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Rayaldee Generic Name & Formulations
Legal Class
Rx
General Description
Calcifediol 30mcg; ext-rel caps.
Pharmacological Class
Vit. D analog.
How Supplied
Caps—30, 60
Manufacturer
Generic Availability
NO
Rayaldee Indications
Indications
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.
Rayaldee Dosage and Administration
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.
Rayaldee Contraindications
Not Applicable
Rayaldee Boxed Warnings
Not Applicable
Rayaldee Warnings/Precautions
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. Nursing mothers: monitor infants.
Rayaldee Pharmacokinetics
See Literature
Rayaldee Interactions
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.
Rayaldee Adverse Reactions
Adverse Reactions
Anemia, nasopharyngitis, increased blood creatinine, dyspnea, cough, CHF, constipation, bronchitis, hyperkalemia, osteoarthritis; hypercalcemia, adynamic bone disease.
Rayaldee Clinical Trials
See Literature
Rayaldee Note
Not Applicable
Rayaldee Patient Counseling
See Literature
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