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INDICATIONS AND IMPORTANT SAFETY INFORMATION
INDICATIONS

Omnitrope is a recombinant human growth hormone indicated for:

  • Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, and Idiopathic Short Stature

  • Adult: Treatment of adults with either adult onset or childhood onset GHD

IMPORTANT SAFETY INFORMATION

Who should not take Omnitrope®?

Omnitrope should not be used in children and adults with any of the following medical conditions because serious side effects, including death, can occur:

  • a critical illness caused by certain types of heart or stomach surgery, serious injury 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

Omnitrope should also not be used in children who have completed growth.

What should patients tell their doctor before taking Omnitrope?

Patients should tell their doctor about their medical and family history, treatment use and past and existing medical conditions, such as but not limited to the following:

  • cancer or any tumor
  • diabetes
  • use of prescription and non-prescription medicines, steroids, vitamins and herbal supplements
  • pregnancy
  • nursing

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.

S-OMN-1349753 10/2017

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