ZOMACTON (somatropin) for Injection
IMPORTANT SAFETY INFORMATION

Indication

ZOMACTON is a prescription medicine that contains human growth hormone and is used to treat pediatric patients who:

• are not growing because they do not make enough growth hormone on their own
• have short stature associated with Turner syndrome
• have Idiopathic Short Stature
• have short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency
• are short stature born small (small for gestational age-SGA) and have not caught up in growth by age 2 to 4 years old

ZOMACTON is also used for adults who do not make enough growth hormone on their own.

Important Safety Information
WHO SHOULD NOT TAKE ZOMACTON?

ZOMACTON is not for:

• Patients who have acute critical illness after open heart or abdominal surgery, multiple accidental trauma, or those with acute respiratory failure due to risk of death
• Pediatric patients with Prader-Willi syndrome who are severely overweight, have sleep apnea or a history of or existing severe breathing problems due to the risk of death
• Patients who have active cancer
• Patients who are allergic to any of the ingredients provided with ZOMACTON
• Patients with severe visual problems caused by diabetes
• Pediatric patients whose growth plates have closed

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ZOMACTON?

• If you have or had cancer as a child as there is an increased risk of getting another tumor. Patients with prior tumors should be monitored for development or recurrence
• ZOMACTON may decrease insulin sensitivity. Your doctor should check your blood sugar regularly, especially if you have diabetes, pre-diabetes, or risk factors for diabetes
• Increased pressure in the brain has occurred. Tell your doctor if you have any visual changes, headache, nausea, and/or vomiting. You may need to stop treatment. Routine eye exams should be performed
• Serious allergic reactions may occur. Seek prompt medical attention
• Water retention during treatment may occur in adults and may be dose dependent
• Your doctor may need to monitor changes in your blood levels and adjust the dose of your medication if you have hypoadrenalism and are on glucocorticoid replacement therapy
• Thyroid function should be checked periodically. Thyroid hormone replacement may be needed or adjusted after starting on ZOMACTON
• A fracture in the ball of the hip joint can occur in pediatric patients. Tell your doctor if a limp develops or you have hip or knee pain
• Progression of preexisting scoliosis can occur and should be monitored
• Pancreatitis has been reported. Tell your doctor if you are having abdominal pain especially if you are a pediatric patient
• ZOMACTON 5 mg comes with a liquid vial (diluent) that contains benzyl alcohol which can cause serious and fatal reactions to a newborn or an infant. Mix with normal saline, instead of the diluent containing benzyl alcohol, when administering to newborns or infants
• Your doctor may adjust the dose of ZOMACTON or of other medications that you are taking
• If ZOMACTON 5 mg is needed while pregnant or nursing, it should be mixed with normal saline or use ZOMACTON 10 mg, which contains a benzyl alcohol-free formulation

WHAT ARE THE POSSIBLE SIDE EFFECTS OF ZOMACTON?

The most common side effects reported include upper respiratory infection, fever, sore throat (pharyngitis), headache, earache (otitis media), swollen hands/feet or ankles (edema), joint or muscle pain/discomfort (arthralgia, paresthesia, myalgia), carpal tunnel syndrome, accumulation of fluid causing swelling (peripheral edema), flu syndrome, hypothyroidism, hyperglycemia, and diabetes.

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

HOW SHOULD I STORE ZOMACTON?

ZOMACTON must be kept refrigerated (36° to 46°F [2° to 8°C]). DO NOT FREEZE. After mixing with liquid, ZOMACTON 5 mg must be used within 14 days and ZOMACTON 10 mg must be used within 28 days. Do not use medication if it is expired or cloudy.

Please see Full Prescribing Information for ZOMACTON.