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. |
| Molecular Weight | 412.53 |
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 | Topical doxovex (calcipotriene) is generally avoided unless clearly needed due to lack of data in pregnant women; animal studies show risk of skeletal abnormalities at high doses. |
| 2nd trimester | Same caution as first trimester; use only if potential benefit justifies potential risk to fetus. |
| 3rd trimester | Same caution; avoid excessive application to minimize systemic absorption and potential fetal effects. |
Clinical note
Comprehensive clinical and safety monograph for DOVONEX (DOVONEX).
| Placental transfer | Minimal data; molecular weight suggests potential for placental transfer, but systemic absorption is low with topical use. |
| Breastfeeding | Topical calcipotriene applied to non-breast area is unlikely to produce significant systemic levels; avoid application to nipples or areolae to prevent infant ingestion. |
■ FDA Black Box Warning
None.
| Serious Effects |
HypercalcemiaKnown hypersensitivity to calcipotriene or any component of the formulationUse on face, scalp, or intertriginous areas (due to irritation risk)
| 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. |
| Food/Dietary | No specific food interactions. DOVONEX is for topical use; systemic absorption is minimal. No dietary restrictions are necessary. |
| Clinical Pearls |
Loading safety data…
| Lactation Rating | L3 (Moderately Safe) - limited data suggests minimal risk with topical use on limited areas. |
| 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. |
| 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. |
| DOVONEX (calcipotriene) is a vitamin D analog for plaque psoriasis. Do not apply to face, groin, or intertriginous areas due to irritation. Limit total weekly dose to 100 g to avoid hypercalcemia. Avoid concurrent use with products containing salicylic acid which can inactivate calcipotriene. Skin lesions may improve within 2 weeks of initiation. |
| Patient Advice | Apply a thin layer only to psoriasis plaques, avoiding unaffected skin. · Do not use on the face or in skin folds. · Wash hands after application to avoid spreading the drug to unintended areas. · Use no more than 100 grams per week to prevent calcium level abnormalities. · Avoid occlusive dressings unless directed by a physician. · Notify your doctor if you develop persistent itching, redness, or skin thinning at the application site. · If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor before use. |