DOVONEX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DOVONEX (DOVONEX).
Vitamin D3 analog; binds to vitamin D receptor (VDR) in keratinocytes, regulating cell proliferation and differentiation.
| Metabolism | Hepatic metabolism via CYP24A1; main metabolite calcitroic acid. |
| Excretion | Renal: <1% as unchanged drug; fecal: ~70% as metabolites. |
| Half-life | Terminal half-life: 5-6 hours for topical administration. |
| Protein binding | >99% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Vd: >5 L/kg, indicating extensive tissue distribution. |
| Bioavailability | Topical: <1% systemic absorption; oral: ~60%. |
| Onset of Action | Topical: 2 weeks for initial improvement in plaque psoriasis. |
| Duration of Action | Duration of action: 8-12 hours after topical application; sustained effect with continued use. |
Apply topically to affected areas once daily; maximum dose: 100 g per week.
| Dosage form | OINTMENT |
| Renal impairment | No dosage adjustment required for renal impairment. |
| Liver impairment | No dosage adjustment required for hepatic impairment. |
| Pediatric use | Safety and efficacy not established in pediatric patients. |
| Geriatric use | No specific dose adjustment; use caution due to potential renal impairment. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DOVONEX (DOVONEX).
| Breastfeeding | It is not known whether calcipotriene is excreted in human milk after topical application. Minimal systemic absorption suggests low risk. However, caution should be exercised when administered to a nursing woman. M/P ratio: not determined. |
| Teratogenic Risk | DOVONEX (calcipotriene) is a topical vitamin D analog. Systemic absorption is minimal with topical use. No adequate and well-controlled studies in pregnant women. Animal studies with oral calcipotriol showed fetal abnormalities at doses 6-12 times the human topical dose. Risk cannot be ruled out. Use only if potential benefit justifies potential fetal risk. First trimester: no data; avoid if possible. Second and third trimesters: limited data; consider risk-benefit. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypercalcemia","Vitamin D toxicity","Known hypersensitivity to calcipotriene"]
| Precautions | ["Hypercalcemia risk with excessive use; avoid application to large areas > 100 g/week.","Not for oral, ophthalmic, or intravaginal use.","Interference with thyroid function tests."] |
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| Fetal Monitoring | No specific maternal-fetal monitoring required beyond routine prenatal care. Monitor for signs of hypercalcemia if large areas of skin are treated, or in patients with renal impairment. Assess calcium metabolism if symptoms occur. |
| Fertility Effects | No studies on fertility in humans. Animal studies with oral calcipotriol showed no impairment of fertility at doses up to 6 times the human topical dose. Effects on human fertility unknown. |