Omnitrope should not be started if your child is ill due to surgery, trauma, or respiratory failure. Also do not start Omnitrope if your child has cancer, active proliferative or nonproliferative diabetic retinopathy, or known hypersensitivity to somatropin.
Omnitrope should not be used to increase height in children after their bone growth plates have closed. Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment should not be given Omnitrope. In addition, formulations containing benzyl alcohol (5 mg/1.5 mL Omnitrope Cartridges and the Bacteriostatic Water for Injection diluent for the Omnitrope 5.8 mg vial) should not be used in premature babies or neonates.
After Omnitrope treatment has been started, speak with your child's doctor about the possible risks of continuing Omnitrope treatment if your child has any of the following: surgery, trauma, difficulty breathing, cancer, diabetes, other hormone deficiencies, limping or complains about hip or knee pain, or scoliosis (curvature of the spine). The doctor should test your child's blood sugar level for diabetes and perform an eye test called a funduscopic examination for intracranial hypertension before starting Omnitrope and periodically afterwards. You should speak with the doctor if your child is being treated for Prader-Willi syndrome and starts having difficulty breathing, starts snoring or snoring increases. Fluid retention may occur in adults treated with Omnitrope. Tell the doctor about any other medications your child is taking.
Along with its benefits, any medication may cause unwanted effects. These effects with Omnitrope may include headaches, lipoatrophy (a loss of fatty tissue under the skin), and a rash at the injection site. Your child’s doctor will explain the potential for unwanted effects.
Be sure to talk to your child’s doctor if you have questions about the uses or safety considerations of Omnitrope.
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc.
at 1-800-525-8747 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Download the full Prescribing Information for Omnitrope.