Calcifediol

Calcifediol Brand Names- Calderol | RAYALDEE

What is Calcifediol

Calcifediol, or 25-hydroxycholecalciferol, is a fat-soluble vitamin D3 analog. It is a prohormone that is structurally similar to calcitriol; however, calcifediol has less vitamin D activity than calcitriol.

Vitamin D has two primary forms: ergocalciferol (vitamin D2), which is produced from plant sterols and is the primary dietary source of vitamin D, and cholecalciferol (vitamin D3), which is synthesized in the skin after exposure to ultraviolet light. Unlike nutritional vitamin D, calcifediol does not require hepatic conversion to correct 25-hydroxyvitamin D concentrations, a process that may be impaired in patients with chronic kidney disease.

Calcifediol has been shown to more effectively increase serum 25-hydroxyvitamin D compared with ergocalciferol or cholecalciferol and is more readily absorbed.

Calcifediol is indicated for the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D concentrations less than 30 ng/mL.

SHPT occurs when excessive intact parathyroid hormone (iPTH) is secreted by the parathyroid gland; it occurs in patients with stage 3 or 4 chronic kidney disease from either vitamin D insufficiency of renal insufficiency.

Calcifediol effectively treats SHPT by reliably correcting vitamin D insufficiency. Unlike other vitamin D analogs (i.e., calcitriol, doxercalciferol, paricalcitol), calcifediol effectively treats SHPT without significant hypercalcemia and hyperphosphatemia, which promote vascular calcification.

The efficacy of calcifediol was demonstrated in 2 randomized, placebo-controlled, double-blind studies.

Response (mean 30% reduction in iPTH from baseline) rates were similar in the 2 studies, 33% and 34% for calcifediol compared with 8% and 7% for placebo (p < 0.001).

Serum total 25-hydroxyvitamin D levels gradually increased to at least 30 ng/mL in 80% and 83% of subjects treated with calcifediol compared with 3% and 7% of subjects treated with placebo (p < 0.001). Calcifediol extended-release capsules were FDA-approved in June 2016.

Indications

  • hyperparathyroidism

For the treatment of secondary hyperparathyroidism in patients with Stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL

NOTE: Calcifediol is not indicated for the treatment of secondary hyperparathyroidism in patients with Stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis.

Side Effects

  1. anemia
  2. anorexia
  3. bone pain
  4. coma
  5. confusion
  6. constipation
  7. cough
  8. dehydration
  9. drowsiness
  10. dyspnea
  11. elevated hepatic enzymes
  12. fatigue
  13. heart failure
  14. hypercalcemia
  15. hypercalciuria
  16. hypercholesterolemia
  17. hyperkalemia
  18. hyperphosphatemia
  19. hypertension
  20. hyperthermia
  21. hyperuricemia
  22. hypervitaminosis D
  23. libido decrease
  24. metallic taste
  25. nocturia
  26. pancreatitis
  27. pharyngitis
  28. photophobia
  29. polydipsia
  30. polyuria
  31. psychosis
  32. rhinorrhea
  33. weakness
  34. weight loss
  35. xerostomia

Monitoring Parameters

  • serum 25(OH)hydroxyvitamin D concentrations
  • serum calcium
  • serum intact parathyroid hormone concentrations (iPTH)
  • serum phosphate

Contraindications

  • bone fractures
  • breast-feeding
  • cardiac arrhythmias
  • dialysis
  • hypercalcemia
  • hypercalciuria
  • hyperphosphatemia
  • hypervitaminosis D
  • pregnancy
  • renal disease
  • seizures

Interactions

  • Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ
  • Aliskiren; Hydrochlorothiazide, HCTZ
  • Aluminum Hydroxide
  • Aluminum Hydroxide; Magnesium Carbonate
  • Aluminum Hydroxide; Magnesium Hydroxide
  • Aluminum Hydroxide; Magnesium Hydroxide; Simethicone
  • Aluminum Hydroxide; Magnesium Trisilicate
  • Amiloride; Hydrochlorothiazide, HCTZ
  • Amlodipine; Hydrochlorothiazide, HCTZ; Olmesartan
  • Amlodipine; Hydrochlorothiazide, HCTZ; Valsartan
  • Amoxicillin; Clarithromycin; Lansoprazole
  • Amoxicillin; Clarithromycin; Omeprazole
  • Atazanavir
  • Atazanavir; Cobicistat
  • Atenolol; Chlorthalidone
  • Azilsartan; Chlorthalidone
  • Barbiturates
  • Benazepril; Hydrochlorothiazide, HCTZ
  • Bendroflumethiazide; Nadolol
  • Bisoprolol; Hydrochlorothiazide, HCTZ
  • Burosumab
  • Calcitonin
  • Calcitriol
  • Calcium
  • Calcium Acetate
  • Calcium Carbonate
  • Calcium Carbonate; Magnesium Hydroxide
  • Calcium Carbonate; Risedronate
  • Calcium Carbonate; Simethicone
  • Calcium Chloride
  • Calcium Gluconate
  • Calcium; Vitamin D
  • Candesartan; Hydrochlorothiazide, HCTZ
  • Captopril; Hydrochlorothiazide, HCTZ
  • Chlorothiazide
  • Chlorthalidone
  • Chlorthalidone; Clonidine
  • Cholestyramine
  • Chromium
  • Clarithromycin
  • Colestipol
  • Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
  • Digoxin
  • Dihydrotachysterol
  • Doxercalciferol
  • Enalapril; Hydrochlorothiazide, HCTZ
  • Eprosartan; Hydrochlorothiazide, HCTZ
  • Fosinopril; Hydrochlorothiazide, HCTZ
  • Fosphenytoin
  • Hetastarch; Dextrose; Electrolytes
  • Hydralazine; Hydrochlorothiazide, HCTZ
  • Hydrochlorothiazide, HCTZ
  • Hydrochlorothiazide, HCTZ; Irbesartan
  • Hydrochlorothiazide, HCTZ; Lisinopril
  • Hydrochlorothiazide, HCTZ; Losartan
  • Hydrochlorothiazide, HCTZ; Methyldopa
  • Hydrochlorothiazide, HCTZ; Metoprolol
  • Hydrochlorothiazide, HCTZ; Moexipril
  • Hydrochlorothiazide, HCTZ; Olmesartan
  • Hydrochlorothiazide, HCTZ; Propranolol
  • Hydrochlorothiazide, HCTZ; Quinapril
  • Hydrochlorothiazide, HCTZ; Spironolactone
  • Hydrochlorothiazide, HCTZ; Telmisartan
  • Hydrochlorothiazide, HCTZ; Triamterene
  • Hydrochlorothiazide, HCTZ; Valsartan
  • Ibritumomab Tiuxetan
  • Itraconazole
  • Ketoconazole
  • Lopinavir; Ritonavir
  • Magnesium
  • Magnesium Citrate
  • Magnesium Hydroxide
  • Magnesium Salts
  • Methyclothiazide
  • Metolazone
  • Mineral Oil
  • Nefazodone
  • Nelfinavir
  • Ombitasvir; Paritaprevir; Ritonavir
  • Orlistat
  • Paricalcitol
  • Phenytoin
  • Phosphorated Carbohydrate Solution
  • Phosphorus
  • Polycarbophil
  • Potassium Phosphate
  • Potassium Phosphate; Sodium Phosphate
  • Ritonavir
  • Saquinavir
  • Telithromycin
  • Thiazide diuretics
  • Voriconazole
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