Calcitriol
Regulatory sources consulted
- openfda-label-9f3e830b-274e-43f4-b056-b607fec13df8
- aemps-ft-55973
- ansm-rcp-62597239
- PubMed PMID:38676447 ↗
- PubMed PMID:37686873 ↗
- PubMed PMID:40875260 ↗
- PubMed PMID:36545746 ↗
- PubMed PMID:39181153 ↗
- OpenFDA · A11CC04
- RxNorm rxcui 1894 ↗
Approved indications
- Management of secondary hyperparathyroidism in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis.
- Management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis.
- Management of hypocalcemia in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.
- Topical treatment of mild to moderate plaque psoriasis (psoriasis vulgaris) affecting up to 35% of the body surface area.
Contraindications
Absolute
- Hypercalcemia or evidence of vitamin D toxicity.
- Known hypersensitivity to calcitriol or drugs of the same class.
- Topical form: Patients with renal or hepatic impairment.
Clinical warnings
- Major warning · Overdosage of any form of vitamin D is dangerous. Progressive hypercalcemia may be so severe as to require emergency attention. — FDA
- Major warning · Chronic hypercalcemia can lead to generalized vascular calcification, nephrocalcinosis and other soft-tissue calcification. — FDA
- The serum calcium times phosphate (Ca x P) product should not be allowed to exceed 70 mg²/dL² to avoid ectopic calcification. — FDA
Drug interactions
- ModerateThiazide diureticsC03AA
Mechanism: Thiazides reduce urinary calcium excretion, increasing the risk of hypercalcemia with concomitant calcitriol use.
Recommendation: Monitor serum calcium levels closely when used concomitantly.
ANSM RCP
- HighDigoxinC01AA05
Mechanism: Calcitriol-induced hypercalcemia sensitizes the myocardium to digoxin, increasing the risk of arrhythmias and digitalis toxicity.
Recommendation: Caution is required. Monitor serum calcium levels and for signs of digoxin toxicity.
ANSM RCP
- ModerateMagnesium-containing antacidsA02AD
Mechanism: In patients on chronic renal dialysis, concomitant use may lead to hypermagnesemia due to impaired magnesium excretion.
Recommendation: Avoid concomitant use in patients on chronic renal dialysis.
FDA label
Adverse events
Common (≥1%)
weakness · headache · nausea · vomiting · constipation · muscle pain · pruritus (topical) · skin irritation (topical)
Rare but serious
hypercalcemia syndrome · nephrocalcinosis · cardiac arrhythmias · overt psychosis
Pregnancy and lactation
There are no adequate data on use in pregnant women. Use only if necessary, monitoring calcium levels. It is excreted in animal milk; use during breastfeeding is not recommended.
Recent literature (PubMed)
Declaración de consenso que revisa el metabolismo, evaluación y suplementación de vitamina D. Discute los niveles óptimos de 25(OH)D, los efectos extraesqueléticos y las formulaciones. Limita el uso de calcitriol a trastornos específicos donde el metabolito activo no se produce fácilmente in vivo.
Revisión sobre la hipofosfatemia ligada al cromosoma X, una enfermedad genética que causa un aumento de FGF23, pérdida renal de fosfato y disminución de la síntesis de calcitriol. El calcitriol es un pilar del tratamiento convencional, aunque las nuevas terapias se dirigen a FGF23.
Guía de práctica clínica para el tratamiento de la hipercalcemia maligna. Recomienda denosumab o bisfosfonatos IV. Sugiere añadir estos agentes en pacientes con hipercalcemia por tumores con altos niveles de calcitriol que ya reciben glucocorticoides.
Revisión sobre el raquitismo, cuya causa más común es la deficiencia de vitamina D. Diferencia las diversas formas de raquitismo y señala que el tratamiento del raquitismo hipofosfatémico puede incluir calcitriol, fósforo y burosumab.
Revisión sistemática sobre el papel de la vitamina D (calcifediol y calcitriol) en la inmunidad. Concluye que mantener niveles séricos de 25(OH)D >50 ng/mL reduce significativamente el riesgo de infecciones y autoinmunidad, aunque el enfoque principal está en la suplementación con colecalciferol/calcifediol.