ance phase. Baseline mean (SD) serum calcium was 14.7 (1.8) mg/dL. The range of change from baseline to last measurement was –7.5 to 2.7 mg/dL during the titration phase and –7.4 to 0.9 mg/dL during the maintenance phase ( Figure 3). No patients maintained a serum calcium level within the normal range. The doses ranged from 70 mg twice daily to 90 mg four times daily for patients in the maintenance phase.
Figure 3. Serum Calcium Values in Parathyroid Carcinoma Patients Receiving Sensipar® at Baseline, Titration and Maintenance Phase Solid lines represent individual patient data B = baseline; T = last value in titration phase; M = last value in maintenance phase Reference lines (dashed) show the normal range for serum calcium values
INDICATIONS AND USAGE
Sensipar® is indicated for the treatment of secondary hyperparathyroidism in patients with Chronic Kidney Disease on dialysis.
Sensipar® is indicated for the treatment of hypercalcemia in patients with parathyroid carcinoma.
CONTRAINDICATIONS
Sensipar® is contraindicated in patients with hypersensitivity to any component(s) of this product.
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 and/or worsening heart failure have been reported in patients with impaired cardiac function, in which a causal relationship to Sensipar® could not be completely excluded and may be mediated by reductions in serum calcium levels. Clinical trial data showed hypotension occurred in 7% of Sensipar®-treated patients, 12% of placebo-treated patients, and heart failure occurred in 2% of patients receiving Sensipar® or placebo.
PRECAUTIONS
General
Hypocalcemia
Sensipar® lowers serum calcium, and therefore patients should be carefully monitored for the occurrence of hypocalcemia. Potential manifestations of hypocalcemia include paresthesias, myalgias, cramping, tetany, and convulsions.
Sensipar® treatment should not be initiated if serum calcium is less than the lower limit of the normal range (8.4 mg/dL). Serum calcium should be measured within 1 week after initiation or dose adjustment of Sensipar®. Once the maintenance dose has been established, serum calcium should be measured approximately monthly (see DOSAGE AND ADMINISTRATION).
If serum calcium falls below 8.4 mg/dL but remains above 7.5 mg/dL, or if symptoms of hypoca |
