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RAYALDEE
Secondary hyperparathyroidism or hypocalcemia
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Drug Name:

RAYALDEE Rx

Generic Name and Formulations:
Calcifediol 30mcg; ext-rel caps.

Company:
OPKO Health Inc.

Therapeutic Use:

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.

Adult:

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.

Children:

Not established.

Warnings/Precautions:

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.

Interactions:

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.

Pharmacological Class:

Vit. D analog.

Adverse Reactions:

Anemia, nasopharyngitis, increased blood creatinine, dyspnea, cough, CHF, constipation, bronchitis, hyperkalemia, osteoarthritis; hypercalcemia, adynamic bone disease.

Generic Availability:

NO

How Supplied:

Caps—30, 60

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