About Omnitrope^®

How does growth hormone treatment work?

Omnitrope (somatropin) injection is a laboratory-created human growth hormone. It is indicated to treat people with: 

• Growth failure due to growth hormone deficiency (GHD)
• Prader-Willi syndrome
• Small for gestational age
• Turner syndrome
• Idiopathic short stature

In children, it works by increasing the amount of growth hormone, helping his or her bones to grow and muscles to develop.¹ It is also indicated for adults with growth hormone disorders.

How is Omnitrope taken?

Omnitrope is taken via daily injection. There are two injection options available for Omnitrope¹

• a liquid-formulation pen 
• a lyophilized powder

Convenient Injection Pens

• Flexible dosing to fit your needs (5 mg and 10 mg)
• Ready-to-use liquid cartridge eliminates the need to reconstitute
• The liquid cartridge stays stable for 28 days after the first injection*
• Once a new cartridge is inserted, the pen must be primed before use

Vial and Syringe (Reconstituted Lyophilized Powder)

• Each 5.8 mg vial of Omnitrope comes with a 1.14 mL vial of bacteriostatic water preserved with benzyl alcohol to mix in a solution before injecting
• Three-week stability once reconstituted or mixed with liquid^†

Reference

_{1. Omnitrope [package insert]. Princeton, NJ: Sandoz Inc; 2019.}
 

_{^* Cartridge must be stored or refrigerated from 36°F to 46°F.
^† Vial must be stored in the refrigerator at 36°F to 46°F.}

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