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