The information on this page is intended for healthcare professionals only.

REAL COMMITMENT.
DOSING FLEXIBILITY.
STRONG SUPPORT.
ENHANCED VALUE.

  • REAL COMMITMENT by Ferring to growth hormone deficiency and ZOMACTON® in the United States
  • DOSING FLEXIBILITY with 5-mg and 10-mg vials available
  • STRONG SUPPORT through the ZoGo Support Program, including a variety of financial assistance programs to meet individual patient needs
  • ENHANCED VALUE with cost-effective, affordable treatment

A needle-free option for patients and caregivers administering ZOMACTON® 5 mg

Available in 5-mg
and 10-mg vials

Also available:

ZOMA-JetTM 5, a needle-free option for patients and caregivers administering ZOMACTON® 5 mg

To learn more about enrolling your patients, call 1-844-944-ZOGO (9646)

ZOOM supports your management of pediatric GHD with ZOMACTON® by providing one-stop access to all ZOMACTON® financial, pre-authorization, patient support, and brand resources while delivering time-saving efficiencies.

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.

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.

 

The individuals depicted are models, not actual patients.