Patients with secondary hyperparathyroidism produce too much parathyroid hormone (PTH). Normally, PTH makes sure that the body has just enough calcium and phosphorous in the blood to keep bones, heart, muscles, nerves and blood vessels working properly. Sensipar® lowers PTH by telling the parathyroid glands to stop releasing too much PTH into the blood. It also lowers calcium and phosphorous levels. Sensipar® is unique in that it lowers PTH directly at the parathyroid glands.
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Important Safety Information
Significant reductions in calcium may lower the threshold for seizures. Secondary hyperparathyroidism (HPT) patients, particularly those with a history of seizure disorder, should be carefully monitored for the occurrence of low serum calcium or symptoms of hypocalcemia.
In Sensipar® postmarketing use, isolated, idiosyncratic cases of hypotension and/or worsening heart failure were reported in patients with impaired cardiac function. The causal relationship to Sensipar® therapy could not be completely excluded and may be mediated by reductions in serum calcium levels.
Sensipar® lowers serum calcium; therefore, it is important that patients have a serum calcium greater than or equal to 8.4 mg/dL when initiating therapy. Adynamic bone disease may develop if intact parathyroid hormone (iPTH) levels are suppressed below 100 pg/mL. Patients with moderate to severe hepatic impairment should be monitored throughout treatment with Sensipar®, as cinacalcet exposure assessed by AUC was higher than patients with normal hepatic function.
Serum calcium and serum phosphorus should be measured within 1 week and iPTH should be measured 1 to 4 weeks after initiation or dose adjustment of Sensipar®. Once the maintenance dose has been established, serum calcium and serum phosphorus should be measured approximately monthly, and PTH every 1 to 3 months.
The most commonly reported side effects were nausea, vomiting, and diarrhea.
