About

About OPKO RENAL The Renal Division of OPKO Health, Inc. develops proprietary products for secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD). Its lead product, Rayaldee® (calcifediol) extended-release capsules, launched in 2016, treats SHPT in adults with stage 3 or 4 CKD and serum total 25-hydroxyvitamin D <30 ng/mL. It is not indicated in stage 5 CKD or dialysis. Rayaldee carries risks: hypercalcemia, digitalis toxicity, and adynamic bone disease; monitoring of calcium and iPTH is required. Common adverse reactions (≥3%) include anemia, nasopharyngitis, increased creatinine, dyspnea, cough, CHF, and constipation. Use caution with CYP450 inhibitors, thiazides, cholestyramine, or drugs that stimulate microsomal hydroxylation. Serum calcium must be <9.8 mg/dL before starting treatment. OPKO is also developing therapies for hyperphosphatemia to improve SHPT management in CKD.