• Secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels <30 ng/mL.

Contraindicated in:

• Hypercalcemia.

Use Cautiously in:

• OB: Safety not established
• Lactation: Use while breastfeeding only if potential maternal benefits justify potential risks to infant
• Pedi: Safety and effectiveness not established in children.

CV: HF, arrhythmias.

F and E: HYPERCALCEMIA, hyperkalemia, hyperphosphatemia, polydipsia.

GI: constipation, nausea, vomiting.

GU: ↑serum creatinine, polyuria.

Hemat: anemia.

Metab: ↓appetite, ↓ weight.

MS: adynamic bone disease, fractures.

Neuro: SEIZURES, confusion.

Resp: bronchitis, cough, dyspnea.

Misc: fatigue.

Drug-Drug:

• May potentiate effects of digoxin on heart, including ↑ risk of arrhythmias.
• Calcium-containing drugs, thiazide diuretics, and other vitamin D analogs may ↑ risk of hypercalcemia.
• CYP450 inhibitors, including atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and voriconazole may ↑ levels and risk of hypercalcemia.
• Carbamazepine, phenobarbital, phenytoin, and rifampin may ↓ levels and effectiveness.
• Cholestyramine may ↓ absorption and effectiveness.

Drug-Food:

• Ingestion of foods high in calcium content (see Appendix M) and foods high in phosphate content may lead to hypercalcemia and hyperphosphatemia.

• Extended-release capsules: 30 mcg;

• PO (Adults): 30 mcg once daily at bedtime; if desired intact PTH level remains elevated after 3 mo, ↑ to 60 mcg once daily at bedtime. Maintenance dose should target total 25-hydroxyvitamin D levels of 30–100 ng/mL, intact PTH levels within desired therapeutic range, serum calcium <9.8 mg/dL, and serum phosphorus 5.5 mg/dL.

Rayaldee

• Calcifediol is a prohormone of the active form of vitamin D₃, calcitriol. Promotes the absorption of calcium and phosphorus and decreases intact parathyroid hormone (PTH) concentrations.

• Reduction in intact PTH concentrations with improved calcium and phosphorous homeostasis.

Therapeutic Classification: vitamins

Pharmacologic Classification: fat soluble vitamins

Absorption: Absorption increased with high-fat meals.

Distribution: Well distributed to extravascular tissues.

Protein Binding: >98%.

Metabolism/Excretion: Converted to calcitriol by the 1-alpha-hydroxylase enzyme, CYP27B1, in kidney; also metabolized by CYP24A1 to inactive metabolites. Primarily excreted in feces.

Half-life: 25 days.

(reduction in plasma intact PTH concentrations)

• Instruct patient to take calcifediol as directed. If a dose is missed, omit and take next dose at the next regularly scheduled time; do not double doses.
• Advise patient to notify health care professional if signs and symptoms of hypercalcemia occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products.
• Emphasize importance of routine lab tests.
• Rep: Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Monitor infants exposed to calcifediol through breast milk for signs and symptoms of hypercalcemia, including seizures, vomiting, constipation and weight loss. Consider monitoring of serum calcium in the infant.

kal-si-fe-DYE-ol

NDC Code^*

• 70301- OPKO Pharmaceuticals LLC
  • 70301-1001- Rayaldee
    • 70301-1001-1- 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-1)

• 70301- OPKO Pharmaceuticals LLC
  • 70301-1001- Rayaldee
    • 70301-1001-2- 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-2)