Posted from: Monday, August 01, 2016 - 02:23 PM - Present

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.

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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.

Last Updated Saturday, November 09, 2019 - 11:17 AM.