ZOMACTON® (somatropin) for Injection
IMPORTANT SAFETY INFORMATION
ZOMACTON® (somatropin) for Injection is a human growth hormone prescription medication for:
- Treatment of pediatric patients who are not growing because they do not make enough growth hormone on their own.
- Replacement of growth hormone in adults who do not make enough on their own.
Important Safety Information
WHO SHOULD NOT TAKE ZOMACTON®?
ZOMACTON® is not for:
- Patients who have acute critical illness after heart or abdominal surgery, multiple trauma or acute severe breathing problems.
- Pediatric patients with Prader-Willi syndrome who are severely overweight, have sleep apnea or a history of or existing severe breathing problems due to 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 SHOULD I TELL MY DOCTOR BEFORE OR WHILE TAKING ZOMACTON®?
- If you have or had cancer as a child. Tell your doctor if you experience changes in behavior, headaches, problems with vision, changes in skin coloration or changes in pre-existing moles/birthmarks.
- If you have diabetes, pre-diabetes, or risk factors for diabetes. All patients should have periodic blood sugar monitoring during ZOMACTON® treatment. New cases of type 2 diabetes mellitus have been reported.
- If you have any visual changes, headache, nausea, and/or vomiting while taking ZOMACTON®. This may be a sign of increased pressure in the brain. Routine eye exams should be performed by your doctor.
- If you are allergic to somatropin or any of its ingredients. Seek prompt medical attention if you experience an allergic reaction.
- If you are retaining water during treatment. This may frequently occur, be brief and dose dependent.
- If you have hypoadrenalism and are receiving glucocorticoid replacement therapy. Your doctor may need to adjust the dose of your medication.
- Thyroid function should be checked periodically. Thyroid hormone replacement may need to be started or adjusted during ZOMACTON® therapy.
- If you develop a limp or have hip or knee pain during ZOMACTON® treatment. A fracture in the ball of the hip joint can occur in pediatric patients who have rapid growth.
- If you have scoliosis. Progression of existing scoliosis can occur and should be monitored during treatment in pediatric patients who have rapid growth.
- If you have abdominal pain. Cases of pancreatitis have been reported in patients and may be greater in pediatric patients receiving somatropin.
- If patient receiving ZOMACTON® 5 mg is a newborn or an infant. ZOMACTON® 5 mg includes a diluent that contains benzyl alcohol which can cause serious and fatal reactions. Mix with normal saline, instead of the diluent provided containing benzyl alcohol, when administering to newborns or infants.
- You should rotate your injection sites to avoid breakdown of skin.
- If you are taking any other medications because they may affect each how each other works. Your doctor may adjust the dose of ZOMACTON® or of the other medications you are taking.
- If you are pregnant or nursing. 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 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), runny or stuffy nose (rhinitis), back pain, flu symptoms, and changes in liver function (AST).
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 if it has expired. Do not inject medication if it is cloudy.
Please see Full Prescribing Information for ZOMACTON®.