Sensipar (Cinacalcet Hydrochloride) - Side Effects and Adverse Reactions

ADVERSE EVENTS

SECONDARY HYPERPARATHYROIDISM IN PATIENTS WITH CHRONIC KIDNEY DISEASE ON DIALYSIS

In 3 double-blind placebo-controlled clinical trials, 1126 CKD patients on dialysis received study drug (656 Sensipar™, 470 placebo) for up to 6 months. The most frequently reported adverse events (incidence of at least 5% in the Sensipar™ group and greater than placebo) are provided in Table 2. The most frequently reported events in the Sensipar™ group were nausea and vomiting.

The incidence of serious adverse events (29% vs. 31%) was similar in the Sensipar™ and placebo groups, respectively.

12-Month Experience with Sensipar™:    Two hundred and sixty-six patients from 2 phase 3 studies continued to receive Sensipar™ or placebo treatment in a 6-month double-blind extension study (12-month total treatment duration). The incidence and nature of adverse events in this study were similar in the two treatment groups, and comparable to those observed in the phase 3 studies.

PARATHYROID CARCINOMA

The most frequent adverse events in this patient group were nausea and vomiting.

Laboratory values:    Serum calcium levels should be closely monitored in patients receiving Sensipar™ (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).