ZOMACTON^® (somatropin) for Injection

Important Safety Information

Indications:

ZOMACTON is a recombinant human growth hormone (GH) indicated for the treatment of pediatric patients with:

• growth failure due to inadequate secretion of endogenous GH
• short stature associated with Turner syndrome
• idiopathic short stature (ISS)
• 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 to 4 years

ZOMACTON is also indicated for the replacement of endogenous GH in adults with GH deficiency

Important Safety Information

CONTRAINDICATIONS

ZOMACTON is contraindicated in patients with:

• Acute critical illness
• 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 death.
• Active malignancy.
• Hypersensitivity to ZOMACTON, its excipients, or diluents.
• Active proliferative or severe non-proliferative diabetic retinopathy.
• Pediatric patients with closed epiphyses.

WARNINGS AND PRECAUTIONS

• Increased Risk of Neoplasm: Second neoplasms have occurred in childhood cancer survivors. Monitor patients with preexisting tumors for progression or recurrence.
• Glucose Intolerance and Diabetes Mellitus: ZOMACTON may decrease insulin sensitivity, particularly at higher doses. Monitor glucose levels periodically, especially in patients with existing diabetes mellitus or at risk for development.
• Intracranial Hypertension (IH): Has been reported usually within 8 weeks of initiation. Perform fundoscopic examinations prior to initiation and periodically thereafter. If papilledema occurs, stop treatment.
• Hypersensitivity: Serious hypersensitivity reactions may occur, seek prompt medical attention.
• Fluid Retention: May occur in adults and may be dose dependent.
• Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism.
• Hypothyroidism: Monitor thyroid function periodically as hypothyroidism may occur or worsen after initiation of somatropin.
• Slipped Capital Femoral Epiphysis in Pediatric Patients: May occur; evaluate patients with onset of a limp or hip/knee pain.
• Progression of Preexisting Scoliosis in Pediatric Patients: Monitor patients with scoliosis for progression.
• Pancreatitis: Has been reported; consider pancreatitis in patients with abdominal pain, especially pediatric patients.
• Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative: Serious and fatal adverse reactions can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including the diluent for ZOMACTON 5 mg. If administering ZOMACTON 5 mg to infants, reconstitute with 0.9% sodium chloride injection.

ADVERSE REACTIONS

Common adverse reactions reported include: upper respiratory infection, fever, pharyngitis, headache, otitis media, edema, arthralgia, paresthesia, myalgia, carpal tunnel syndrome, peripheral edema, flu syndrome, hypothyroidism, hyperglycemia, and impaired glucose
tolerance.

DRUG INTERACTIONS

• Glucocorticoids: Patients treated with glucocorticoids may require an increased dose.
• Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment: Adjust dosing in pediatric patients to avoid hypoadrenalism or an inhibitory effect on growth.
• Cytochrome P450-Metabolized Drugs: Monitor carefully if used with ZOMACTON as clearance may be altered.
• Oral Estrogen: Larger doses of ZOMACTON may be required.
• Insulin and/or Other Hypoglycemic Agents: Dose adjustment may be required.

USE IN SPECIFIC POPULATIONS

• Pregnancy and Lactation: If ZOMACTON 5 mg is needed, reconstitute with 0.9% sodium chloride injection or use the ZOMACTON 10 mg benzyl alcohol-free formulation.

ZN/291/2018/US(4)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 800.FDA.1088.

Please see Full Prescribing Information.