will need to be checked often.

Teriflunomide can lower your blood cell counts. Your blood will need to be tested often. Your treatment may be delayed based on the results.

After you stop taking Aubagio, you may need to be treated with other medicines to help your body eliminate teriflunomide quickly. If you do not undergo this drug elimination procedure, teriflunomide could stay in your body for up to 2 years. Follow your doctor’s instructions.

You will also need to go through this drug elimination procedure if you plan to become pregnant after you stop taking this medicine.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Multiple Sclerosis:

7 mg or 14 mg orally once a day

Use: Treatment of patients with relapsing forms of multiple sclerosis.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a “live” vaccine while using Aubagio, and for at least 6 months after you stop taking it. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What other drugs will affect Aubagio?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Many drugs can interact with teriflunomide. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.