Rx Item-RAYALDEE- calcifediol capsule, 30 extended release by Opko Pharma

For: Secondary Hyperparathyroidism

Rayaldee (calcifediol) is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism associated with vitamin D Insufficiency in stage 3-4 chronic kidney disease. These highlights do not include all the information needed to use RAYALDEE® safely and effectively. See full prescribing information for RAYALDEE.

RAYALDEE® (calcifediol) extended-release capsules, for oral use
Initial U.S. Approval: 2016
INDICATIONS AND USAGE

RAYALDEE is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. (1)

Limitations of Use:

RAYALDEE is not indicated in patients with stage 5 chronic kidney disease or end-stage renal disease on dialysis. (1)
DOSAGE AND ADMINISTRATION

•
The initial dose of RAYALDEE is 30 mcg administered orally once daily at bedtime. Serum calcium should be below 9.8 mg/dL before initiating treatment. (2)
•
Monitor serum calcium, phosphorus, 25-hydroxyvitamin D and intact parathyroid hormone (PTH) 3 months after starting therapy or changing dose. (2.2, 5.3)
•
Increase the dose to 60 mcg once daily after 3 months if intact PTH is above the treatment goal. Ensure serum calcium is below 9.8 mg/dL, phosphorus is below 5.5 mg/dL and 25-hydroxyvitamin D is below 100 ng/mL before increasing the dose. (2.2)
•
Suspend dosing if intact PTH is persistently abnormally low, serum calcium is consistently above the normal range or serum 25-hydroxyvitamin D is consistently above 100 ng/mL. (2.2)

DOSAGE FORMS AND STRENGTHS

Extended-release 30 mcg capsules (3)
CONTRAINDICATIONS

None (4)
WARNINGS AND PRECAUTIONS

•
Hypercalcemia: Excessive administration of vitamin D compounds, including RAYALDEE, can cause hypercalcemia and hypercalciuria. Severe hypercalcemia due to substantial overdosage of vitamin D and its metabolites may require emergency attention. Patients should be informed about the symptoms of elevated calcium. (5.1)
•
Digitalis toxicity: Potentiated by hypercalcemia of any cause. Monitor serum calcium and signs and symptoms of digitalis toxicity more frequently when initiating or adjusting the dose of RAYALDEE. (5.2)
•
Adynamic Bone Disease: Monitor for abnormally low levels of intact PTH levels when using RAYALDEE, and adjust dose if needed. (2.2, 5.3)

ADVERSE REACTIONS

The most common adverse reactions (≥3% and more frequent than placebo) were anemia, nasopharyngitis, increased blood creatinine, dyspnea, cough, congestive heart failure and constipation. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact OPKO Pharmaceuticals, LLC at 1-844-729-2539 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS

•
Co-administration of cytochrome P450 inhibitors, such as ketoconazole, may alter serum levels of calcifediol. (7.1)
•
Co-administration of thiazides may cause hypercalcemia. (7.2)
•
Cholestyramine may impair the absorption of calcifediol. (7.3)
•
The half-life of calcifediol is reduced by drugs stimulating microsomal hydroxylation, such as phenobarbital or other anticonvulsants. (7.4)

USE IN SPECIFIC POPULATIONS

•
Lactation: Monitor infants exposed to RAYALDEE through breast milk for seizures, vomiting, constipation and weight loss. (8.2)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2019

RAYALDEE- calcifediol capsule,
RAYALDEE- calcifediol capsule, extended release by Opko Pharma

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RAYALDEE- calcifediol capsule,
RAYALDEE- calcifediol capsule, extended release by Opko Pharma

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