Usual Adult Dose for Secondary Hyperparathyroidism

Initial dose: 30 mg orally once a day
Titration: The dose should be titrated no more frequently than every 2 to 4 weeks through sequential doses of 30, 60, 90, 120, and 180 mg orally once a day to target iPTH levels of 150 to 300 pg/mL. (Serum iPTH levels should be assessed no earlier than 12 hours after dosing)
Maximum dose: 180 mg orally once a day

Comments:

• Tablets should be taken whole and not divided.
• This drug should be taken with food or shortly after a meal.
• This drug can be used alone or in combination with vitamin D sterols and/or phosphate binders.
• Serum calcium and serum phosphorus should be measured within 1 week and intact parathyroid hormone (iPTH) should be measured 1 to 4 weeks after initiation or dose adjustment.
• During dose titration, serum calcium levels should be monitored frequently and if levels decrease below the normal range, appropriate steps should be taken, such as by providing supplemental calcium, initiating or increasing the dose of calcium-based phosphate binder, initiating or increasing the dose of vitamin D sterols, or temporarily withholding treatment with this drug.
• Once the maintenance dose has been established, serum calcium should be measured approximately monthly.

Use: Secondary Hyperparathyroidism: For the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (This drug is not indicated for use in adult patients with CKD who are not on dialysis because of an increased risk of hypocalcemia)

Usual Adult Dose for Hypercalcemia of Malignancy

Initial dose: 30 mg orally twice a day
Titration: Titrate dose every 2 to 4 weeks through sequential doses of 30 mg orally twice a day, 60 mg orally twice a day, 90 mg orally twice daily, and 90 mg 3 or 4 times a day
Maintenance dose: 60 to 360 mg orally per day
Maximum dose: 90 mg orally 4 times a day

Comments:

• Tablets should be taken whole and not divided.
• This drug should be taken with food or shortly after a meal.
• Serum calcium should be measured within 1 week after initiation or dose adjustment. Once maintenance dose levels have been established, serum calcium should be measured every 2 to 3 months. After titration to the maximum dose, serum calcium should be periodically monitored; if clinically relevant reductions in serum calcium are not maintained, discontinuation of therapy should be considered.

Use: Parathyroid carcinoma and primary hyperparathyroidism who are unable to undergo parathyroidectomy

Usual Adult Dose for Primary Hyperparathyroidism

Initial dose: 30 mg orally twice a day
Titration: Titrate dose every 2 to 4 weeks through sequential doses of 30 mg orally twice a day, 60 mg orally twice a day, 90 mg orally twice daily, and 90 mg 3 or 4 times a day
Maintenance dose: 60 to 360 mg orally per day
Maximum dose: 90 mg orally 4 times a day

Comments:

• Tablets should be taken whole and not divided.
• This drug should be taken with food or shortly after a meal.
• Serum calcium should be measured within 1 week after initiation or dose adjustment. Once maintenance dose levels have been established, serum calcium should be measured every 2 to 3 months. After titration to the maximum dose, serum calcium should be periodically monitored; if clinically relevant reductions in serum calcium are not maintained, discontinuation of therapy should be considered.

Use: Parathyroid carcinoma and primary hyperparathyroidism who are unable to undergo parathyroidectomy

Renal Dose Adjustments

No dose adjustment recommended

Liver Dose Adjustments

Moderate to severe hepatic impairment increases concentrations of this drug by approximately 2 to 4 fold. In patients with moderate-severe hepatic impairment, PTH and serum calcium concentrations should be closely monitored during dose titration.

Dose Adjustments

For secondary hyperparathyroidism patients with CKD on dialysis, if serum calcium falls below 8.4 mg/dL but remains above 7.5 mg/dL, or if symptoms of hypocalcemia occur, calcium-containing phosphate binders and/or vitamin D sterols can be used to raise serum calcium. If serum calcium falls below 7.5 mg/dL, or if symptoms of hypocalcemia persist and the dose of vitamin D cannot be increased, therapy should be withheld until serum calcium levels reach 8 mg/dL and/or symptoms of hypocalcemia have resolved. Treatment should be reinitiated using the next lowest dose.

Precautions

This drug is not recommended for use in children.

Consult WARNINGS section for additional precautions.

Dialysis

• Doses titrated up to 300 mg once daily have been safely administered to patients on dialysis.
• Since cinacalcet is highly protein bound, hemodialysis is not an effective treatment for overdosage.