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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Explore the importance of monitoring and managing each of these factors

25D and iPTH

Vitamin D insufficency (defined as 25D <30 ng/mL)

Affects an estimated 71% to 84% of patients with stage 3 or 4 CKD9

Associated with an increased risk for cardiovascular mortality in patients with CKD10

Elevated iPTH (defined as iPTH >70 pg/mL)

Prolonged elevation can cause excessive calcium and phosphorus to be released from the bones, which can lead to:

  • Metabolic bone disease7
  • Calcification of cardiovascular tissue7
  • Calcification of non-cardiovascular tissues6

Calcium and Phosphorus

Calcium and phosphorus dysregulation

Contributes to vascular calcification6

Is associated with cardiovascular disease, the primary cause of death in patients with CKD11

Rayaldee has not been proven to reduce the risk of metabolic bone disease, calcification of CV and non-CV tissues, and CV disease.