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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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About Rayaldee

Rayaldee® (calcifediol) is the only FDA-approved extended-release formulation of 25-hydroxyvitamin D3 (25D) indicated to treat secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.1

What makes Rayaldee different?

Rayaldee takes a dual-action approach to treating SHPT1

Rayaldee increases 25D to the kidneys, becomes 1,25D and is delivered to parathyroid glands, which lowers iPTH.
Rayaldee increases 25D to the kidneys, becomes 1,25D and is delivered to parathyroid glands, which lowers iPTH.

Slowly and reliably increases serum 25D levels to ≥50 ng/mL, avoiding pharmacological surges2,3

25D is gradually converted to 1,25-dihydroxyvitamin D3 (1,25D), primarily in the kidneys but also in other tissues1,2,4

Produces sustained reductions of ≥30% in intact parathyroid hormone (iPTH), which are associated with slower CKD progression5

Has no clinically significant impact on safety parameters (calcium, phosphorus, and FGF23)*2,6

Traditional SHPT treatments may have limitations for CKD patients with SHPT.7

* Calcium: Rayaldee® 0.2 (0.02) mg/dL versus placebo 0.1 (0.03) mg/dL (P<0.001); Phosphorus: Rayaldee® 0.2 (0.03) mg/dL versus placebo 0.1 (0.04) mg/dL.8
MOA video link
Watch this video to see how the gradual, progressive metabolism of Rayaldee leads to decreased iPTH.1,4,8
MOA video link
Watch this video to see how the gradual, progressive metabolism of Rayaldee leads to decreased iPTH.1,4,9
1 time daily

Dosing for Rayaldee

Rayaldee offers once-daily dosing1

  • Before starting treatment, ensure that serum calcium is <9.8 mg/dL1
  • The starting dosage of Rayaldee is 30 mcg administered orally once daily at bedtime1
  • Dosage may be increased to 60 mcg if, after approximately 3 months, iPTH levels remain above the desired therapeutic range1
  • Instruct patients to swallow Rayaldee capsules whole1

If a patient misses a dose

  • Instruct the patient to skip a missed dose and to resume taking the medicine at the next regularly scheduled time1
  • Do not administer an extra dose1

Monitoring serum levels and titrating dosage

The maintenance dosage of Rayaldee should target serum levels of1

  • Total 25D between 30 and 100 ng/mL
  • iPTH within the desired therapeutic range
  • Calcium levels (corrected for low albumin) within the normal range
  • Phosphorus levels <5.5 mg/dL

If iPTH remains above the desired range after approximately 3 months, dosing may be increased to 60 mcg.1

Patient profiles: REAL faces of SHPT

Select a patient to get the whole picture.

* Actual patient records; photos and names do not represent the real patients.
  • CKD Stage 3b (eGFR: 37)
  • Comorbidities: hypertension and sleep apnea
  • BMI of 31.46
  • Medications: antihypertensives; previously diuretics
  • On Medicare

Most recent labs

25D: 15 ng/mL PTH: 126 pg/mL
Blood pressure: 144/80 Calcium: 8.7 mg/dL
Serum creatinine: 2.0 mg/dL Hemoglobin: 12.3 g/dL
Potassium: 4.6 mmol/L Phosphorus: 4.2 mg/dL

Prior care

  • Patient has been seeing his current nephrologist for 1 year; referred by his primary care physician because of his serum creatinine level
  • In the past 12 months, this patient had 2 screenings for 25D and 5 screenings for phosphorus and potassium

Current care

  • Patient seen 2 times in past year
  • Most recent visit included discussion on hypertension management
  • Tests ordered at most recent visit included renal panel, hemoglobin/hematocrit, iron studies, UACR, iPTH, and phosphorus
* Actual patient record; photo and name “Bryan” do not represent the real patient. Actual patient record from the latest chart audit included in Spherix’s RealWorld Dynamix™: CKD Non-Dialysis (US) service, published in December 2020.
  • CKD Stage 3b (eGFR: 30)
  • Comorbidities: type 2 diabetes, anemia, hypertension, coronary artery disease, SHPT, vitamin D deficiency
  • BMI of 30
  • Medications: nutritional vitamin D, antihypertensives, statins
  • On Medicare

Most recent labs

25D: 18 ng/mL PTH: 163 pg/mL
Blood pressure: 123/61 Calcium: 9.3 mg/dL
Serum creatinine: 1.6 mg/dL Glucose: 220 mg/dL
Hemoglobin: 11.2 g/dL Phosphorus: 2.7 mg/dL (referral levels)

Prior care

  • Patient has been seeing her current nephrologist for 2 years, after being referred from the emergency department/hospital because of her serum creatinine level
  • In the past 12 months, this patient had 3 screenings for 25D and 3 screenings for hemoglobin

Current care

  • Patient seen 4 times in past year
  • Most recent visit included discussions on diabetes control, including glucose control and Hba1c levels
  • Tests ordered at most recent visit included basic metabolic panel, renal panel, hemoglobin/hematocrit, and iron studies
* Actual patient record; photo and name “Christina” do not represent the real patient. Actual patient record from the latest chart audit included in Spherix’s RealWorld Dynamix™: CKD Non-Dialysis (US) service, published in December 2020.
  • CKD Stage 4 (eGFR: 22)
  • Comorbidities: hypertension
  • BMI of 22
  • Medications: nutritional vitamin D, angiotensin receptor blockers and other antihypertensive, immunosuppressive, diuretic
  • Has commercial insurance

Most recent labs

25D: 20 ng/mL PTH: 220 pg/mL
Blood pressure: 142/88 Calcium: 8.4 mg/dL
Serum creatinine: 3.6 mg/dL Hemoglobin: 10.5 g/dL
Potassium: 4.7 mmol/L Phosphorus: 4.8 mg/dL

Prior care

  • Patient has been seeing her current nephrologist for 2 years, after being referred because of her serum creatinine level (1.8 mg/dL)
  • In the past 12 months, this patient had 5 screenings for 25D, 3 screenings for PTH, and 5 screenings for phosphorus

Current care

  • Patient seen 2 times in past year
  • Most recent visit was 30 minutes
  • Tests ordered at most recent visit included kidney biopsy, renal panel, hemoglobin/hematocrit, and urine analysis
* Actual patient record; photo and name “Frances” do not represent the real patient. Actual patient record from the latest chart audit included in Spherix’s RealWorld Dynamix™: CKD Non-Dialysis (US) service, published in December 2020.

Abbreviations: 25D, 25-hydroxyvitamin D; BMI, body mass index; eGFR, estimated glomerular filtration rate; iPTH, intact parathyroid hormone; PTH, parathyroid hormone.

References: 1.  Rayaldee. Prescribing information. OPKO Pharmaceuticals, LLC; January 2024. 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. 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 4. Melamed ML, Thadhani RI. Vitamin D therapy in chronic kidney disease and end stage renal disease. Clin J Am Soc Nephrol. 2012(2);7:358-365. doi:10.2215/CJN.04040411 5. 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 6. Ashfaq A, Choe J, Strugnell SA, et al. Adjunctive active vitamin D (AVD) decreases kidney function during treatment of secondary hyperparathyroidism (SHPT) with extended-release calcifediol (ERC) in non-dialysis chronic kidney disease (ND-CKD). Am J Nephrol. Published online February 21, 2025. doi:10.1159/000544086 7. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 clinical practice guideline update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease-mineral and bone disorder (CKD-MBD). Kidney Int Suppl (2011). 2017;7(1):1-59. doi:10.1016/j.kisu.2017.04.001 8. Petkovich M, Bishop CW. Extended-release calcifediol in renal disease. In: Feldman D, ed. Vitamin D, Volume 2: Health, Disease and Therapeutics. 4th ed. Academic Press. 2018;667-678. 9. Sprague SM, Strugnell SA, Bishop CW. Extended-release calcifediol for secondary hyperparathyroidism in stage 3-4 chronic kidney disease. Expert Rev Endocrinol Metab. 2017;12(5):289-301. doi:10.1080/17446651.2017.1347501

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.