Simultaneous Control of Parathyroid Hormone and Calcium

Starting Sensipar® earlier helped more dialysis patients achieve simultaneous control of parathyroid hormone (PTH) and calcium¹

In the phase 3 trials, more dialysis patients achieved PTH and calcium goals when Sensipar® was added to traditional therapy earlier (iPTH 300 - 500 pg/mL) compared with initiating therapy later in the course of disease (iPTH > 800 pg/mL).¹ Traditional therapy included vitamin D and phosphate binders, if prescribed.

Phase 3 results were based on three 6-month, multicenter, randomized, double-blind, placebo-controlled clinical studies conducted in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (HPT) on dialysis (N = 1,136).²

More patients achieved PTH and calcium goals with earlier initiation of Sensipar®¹

Data on file, Amgen.¹

Pooled phase 3 studies published in: Moe et al, Kidney Int, 2005.² Click here for Phase 3 summary description.

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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

Data on file, 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.

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Simultaneous Control of Parathyroid Hormone and Calcium

Starting Sensipar® earlier helped more dialysis patients achieve simultaneous control of parathyroid hormone (PTH) and calcium1

More patients achieved PTH and calcium goals with earlier initiation of Sensipar®1

Important Safety Information

References

Starting Sensipar® earlier helped more dialysis patients achieve simultaneous control of parathyroid hormone (PTH) and calcium¹

More patients achieved PTH and calcium goals with earlier initiation of Sensipar®¹