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
Rayaldee is not indicated in patients with stage 5 chronic kidney disease or end-stage renal disease on dialysis.
Important Safety Information:
Hypercalcemia: Excessive administration of vitamin D
compounds, including Rayaldee, can cause hypercalcemia and hypercalciuria.
Severe hypercalcemia due to substantial overdosage of vitamin D and its
metabolites may require emergency attention. Patients should be informed about the symptoms of elevated calcium.
Digitalis toxicity: Potentiated by hypercalcemia of any cause.
Monitor serum calcium and signs and symptoms of digitalis toxicity more frequently when initiating or adjusting the dose
Adynamic Bone Disease: Monitor for abnormally low levels of intact parathyroid hormone (iPTH) levels when using Rayaldee, and adjust dose if needed.
The most common adverse reactions (≥3% and more frequent than placebo) were anemia, nasopharyngitis, increased blood creatinine, dyspnea, cough, congestive heart failure and constipation.
Care should be taken while dosing Rayaldee with cytochrome P450 inhibitors, thiazides, cholestyramine or drugs stimulating microsomal hydroxylation due to the potential for drug interactions.
Serum calcium should be below 9.8 mg/dL before initiating treatment.
Monitor serum calcium, phosphorus, 25-hydroxyvitamin D and iPTH 3 months after starting therapy or changing dose.
Please see Full Prescribing Information.