CUTIVATE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CUTIVATE (CUTIVATE).
Glucocorticoid receptor agonist; modulates gene expression to inhibit inflammatory mediators, vasoconstriction, and immunosuppression.
| Metabolism | Hepatic; primarily via CYP3A4-mediated oxidation and glucuronidation. |
| Excretion | Primarily hepatic metabolism; metabolites are excreted renally and fecally. Unchanged drug is negligible in urine. Route: renal (~60% as metabolites), fecal (~40% as metabolites). |
| Half-life | 2-4 hours (terminal elimination half-life); short half-life supports twice-daily dosing for maintenance of clinical effect. |
| Protein binding | Approximately 88-94% bound to plasma proteins, primarily albumin and corticosteroid-binding globulin. |
| Volume of Distribution | 0.5-1.0 L/kg after systemic absorption; extensive distribution to tissues due to moderate lipophilicity. |
| Bioavailability | Topical: minimal systemic absorption (approximately 1-5% of applied dose) when applied to intact skin. Absorption increases with occluded or damaged skin. |
| Onset of Action | Topical: improvement often noted within 1 week of regular twice-daily application; effect may be seen as early as 2-3 days in some patients. |
| Duration of Action | Duration of effect is approximately 12-24 hours after topical application, necessitating twice-daily application for continuous efficacy. |
| Molecular Weight | 500.57 |
Apply a thin layer to affected skin areas once or twice daily. Therapy should be discontinued when control is achieved; if no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
| Dosage form | LOTION |
| Renal impairment | No dose adjustment required. |
| Liver impairment | No dose adjustment required for topical use. |
| Pediatric use | Apply a thin layer to affected areas once or twice daily. Use the least amount necessary to control symptoms. Treatment duration should be limited to the minimum necessary due to increased systemic absorption. Not recommended for use in children under 12 years of age unless directed by a physician. |
| Geriatric use | Use with caution. Apply the smallest amount for the shortest duration necessary to achieve desired clinical benefit due to increased risk of skin atrophy and systemic effects. Monitor for local adverse effects. |
| 1st trimester | No adequate studies in pregnant women; use only if potential benefit justifies potential risk to fetus. Animal studies have shown adverse effects. |
| 2nd trimester | Corticosteroids cross placenta; avoid use unless clearly needed. May cause fetal growth restriction, adrenal suppression, or cleft palate (rare). |
| 3rd trimester | Corticosteroids cross placenta; prolonged use may lead to fetal adrenal suppression. Use caution, especially near term. |
Clinical note
Comprehensive clinical and safety monograph for CUTIVATE (CUTIVATE).
| Placental transfer | Corticosteroids including fluticasone propionate cross the placenta. Systemic bioavailability after topical application is low (approx. 1-3% of applied dose), but prolonged or extensive use may increase transfer. |
| Breastfeeding | Topical corticosteroids are minimally absorbed and unlikely to produce systemic effects in infant if used on small areas for short duration. Avoid application to breast area to prevent infant ingestion. Caution with extensive or prolonged use. |
■ FDA Black Box Warning
No FDA boxed warning.
| Serious Effects |
Hypersensitivity to fluticasone propionate or any component of the formulation
| Precautions | HPA axis suppression, Cushing's syndrome, Systemic absorption with prolonged use or large surface area, Local adverse reactions (e.g., atrophy, striae, acneiform eruptions), Allergic contact dermatitis, Ophthalmic effects (e.g., glaucoma, cataracts) |
| Food/Dietary | None known. |
| Clinical Pearls | CUTIVATE (fluticasone propionate) is a medium-potency topical corticosteroid. Avoid use on face, intertriginous areas, or under occlusion unless directed. Limit treatment duration to 2 consecutive weeks to reduce risk of atrophy. Use with caution in pediatric patients due to higher systemic absorption. |
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| Lactation Rating | L3 (Moderately Safe) - limited data, but topical use considered safe with precautions. |
| Teratogenic Risk | CUTIVATE (fluticasone propionate) is a topical corticosteroid. Systemic absorption is minimal with topical use, but high-dose or prolonged application may increase risk. In animal studies, corticosteroids have shown teratogenicity (cleft palate, intrauterine growth retardation). For humans, data are limited; avoid use in first trimester unless benefit outweighs risk. In second and third trimesters, use lowest effective dose for shortest duration. |
| Fetal Monitoring | Monitor for signs of adrenal suppression in the mother if used extensively, especially with occlusive dressings. In pregnancy, monitor fetal growth via ultrasound if prolonged use of high-potency corticosteroid. Assess for maternal hyperglycemia and hypertension. No specific fetal monitoring required for short-term low-potency use. |
| Fertility Effects | No studies on fertility effects of topical fluticasone propionate in humans. Animal studies with corticosteroids have shown reduced fertility at high systemic doses. Topical use with minimal absorption is unlikely to impact fertility significantly. |
| Patient Advice | Apply a thin layer to affected skin only; do not cover with bandages or wraps unless instructed. · Wash hands after application unless treating hands. · Avoid contact with eyes and mucous membranes. · Do not use for more than 2 weeks unless directed by your doctor. · Inform your doctor if condition worsens or does not improve within 2 weeks. |