INDICATIONS AND USAGE（适应症）

Secondary Hyperparathyroidism

Cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.

Limitations of Use:

Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia.

Parathyroid Carcinoma

Cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma.

Primary Hyperparathyroidism

Cinacalcet tablets are indicated for the treatment of severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy.

DOSAGE（服用剂量）

Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease on Dialysis

The recommended starting oral dose of cinacalcet tablets is 30 mg once daily. 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 of cinacalcet tablets. Cinacalcet tablets should be titrated no more frequently than every 2 to 4 weeks through sequential doses of 30, 60, 90, 120, and 180 mg once daily to target iPTH levels of 150 to 300 pg/mL. Serum iPTH levels should be assessed no earlier than 12 hours after dosing with cinacalcet tablets.

Cinacalcet tablets can be used alone or in combination with vitamin D sterols and/or phosphate binders.

During dose titration, serum calcium levels should be monitored frequently and if levels decrease below the normal range, appropriate steps should be taken to increase serum calcium levels, 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 cinacalcet tablets.

Patients with Parathyroid Carcinoma and Primary Hyperparathyroidism

The recommended starting oral dose of cinacalcet tablets is 30 mg twice daily.

The dose of cinacalcet tablets should be titrated every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, and 90 mg twice daily, and 90 mg 3 or 4 times daily as necessary to normalize serum calcium levels. Serum calcium should be measured within 1 week after initiation or dose adjustment of cinacalcet tablets.

ADVERSE REACTIONS（不良反应）

Hypocalcemia

Upper Gastrointestinal Bleeding

Hypotension, Worsening Heart Failure and/or Arrhythmias

Adynamic Bone Disease

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/42e99112-c402-4662-877f-9e3a84dff9f2/spl-doc?hl=Cinacalcet

Cinacalcetinformation