pasireotide - Generic Medications

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,6,9,12,15,18-hexaazacyclopentacyclooctadecen-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 C 58 H 66 N 10 O 9 • 2 C 4 H 7 NO 4 and the molecular weight is 1313.41 g/mol. The structural formula is: 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: * 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. 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 The structural formula of pasireotide diaspartate.

SIGNIFOR LAR (pasireotide) for injectable suspension is a long-acting release form of pasireotide pamoate, as powder to be suspended in the provided diluent immediately prior to intramuscular injection. SIGNIFOR LAR contains pasireotide, a somatostatin analog in the form of pasireotide pamoate (pamoic acid salt). Pasireotide is a cyclohexapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Pasireotide pamoate has a chemical name of (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,6,9,12,15,18-hexaazacyclopentacyclooctadecen-2-yl ester pamoic acid salt. The molecular formula of pasireotide pamoate is C 58 H 66 N 10 O 9 • C 23 H 16 O 6 and the molecular weight is 1435.58 g/mol. The structural formula is: The drug product consists of pasireotide pamoate uniformly distributed within microspheres which are made of biodegradable copolymers of poly (D,L-lactide-co-glycolide) acids (PLGA). SIGNIFOR LAR is available in a vial containing the sterile pasireotide pamoate, PLGA microspheres powder, 10 mg, 20 mg, 30 mg, 40 mg, and 60 mg to be reconstituted with the provided 2 mL sterile diluent. Each vial contains: *corresponds to 10 mg, 20 mg, 30 mg, 40 mg, and 60 mg of pasireotide base, respectively. 10 mg 20 mg 30 mg 40 mg 60 mg Pasireotide pamoate 13.71 mg* 27.42 mg* 41.13 mg* 54.84 mg* 82.26 mg* Poly(D,L-lactide-co-glycolide) [50-60:40-50] 13.15 mg 26.29 mg 39.44 mg 52.58 mg 78.87 mg Poly(D,L-lactide-co-glycolide) [50:50] 13.15 mg 26.29 mg 39.44 mg 52.58 mg 78.87 mg Each diluent prefilled syringe contains: Mannitol 90 mg Carboxymethylcellulose sodium 14 mg Poloxamer 188 4 mg Water for injections add to 2 mL structural formula