DUOBRII
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DUOBRII (DUOBRII).
Duobrii (halobetasol propionate and tazarotene) is a combination of a corticosteroid and a retinoid. Halobetasol propionate is a high-potency corticosteroid that acts via glucocorticoid receptors to induce anti-inflammatory, antiproliferative, and immunosuppressive effects. Tazarotene is a retinoid prodrug that is converted to its active form, tazarotenic acid, which binds to retinoic acid receptors (RAR-β, RAR-γ) to modulate gene expression, thereby reducing keratinocyte proliferation and promoting differentiation.
| Metabolism | Halobetasol propionate is metabolized primarily in the liver via ester hydrolysis. Tazarotene is metabolized via ester hydrolysis to its active form tazarotenic acid, which is further metabolized by oxidation and conjugation; metabolism involves cytochrome P450 enzymes (CYP2C8 and CYP3A4) and conjugation reactions. |
| Excretion | Halobetasol propionate: 60% renal, 40% fecal; Tazarotene: <1% renal, 93% fecal, 6% biliary. |
| Half-life | Halobetasol propionate: 7.5 hours (terminal); Tazarotene: 9-12 hours (terminal). |
| Protein binding | Halobetasol propionate: 99% bound to albumin and corticosteroid-binding globulin; Tazarotene: >99% bound to albumin and lipoproteins. |
| Volume of Distribution | Halobetasol propionate: 2.3 L/kg (extensive tissue distribution); Tazarotene: not applicable (topical application, minimal systemic absorption). |
| Bioavailability | Topical: minimal systemic absorption (approximately 1-3% for halobetasol; <6% for tazarotene). |
| Onset of Action | Topical: reduction in plaque elevation and scaling within 2 weeks; significant improvement by 8 weeks. |
| Duration of Action | Dryness, redness, and scaling continue to improve for up to 4 weeks after stopping treatment; therapeutic effect persists for several weeks post-treatment. |
| Molecular Weight | 230.26 |
Apply a thin layer to affected areas of the scalp once daily for 8 weeks. For external use only.
| Dosage form | LOTION |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No dose adjustment required for hepatic impairment. |
| Pediatric use | Safety and efficacy in pediatric patients have not been established. |
| Geriatric use | No specific dose adjustment recommended; use with caution due to potential for increased skin fragility. |
| 1st trimester | Avoid due to potential teratogenicity; use only if benefit outweighs risk. |
| 2nd trimester | Limited data; caution advised; may be used if clearly needed. |
| 3rd trimester | May cause premature closure of ductus arteriosus and oligohydramnios; avoid after 30 weeks. |
Clinical note
Comprehensive clinical and safety monograph for DUOBRII (DUOBRII).
| Placental transfer | Crosses placenta; detected in fetal plasma and amniotic fluid. |
| Breastfeeding | Excreted in breast milk in small amounts; consider risk of infant NSAID exposure; use with caution, especially in infants with cardiovascular or renal issues. |
| Lactation Rating |
■ FDA Black Box Warning
No black box warning.
| Serious Effects |
Hypersensitivity to diclofenac or any componentHistory of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDsIn the setting of coronary artery bypass graft (CABG) surgeryAdvanced renal diseaseActive peptic ulcer disease or gastrointestinal bleeding
| Precautions | Topical corticosteroids may cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, especially with use on large surface areas, prolonged use, or occlusive dressings., Topical retinoids may cause skin irritation, photosensitivity, and teratogenicity; avoid use in women of childbearing potential unless contraception is used., Do not use on infected skin, open wounds, or areas with exudative dermatitis., Monitor for signs of systemic toxicity, including hypercortisolism, hyperglycemia, and ocular effects (e.g., cataracts, glaucoma) with prolonged use. |
| Food/Dietary | No clinically significant food interactions identified. Alcohol intake is not known to interact directly, but may complicate psoriasis management. Avoid excessive consumption of foods that may trigger psoriasis flares (e.g., red meat, dairy, gluten) per individual tolerance. |
Loading safety data…
| L3 (Moderately Safe) |
| Teratogenic Risk | DUOBRII (halobetasol propionate 0.01% and tazarotene 0.045% lotion) is categorized as Pregnancy Category X. Tazarotene is a retinoid and known teratogen. Systemic exposure is minimal with topical application, but due to the teratogenic potential, use is contraindicated in women who are or may become pregnant. First trimester: High risk of fetal malformations (CNS, cardiovascular, skeletal). Second and third trimesters: Risk remains, and use is not recommended. Discontinue if pregnancy occurs. |
| Fetal Monitoring | Not applicable as DUOBRII is contraindicated in pregnancy. If inadvertent exposure occurs, fetal ultrasound for anomalies may be considered. |
| Fertility Effects | No human fertility studies. Animal studies with tazarotene showed reduced fertility at high oral doses. Topical application is expected to have minimal systemic exposure, but potential effects cannot be ruled out. Women of childbearing potential should use effective contraception. |
| Clinical Pearls | DUOBRII (halobetasol propionate 0.01% and tazarotene 0.045% lotion) is a fixed-dose combination for plaque psoriasis. Apply once daily; limit total weekly dose to 50 g or less to minimize corticosteroid absorption risk. Avoid use on face, axillae, groin, or intertriginous areas due to increased absorption. Re-evaluate if no improvement after 4 weeks. Use with caution in patients with a history of hepatic impairment as tazarotene is metabolized via CYP450. Pregnancy category X due to tazarotene; rule out pregnancy before initiating. Monitor for hypercalcemia if used over large surface areas or with concurrent vitamin D analogs. Not recommended for use with topical corticosteroids due to increased side effect risk. |
| Patient Advice | Apply only once daily to affected areas of the skin; do not use more than prescribed. · Avoid contact with eyes, mouth, and mucous membranes; wash hands after application. · Do not cover the treated area with bandages or dressings unless directed by your doctor. · Use a sunscreen and protective clothing as this medicine increases sun sensitivity (photosensitivity). · Do not use on large areas of the body (more than 20% body surface area) or for longer than 4 weeks. · Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding; this medicine can cause birth defects. · Avoid using other skin products containing corticosteroids, retinoids, or strong ingredients without talking to your doctor. · Report sudden weight gain, swelling, or shortness of breath as these may indicate side effects from corticosteroid absorption. |