July 4, 2015

Signifor

SIGNIFOR
(pasireotide) Injection

DRUG DESCRIPTION

SIGNIFOR (pasireotide) injection is prepared as a sterile solution of pasireotide diaspartate in a tartaric acid buffer for administration by subcutaneous injection. SIGNIFOR is a somatostatin analog. Pasireotide diaspartate, chemically known as (2-Aminoethyl) carbamic acid (2R,5S,8S,11S,14R,17S,19aS)-11-(4-aminobutyl)-5-benzyl-8-(4-benzyloxybenzyl)-14(1H-indol-3-ylmethyl)-4,7,10,13,16,19-hexaoxo-17-phenyloctadecahydro-3a,6,9,12,15,18hexaazacyclopentacyclooctadecen-2-yl ester, di[(S)-2-aminosuccinic acid] salt, is a cyclohexapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin.

The molecular formula of pasireotide diaspartate is C58H66N10O9 • 2C4H7NO4 and the molecular weight is 1313.41. The structural formula is:

SIGNIFOR (pasireotide) Structural Formula Illustration

SIGNIFOR is supplied as a sterile solution in a single-dose, 1 mL colorless glass ampule containing pasireotide in 0.3 mg/mL, 0.6 mg/mL, or 0.9 mg/mL strengths for subcutaneous injection.

Each glass ampule contains:

  0.3 mg 0.6 mg 0.9 mg
Pasireotide diaspartate 0.3762* 0.7524* 1.1286*
Mannitol 49.50 49.50 49.50
Tartaric acid 1.501 1.501 1.501
Sodium hydroxide ad pH 4.2 ad pH 4.2 ad pH 4.2
Water for injection ad 1 mL ad 1 mL ad 1 mL
* corresponds to 0.3/0.6/0.9 mg pasireotide base
Note: Each ampule contains an overfill of 0.1 mL to allow accurate administration of 1 mL from the ampule.

Last reviewed on RxList: 4/7/2015
This monograph has been modified to include the generic and brand name in many instances.

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