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No Title 1.41 MB
Registration Date 27 Jul 2016
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SOMAVERT®

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Medicine Pharmaceuticals Product Number : 0009-5180-01

Endocrine-metabolic Agent

Drug Information

Generic
Pegvisomant
NDC Code
0009-5180-01
Drug Class
Metabolic and Endocrine
Dosage form
Powder
Route of Administration
SUBCUTANEOUS
Therapeutic Area
1.Acromegaly

Nanomaterials

Manufacturer Asserted

Polymeric Nanoparticle

Nanoparticle /Nanopowder

Indication

SOMAVERT® (pegvisomant for injection) is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-I (IGF-I) levels.

Benefit

Somavert (pegvisomant) is a PEGylated analog of human growth hormone (GH) for acromegaly treatment in patients with acromegaly, resulting in abnormal enlargement of the forehead, jaw, hands, and feet. Somavert is a GH receptor antagonist that blocks GH binding and interferes with GH signal transduction pathways, thereby reducing IGF-I serum concentration by at least 50%. PEGylation of the active ingredient of Somavert results in reduced clearance and an increased half-life (approximately 6 days)