About Rayaldee

Dosing for Rayaldee

Moon and stars. Rayaldee is taken at bedtime.

Rayaldee offers once-daily dosing.1

Before starting treatment, ensure that serum calcium is <9.8 mg/dL.1

The starting dosage of Rayaldee is 30 mcg administered orally once daily at bedtime.1

Dosage may be increased to 60 mcg if, after approximately 3 months, intact parathyroid hormone (iPTH) levels remain above the desired therapeutic range.1

Instruct patients to swallow Rayaldee capsules whole.1

Moon and stars. Rayaldee is taken at bedtime.

The starting dosage of Rayaldee is 30 mcg administered orally once daily at bedtime.1

Dosage may be increased to 60 mcg if, after approximately 3 months, intact parathyroid hormone (iPTH) levels remain above the desired therapeutic range.1

Instruct patients to swallow Rayaldee capsules whole.1

Monitoring serum levels and titrating dosage

The maintenance dosage of Rayaldee should target serum levels of1

Arrow and target.

The maintenance dosage of Rayaldee should target serum levels of1

Total 25-hydroxyvitamin D [25(OH)D] between 30 and 100 ng/mL
Intact parathyroid hormone (iPTH) within the desired therapeutic range
Calcium levels (corrected for low albumin) within the normal range
Phosphorus levels <5.5 mg/dL
Arrow and target

Rayaldee takes a dual-action approach to treating SHPT1

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

Rayaldee® (calcifediol) extended-release capsules offers a dual-action approach by gradually raising 25-hydroxyvitamin D [25(OH)D] and lowering intact parathyroid hormone (iPTH) levels in adults with secondary hyperparathyroidism (SHPT) and stage 3 or 4 chronic kidney disease (CKD) and insufficient vitamin D levels.1,2,4

Watch this video to see how the gradual, progressive metabolism of Rayaldee leads to decreased iPTH.1,3,4

The faces of SHPT

Select a patient to get the whole picture

Smiling woman standing with her arms comfortably crossed.

Stacy is a proud grandmother of newborn twins. You have recently diagnosed SHPT. You are looking for a proactive treatment that will help optimally manage her 25(OH)D and iPTH levels early on and into the later stages of CKD (3 & 4).

Actor portrayal does not represent real patient.

CKD 3A 25(OH)D 10 ng/mL
iPTH 188 pg/mL Ca 9.6 mg/dL

Do you see patients like Stacy in your practice?

Learn how Rayaldee may help
Smiling woman standing with her arms comfortably crossed.

Gina has entered retirement and is excited to start this new stage in her life. You’re happy for her but concerned because her iPTH level is heading in the wrong direction despite her taking nutritional vitamin D. You are frustrated with the lack of control and want to consider different options.

Actor portrayal does not represent real patient.

CKD 3B 25(OH)D 22 ng/mL
iPTH 139 pg/mL Ca 9.4 mg/dL

Do you see patients like Gina in your practice?

Learn how Rayaldee may help
Smiling man standing with his hands in his pockets.

Harold has been taking active vitamin D for a while now, and you are noticing that his iPTH level is still rising and his 25(OH)D level is low. In addition, you are concerned about the risk of hypercalcemia associated with active vitamin D use and think it may be time for a switch.

Actor portrayal does not represent real patient.

CKD 4 25(OH)D 17 ng/mL
iPTH 209 pg/mL Ca 9.7 mg/dL

Do you see patients like Harold in your practice?

Learn how Rayaldee may help

*Not actual patient

References: 1. Rayaldee [package insert]. Miami, FL: OPKO Pharmaceuticals, LLC; June 2016. 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. 3. 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. 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.

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.

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.