Indications and Important Safety Information
Indications
Omnitrope is a prescription medicine that contains human growth hormone and is used to treat:
- Children with growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, and Idiopathic Short Stature
- Adults with either adult onset or childhood onset GHD
IMPORTANT SAFETY INFORMATION
Who should not take Omnitrope®?
Omnitrope should not be used by children or adults that have:
- a critical illness caused by certain types of heart or stomach surgery, accidental trauma, or a sudden and severe breathing problem (respiratory failure)
- Prader-Willi syndrome who are severely overweight or have a history of breathing problems including sleep apnea
- cancer or other tumors
- allergies to growth hormone or any of the ingredients in the medicine
- certain types of eye problems caused by diabetes
- closed bone growth plates
What should patients tell their healthcare provider before taking Omnitrope?
Patients should tell their healthcare provider about all of their medical conditions, including if they:
- have had heart or stomach surgery, trauma, or serious breathing
problems - have or have had cancer or any tumor
- have diabetes
- take any prescription and non-prescription medicines, steroids, vitamins, or herbal supplements
- are pregnant or breastfeeding, or plan to become pregnant or
breastfeed
What are the most common side effects of Omnitrope?
- local reactions at the injection site (such as pain, numbness,
redness and swelling) - headaches
- swelling associated with fluid retention
- pain in joints and muscle pain
- carpal tunnel syndrome
- tingling and numbness
- high blood sugar (hyperglycemia/diabetes) and sugar in your urine
(glucosuria) - unusual skin sensations
- low levels of thyroid hormone (hypothyroidism)
Other possible side effects of Omnitrope are:
- return of tumor or cancerous growths
- headaches, changes in vision, nausea or vomiting (these may be
symptoms of raised pressure in the brain which requires immediate
medical attention) - hip and knee pain or a limp in children, that can be a sign of
slipped capital femoral epiphysis - worsening of pre-existing curvature of the spine in children
(scoliosis) - increased ear infections and ear disorders in children with Turner
syndrome; check for cardiovascular disorders (hypertension,
stroke) - intense pain and tenderness in the abdomen as consequence of an
inflammation of the pancreas (pancreatitis) - gasping syndrome (decreased rate of breathing) in children from
high levels of benzyl alcohol (an inactive ingredient) - Increased mortality in patients with Prader Willi and acute illness
Please see full Prescribing Information for Omnitrope.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.