OPKO Announces U.S. Launch Of RAYALDEE™

MIAMI, Nov. 23, 2016 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (Nasdaq:OPK), today announced that it will commence shipments of RAYALDEE™ (calcifediol) extended-release capsules to distributors in the United States on Tuesday, November 29, 2016.  The product will be available nationwide at retail pharmacies as early as Wednesday, November 30, 2016. 

The U.S. launch of RAYALDEE follows the successful introduction of the product to thousands of nephrologists attending the American Society of Nephrology (ASN) Kidney Week Meeting last week in Chicago.  RAYALDEE was approved by the U.S. Food and Drug Administration (FDA) on June 17, 2016.

"The RAYALDEE launch represents a major milestone for OPKO," commented Phillip Frost, M.D., CEO and Chairman of OPKO.  "RAYALDEE is the first product developed by OPKO to be commercialized by our own marketing and sales teams, and represents an important contribution to the care of patients with chronic kidney disease.  Based on the highly positive reception of RAYALDEE by nephrologists attending the recent ASN meeting, we believe that RAYALDEE will become a mainstay in the armamentarium of treatment options available for kidney disease patients."


RAYALDEE (calcifediol) extended-release capsules are approved by the FDA for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.  RAYALDEE is not indicated for the treatment of SHPT in patients with stage 5 CKD or end-stage renal disease on dialysis.  RAYALDEE has a patented formulation and is designed to raise serum total 25-hydroxyvitamin D (prohormone) concentrations to targeted levels (at least 30 ng/mL) and to reduce elevated intact parathyroid hormone (iPTH).  The full prescribing information for RAYALDEE is available at www.rayaldee.com.

Potential side effects of RAYALDEE include hypercalcemia (elevated serum calcium), which can also lead to digitalis toxicity, and adynamic bone disease with subsequent increased risk of fractures if intact PTH levels are suppressed by RAYALDEE to abnormally low levels.  Severe hypercalcemia may require emergency attention; symptoms of hypercalcemia may include feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination, and weight loss.  Digitalis toxicity can be potentiated by hypercalcemia of any cause.  Excessive administration of RAYALDEE can cause hypercalciuria, hypercalcemia, hyperphosphatemia, or oversuppression of iPTH.  Common symptoms of vitamin D overdosage may include constipation, decreased appetite, dehydration, fatigue, irritability, muscle weakness, or vomiting.  Patients concomitantly taking cytochrome P450 inhibitors, thiazides, cholestyramine, phenobarbital or other anticonvulsants may require dose adjustments and more frequent monitoring.

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