Accretropin

Generic name:somatropin [ rDNA-origin ]
Drug class:Growth hormones
Approval date: January 23, 2008
Company: Cangene Corporation
Treatment for: Pediatric Growth Hormone Deficiency; Turner Syndrome

FDA Approves Accretropin

The U.S. Food and Drug Administration has approved Accretropin (somatropin (rDNA origin)) Injection, a recombinant human growth hormone indicated for treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone. Accretropin is also indicated for the treatment of short stature associated with Turner Syndrome in pediatric patients whose epiphyses are not closed.

Accretropin is identical in sequence to authentic human growth hormone of pituitary origin. Natural human growth hormone is a protein produced by the pituitary gland that acts on the ends of the long bones of the body (epiphyses) until the onset of puberty and promotes growth to normal stature. A deficiency of this hormone during childhood results in abnormally small stature.

Turner Syndrome is an X-chromosome-linked genetic disorder in girls that results in short stature and infertility.

Source: Cangene

Accretropin Consumer Information

What is Accretropin?

Accretropin is a form of human growth hormone.

Accretropin is used to treat growth failure in children who lack natural growth hormone. Accretropin is also used for the treatment of short stature associated with Turner Syndrome in children.

What is the most important information I should know about Accretropin?

If you use a steroid or any medicine to treat diabetes, your doses may need to be changed when you start using Accretropin. Do not stop using or change the dose of your steroid or diabetes medication without your doctor's advice.

Call your doctor at once if you have sudden and severe pain or tenderness in your upper stomach, with nausea, vomiting, sweating, fever, fast heartbeat, and yellowing of the skin or eyes. You should also call your doctor promptly if you have vision changes and sudden, severe pain behind your eyes.

Accretropin should be stored in the refrigerator. Avoid freezing and shaking. Do not use after expiration date stated on the vial and carton labels.

Once opened, Accretropin may be stored up to 14 days when refrigerated. Discard 14 days after first use. Protect from light.

What should I discuss with my healthcare provider before using Accretropin?

Before you receive Accretropin, tell your doctor if you have ever had an allergic reaction to a growth hormone medicine.

Do not use this medication if you are allergic to Accretropin, or if you have:

• diabetic retinopathy (a serious eye condition caused by diabetes);
• cancer; or
• Prader-Willi syndrome and are also overweight or have sleep apnea or severe respiratory (lung) problems.

You should also not use Accretropin if you have a serious medical condition ...