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.
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OPKO Connect provides comprehensive support
Patient assistance programs
For patients identified as not having affordable access to Rayaldee therapy, OPKO offers a free drug patient assistance program; eligibility criteria apply and annual re-enrollment is required.
Copay assistance
With this program, eligible commercially insured patients can fill their Rayaldee prescription for no more than $5 per month until the annual maximum limit is reached.
Starter dose program
This program provides a one-time-only free, 14-day supply of product to eligible patients whose initial Rayaldee coverage determination is delayed more than 5 days based on payer review timelines.
Prior authorization support
Can assist with any insurer-required PAs for Rayaldee on behalf of patients.
For information on how to request
exception coverage for Medicare Part D beneficiaries please visit www.cms.gov.
OPKO Connect services are available
by phone at 844‑414‑6756
Monday through Friday, 8 AM‑8 PM ET
Please see Full Prescribing Information.
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 safety information.
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 medicalinformation@opko.com.
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.
1,25D = 1,25-dihydroxyvitamin D
25D = 25-hydroxyvitamin D
CKD = chronic kidney disease
CV = cardiovascular
iPTH = intact parathyroid hormone
SHPT = secondary hyperparathyroidism
RAYALDEE is a registered trademark of OPKO Ireland Global Holdings Ltd.
OPKO Renal is a division of OPKO Health, Inc.
© 2017 OPKO Pharmaceuticals, LLC. All rights reserved.
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