Generic Name and Formulations:
Calcifediol 30mcg; ext-rel caps.
OPKO Health Inc.
Indications for RAYALDEE:
Secondary hyperparathyroidism in adults with chronic kidney disease (CKD) Stages 3 or 4 and serum total 25-hydroxyvitamin D levels <30ng/mL.
Limitations Of use:
Not for secondary hyperparathyroidism in patients with Stage 5 CKD or ESRD on dialysis.
Confirm serum calcium is <9.8mg/dL prior to initiation. Swallow whole. Initially 30mcg once daily at bedtime. If iPTH remains above desired therapeutic range, increase to 60mcg once daily at bedtime after approx. 3 months; prior to dose increase, ensure serum calcium <9.8mg/dL, serum phosphorous <5.5mg/dL, and serum total 25-hydroxyvitamin D <100ng/mL.
History or risk of hypercalcemia. Monitor serum calcium, phosphorus, 25-hydroxyvitamin D, and iPTH at least 3 months after starting or dose changes, then every 6–12 months. Suspend dosing if iPTH is persistently abnormally low, serum calcium consistently above the normal range, or serum total 25-hydroxyvitamin D >100ng/mL; resume at lower dose after values have normalized. Adynamic bone disease. Pregnancy (Cat.C). Nursing mothers.
Potentiated by potent CYP3A inhibitors (eg, ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole); monitor and dose adjustment may be needed. Cholestyramine may impair absorption; monitor and adjust dose. Increased risk of hypercalcemia with concomitant Vit. D, phosphate, calcium-containing products, or thiazide diuretics; monitor more frequently and adjust dose. Caution with concomitant digitalis compounds; monitor for toxicity. Antagonized by phenobarbital, other anticonvulsants, or compounds that stimulate microsomal hydroxylation; monitor and dose adjustment may be needed.
Vit. D analog.
Anemia, nasopharyngitis, increased blood creatinine, dyspnea, cough, CHF, constipation, bronchitis, hyperkalemia, osteoarthritis; hypercalcemia, adynamic bone disease.