Serostim (Somatropin (rDNA origin)) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 9, 2012

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Serostim

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Serostim®
[somatropin (rDNA origin) for injection]

DRUG DESCRIPTION

Serostim® [somatropin (rDNA origin) for injection] is a human growth hormone (hGH) produced by recombinant DNA technology. Serostim® (somatropin rdna origin) has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary GH. Serostim® (somatropin rdna origin) is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the hGH gene. Serostim® (somatropin rdna origin) is secreted directly through the cell membrane into the cell-culture medium for collection and purification.

Serostim® (somatropin rdna origin) is a highly purified preparation. Biological potency is determined by measuring the increase in the body weight induced in hypophysectomized rats.

Serostim® (somatropin rdna origin) is available in 5 mg and 6 mg vials for single dose administration. Serostim® (somatropin rdna origin) is also available in 4 mg and 8.8 mg vials for multi-dose administration. Each 4 mg vial contains 4.0 mg (approximately 12 IU) somatropin, 27.3 mg sucrose, 0.9 mg phosphoric acid. Each 5 mg vial contains 5.0 mg (approximately 15 IU) somatropin, 34.2 mg sucrose and 1.2 mg phosphoric acid. Each 6 mg vial contains 6.0 mg (approximately 18 IU) somatropin, 41.0 mg sucrose and 1.4 mg phosphoric acid. Each 8.8 mg vial contains 8.8 mg (approximately 26.4 IU) somatropin, 60.19 mg sucrose and 2.05 mg phosphoric acid. The pH is adjusted with sodium hydroxide or phosphoric acid to give a pH of 7.4 to 8.5 after reconstitution with Water for Injection, USP. The pH is adjusted with sodium hydroxide or phosphoric acid to give a pH of 6.5 to 8.5 after reconstitution with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol).

What are the possible side effects of somatropin?

If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring. Rare cases of serious breathing problems have occurred in patients with Prader-Willi syndrome who use somatropin.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

sudden...

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What are the precautions when taking somatropin (rdna origin) (Serostim)?

Before using somatropin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: eye problems (e.g., diabetic retinopathy), major surgery or trauma, severe breathing problems (acute respiratory failure), undergoing therapy for tumors (cancer), Prader-Willi syndrome (see Side Effects section above), normal growth has stopped (closed epiphyses).

Before using this medication, tell your doctor or pharmacist...

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Last reviewed on RxList: 10/8/2007
This monograph has been modified to include the generic and brand name in many instances.