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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Monitoring and dose adjustments1

30 mcg

The maintenance dose of Rayaldee should target:

  • Serum total 25-hydroxyvitamin D levels between 30 and 100 ng/mL
  • iPTH levels within the desired therapeutic range
  • Serum calcium (corrected for low albumin) within the normal range
  • Serum phosphorus <5.5 mg/dL

Monitor serum calcium, serum phosphorus, serum 25D, and iPTH levels at a minimum of 3 months after initiation of therapy or dose adjustment, and subsequently at least every 6 to 12 months.

60 mcg

Dose may be increased to 60 mcg orally once daily at bedtime after approximately 3 months, if iPTH remains above the desired therapeutic range.

Prior to raising the dose, ensure:

  • Serum calcium <9.8 mg/dL
  • Serum phosphorus <5.5 mg/dL
  • Serum 25D <100 ng/mL

Suspend dosing if any of the following occur:

  • iPTH is persistently and abnormally low (to reduce the risk of a dynamic bone disease)
  • Serum calcium is consistently above the normal range (to reduce the risk of hypercalcemia)
  • Serum total 25-hydroxyvitamin D is consistently above 100 ng/mL

Restart at a reduced dose after these laboratory values have normalized.