In clinical trials, the most commonly reported side effects were nausea, vomiting, and diarrhea1
The most frequent adverse events associated with Sensipar® treatment in the phase 31 TARGET,2 CONTROL,3 and OPTIMA studies4
Serum calcium reductions are greatest in patients with higher baseline calcium levels5‡
In data pooled from the phase 3 studies:
- Sixty-six percent of Sensipar®-treated patients compared with 25% of patients on traditional therapy§ experienced 1 serum calcium level < 8.4 mg/dL1
- Five percent of Sensipar®-treated patients compared with < 1% of patients6 on traditional therapy experienced at least 2 consecutive serum calcium measurements
< 7.5 mg/dL
- Less than 1% of patients discontinued Sensipar® due to hypocalcemia1
Sensipar® lowers serum calcium, and therefore patients should be carefully monitored for the occurrence of hypocalcemia.1
- 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
- If serum calcium falls below 8.4 mg/dL but remains above 7.5 mg/dL, or if symptoms of hypocalcemia occur, calcium-containing phosphate binders and/or vitamin D sterols can be used to raise serum calcium
- If serum calcium falls below 7.5 mg/dL, or if symptoms of hypocalcemia persist and the dose of vitamin D cannot be increased, withhold administration of Sensipar® until serum calcium levels reach 8.0 mg/dL, and/or symptoms of hypocalcemia have resolved. Treatment should be re-initiated using the next-lowest dose of Sensipar®
- In clinical studies, less than 1% of patients discontinued Sensipar® due to hypocalcemia
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