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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.
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Rayaldee helped significantly more patients with stage 3 or 4 CKD reduce iPTH by ≥30% from baseline and increase 25D to adequate levels (≥30 ng/mL), compared with placebo1