Cinacalcet
Drug Details
- Generic Name
- Cinacalcet
- Brand Names
- Cinacalcet, Cinacalcet Hydrochloride, CINACALCET
- Application Number
- ANDA209403
- Sponsor
- XLCare Pharmaceuticals Inc.
- NDC Codes
- 38
- Dosage Forms
- TABLET, FILM COATED, TABLET
- Routes
- ORAL
- Active Ingredients
- CINACALCET HYDROCHLORIDE
Indications and Usage
1 INDICATIONS & USAGE Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis (1.1) Limitations of Use: Cinacalcet is not indicated for use in patients with CKD who are not on dialysis. Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2) Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. (1.3) 1.1 Secondary Hyperparathyroidism Cinacalcet are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis [see Clinical Studies ( 14.1 )]. Limitations of Use: Cinacalcet is not indicated for use in adult patients with CKD who are not on dialysis because of an increased risk of hypocalcemia [see Warnings and Precautions ( 5.1 )]. 1.2 Parathyroid Carcinoma Cinacalcet is indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma [see Clinical Studies ( 14.2) ] . 1.3 Primary Hyperparathyroidism Cinacalcet are indicated for the treatment of severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy [ see Clinical Studies (14.3) ].