For US healthcare professionals only. Healthcare professionals outside of the US: click here.

Indication
Important Safety Information
Prescribing Information
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For US healthcare professionals only.
Healthcare professionals outside of the US: click here.

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Real Results.
Real Benefits.

That’s Rayaldee®.

Not an actual patient.

 Lowers iPTH1,2

 May slow CKD progression*3

 Raises 25D1,2

 Established safety profile1,4

*

Rayaldee is not indicated to treat CKD progression.

Not an actual patient.

*

Rayaldee is not indicated to treat CKD progression.

Get REAL results for your SHPT patients with Rayaldee (calcifediol)

Rayaldee is the only FDA-approved extended-release formulation of 25-hydroxyvitamin D3 (25D) for your adult patients with stage 3 or 4 chronic kidney disease (CKD), secondary hyperparathyroidism (SHPT), and vitamin D insufficiency (VDI)2,4 designed to:

  • Reliably raise mean serum 25D to ≥50 ng/mL despite obesity1,2,5
  • Gradually raise serum 1,25-dihydroxyvitamin D in both stages 3 and 4 CKD1,2
  • Achieve sustained >30% intact parathyroid hormone (iPTH) reductions associated with slower CKD progression3
  • Produce no clinically significant increases in serum calcium (Ca), phosphorus (P), or FGF231,2
  • Have a safety profile similar to that of placebo2†
† Pooled data from 2 pivotal trials showed similar mean increases (mean [SE]) in serum Ca (0.2 [0.02] vs 0.1 [0.03] mg/dL, P < 0.001) and P (0.2 [0.03] vs 0.1 [0.04] mg/dL) for Rayaldee and placebo over 6 months.2
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References: 1. Strugnell SA, Sprague SM, Ashfaq A, Petkovich M, Bishop CW. Rationale for raising current clinical practice guideline target for serum 25-hydroxyvitamin D in chronic kidney disease. Am J Nephrol. 2019;49(4):284-293. doi:10.1159/000499187 2. 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(4):316-325. doi:10.1159/000450766 3. Bishop CW, Ashfaq A, Strugnell SA, et al. Sustained reduction of elevated intact parathyroid hormone concentrations with extended-release calcifediol slows chronic kidney disease progression in secondary hyperparathyroidism patients. Am J Nephrol. Published online August 27, 2024. doi:10.1159/000541138 4. Rayaldee. Prescribing information. OPKO Pharmaceuticals, LLC; January 2024. 5. Bishop CW, Strugnell SA, Csomor P, Kaiser E, Ashfaq A. Extended-release calcifediol effectively raises serum total 25-hydroxyvitamin D even in overweight nondialysis chronic kidney disease patients with secondary hyperparathyroidism. Am J Nephrol. 2022;53(6):446-454. doi:10.1159/000524289

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 of Rayaldee.
  • 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.

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.

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 of Rayaldee.
  • 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.