盐酸西那卡塞FDA说明书.pdf

FDA approved label August 1, 2011 HIGHLIGHTS OF PRESCRIBING INFORMATION CONTRAINDICATIONS These highlights do not include all the information needed to use Sensipar Hypocalcemia: Sensipar treatment should not be initiated if serum calcium is safely and effectively. See full prescribing information for Sensipar. less than the lower limit of the normal range. (4, 5.1) Sensipar® (cinacalcet) Tablets WARNINGS AND PRECAUTIONS­ Initial US Approval: 2004 • Hypocalcemia and/or seizures: May occur due to significant reductions in serum calcium. (5.1, 5.2) RECENT MAJOR CHANGES • Isolated, idiosyncratic occurrences of hypotension, worsening heart failure, Indications and Usage: Primary Hyperparathyroidism (1.3) 02/2011 and/or arrhythmia: Have been reported in patients with impaired cardiac Dosage and Administration: Parathyroid Carcinoma / Primary function during Sensipar treatment, which may be mediated by reductions Hyperparathyroidism (2.2) 02/2011 in serum calcium. (5.3) Contraindications: Hypocalcemia (4) 02/2011 • Adynamic bone disease: May develop if iPTH levels are suppressed below 100 pg/mL. (5.4) INDICATIONS AND USAGE