Secondary Hyperparathyroidism Rayaldee Approved
June 17, 2016 – The U.S. FDA approved Rayaldee® (calcifediol) extended-release capsules, manufactured by OPKP Health, for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and with serum total 25-hydroxyvitamin D levels less than 30ng/mL. The initial recommended dose is 30mcg once daily at bedtime. Rayaldee can be increased to 60mcg after three months if intact parathyroid hormone is above the treatment goal. OPKO Health plans to launch Rayaldee in the second half of 2016.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.