Signifor
SIGNIFOR
(pasireotide diaspartate) Injection
DRUG DESCRIPTION
SIGNIFOR (pasireotide diaspartate) 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-3ylmethyl)-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:
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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 | 49.5 | 49.5 | 49.5 |
| 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 1ml | ad 1ml | ad 1ml |
| * corresponds to 0.3/0.6/0.9 mg pasireotide base Note: Each ampule contains an overfill of 0.1ml to allow accurate administration of 1 ml from the ampule. |
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Last reviewed on RxList: 1/3/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Signifor Information
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