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 that 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.

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.

• Higher risk of new tumors: Some people who survived childhood cancer have developed new tumors later. If a patient has had a tumor before, the doctor should watch closely for any signs that it is growing again or coming back.
• High blood sugar and diabetes: Humatrope can make it harder for the body to control blood sugar, especially at higher doses. Blood sugar should be checked from time to time, especially in people who already have diabetes or are at higher risk for it.
• Increased pressure in the brain (Intracranial Hypertension (IH)): This has been reported, usually within the first 8 weeks after starting treatment. Eye exams should be done before treatment starts and again during treatment. If swelling is seen in the eye, treatment should be stopped.
• Allergic reactions: Serious allergic reactions can happen. Get medical help right away if there are signs of an allergic reaction.
• Fluid retention: Adults may retain extra fluid while taking this medicine. This may be more likely at higher doses.
• Low adrenal hormone levels (hypoadrenalism): Some patients may have lower cortisol levels or may need higher doses of steroid medicine. These patients should be monitored.
• Low thyroid hormone levels (hypothyroidism): Thyroid problems can start or get worse after beginning somatropin. Thyroid function should be checked regularly.
• Hip problem in children: Some children may develop a hip condition called slipped capital femoral epiphysis. Contact a doctor if a child starts limping or has hip or knee pain.
• Worsening scoliosis in children: Children who already have scoliosis should be monitored because it may get worse during treatment.
• Pancreatitis: Inflammation of the pancreas has been reported. Consider this possibility in patients with stomach pain, especially children.

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.

• 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.

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.

Humatrope is given as an injection under the skin (subcutaneous injection) using the HumatroPen.

A healthcare provider can teach you how to properly use the HumatroPen 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 Cartridge Kit Instructions for Use

Use only the HumatroPen 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 cartridge 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.

Humatrope is available as the HumatropePen in 6 mg, 12 mg, and 24 mg strengths.

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.

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.

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.

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.

• 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.

Active Ingredient: Somatropin

Inactive ingredients: dibasic sodium phosphate, glycine, mannitol.

Humatrope Eli Lilly and Company, Pharmaceutical Delivery Systems, Lilly Corporate Center, Indianapolis, IN 46285, USA