Sensipar HCP Home

Benefits of Initiating Sensipar® Earlier

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Simultaneous Control of Parathyroid Hormone (PTH) and Phosphorus

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Improving Care for Patients
Monitoring and Titration Are Key

Patient Support Materials

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.

References

Sensipar® (cinacalcet) prescribing information, Amgen.
Moe SM, Chertow GM, Coburn JW, et al. Achieving NKF-K/DOQI™ bone metabolism and disease treatment goals with cinacalcet HCl. Kidney Int. 2005;67:760-771.
National Kidney Foundation. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis. 2003;42(suppl 3):S1-S201.
Data on file, Amgen.

*KDOQI™ goal was defined as mean iPTH ≤ 300 pg/mL.

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