Clinical Literature

The safety and efficacy of Sensipar® has been demonstrated in multiple clinical studies. Follow the links below to view summaries of these studies.

Combined therapy with cinacalcet and low doses of vitamin D sterols in patients with moderate to severe secondary hyperparathyroidism.

Nephrology Dialysis Transplantation, 2008.

The OPTIMA study: assessing a new cinacalcet (Sensipar®/Mimpara®) treatment algorithm for secondary hyperparathyroidism.

Clinical Journal of the American Society of Nephrology, 2008.

Achieving NKF-K/DOQI™ bone metabolism and disease treatment goals with cinacalcet HCI.

Kidney International, 2005.

Cinacalcet hydrochloride (Sensipar®) in hemodialysis patients on active vitamin D derivatives with controlled PTH and elevated calcium x phosphate.

Clinical Journal of the American Society of Nephrology, 2006.

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Sensipar® is indicated for the treatment of secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD) on dialysis.

Sensipar® is indicated for the treatment of hypercalcemia in patients with parathyroid carcinoma.

Sensipar® is indicated for the treatment of severe hypercalcemia in patients with primary hyperparathyroidism (HPT) who are unable to undergo parathyroidectomy.

Important Safety Information

Sensipar® treatment should not be initiated if serum calcium is less than the lower limit of the normal range (8.4 mg/dL).

Sensipar® lowers serum calcium; therefore, it is important that patients are carefully monitored for the occurrence of hypocalcemia.

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, worsening heart failure, and/or arrhythmia 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.

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 area under the curve (AUC) was higher than in patients with normal hepatic function.

Serum calcium and serum phosphorus should be measured within 1 week and PTH 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.

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