Humatrope
Generic name: somatropin
Dosage form: injection (6mg, 12 mg, 24 mg)
Drug class: Growth hormones
What is Humatrope?
Humatrope (somatropin) is a form of human growth hormone important for the growth of bones and muscles.
Humatrope injection is used to treat growth failure in children and adults who lack natural growth hormones. This includes people with short stature due to Turner syndrome, short stature at birth with no catch-up growth, and other causes.
Humatrope 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.
Humatrope is given as a subcutaneous injection using the Humatrope pen (called the HumatroPen injection device).
Who can use Humatrope?
Humatrope is FDA-approved to treat:
Pediatric Patients with:
- growth failure due to inadequate secretion of endogenous growth hormone (GH)
- short stature associated with Turner syndrome
- Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range
- short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency
- short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age.
Adult Patients for:
- replacement of endogenous GH in adults with GH deficiency.
Humatrope side effects
Common Humatrope side effects
Common side effects of Humatrope 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.
Serious Humatrope side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Serious breathing problems may occur in patients with Prader-Willi syndrome who use Humatrope. 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.
Other serious side effects may occur, 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 FDA at 1-800-FDA-1088.
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Warnings
You should not use Humatrope 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 Humatrope if you are allergic to the active ingredient somatropin or any of the inactive ingredients, 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).
Tell your doctor if you have ever had:
- 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, Humatrope 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.
Conditions contraindicated with Humatrope?
- Acute critical illness after open heart surgery, abdominal surgery, or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with the use of pharmacologic doses of somatropin
- Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to the risk of sudden death.
- Active malignancy.
- Known hypersensitivity to somatropin or any of the inactive ingredients.
- Active proliferative or severe non-proliferative diabetic retinopathy.
- Pediatric patients with closed epiphyses.
How should I use Humatrope?
Humatrope is given as an injection under the skin (subcutaneous injection) using the Humatrope pen device with the Humatrope cartridge.
A healthcare provider can teach you how to properly use the medication by yourself.
Humatrope weekly dose should be divided into equal doses, given either 6 or 7 days per week.
Do not inject into the same place two times in a row.
Prepare your injection only when you are ready to give it.
For full instructions with diagrams see Humatrope Cartrige Kit Instuctions for Use
Use only that device that you have been given to administer your medicine.
You may need frequent medical tests.
Follow any diet plan created for you by your doctor or nutrition counselor to help control your condition.
Throw away any Humatrope left over after the expiration date on the label has passed.
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.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
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 at 1-800-222-1222.
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 other drugs will affect Humatrope?
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)
- Cytochrome P450-Metabolized Drugs as Humatrope may alter the clearance
This list is not complete. Other drugs may affect Humatrope, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Humatrope Package Insert
HCPs and patients often use the Humatrope Package Insert (PI) for more detailed information about this medicine. The Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.
The Package Insert is sometimes called Humatrope Prescribing Information (PI) or FDA label.
Storage
- Refrigerate cartridges and diluent at 36° to 46°F (2° to 8°C).
- Avoid freezing Diluent.
- Store in the original carton to protect from light.
Ingredients
Active Ingredient: Somatropin
Inactive ingredients: dibasic sodium phosphate, glycine, mannitol.
Company
Humatrope Eli Lilly and Company, Pharmaceutical Delivery Systems, Lilly Corporate Center, Indianapolis, IN 46285, USA
Humatrope 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 Humatrope.
Accretropin (somatropin) - Emergent Biosolutions Canada Inc.
Formulation type | Strength |
---|---|
Multi-Dose Vial | 5 mg/mL Discontinued, Voluntarily Revoked |
View Accretropin information in detail.
Genotropin (somatropin) - Pharmacia & Upjohn Company LLC
Formulation type | Strength |
---|---|
Multi-Dose Cartridge | 12 mg |
Multi-Dose Cartridge | 5 mg |
Pre-Filled Syringe | 0.2 mg |
Pre-Filled Syringe | 0.4 mg |
Pre-Filled Syringe | 0.6 mg |
Pre-Filled Syringe | 0.8 mg |
Pre-Filled Syringe | 1.2 mg |
Pre-Filled Syringe | 1.4 mg |
Pre-Filled Syringe | 1.5 mg Discontinued |
Pre-Filled Syringe | 1.6 mg |
Pre-Filled Syringe | 1.8 mg |
Pre-Filled Syringe | 1 mg |
Pre-Filled Syringe | 2 mg |
View Genotropin information in detail.
Humatrope (somatropin) - Eli Lilly and Company
Formulation type | Strength |
---|---|
Multi-Dose Cartridge | 12 mg |
Multi-Dose Cartridge | 24 mg |
Multi-Dose Cartridge | 6 mg |
Single-Dose Vial | 2 mg Discontinued |
Single-Dose Vial | 5 mg Discontinued |
Norditropin (somatropin) - Novo Nordisk Inc.
Formulation type | Strength |
---|---|
Autoinjector | 10 mg/1.5 mL |
Autoinjector | 15 mg/1.5 mL |
Autoinjector | 30 mg/3 mL |
Autoinjector | 5 mg/1.5 mL |
Multi-Dose Cartridge | 10 mg/1.5 mL Discontinued |
Multi-Dose Cartridge | 15 mg/1.5 mL Discontinued |
Multi-Dose Cartridge | 5 mg/1.5 mL Discontinued |
View Norditropin information in detail.
Nutropin (somatropin) - Genentech, Inc.
Formulation type | Strength |
---|---|
Multi-Dose Vial | 10 mg Discontinued, Voluntarily Revoked |
Multi-Dose Vial | 5 mg Discontinued, Voluntarily Revoked |
View Nutropin information in detail.
Nutropin AQ (somatropin) - Genentech, Inc.
Formulation type | Strength |
---|---|
Autoinjector | 10 mg/2 mL |
Autoinjector | 20 mg/2 mL |
Autoinjector | 5 mg/2 mL |
Multi-Dose Cartridge | 10 mg/2 mL Discontinued |
Multi-Dose Cartridge | 20 mg/2 mL Discontinued |
Vial | 10 mg/2 mL Discontinued |
View Nutropin AQ information in detail.
Omnitrope (somatropin) - Sandoz Inc.
Formulation type | Strength |
---|---|
Multi-Dose Cartridge | 10 mg/1.5 mL |
Multi-Dose Cartridge | 5 mg/1.5 mL |
Multi-Dose Vial | 5.8 mg |
Single-Dose Vial | 1.5 mg Discontinued |
View Omnitrope information in detail.
Saizen (somatropin) - EMD Serono, Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 4 mg Discontinued, Voluntarily Revoked |
Single-Dose Vial | 5 mg Discontinued, Voluntarily Revoked |
Single-Dose Vial | 6 mg Discontinued, Voluntarily Revoked |
Single-Dose Vial | 8.8 mg Discontinued, Voluntarily Revoked |
View Saizen information in detail.
Serostim (somatropin) - EMD Serono, Inc.
Formulation type | Strength |
---|---|
Multi-Dose Vial | 4 mg |
Single-Dose Cartridge | 6 mg/0.5 mL Discontinued |
Single-Dose Vial | 5 mg |
Single-Dose Vial | 6 mg |
View Serostim information in detail.
Zomacton (somatropin) - Ferring Pharmaceuticals Inc.
Formulation type | Strength |
---|---|
Multi-Dose Vial | 10 mg |
Multi-Dose Vial | 4.8 mg Discontinued |
Multi-Dose Vial | 5 mg |
View Zomacton information in detail.
Zorbtive/Serostim (somatropin) - EMD Serono, Inc.
Formulation type | Strength |
---|---|
Multi-Dose Vial | 8.8 mg Discontinued |
View Zorbtive/Serostim information in detail.
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References
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