Duobrii halobetasol propionate and tazarotene .1 mg/g; .45 mg/g Lotion
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Halobetasol topical is used to treat redness, swelling, itching, and discomfort of various skin conditions in adults and children 12 years of age and older, including plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Halobetasol is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
Where does this data come from?
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 809Y72KV36
A synthetic polymer made from acrylic acid and crosslinked with allyl pentaerythritol. It's used as a thickening agent and gelling ingredient in creams, gels, and lotions to create the proper texture and help the medicine spread and stay on the skin.
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UNII F68VH75CJC
A synthetic polymer made from acrylic acid that thickens and stabilizes liquid or gel formulations. It's used as a gelling agent and emulsifier to create the desired texture and consistency in topical medicines.
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UNII I41B9FJK6V
Diethyl sebacate is a clear, oily compound derived from sebacic acid. It serves as a plasticizer in tablet and capsule coatings, making them flexible and less brittle so they dissolve properly in the digestive system.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII N6K5787QVP
Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 06XEA2VD56
Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
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UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
11 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $9.999 | $999.85 / 100 g |
| Medicaid paysCMS SDUD · 12 mo | $10.08 | $1,007.85 / 100 g |
| Medicare drug plans payPart D · Q2 2026 | $10.59 | $1,058.89 / 100 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Duobrii .1 mg/g; .45 mg/gthis 00187-0653-01 | Bausch | 1 tube | $9.998 | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 10478502 ↗ | Method of use | U-2625 | Nov 2, 2031 |
| US 10426787 ↗ | Method of use | U-2625 | Jun 6, 2036 |
| US 11648256 ↗ | Method of use | U-2625 | Jun 6, 2036 |
| US 11679115 ↗ | Method of use | U-2625 | Jun 6, 2036 |
| US 11839656 ↗ | Method of use | U-2625 | Nov 2, 2031 |
| US 11986527 ↗ | Method of use | U-2625 | Nov 2, 2031 |
| US 12076403 ↗ | Drug product | — | Nov 2, 2031 |
| US 10251895 ↗ | Drug product | — | Jun 6, 2036 |
| US 8809307 ↗ | Drug product | — | Nov 2, 2031 |
| US 11957753 ↗ | Drug product | — | Nov 2, 2031 |
Is there a generic version of DUOBRII 0.01%-0.045% LOTION?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00187-0653-01 You're viewing this | 1 TUBE in 1 CARTON (0187-0653-01) / 100 g in 1 TUBE | $10.00 / g | $999.85 | 2019-04-25 | Active |
| 00187-0653-03 | 6 TUBE in 1 CARTON (0187-0653-03) / 3 g in 1 TUBE | — | — | 2019-04-25 | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00187-0653-01?
What NDC number is used to bill for this package of Duobrii halobetasol propionate and tazarotene .1 mg/g; .45 mg/g Lotion?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE DUOBRII ® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is indicated for the topical treatment of plaque psoriasis in adults. DUOBRII Lotion is a combination of halobetasol propionate and tazarotene indicated for the topical treatment of plaque psoriasis in adults. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Apply a thin layer of DUOBRII Lotion once daily to cover only affected areas and rub in gently. If a bath or shower is taken prior to application, the skin should be dry before applying the lotion. The total dosage should not exceed approximately 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions (5.2) ] .
Do not use with occlusive dressings unless directed by a physician. Discontinue treatment when control is achieved. Avoid application of DUOBRII Lotion on the face, groin, or in the axillae.
DUOBRII Lotion is not for oral, ophthalmic, or intravaginal use. • Apply a thin layer of DUOBRII Lotion to the affected areas once daily. ( 2 ) • Not for oral, ophthalmic, or intravaginal use. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Lotion, 0.01%/0.045% Each gram of DUOBRII Lotion contains 0.1 mg (0.01%) halobetasol propionate and 0.45 mg (0.045%) tazarotene in a white to off-white lotion. Lotion, 0.01%/0.045% ( 3 ) Each gram of DUOBRII Lotion contains 0.1 mg (0.01%) halobetasol propionate and 0.45 mg (0.045%) tazarotene. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS DUOBRII Lotion is contraindicated in pregnancy ( 4.1 , 8.1 )
4.1Pregnancy DUOBRII Lotion is contraindicated in pregnancy [ see Warnings and Precautions (5.1) , Use in Specific Populations ( 8.1 , 8.3) ].
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Embryofetal risk : DUOBRII Lotion contains tazarotene, which is a teratogenic substance. In females of reproductive potential, obtain a negative pregnancy test within 2 weeks prior to initiating treatment and advise patients to use an effective method of contraception during treatment. (5.1) • Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment.
(5.2) • Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria. (5.2) • Systemic absorption may require evaluation for HPA axis suppression. (5.2) • Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure.
(5.2) • Local Adverse Reactions : Local adverse reactions may include atrophy, striae, telangiectasias, and folliculitis. If these effects occur, discontinue at least until the integrity of the skin has been restored. DUOBRII Lotion should not be used on eczematous skin, as it may cause severe irritation.
(5.3) • Photosensitivity and Risk for Sunburn : Avoid exposure to sunlight, sunlamps, and weather extremes. DUOBRII Lotion should be administered with caution if the patient is also taking drugs known to be photosensitizers. (5.4) • Ophthalmic Adverse Reactions : Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma.
If visual symptoms occur, consider referral to an ophthalmologist (5.5) .
5.1Embryofetal Risk Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, DUOBRII Lotion may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Tazarotene is teratogenic, and it is not known what level of exposure is required for teratogenicity in humans [see Contraindications (4) , Clinical Pharmacology (12.3) ]. Tazarotene elicits teratogenic and developmental effects associated with retinoids after topical or systemic administration in rats and rabbits [see Use in Specific Populations (8.1 )].
Advise pregnant females of the potential risk to a fetus. Obtain a pregnancy test within 2 weeks prior to DUOBRII Lotion therapy. Initiate DUOBRII Lotion therapy during a menstrual period.
Advise females of reproductive potential to use effective contraception during treatment with DUOBRII Lotion therapy [see Use in Specific Populations ( 8.1 and 8.3 )] .
5.2Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Unwanted Systemic Glucocorticoid Effects DUOBRII Lotion contains halobetasol propionate, a corticosteroid, and has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Systemic effects of topical corticosteroids may include reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment of the topical corticosteroid.
The potential for hypothalamic-pituitary-adrenal (HPA) axis suppression with DUOBRII Lotion was evaluated in a study of 20 adult subjects with moderate to severe plaque psoriasis involving ≥20% of their body surface area. The subjects were treated once daily for 8 weeks and assessed for HPA axis suppression at Weeks 4 and 8. HPA axis suppression occurred in 3 out of 20 (15%) subjects at Week 4 and none (0%) of these 20 subjects had HPA axis suppression at Week 8 [see Clinical Pharmacology (12.2) ] .
Because of the potential for systemic absorption, use of topical corticosteroids, including DUOBRII Lotion, may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent corticosteroids, use over large surface areas, occlusive use, use on an altered skin barrier, concomitant use of multipl…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS • The most common adverse reactions are contact dermatitis (7%), application site pain (3%), folliculitis (2%), skin atrophy (2%), and excoriation (2%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In randomized, double-blind, multicenter, vehicle-controlled clinical trials, 410 adults with plaque psoriasis were treated with DUOBRII Lotion or vehicle lotion and had post-baseline safety data. Subjects applied DUOBRII Lotion or vehicle lotion once daily for up to 8 weeks.
Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with DUOBRII Lotion and more frequently than in vehicle-treated subjects. Table 1: Adverse Reactions Occurring in ≥1% of the Subjects Treated with DUOBRII Lotion through Week 8 Adverse Reaction DUOBRII Lotion (N=270) Vehicle Lotion (N=140) Contact Dermatitis 20 (7%) 0 Application Site Pain 7 (3%) 1 (1%) Folliculitis 5 (2%) 0 Skin Atrophy 5 (2%) 0 Excoriation 5 (2%) 0 Rash 4 (1%) 0 Skin Abrasion 3 (1%) 0 Skin Exfoliation 2 (1%) 0
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, DUOBRII Lotion may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Safety in pregnant females has not been established. The potential risk to the fetus outweighs the potential benefit to the mother from DUOBRII Lotion during pregnancy; therefore, DUOBRII Lotion should be discontinued as soon as pregnancy is recognized [see Contraindications (4) , Warnings and Precautions (5.1) , Clinical Pharmacology (12.3) ] .
Observational studies suggest an increased risk of low birthweight in infants with the maternal use of potent or very potent topical corticosteroids ( see Data ). In animal reproduction studies with pregnant rats, reduced fetal body weights and reduced skeletal ossification were observed after topical administration of a tazarotene gel formulation during the period of organogenesis at a dose 11 times the maximum recommended human dose (MRHD) (based on AUC comparison). In animal reproduction studies with pregnant rabbits, single incidences of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies were observed after topical administration of a tazarotene gel formulation at 116 times the MRHD (based on AUC comparison) (see Data) .
In animal reproduction studies with pregnant rats and rabbits, malformations, fetal toxicity, developmental delays, and/or behavioral delays were observed after oral administration of tazarotene during the period of organogenesis at doses 9 and 228 times, respectively, the MRHD (based on AUC comparison). In pregnant rats, decreased litter size, decreased numbers of live fetuses, decreased fetal body weights, and increased malformations were observed after oral administration of tazarotene prior to mating through early gestation at doses 9 times the MRHD (based on AUC comparison) (see Data) .
In animal reproduction studies, increased malformations, including cleft palate and omphalocele, were observed after oral administration of halobetasol propionate during the period of organogenesis to pregnant rats and rabbits (see Data) . The available data do not support relevant comparisons of systemic halobetasol propionate exposures achieved in the animal studies to exposures observed in humans after topical use of DUOBRII Lotion. The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. Data Human Data Available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency.
However, when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 g during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants. Animal Data Halobetasol propionate has been shown to cause malformations in rats and rabbits when given orally during organogenesis at doses of 0.04 to 0.1 mg/kg/day in rats and 0.01 mg/kg/day in rabbits. Halobetasol propionate was embryotoxic in rabbits but not in rats.
Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats but not in rabbits. In an embryofetal development study in rats, a tazarotene gel formulation, 0.5% (0.25 mg/kg/day tazarotene) was topically administered to pregnant rats during gestation days 6 through 17.
Reduced fetal body weights and reduced skeletal ossification occurred at this dose (11 times the MRHD based on AUC comparison). In an embryofetal development study in rabbits, a tazarotene gel formulation (0.5%, 0…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, DUOBRII Lotion may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Safety in pregnant females has not been established. The potential risk to the fetus outweighs the potential benefit to the mother from DUOBRII Lotion during pregnancy; therefore, DUOBRII Lotion should be discontinued as soon as pregnancy is recognized [see Contraindications (4) , Warnings and Precautions (5.1) , Clinical Pharmacology (12.3) ] .
Observational studies suggest an increased risk of low birthweight in infants with the maternal use of potent or very potent topical corticosteroids ( see Data ). In animal reproduction studies with pregnant rats, reduced fetal body weights and reduced skeletal ossification were observed after topical administration of a tazarotene gel formulation during the period of organogenesis at a dose 11 times the maximum recommended human dose (MRHD) (based on AUC comparison). In animal reproduction studies with pregnant rabbits, single incidences of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies were observed after topical administration of a tazarotene gel formulation at 116 times the MRHD (based on AUC comparison) (see Data) .
In animal reproduction studies with pregnant rats and rabbits, malformations, fetal toxicity, developmental delays, and/or behavioral delays were observed after oral administration of tazarotene during the period of organogenesis at doses 9 and 228 times, respectively, the MRHD (based on AUC comparison). In pregnant rats, decreased litter size, decreased numbers of live fetuses, decreased fetal body weights, and increased malformations were observed after oral administration of tazarotene prior to mating through early gestation at doses 9 times the MRHD (based on AUC comparison) (see Data) .
In animal reproduction studies, increased malformations, including cleft palate and omphalocele, were observed after oral administration of halobetasol propionate during the period of organogenesis to pregnant rats and rabbits (see Data) . The available data do not support relevant comparisons of systemic halobetasol propionate exposures achieved in the animal studies to exposures observed in humans after topical use of DUOBRII Lotion. The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. Data Human Data Available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency.
However, when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 g during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants. Animal Data Halobetasol propionate has been shown to cause malformations in rats and rabbits when given orally during organogenesis at doses of 0.04 to 0.1 mg/kg/day in rats and 0.01 mg/kg/day in rabbits. Halobetasol propionate was embryotoxic in rabbits but not in rats.
Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats but not in rabbits. In an embryofetal development study in rats, a tazarotene gel formulation, 0.5% (0.25 mg/kg/day tazarotene) was topically administered to pregnant rats during gestation days 6 through 17.
Reduced fetal body weights and reduced skeletal ossification occurred at this dose (11 times the MRHD based on AUC comparison). In an embryofetal development study in rabbits, a tazarotene gel formulation (0.5%, 0.25 mg/kg/day tazarotene) was…
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of DUOBRII Lotion in pediatric patients under the age of 18 years have not been evaluated. Because of higher skin-surface-area-to-body-mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment.
Adverse reactions including striae have been reported with use of topical corticosteroids in infants and children [see Warnings and Precautions (5.2) ] . HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation.
Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema [see Warnings and Precautions (5.2) ] .
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 270 subjects exposed to DUOBRII Lotion in clinical trials, 39 subjects were 65 years or older. Clinical trials of DUOBRII Lotion did not include sufficient numbers of subjects age 65 years and older to determine whether they respond differently from younger subjects.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown. Tazarotene is a retinoid prodrug which is converted to its active form, tazarotenic acid, the carboxylic acid of tazarotene, by deesterification. Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR) family: RARα, RARβ and RARγ, but shows relative selectivity for RARβ, and RARγ and may modify gene expression.
The clinical significance of these findings for the treatment of plaque psoriasis is unknown.
12.2Pharmacodynamics A vasoconstrictor assay in healthy subjects with DUOBRII Lotion indicated that it is in the high to super-high range of potency as compared to other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence. The potential for hypothalamic-pituitary-adrenal (HPA) axis suppression was evaluated in a study in adult subjects with moderate to severe plaque psoriasis. A median dose of 8.2 grams DUOBRII Lotion was applied once daily for 8 weeks and 20 subjects were assessed for HPA axis suppression at Weeks 4 and 8.
HPA axis suppression was observed in 3 out of 20 (15%) subjects at Week 4. None of the 20 (0%) subjects had HPA axis suppression at Week 8. In this study, the criteria for HPA axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (adrenocorticotropic hormone). [See Warnings and Precautions (5.2) .] The pharmacodynamics of tazarotene is unknown.
12.3Pharmacokinetics Following topical application, tazarotene undergoes esterase hydrolysis to form its active metabolite, tazarotenic acid. Systemic exposure following topical application of DUOBRII Lotion was evaluated in the same study that evaluated the HPA axis suppression. It was an open-label, randomized, pharmacokinetics (PK) study conducted in subjects aged 18 years and older with moderate to severe plaque psoriasis affecting at least 20% body surface area.
The PK of halobetasol propionate, tazarotene, and tazarotenic acid was evaluated in 22 subjects following application of DUOBRII Lotion to the affected area once daily for 28 days. Systemic concentrations of halobetasol propionate (lower limit of quantification (LLOQ) = 50 pg/mL) and tazarotene (LLOQ = 5 pg/mL) on Day 28 were quantifiable in 13 and 18 out of a total number of 22 subjects, respectively. Tazarotenic acid (LLOQ = 5 pg/mL) was quantifiable in all subjects.
Systemic exposure of the three moieties was at or near steady state by Day 28. The mean (standard deviation) of PK parameters on Day 28 is shown in Table 2. Table 2:PK Parameters of Halobetasol Propionate, Tazarotene, and Tazarotenic Acid Following Once Daily Administration of DUOBRII Lotion for 28 Days in Subjects with Moderate to Severe Plaque Psoriasis Mean (Standard Deviation) (N=22) PK Parameters Halobetasol Propionate Tazarotene Tazarotenic Acid Day 28 C max (pg/mL) 101.9 (135.4) 24.6 (27.3) 523.4 (523.3) AUC 0-24 (pg*hr/mL) 1300 (1959) 273 (403) 9954 (10091)
🧬 Mechanism of Action ▾
12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown. Tazarotene is a retinoid prodrug which is converted to its active form, tazarotenic acid, the carboxylic acid of tazarotene, by deesterification. Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR) family: RARα, RARβ and RARγ, but shows relative selectivity for RARβ, and RARγ and may modify gene expression.
The clinical significance of these findings for the treatment of plaque psoriasis is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is a white to off-white lotion supplied in a white aluminum tube as follows: • 100 g (NDC 0187-0653-01) Storage and Handling Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] . Protect from freezing.
📋 Description ▾
11 DESCRIPTION DUOBRII Lotion is a combination product with halobetasol propionate and tazarotene as the active ingredients in a white to off-white lotion formulation intended for topical use. Halobetasol propionate is a synthetic corticosteroid. The chemical name for halobetasol propionate is [(6S,9R,16S,17R)-17-(2-chloroacetyl)-6,9-difluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate.
The structural formula for halobetasol propionate is represented below: Molecular Formula: C 25 H 31 ClF 2 O 5 Molecular Weight: 484.96 Tazarotene is a member of the acetylenic class of retinoids. The chemical name for tazarotene is 6-[(3,4-Dihydro-4,4-dimethyl-2H-1-benzothiopyran-6-yl)ethynyl]-3-pyridinecarboxylic acid ethyl ester. The structural formula for tazarotene is represented below: Molecular Formula: C 21 H 21 NO 2 S Molecular Weight: 351.46 Each gram of DUOBRII Lotion contains 0.1 mg (0.01%) halobetasol propionate and 0.45 mg (0.045%) tazarotene in a white to off-white lotion base consisting of carbomer copolymer type B, carbomer homopolymer type A, diethyl sebacate, edetate disodium dihydrate, light mineral oil, methylparaben, propylparaben, purified water, sodium hydroxide, sorbitan monooleate and sorbitol solution, 70%. chem1.jpg chem2.jpg
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all administration instructions or all possible adverse or unintended effects.
Advise patients using DUOBRII Lotion of the following information and instructions: Important Administration Instructions If undue irritation (redness, peeling, or discomfort) occurs, reduce frequency of application or temporarily interrupt treatment. Treatment may be resumed once irritation subsides [ see Dosage and Administration ( 2 ) and Warnings and Precautions ( 5.2 ) ]. Inform patients that total dosage should not exceed 50 grams per week [see Dosage and Administration (2) ] .
Instruct patients to avoid bandaging, wrapping or otherwise occluding the treatment area(s), unless directed by physician. Advise patients to avoid use on the face, groin, or axillae [see Dosage and Administration ( 2 )] . Inform patients that DUOBRII Lotion is for external use only.
Advise patients that DUOBRII Lotion is not for oral, ophthalmic, or intravaginal use [see Dosage and Administration ( 2 )]. Fetal risk is associated with DUOBRII Lotion for females of reproductive potential. Advise patients to use an effective method of contraception during treatment to avoid pregnancy.
Advise the patient to stop medication if she becomes pregnant and call her doctor [ see Contraindications ( 4.1 ), Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 ) ]. Breastfeeding women should not apply DUOBRII Lotion directly to the nipple and areola to avoid directly exposing the infant [see Use in Specific Populations ( 8.2 )] . Avoid exposure of the treated areas to either natural or artificial sunlight, including tanning beds and sunlamps.
Use sunscreen and protective clothing if exposure to sunlight is unavoidable when using DUOBRII Lotion [see Warnings and Precautions ( 5.4 )] . HPA Axis Suppression and Other Unwanted Systemic Glucocorticoid Effects DUOBRII Lotion may cause HPA axis suppression. Advise patients that use of topical corticosteroids, including DUOBRII Lotion, may require periodic evaluation for HPA axis suppression.
Topical corticosteroids may have other endocrine effects. Concomitant use of multiple corticosteroid-containing products may increase the total systemic exposure to topical corticosteroids [see Warnings and Precautions (5.2) ] . Local Adverse Reactions Inform patients that DUOBRII Lotion may cause local adverse reactions.
These reactions may be more likely to occur with occlusive use or use of DUOBRII Lotion. If undue irritation (redness, peeling, or discomfort) occurs, reduce frequency of application or temporarily interrupt treatment. Treatment may be resumed once irritation subsides, unless allergic contact dermatitis is identified [see Warnings and Precautions (5.3) ].
Ophthalmic Adverse Reactions Advise patients to report any visual symptoms to their healthcare providers. Distributed by: Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Laval, Quebec H7L 4A8, Canada U.S.
Patent Numbers: 6,517,847; 8,809,307; 10,251,895 and 10,478,502 DUOBRII is a trademark of Bausch Health Companies Inc. or its affiliates. © 2020 Bausch Health Companies Inc. or its affiliates 9645602