calcifediol
Drug Details
- Generic Name
- calcifediol
- Brand Names
- Rayaldee
- Application Number
- NDA208010
- Sponsor
- OPKO Pharmaceuticals LLC
- NDC Codes
- 2
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- CALCIFEDIOL
Indications and Usage
1 INDICATIONS AND USAGE RAYALDEE is a vitamin D 3 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Limitations of Use RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis. RAYALDEE is a vitamin D 3 analog indicated for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. ( 1 ) Limitations of Use: RAYALDEE is not indicated in patients with stage 5 chronic kidney disease or end-stage renal disease on dialysis. ( 1 )