What is Genotropin?

Genotropin (somatropin) is a human growth hormone (HGH, hGH) important for the growth of bones and muscles.

Genotropin is used to treat growth failure in children and adults who lack natural growth hormone. This includes people with short stature due to Turner syndrome, Prader-Willi syndrome, short stature at birth with no catch-up growth, and other causes. 

Genotropin mechanism of action (MOA) is it behaves like a natural human growth hormone by binding to the GH receptor on target cells which signals skeletal growth, muscle growth, and protein synthesis.  Genotropin is a hormone produced in the pituitary gland at the base of the brain. If the pituitary gland doesn’t make enough, or any, human growth hormone it causes a condition called growth-related disorder. 

Genotropin is given as a subcutaneous injection using the Genotropin pen device or the Genotropin Miniquick.

Genotropin Pfizer Inc, a Division – Pharmacia & Upjohn Co.

Who can use Genotropin?

Genotropin injection is FDA-approved to be used for growth failure in:

Pediatric patients who have:

• growth failure due to an inadequate secretion of endogenous growth hormone
• Prader-Willi syndrome (PWS) which has been confirmed by appropriate genetic testing
• Turner syndrome
• idiopathic short stature (ISS), also called non-growth hormone-deficient short stature in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means. 

Adult patients as replacement of endogenous growth hormone in adults with growth hormone deficiency who have:

• Adult Onset (AO) Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
• Childhood Onset (CO): Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes. 

Genotropin side effects

Common side effects of Genotropin may include:

• pain, itching, or skin changes where the medicine was injected;
• swelling, rapid weight gain;
• muscle or joint pain;
• numbness or tingling;
• stomach pain, gas;
• headache, back pain; or
• cold or flu symptoms, stuffy nose, sneezing, sore throat, ear pain.

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

Serious Genotropin side effects

Serious breathing problems may occur in patients with Prader-Willi syndrome who use Genotropin injection. If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring.

Also, call your doctor at once if you have:

• pain in your knees or hips, walking with a limp;
• ear pain, swelling, warmth, or drainage;
• numbness or tingling in your wrist, hand, or fingers;
• severe swelling or puffiness in your hands and feet;
• changes in behavior;
• vision problems, unusual headaches;
• changes in the shape or size of a mole;
• pain or swelling in your joints;
• pancreatitis – severe pain in your upper stomach spreading to your back, nausea and vomiting;
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor;
• increased pressure inside the skull – severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
• signs of an adrenal gland problem – extreme weakness, severe dizziness, weight loss, changes in skin color, feeling very weak or tired.

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

You should not use Genotropin injection if you have cancer, diabetic retinopathy, or if you are being treated for Prader-Willi syndrome and you are overweight or have severe breathing problems. You should not use this medicine if you have a serious illness due to lung failure or complications from recent surgery, injury, or medical trauma.

Before taking this medicine

You should not use Genotropin injection if you are allergic to the active ingredient somatropin,  benzyl alcohol, or if you have:

• a serious illness due to lung failure, or complications from recent surgery, injury, or medical trauma;
• closed epiphyses;
• active cancer;
• eye problems caused by diabetes (diabetic retinopathy); or
• you are being treated for Prader-Willi syndrome and you are overweight or have severe breathing problems (including sleep apnea).

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

• cancer (especially during childhood);
• diabetes;
• breathing problems, sleep apnea (breathing stops during sleep);
• a pituitary gland disorder;
• abnormal curvature of the spine (scoliosis);
• underactive thyroid;
• a head injury or brain tumor; or
• childhood brain cancer and radiation treatment.

In some cases, Genotropin should not be used in a child. Certain brands of somatropin contain an ingredient that can cause serious side effects or death in very young infants or premature babies. Do not give this medicine to a child without medical advice.

Tell your doctor if you are pregnant or breastfeeding.

How should I use Genotropin?

The weekly dose should be divided into 6 or 7 subcutaneous (under the skin) injections. Genotropin must not be injected intravenously.

A healthcare provider will teach you how to properly use the medication by yourself.

Do not inject the subcutaneous injection (under the skin) into the same place two times in a row.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Do not use Genotropin if you don’t understand all the instructions for proper use. Ask your doctor or pharmacist if you have questions.

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

Genotropin is available as Genotropin Pen Device and Genotropin Miniquick. Read the full directions for your device or read the full Instructions for Use.

Choose an injection site (thigh, buttocks, or abdomen) as recommended by your healthcare provider. Choose a different site each time you give yourself an injection. Each new injection should be given at least 1 inch from the site you used before.

Avoid areas that are bony, bruised, red, sore, or hard. You should also avoid areas of the skin that have scars or skin problems.

Clean the injection site with the alcohol swab.

Genotropin Pen device instructions

• Firmly pinch a fold of skin at the injection area. Use the Genotropin Pen device to push the needle fully into the skin fold at a 90° angle.
• Push the pen device injection button until it clicks. Wait while counting slowly for 5 seconds, and then remove the needle from the skin. This is to make sure that the entire dose has been injected.

Genotropin Miniquick instructions

• Remove the outer needle cover and the inner needle cover from the needle of the Genotrophin Miniquick. Save the outer needle cover.
• Pinch a fold of skin at the injection site firmly, and push the needle straight into the skin at a 90°angle. 
• Push the plunger rod in as far as it will go, to inject all of the medicine in the Genotropin Miniquick into the fold of skin. 
• Wait a few seconds to be sure that all of the growth hormone solution has been injected. Pull out the needle.
• Replace the outer needle cover on the needle.

Genotropin Pen Device and Genotropin Miniquick Strengths

Genotropin Miniquick: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg in a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge (without preservative)

Genotropin 12 mg Pen, Genotropin Pen Device 5mg in a single-patient-use two-chamber cartridge (with preservative).

Genotropin pen replacement​. The pen has a use period of 2 years starting from the first use by the patient.

Genotropin Dosing Information

Genotropin is given as a subcutaneous injection

• Pediatric GHD: 0.16 to 0.24 mg/kg/week
• Prader-Willi Syndrome: 0.24 mg/kg/week
• Small for Gestational Age: Up to 0.48 mg/kg/week
• Turner Syndrome: 0.33 mg/kg/week
• Idiopathic Short Stature: up to 0.47 mg/kg/week.

Adult GHD: Either a non-weight-based or a weight-based dosing regimen may be followed, with doses adjusted based on treatment response and IGF-I concentrations 

• Non-weight-based dosing: A starting dose of approximately 0.2 mg/day (range, 0.15–0.30 mg/day) may be used without consideration of body weight, and increased gradually every 1–2 months by increments of approximately 0.1–0.2 mg/day. 
• Weight-based dosing: The recommended initial dose is not more than 0.04 mg/kg/week; the dose may be increased as tolerated to not more than 0.08 mg/kg/week at 4–8 week intervals. 

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.

Call your doctor if you miss more than 3 doses in a row.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.

Who should not use Genotropin?

Genotropin injection should not be used in

• Acute Critical Illness due to complications following open heart surgery, abdominal surgery, or multiple accidental trauma, or those with acute respiratory failure 
• Prader-Willi Syndrome in Children who are severely obese, have a history of upper airway obstruction or sleep apnea, or have a severe respiratory impairment. There have been reports of sudden death when somatropin was used in such patients.
• Active Malignancy. Any preexisting malignancy should be inactive and its treatment complete before starting therapy with somatropin. Since growth hormone deficiency may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors should be ruled out prior to initiation of treatment. Somatropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor.
• Hypersensitivity to somatropin or any of its excipients. The 5 mg and 12 mg presentations of lyophilized powder contain m-cresol as a preservative. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropins.
• Diabetic Retinopathy in patients with active proliferative or severe non-proliferative diabetic retinopathy.
• Closed Epiphyses this medicine should not be used for growth promotion in pediatric patients with closed epiphyses.

What other drugs will affect Genotropin?

Tell your doctor about all your other medicines, especially:

• birth control pills or hormone replacement therapy;
• insulin or oral diabetes medicine; or
• a steroid (prednisone, dexamethasone, methylprednisolone, and others).

What is Ngenla?

Ngenla is a long-acting human growth hormone used to treat children aged 3 and older who are not growing because of growth hormone deficiency (GHD). It is given by injection under the skin (subcutaneously) once a week, and older children and caregivers can be taught how to administer it.

Ngenla (somatrogon) gained FDA approval on June 28, 2023 and is manufactured by Pfizer Ireland Pharmaceuticals. There is no generic or biosimilar.

How does Ngenla work?

Ngenla works by binding to growth hormone receptors throughout the body, particularly in the liver, muscles, bones and other tissues. This stimulates the production of a substance called Insulin-Like Growth Factor (IGF-1) that mediates metabolic and other changes to regulate metabolism, stimulate the growth plates in long bones, and enhance growth.

Ngenla has a modified structure that allows one-weekly administration compared with other growth hormone treatments that are given daily. It contains human growth hormone fused with a portion of human chorionic gonadotropin (hCG) to make a larger protein (somatrogon) that stays in the blood stream longer. Somatrogon has a half-life of about 70-80 hours compared to the 3.8-hour half-life of natural growth hormone.

Side effects

The most common side effects of Ngenla are:

• injection site reactions (such as pain, swelling, rash, itching, bleeding)
• common cold
• headache
• fever
• low red blood cells (anemia)
• cough
• vomiting
• decrease in thyroid hormone levels
• stomach (abdominal) pain
• rash
• throat pain.

Serious side effects and warnings

Ngenla may cause the following serious side effects:

• high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems
• serious allergic reactions. Get medical help right away if your child has the following symptoms:
  • swelling of the face, lips, mouth, or tongue
  • trouble breathing
  • wheezing
  • severe itching
  • skin rashes, redness, or swelling
  • dizziness or fainting
  • fast heartbeat or pounding in the chest
  • sweating.
• increased risk of growth of cancer or a tumor that is already present, and increased risk of the return of cancer or a tumor in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. Your child’s healthcare provider will need to monitor your child for a return of cancer or a tumor. Contact your child’s healthcare provider if your child starts to have headaches, or has changes in behavior, changes in vision, or changes in moles, birthmarks, or the color of the skin
• new or worsening high blood sugar (hyperglycemia) or diabetes. Your child’s blood sugar may need to be monitored during treatment with Ngenla
• increase in pressure inside the skull (intracranial hypertension). If your child has headaches, eye problems, nausea or vomiting, contact your child’s healthcare provider
• your child’s body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in the joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet. Fluid retention can happen in children during treatment with NGENLA. Tell your child’s healthcare provider if your child has any of these signs or symptoms of fluid retention
• decrease in a hormone called cortisol. Your child’s healthcare provider will do blood tests to check your child’s cortisol levels. Tell your child’s healthcare provider if your child has severe fatigue, dizziness, weakness, vomiting, dehydration, or weight loss
• decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well NGENLA works. Your child’s healthcare provider will do blood tests to check your child’s hormone levels
• hip and knee pain or limp (slipped capital femoral epiphysis). Tell your child’s healthcare provider if your child has any of these signs or symptoms
• worsening of curvature of the spine (scoliosis). If your child has scoliosis, your child will need to be checked often for an increase in the curve of the spine
• severe and constant stomach (abdominal) pain. This could be a sign of pancreatitis. Tell your child’s healthcare provider if your child has any new abdominal pain
• loss of fat and tissue weakness in the area of skin you inject. Talk to your child’s healthcare provider about rotating the areas where you inject Ngenla
• high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea
• increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in the blood.

Before receiving

Your child should not receive Ngenla if they:

• have a critical illness caused by certain types of heart or stomach surgery, trauma, or breathing (respiratory) problems
• are allergic to somatrogon-ghla or any of the ingredients in Ngenla
• have closed bone growth plates (epiphyses)
• have cancer or other tumors
• have certain eye problems caused by diabetes (such as diabetic retinopathy)
• have Prader-Willi syndrome, are severely obese, or have breathing problems including sleep apnea.

Tell your healthcare provider about all the medical conditions your child has, including if your child:

• has had heart or stomach surgery, trauma or serious breathing (respiratory) problems
• has had a history of problems breathing while they slept (sleep apnea)
• has or has had cancer or any tumor
• has diabetes
• is pregnant or plans to become pregnant
• is breastfeeding or plans to breastfeed.

Pregnancy

It is not known if Ngenla will harm your child’s unborn baby. Talk to your child’s healthcare provider if your child is pregnant or plans to become pregnant.

Breastfeeding

It is not known if Ngenla passes into breast milk. You and your child’s healthcare provider should decide if they will receive it while breastfeeding.

How is Ngenla administered?

Read the detailed Instructions for Use that come with Ngenla.

• Ngenla comes in 2 different dosage strengths. Your child’s healthcare provider will prescribe the dose of medicine and the dosage strength that is right for your child.
• Your child’s healthcare provider will show you how to inject Ngenla before it is used for the first time. Do not try to inject Ngenla until you have been shown the right way by your child’s healthcare provider.
• Inject Ngenla exactly as your child’s healthcare provider tells you to.

Ngenla is injected under the skin (subcutaneously) and can be given in the stomach (abdomen), thighs, buttocks, or upper arms. Rotate the site of injection weekly.

• Inject Ngenla 1 time each week, on the same day each week, at any time of the day.
• You may change the day of the week Ngenla is used as long as the last dose was injected 3 or more days before. After the new day of the week has been chosen, continue with the 1 time a week schedule.

Ngenla prefilled pens are for use by 1 person only.

• Do not share your child’s Ngenla prefilled pens and needles with another person, even if the needle has been changed. Your child may give another person an infection or get an infection from them.

Dosing information

The recommended dosage is 0.66 mg/kg based on actual body weight administered once weekly.

• Individualize dosage for each patient based on the growth response.
• If you are switching from daily growth hormone injections, you may start treatment with once-weekly Ngenla on the day following your last daily injection.
• If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site.

Ngenla pen directions

The Ngenla pen is available in 2 strengths:

• 24 mg/1.2 mL (20 mg/mL) that delivers a dose in 0.2 mg increments
• 60 mg/1.2 mL (50 mg/mL) that delivers a dose in 0.5 mg increments.

Each turn (click) of the dose knob dials 0.2mg or 0.5 mg of medicine, depending on the pen’s strength.

Always use a new sterile needle for each injection. This will decrease the risk of contamination, infection, leakage of medicine, and blocked needles leading to the wrong dose.

Do not shake your pen. Shaking can damage the medicine.

24 mg/1.2 mL Pen

• You can give from 0.2 mg to 12 mg in a single injection with the 24 mg/1.2mL pen.
• If your dose is more than 12 mg, you will need to give more than 1 injection or ask for the higher strength pen.

60 mg/1.2 mL pen

• You can give from 0.5 mg to 30 mg in a single injection with the 60 mg/1.2mL pen.
• If your dose is more than 30 mg, you will need to give more than 1 injection.
• A new pen may contain slightly more than 60 mg of medicine, this is normal.

What happens if I miss a dose?

If your child misses a dose of Ngenla the missed dose should be injected as soon as possible within 3 days after the missed dose. If more than 3 days have passed, skip your child’s missed dose. Inject the next dose on the regularly scheduled day.

What happens if I overdose?

An acute overdosage may lead initially to low blood glucose levels and subsequently to high blood glucose levels. Overdose with growth hormone may cause fluid retention. Long-term overdosage could result in signs and symptoms of gigantism consistent with the effects of excess growth hormone.

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Ngenla?

Do not share your pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

The pen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product.

What other drugs will affect Ngenla?

Tell your child’s healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Medications that may interact with Ngenla include:

• Glucocorticoid treatment
• Cytochrome P450-metabolized drugs (Ngenla may alter their clearance)
• Oral estrogen (larger doses of Ngenla may be required)
• Insulin and/or other antihyperglycemics (a dosage adjustment of these may be required).

This list is not complete. Other drugs may affect Ngenla, including prescription and over-the-counter medicines, vitamins, and herbal products.

How should I store Ngenla?

• Do not freeze your pen or expose it to heat.
• Do not use your pen if it has been frozen or stored in direct sunlight.
• Do not use after the expiration date printed on the label has passed or if it has been more than 28 days after first use.

Before you use Ngenla pens for the first time (unused pens):

• Store in the original carton.
• Store the new, unused Ngenla pen in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Unused prefilled pens may be used until the expiration date printed on the pen label, if kept in the refrigerator.

After you use Ngenla pens and there is still medicine left (up to 28 days of use):

• To help you remember when to dispose of (throw away) the pen, write the date of first use on the pen label.
• Store remaining Ngenla in the refrigerator between 36°F to 46°F (2°C to 8°C) and use within 28 days.
• Keep the pen cap on the Ngenla pen when it is not in use.
• Do not store the remaining Ngenla pen with a needle attached.
• Do not use the Ngenla pen if it has been more than 28 days after first use, even if it contains unused medicine.

Keep Ngenla and all medicines out of the reach of children.

Ingredients

Active ingredient: somatrogon-ghla

Inactive ingredients: citric acid monohydrate, histidine, metacresol (as a preservative), poloxamer 188, sodium chloride, sodium citrate, and water for injection.

Available in two different strengths:

• 24 mg/1.2 mL (20 mg/mL) single-patient-use prefilled pen that delivers the dose in 0.2 mg increments
• 60 mg/1.2 mL (50 mg/mL) single-patient-use prefilled pen that delivers the dose in 0.5 mg increments.

The pens are disposable and should be thrown away in a sharps bin once empty. You can give more than 1 dose from the pen.

Manufacturer

Ngenla (somatrogon) is manufactured by Pfizer Ireland Pharmaceuticals, and distributed by Pfizer Labs, a division of Pfizer Inc., one of the world’s largest pharmaceutical companies.

Ngenla 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 Ngenla.Ngenla (somatrogon-ghla) – Pfizer Ireland Pharmaceuticals

What is Omnitrope?

Omnitrope is a form of human growth hormone important for the growth of bones and muscles.

Omnitrope is used to treat growth failure in children and adults who lack natural growth hormone. This includes people with with Turner syndrome, Prader-Willi syndrome, short stature at birth with no catch-up growth, and other causes.

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

Warnings

You should not use Omnitrope if you have cancer, eye problems caused by diabetes, or if you are being treated for Prader-Willi syndrome and you are overweight or have severe breathing problems. You should not use Omnitrope if you have a serious illness due to lung failure or complications from recent surgery, injury, or medical trauma.

Before you receive Omnitrope, tell your doctor about all your past and present medical conditions, especially allergies, trauma, surgery, diabetes, cancer, breathing problems, liver or kidney disease, scoliosis, high blood pressure, pancreas disorder, underactive thyroid, or a brain tumor.

Also tell your doctor about all other medications you use, especially steroids or diabetes medications. Your dosages of these medicines may need to be changed when you start using Omnitrope. Do not stop using a steroid suddenly or change any of your medication doses without your doctor’s advice.

Call your doctor at once if you have sudden and severe pain in your upper stomach with nausea and vomiting, fast heartbeat, increased thirst or urination, weight loss, or vision changes and sudden, severe pain behind your eyes.

Before taking this medicine

You should not use Omnitrope if you are allergic to somatropin or benzyl alcohol, or if you have:

• a serious illness due to lung failure or complications from recent surgery, injury, or medical trauma;
• closed epiphyses;
• active cancer;
• eye problems caused by diabetes (diabetic retinopathy); or
• if you are being treated for Prader-Willi syndrome and you are overweight or have severe breathing problems (including sleep apnea).

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

• cancer (especially during childhood);
• diabetes;
• breathing problems, sleep apnea (breathing stops during sleep);
• a pituitary gland disorder;
• abnormal curvature of the spine (scoliosis);
• underactive thyroid;
• a head injury or brain tumor; or
• childhood brain cancer and radiation treatment.

It is not known whether Omnitrope will cause harm to an unborn baby when used by a pregnant woman.

Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Omnitrope contains benzyl alcohol, an ingredient that can cause serious side effects or death in very young or premature babies. Do not give this medicine to a child without medical advice.

How should I use Omnitrope?

Use Omnitrope exactly as prescribed by your doctor. Your dose will depend on what you are being treated for. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Omnitrope is injected into a muscle or under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

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

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

Use a disposable needle and 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.

While using Omnitrope, you may need frequent blood tests. Your growth progress will need to be tested often. Your eyes may also need to be checked.

If you have Prader-Willi syndrome, your treatment program may also include weight control. Follow your doctor’s instructions very closely.

Throw away any Omnitrope left over after the expiration date on the label has passed.

What happens if I miss a dose?

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

Call your doctor if you miss more than 3 doses in a row.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.

What should I avoid while using Omnitrope?

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

Serious breathing problems may occur in patients with Prader-Willi syndrome who use Omnitrope. If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring.

Also call your doctor at once if you have:

• pain in your knees or hips, walking with a limp;
• ear pain, swelling, warmth, or drainage;
• numbness or tingling in your wrist, hand, or fingers;
• severe swelling or puffiness in your hands and feet;
• changes in behavior;
• vision problems, unusual headaches;
• changes in the shape or size of a mole;
• pain or swelling in your joints;
• pancreatitis – severe pain in your upper stomach spreading to your back, nausea and vomiting;
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor;
• increased pressure inside the skull – severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
• signs of an adrenal gland problem – extreme weakness, severe dizziness, weight loss, changes in skin color, feeling very weak or tired.

Common Omnitrope side effects may include:

• swelling, rapid weight gain;
• muscle or joint pain;
• headache; or
• pain, itching, or skin changes where the medicine was injected.

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 at 1-800-FDA-1088.

What other drugs will affect Omnitrope?

Tell your doctor about all your current medicines, and those you start or stop using during your treatment with Omnitrope, especially:

• birth control pills or hormone replacement therapy
• insulin or oral diabetes medicine; or
• steroid medicine (prednisone, dexamethasone, methylprednisolone, and others).

This list is not complete. Other drugs may interact with somatropin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Omnitrope 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 11 for Omnitrope.Accretropin (somatropin) – Emergent Biosolutions Canada Inc.