For US healthcare professionals only. Healthcare professionals outside of the US: click here.
These downloadable information sheets, guides, and tools, as well as links to clinical guidelines, professional associations, and other helpful resources, are provided to help support healthcare providers like you in your work with patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT).
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Capsule transition information sheet |
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Capsule transition FAQs |
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Information for patients: How to stay on track with Rayaldee treatment |
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Rayaldee Patient Sticker with ICD-10 codes |
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Clinician-patient conversation guide (National Kidney Foundation): How kidney disease affects bone and heart health; includes reference levels, treatments, and nutritional considerations |
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Information for patients (National Kidney Foundation): How kidney disease can lead to bone and heart disease; includes space to record lab results |
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Infographic poster for patients (National Kidney Foundation): How kidney disease can lead to bone and heart disease |
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KDIGO CKD-MBD Quick Reference Guide: Recommendation statements updated in 2017 and those unchanged from 2009 |
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Information and resources for healthcare providers about CKD-MBD, SHPT, vitamin D deficiency, and other related conditions | National Kidney Foundation |
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American Society of Nephrology (ASN) |
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National Kidney Foundation (NKF) |
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Renal Physicians Association (RPA) |
Watch to learn more about Rayaldee, CKD, and SHPT. Find out about the resources available to help your patients access the medication you’ve prescribed, and keep up with informative presentations and discussion of treatment.
Rayaldee Reimbursement Navigation Guide for Healthcare Providers
What Is OPKO Connect, and How Can It Help My Patients Receive Rayaldee?
Mechanism of Action of Rayaldee® (calcifediol)
Management of Secondary Hyperparathyroidism: a Patient Case (Presented by Dr. Stuart Sprague, DO, FACP, FASN, FNKF)
Rationale for Raising Current Clinical Practice Guideline Targets for Serum 25D in CKD | RPA Satellite Symposium 2019
Rayaldee Capsule Extended-Release Formulation (Updated)
Read the latest press releases from OPKO, and stay current on information about Rayaldee, including recent publications with informative assessments and evaluation of SHPT treatment.
PLoS One 2023. doi:10.1371/journal.pone.0283531
Am J Nephrol 2021. doi:10.1159/000518545
Expert Rev Endocrinol Metab 2017. doi:10.1080/17446651.2017.1347501
J Steroid Biochem Mol Biol 2015. doi:10.1016/j.jsbmb.2014.11.022
Am J Nephrol 2014. doi:10.1159/000369939
Kidney Dis 2023. doi:10.1159/000529523
BMC Nephrol 2022;23(1):362. doi:10.1186/s12882-022-02993-3
Clin J Am Soc Nephrol 2020;15(7):1041-1043.
Am J Nephrol 2019;49(4):281-283
Am J Nephrol 2019;49(4):284-293
Am J Nephrol 2016;44(4):316-325
Beginning March 2024, Rayaldee transitions from a blue oval soft capsule to a white two-piece banded hard capsule. Find answers to common questions about the transition.
OPKO decided to bring manufacturing capabilities in-house, which led to a change in the capsule's appearance.
No, the pharmacokinetic profile remains the same. The new hard capsule has been tested to ensure it delivers the same amount of active ingredient in the body as the original soft capsule.
There are no changes in the stability or the expiration date of the product. The hard capsule meets the same stability criteria as the soft capsule.
The components of the hard capsule are commonly used in pharmaceuticals and do not contain any allergens not already present in the soft capsule form. However, you should always check the full list of excipients if your patient has known allergies.
No, there are no changes in how Rayaldee should be administered. The dosing and administration instructions remain consistent with the soft capsule.
Patients should be informed that although the capsule's appearance has changed, the efficacy, safety, and dosing remain the same. It's important to reassure them that they will receive the same therapeutic benefits. Patients can find more information here.
No, there are no new interactions expected due to the change in capsule form. The interaction profile for Rayaldee remains the same.
The absorption rate of Rayaldee with the new hard capsule has been shown to be equivalent to the original soft capsule.
No, Rayaldee should be stored in the same conditions as before: at room temperature (at 20° C to 25° C / 68° F to 77° F), away from moisture and direct light.
There are no new contraindications or precautions specific to the hard capsule form. The prescribing information remains consistent with the previous formulation.
Healthcare providers should always refer to the latest prescribing information provided by OPKO for the most up-to-date product details.
If you have further questions or need additional clarification, please contact the OPKO Medical Affairs department at 1-844-729-2539.
Yes, the new NDC number for the hard capsule is 70301-1002-1. Pharmacists should ensure they are using the correct number when processing prescriptions.
It's important to rotate stock to ensure the soft capsules are dispensed first. Pharmacists should monitor inventory closely and communicate with suppliers to manage the transition smoothly.
The capsule change should not affect the price or insurance coverage. However, it is always recommended to verify with the specific insurance plans.
Yes, with the new NDC numbers, the barcodes will also change. Pharmacists should update their systems accordingly.
Yes, pharmacists will need to update their pharmacy management systems with the new NDC number and ensure that the product information reflects the current form of the medication.
If you have further questions or need additional clarification, please contact Rayaldee’s patient hub services, OPKO Connect, at 1-844-414-OPKO (6756).
Please see Full Prescribing Information.
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.
Please see Full Prescribing Information.
