SPL Set ID: a09a25fc-a5a3-0c82-e053-2995a90a5d74

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.