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.