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

For immediate product information please refer to the Full Prescribing Information.

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phone 800-77-AMGEN (800-772-6436) or visit Amgen MedInfo.

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 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.

Patients with secondary HPT: 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.

Patients with parathyroid carcinoma or primary HPT: Serum calcium should be measured within 1 week after initiation or dose
adjustment of Sensipar®. Once maintenance dose levels have been established, serum calcium should be measured every 2 months.

The most commonly reported side effects in clinical trials of patients with secondary HPT were nausea, vomiting, and diarrhea.

The most commonly reported side effects in clinical trials of patients with parathyroid carcinoma or primary HPT were nausea,
vomiting, and paresthesia.