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.
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
Potentiated by hypercalcemia of any cause. Monitor serum
calcium and signs and symptoms of digitalis toxicity more
frequently when initiating or adjusting the dose of
Adynamic Bone Disease:
Monitor for abnormally low levels of intact parathyroid
hormone (iPTH) levels when using Rayaldee, and adjust dose
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
Monitor serum calcium, phosphorus, 25-hydroxyvitamin D
and iPTH 3 months after starting therapy or changing
OPKO recommends the use of its products only in accordance
with the Food and Drug Administration (FDA)–approved
prescribing information. Please refer to the full prescribing
information for approved product labeling and important
Please report suspected side effects of Rayaldee to OPKO
Pharmaceuticals, LLC. at 305-575-4226.
For more information about Rayaldee, please contact OPKO
Medical Information at 1-844-729-2539 or
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.
Rayaldee [prescribing information]. Miami, FL:
OPKO Pharmaceuticals, LLC; June 2016.
Sprague SM, Crawford PW, Melnick JZ, et al. Use
of extended-release calcifediol to treat secondary
hyperparathyroidism in stages 3 and 4 chronic kidney
disease. Am J Nephrol. 2016;44:316–325.
Data on file. OPKO Pharmaceuticals,
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