Description

ZOMACTON is a prescription drug containing human growth hormone used to treat pediatric patients with:

There is no growth because they cannot produce enough growth hormone on their own

Short stature is associated with Turner syndrome

Idiopathic short stature

Lack of short stature homologous frame gene (SHOX) can lead to short stature or growth failure

Short in stature, short at birth (suitable for gestational age SGA), and still unable to catch up with growth at 2 to 4 years of age

ZOMACTON is also used in adults who cannot produce enough growth hormone on their own.

Important safety information

Who shouldn’t take ZOMACTON?

ZOMACTON does not apply to:

Patients undergoing open heart surgery or abdominal surgery, serious health problems, multiple accidental injuries due to accidental deaths, or acute respiratory failure

People with overweight, sleep apnea or deaths from prader-willi syndrome have a history of severe respiratory problems in children

Patients with active cancer

Patients who are allergic to any of the ingredients offered by ZOMACTON

Patients with severe vision problems caused by diabetes

The pediatric growth plate has been closed for the patient

What should I know most about ZOMACTON?

If you had cancer as a child, you are at increased risk for another form of cancer.Patients with prior tumors should be monitored for progression or recurrence

ZOMACTON may reduce insulin sensitivity.Your doctor should check your blood sugar regularly, especially if you have diabetes, a risk factor for prediabetes or diabetes

Increased stress in the brain.If you have any visual changes, headache, nausea and/or vomiting, please tell your doctor.You may need to discontinue treatment.Routine eye exams should be performed

Severe allergic reactions may occur.Go to a doctor immediately

Water retention may develop during adult therapy and may be dose-related

If you have adrenocortical hypofunction and are receiving glucocorticoid replacement therapy, your doctor may need to monitor your blood levels and adjust the dose of the medication

Thyroid function should be checked regularly.Starting with ZOMACTON, thyroid hormone replacement may be needed or adjusted

Pediatric patients may have a hip bulb fracture.If you have hip or knee pain, tell your doctor

Previous scoliosis progression may occur and should be monitored

Pancreatitis has been reported.If you have abdominal pain, especially in children, talk to your doctor

ZOMACTON 5 mg carries liquid vials (diluents) containing benzyl alcohol, which can cause severe and fatal reactions in newborns or infants. When administered to newborns or infants, the drug should be mixed with normal saline, not with diluents containing benzyl alcohol

Your doctor may adjust the dosage of ZOMACTON or any other medication you’re taking

If you need 5 mg ZOMACTON during pregnancy or lactation, please mix it with normal saline or use 10 mg ZOMACTON (no benzyl alcohol formula).

What side effects might ZOMACTON have?

Report is one of the most common side effects include upper respiratory tract infection, fever, sore throat (pharyngitis), headaches, ear pain (some), hand/foot, or ankle swelling (edema), joint or muscle pain/discomfort, joint pain, paresthesia, muscle pain, carpal tunnel syndrome, body fluid accumulation (surrounding edema) caused by swelling, flu syndrome, thyroid function is low, hyperglycemia and diabetes.

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

How do I store ZOMACTON?

ZOMACTON must be refrigerated (36° to 46°F [2° to 8°C]).Don’t freeze.When mixed with liquid, ZOMACTON 5 mg must be used within 14 days, and ZOMACTON 10 mg must be used within 28 days.Do not use if the medication has expired or is cloudy.

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