Safety

Side Effects Reported in Phase 3 Studies

The most commonly reported side effects were nausea, vomiting, and diarrhea1

The most commonly reported side effects of Sensipar® were nausea, vomiting, and diarrhea. The most commonly reported side effects of Sensipar® were nausea, vomiting, and diarrhea.

Study Design

Results are pooled from three phase 3, 6-month, multicenter, randomized, double-blind, placebo-controlled clinical studies comparing Sensipar® with placebo in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (HPT) on dialysis with intact parathyroid hormone (iPTH) ≥ 300 pg/mL and serum calcium (Ca) ≥ 8.4 mg/dL (N = 1136). Patients in both treatment arms could be treated with vitamin D sterols and/or phosphate binders. Sensipar® dose was titrated sequentially every 4 weeks unless iPTH ≤ 200 pg/mL, Ca < 7.8 mg/dL, or an adverse event precluded a dose increase. If Ca < 8.4 mg/dL or symptomatic hypocalcemia developed, calcium supplement and/or phosphate binder dose could be increased. If these measures were insufficient, vitamin D dose could be increased. Mean baseline iPTH values in the Sensipar® group and placebo group were 733 pg/mL and 683 pg/mL, respectively. The primary endpoint of the studies was the proportion of patients achieving parathyroid hormone (PTH) level ≤ 250 pg/mL during the efficacy assessment phase. Patients were followed for a total of 26 weeks and were eligible for a 6-month extension, totaling 12 months of therapy.1


Reference

  • 1. Sensipar® (cinacalcet) prescribing information, Amgen.

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Indications

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

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

Sensipar® (cinacalcet) is indicated for the treatment of hypercalcemia in patients with Parathyroid Carcinoma.

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.

Indications

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

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

Sensipar® (cinacalcet) is indicated for the treatment of hypercalcemia in patients with Parathyroid Carcinoma.

Important Safety Information

Sensipar® (cinacalcet) 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. 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.

In clinical trials of patients with secondary HPT comparing Sensipar® to placebo, the most commonly reported side effects were nausea (31% vs. 19%), vomiting (27% vs. 15%), and diarrhea (21% vs. 20%).

Please see Full Prescribing Information

Reference

  1. Sensipar® (cinacalcet) prescribing information, Amgen.
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