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WARNINGS Seizures In three clinical studies of CKD patients on dialysis, 5% of the patients in both the Sensipar ® and placebo groups reported a history of seizure disorder at baseline. During the trials, seizures (primarily generalized or tonic-clonic) were observed in 1.4% (9/656) of Sensipar ® -treated patients and 0.4% (2/470) of placebo-treated patients. Five of the nine Sensipar ® -treated patients had a history of a seizure disorder and two were receiving anti-seizure medication at the time of their seizure. Both placebo-treated patients had a history of seizure disorder and were receiving anti-seizure medication at the time of their seizure. While the basis for the reported difference in seizure rate is not clear, the threshold for seizures is lowered by significant reductions in serum calcium levels. Therefore, serum calcium levels should be closely monitored in patients receiving Sensipar ® , particularly in patients with a history of a seizure disorder (see PRECAUTIONS, Hypocalcemia ). Hypotension and/or Worsening Heart Failure In postmarketing safety surveillance, isolated, idiosyncratic cases of hypotension, worsening heart failure, and/or arrhythmia have been reported in patients with impaired cardiac function, in which a causal relationship to Sensipar ® could not be completely excluded and which may be mediated by reductions in serum calcium levels. Clinical trial data showed hypotension occurred in 7% of Sensipar ® -treated patients and 12% of placebo-treated patients, heart failure occurred in 2% of both Sensipar ® - and placebo-treated patients.
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, vomiting, and diarrhea. Table 2. Adverse Event Incidence (≥ 5%) in Patients on Dialysis Event Included are events that were reported at a greater incidence in the Sensipar ® group than in the placebo group. : Placebo (n = 470) (%) Sensipar ® (n = 656) (%) Nausea 19 31 Vomiting 15 27 Diarrhea 20 21 Myalgia 14 15 Dizziness 8 10 Hypertension 5 7 Asthenia 4 7 Anorexia 4 6 Pain Chest, NonCardiac 4 6 Access Infection 4 5 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. Postmarketing Experience with Sensipar ® : Rash, hypersensitivity reactions (including angioedema and urticaria), diarrhea and myalgia have been identified as adverse reactions during post-approval use of Sensipar ® . Isolated, idiosyncratic cases of hypotension, worsening heart failure, and/ or arrhythmia have been reported in Sensipar ® -treated patients with impaired cardiac function in postmarketing safety surveillance. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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 ).