calcifediol monohydrate: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
calcifediol monohydrate: clinical details
Prescribing considerations
- Licensed for adults; the UK product is not recommended for children.
- Review baseline vitamin D status, calcium intake, sun exposure, fortified foods, supplements and medicines affecting vitamin D metabolism.
- Use particular caution with renal impairment, heart failure or digitalis therapy, hypoparathyroidism, previous calcium stones, prolonged immobilisation and granulomatous disease.
- Calcifediol may interfere with cholesterol measurement using the Zlatkis–Zak method.
Contraindications and cautions
- Hypersensitivity to calcifediol or an excipient.
- Hypercalcaemia or hypercalciuria.
- Calcium-containing renal stones.
- Hypervitaminosis D.
Monitoring
- Monitor serum 25-hydroxyvitamin D and calcium; phosphate, alkaline phosphatase and urinary calcium or phosphate may also be relevant.
- Increase vigilance in chronic kidney disease, granulomatous disease, stone risk or concurrent cardiac glycoside treatment.
- Investigate symptoms suggesting hypercalcaemia or vitamin D toxicity promptly.
Clinical pharmacology
Calcifediol is 25-hydroxycholecalciferol and bypasses hepatic 25-hydroxylation. CYP27B1 converts it mainly in the kidney to calcitriol; CYP24A1 produces inactive metabolites, and elimination is primarily biliary.
Formulation and product differences
- The UK formulation is an oral yellow oval soft gelatin capsule containing a liquid fill.
- Excipients include gelatin, ethanol, sorbitol and medium-chain triglycerides.
- Keep it in its original moisture-protective packaging and do not refrigerate.
calcifediol monohydrate preparations and strengths
Capsule
Route: Oral
Strengths: 266 micrograms
calcifediol monohydrate interactions
Check prescribed, purchased and nutritional products because some combinations alter calcifediol exposure or increase calcium-related toxicity.
Phenytoin, phenobarbital, primidone and other enzyme-inducing antiepileptics
They may increase calcifediol metabolism and reduce its effect, making vitamin D monitoring important.
Digoxin and other cardiac glycosides
Calcifediol-related hypercalcaemia can increase toxicity and provoke arrhythmias.
Thiazide diuretics
The combination can increase hypercalcaemia risk, particularly in hypoparathyroidism.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.