Dosage, Safety, and Monitoring in Parathyroid Carcinoma

Dosage for treatment of hypercalcemia in parathyroid carcinoma with Sensipar®

Recommended starting dose: 30 mg twice daily. Titrate every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg 3 or 4 times daily as necessary to normalize serum calcium.¹

Safety profile

The most frequent adverse events associated with Sensipar® treatment of parathyroid carcinoma were nausea and vomiting.¹

Sensipar® monitoring in patients with parathyroid carcinoma¹

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
Sensipar® should be taken with food or shortly after a meal
Sensipar® should be taken whole and not divided

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Important Safety Information

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.

Sensipar® lowers serum calcium; therefore, it is important that patients have a serum calcium ≥ 8.4 mg/dL when initiating therapy.

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 HCl) prescribing information, Amgen.