Indication and Limitations of Use

Rayaldee® (calcifediol) extended-release 30 mcg capsules is 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. Rayaldee is not indicated in patients with stage 5 chronic kidney disease or end-stage renal disease on dialysis.

×

This website is intended for US Healthcare Professionals

The effect of Rayaldee on serum calcium and phosphorus was similar to placebo1*

Study Design

Mean serum calcium over time in clinical trials2†

Mean data from patient clinical trials do not guarantee individual results.

Mean serum phosphorus over time in clinical trials2†

Mean data from patient clinical trials do not guarantee individual results.

*Patients randomized to Rayaldee had a greater mean (SE) increase in calcium and phosphorus than patients randomized to placebo [Calcium: Rayaldee 0.2 (0.02) mg/dL versus placebo 0.1 (0.03) mg/dL (P<0.001); Phosphorus: Rayaldee 0.2 (0.03) mg/dL versus placebo 0.1 (0.04) mg/dL]. A total of 4.2% of Rayaldee-treated subjects and 2.1% of placebo-treated subjects had at least 1 elevation in calcium above the upper limit of normal (10.5 mg/dL). A total of 45% of Rayaldee-treated subjects and 44% of placebo-treated subjects had at least one elevation in phosphorus above the upper limit of normal (4.5 mg/dL).2