Genotropin®(somatropin)

GENOTROPIN is a prescription medicine that contains human growth hormone (somatropin).

GENOTROPIN is used to treat children who have:

• growth failure due to inadequate secretion of growth hormone (growth hormone deficiency or GHD)
• growth failure due to Prader-Willi syndrome
• growth failure in children born small for gestational age (SGA) who fail to show catch-up growth by age 2
• growth failure associated with Turner syndrome
• idiopathic short stature (ISS) - short stature without a known cause

GENOTROPIN is used to treat adults who have:

• growth hormone deficiency that began either in childhood or as an adult

• have an acute critical illness due to complications following open heart surgery, abdominal surgery, or multiple accidental trauma, or if you have acute respiratory failure
• are a child with Prader-Willi syndrome who is severely obese or has severe breathing problems including sleep apnea
• have active cancer or other tumors
• are allergic to somatropin or any of the ingredients in GENOTROPIN. The 5 mg and 12 mg presentations contain m-cresol as a preservative.
• have active proliferative or severe non-proliferative diabetic retinopathy
• are a child with closed growth plates (epiphyses)

• have diabetes or a family history of diabetes
• have or have had cancer or any tumor
• have kidney or liver problems
• have a history of scoliosis (curving of the spine)
• have hypothyroidism (underactive thyroid)
• take replacement therapy with adrenal corticosteroid hormones
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

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

GENOTROPIN may affect how other medicines work, especially:

• insulin or other diabetes medicines
• corticosteroids (steroids)
• seizure medicines
• sex hormones (estrogen, androgen)
• cyclosporine

• Use GENOTROPIN exactly as your healthcare provider tells you to.
• Your healthcare provider will show you how to inject GENOTROPIN properly.
• GENOTROPIN is given as an injection under the skin (subcutaneously).
• Change (rotate) the injection site with each injection.
• Do not shake the medicine. Shaking may cause denaturation of the active ingredient.
• Follow the directions for reconstitution provided with each device.
• Do not inject GENOTROPIN if the solution is cloudy or contains particles.

GENOTROPIN can cause serious side effects, including:

• Increased risk of death in patients with acute critical illness. Treatment with GENOTROPIN should not be started in patients who are critically ill.
• Sudden death in children with Prader-Willi syndrome. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before starting GENOTROPIN.
• Increased risk of tumor growth or recurrence. Patients with a history of cancer should be monitored for tumor recurrence.
• New or worsened diabetes. Your blood sugar levels should be monitored.
• Increased pressure in the brain (intracranial hypertension). Tell your healthcare provider if you have severe or recurrent headache, visual problems, nausea, or vomiting.
• Serious allergic reactions. Get medical help right away if you have trouble breathing, swelling of the face, lips, or throat.
• Fluid retention. May cause swelling, joint pain, carpal tunnel syndrome, and numbness/tingling.
• Hip and knee problems in children. Children may develop a limp or have hip or knee pain. This could be a sign of slipped capital femoral epiphysis.

The most common side effects of GENOTROPIN include:

• injection site reactions (pain, redness, swelling)
• fluid retention (swelling)
• joint pain or stiffness
• muscle pain
• headache

These are not all the possible side effects of GENOTROPIN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Store GENOTROPIN in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Keep GENOTROPIN in its protective packaging.
• Do not freeze GENOTROPIN.
• After reconstitution:

◦ GENOTROPIN 5 mg and 12 mg cartridges: Store in the refrigerator. Use within 28 days.

◦ GENOTROPIN MINIQUICK: Use immediately after reconstitution. May store in the refrigerator for up to 24 hours before use.

• Keep GENOTROPIN and all medicines out of the reach of children.

Active ingredient: somatropin (recombinant human growth hormone) Inactive ingredients in GENOTROPIN 5 mg and 12 mg: dibasic sodium phosphate, glycine, mannitol, m-cresol (as a preservative), monobasic sodium phosphate, and water for injection Inactive ingredients in GENOTROPIN MINIQUICK: dibasic sodium phosphate, glycine, mannitol, monobasic sodium phosphate, and water for injection