Saizen (Somatropin Injection) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 9, 2012

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Saizen

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Saizen®
[somatropin (rDNA origin) for injection]

For subcutaneous or intramuscular injection

DRUG DESCRIPTION

Saizen® [somatropin (rDNA origin) for injection] is a human growth hormone produced by recombinant DNA technology. Saizen® (somatropin injection) 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 growth hormone. Saizen® (somatropin injection) is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the human growth hormone gene. Saizen® (somatropin injection) , with the correct three-dimensional configuration, is secreted directly through the cell membrane into the cell-culture medium for collection and purification.

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

Saizen® (somatropin injection) is a sterile, non-pyrogenic, white, lyophilized powder intended for subcutaneous or intramuscular injection after reconstitution with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol). The reconstituted solution has a pH of 6.5 to 8.5.

Saizen® (somatropin injection) is available in 5 mg and 8.8 mg vials. The quantitative composition per vial is:

5 mg vial:

Each vial contains 5 mg somatropin, 34.2 mg sucrose and 1.16 mg O-phosphoric acid. The pH is adjusted with sodium hydroxide or O-phosphoric acid.

8.8 mg vial:

Each vial contains 8.8 mg somatropin, 60.2 mg sucrose and 2.05 mg O-phosphoric acid. The pH is adjusted with sodium hydroxide or O-phosphoric acid.

The diluent is Bacteriostatic Water for Injection, USP containing 0.9% Benzyl Alcohol added as an antimicrobial preservative.

Saizen® (somatropin injection) is also available in the click.easy® reconstitution device. The quantitative composition per vial contained in the click.easy® reconstitution device is:

8.8 mg vial contained in the click.easy® device:

Each vial contains 8.8 mg somatropin, 60.2 mg sucrose and 2.05 mg O-phosphoric acid. The pH is adjusted with sodium hydroxide or O-phosphoric acid.

4 mg vial contained in the click.easy® device:

Each vial contains 4 mg somatropin, 27.3 mg sucrose and 0.9 mg O-phosphoric acid. The pH is adjusted with sodium hydroxide or O-phosphoric acid.

The diluent in the click.easy® device contains 0.3% (w/v) metacresol in Sterile Water for Injection added as an antimicrobial preservative. The reconstituted solution has a pH of 6.5 to 8.5.

What are the precautions when taking somatropin injection (Saizen)?

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...

Read All Potential Precautions of Saizen »

Last reviewed on RxList: 12/26/2007
This monograph has been modified to include the generic and brand name in many instances.