What is a Growth-Related Disorder?

Getting Diagnosed with a Growth-Related Disorder

During a routine check-up, if a growth-related disorder is suspected, the doctor may refer your child to a pediatric endocrinologist. 

A pediatric endocrinologist is a healthcare professional who specializes in treating children with growth and hormone conditions. They will perform a thorough physical examination and a series of tests.¹

These may include:^1,2

• An X-ray of the left hand and wrist to measure bone development
• Exams to detect an underlying physical problem or disease
• A test to check the levels of certain substances in the blood, including growth hormone

Human growth hormone (HGH) is a protein that is critical for normal growth. It is made in the pituitary gland, which is often called the "master gland" because it makes many hormones that the body needs to function properly.³

The pituitary gland is located in the brain and is the size of a pea. It releases hormones, including growth hormone, into the bloodstream. The hormones then travel to organs and tissues, sending them messages to act in a certain way. The role of growth hormone is to tell the body's tissues, including muscles and bones, to grow.³

When the pituitary gland doesn't make enough human growth hormone—or, in some cases, doesn't make any at all—this condition is called growth-related disorder. Hormone deficiencies may be present at birth or may develop over time. Scientists are still learning more about the causes of growth-related disorders.³

How Does Omnitrope^® Work?

Omnitrope is a prescription medicine that contains human growth hormone used for the treatment of growth failure due to growth hormone deficiency and certain growth hormone conditions. 

In children, it works by increasing the amount of growth hormone in your child, helping his or her bones to grow and muscles to develop.⁴

References

^{1. Growth hormone deficiency–children. Medline Plus website. https://www.nlm.nih.gov/medlineplus/ency/article/001176.htm. Accessed October 15, 2020.}

^{2. X-ray exam: bone age study. KidsHealth website. http://kidshealth.org/en/parents/xray-bone-age.html. Accessed October 15, 2020.}

^{3. Rieser PA. Pediatric growth hormone deficiency. Human Growth Foundation website. https://www.hgfound.org/pediatric-growth-hormone-deficiency. Accessed October 15, 2020.}

^{4. Omnitrope [package insert]. Princeton, NJ: Sandoz Inc; 2019.}

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