Growth-Related Disorders

During routine doctor visits, if a growth-related disorder is suspected, the healthcare professional may refer the child to a pediatric endocrinologist. A pediatric endocrinologist is a healthcare professional who specializes in treating children with growth and hormone conditions. This healthcare professional will perform a thorough physical examination along with a series of tests.1

These may include:

  • 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

 

What is human 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

 

What is a growth-related disorder?

Omnitrope is a recombinant 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

Omnitrope Co-Pay Savings Program Eligibility

The Omnitrope Co-Pay Savings Program provides up to $5,000 in annual co-pay support for Omnitrope prescriptions. With the Omnitrope Co-Pay Savings Program, eligible patients may pay $0 for their co-pay. Eligible patients who are commercially insured may receive co-pay support in the amount of up to $5,000 annually and patients who are uninsured may receive co-pay support in the amount of up to $417 monthly, with an annual cap of $5,000. Prescription must be for an approved indication. This program is not health insurance. Patients are not eligible if prescriptions are paid, in whole or in part, by any state or federally funded programs, including but not limited to Medicare (including Part D, even in the coverage gap) or Medicaid, Medigap, VA, DOD, or TriCare, or private indemnity, or HMO insurance plans that reimburse you for the entire cost of your prescription drugs, or where prohibited by law. Patients can participate for a maximum of 12 months. Eligible patients must have a first use of the program by December 31 of the current year. Omnitrope Co-Pay Savings Program may not be combined with any other rebate, coupon, or offer. Sandoz reserves the right to rescind, revoke, or amend this offer without further notice.

1. Growth hormone deficiency–children. Medline Plus website. https://www.nlm.nih.gov/medlineplus/ency/article/001176.htm. Accessed March 24, 2017. 2. X-ray exam: bone age study. KidsHealth website. http://kidshealth.org/en/parents/xray-bone-age.html. Accessed March 24, 2017. 3. Rieser PA. Pediatric growth hormone deficiency. Human Growth Foundation website. http://hgfound.org/resources/ pediatric-growth-hormone. Accessed March 24, 2017. 4. Omnitrope [package insert]. Princeton, NJ: Sandoz Inc; 2016.

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)

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