Bryhali halobetasol propionate .1 mg/g Lotion — NDC 0187-0002-60 (Billing 00187-0002-60)
This is a package of Bryhali halobetasol propionate .1 mg/g Lotion from Bausch Health US, LLC, marketed since Nov 2018 and currently FDA-listed; retail pharmacies pay about $5.13 per g (NADAC).
NDC database record
One package, one record: these facts belong to NDC 0187-0002-60 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0187 labeler · 0002 product · 60 package
- Package marketed since
- Nov 6, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 0187000260 7
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 079262
- GCN: 45728
- GPI-14 (Medi-Span): 90550073104105
- HICL (First Databank): 006037
- AHFS class code: 84:06.08.00
- RxCUI (RxNorm): 2101710
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- Halobetasol topical is used to treat inflammatory skin conditions — conditions that cause redness, swelling, and itching. The ointment form is used broadly for skin conditions that...
- You should use halobetasol topical for no longer than two consecutive weeks, and no more than 50 grams total per week. It's a very potent steroid, and using it longer or in larger...
- Yes — avoid applying halobetasol to your face, groin, or underarms. These areas have thinner skin and absorb much more of the medication, increasing your risk of side effects. Also...
- Are there places I should not apply this?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Halobetasol Propionate — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $5.134 | $308.02 / 60 g |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file · file of Feb 21, 2024
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00187-0002-01 0187-0002-01 Main listing | 1 TUBE in 1 CARTON / 100 g in 1 TUBE | $5.11 / g | $510.97 | 2018-11-06 | — | Active |
| 00187-0002-03 0187-0002-03 | 1 TUBE in 1 CARTON / 3 g in 1 TUBE Sample | — | — | 2018-11-06 | — | Active |
| 00187-0002-60 You're viewing this | 1 TUBE in 1 CARTON / 60 g in 1 TUBE | $5.13 / g | $308.01 | 2018-11-06 | — | Active |
This pack effectively ties for the lowest per-g cost of the 2 priced pack sizes ($5.13 NADAC).
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Bryhali halobetasol propionate .1 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.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Bryhali .1 mg/gthis 00187-0002-60 | Bausch | 1 tube | $5.134 | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Feb 21, 2024
Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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 11986527 ↗ | Method of use | U-2625 | Nov 2, 2031 |
| US 11839656 ↗ | Method of use | U-2625 | Nov 2, 2031 |
| US 11957753 ↗ | Drug product | — | Nov 2, 2031 |
| US 12076403 ↗ | Drug product | — | Nov 2, 2031 |
| US 8809307 ↗ | Drug product | — | Nov 2, 2031 |
Is there a generic version of BRYHALI 0.01% 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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Halobetasol Topical inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Bausch Health US, LLC labeler code 00187
- Siliq Brodalumab 210 mg Injection NDC 0187-0004-02
- Altreno tretinoin .5 mg/g Lotion NDC 0187-0005-03
- Cabtreo clindamycin phosphate/benzoyl peroxide/adapalene 12 mg/g; 31 mg/g; 1.5 mg/g Gel NDC 0187-0006-10
- Ativan lorazepam .5 mg Tablet NDC 0187-0063-01
- Ativan lorazepam 1 mg Tablet NDC 0187-0064-01
- Ativan lorazepam 2 mg Tablet NDC 0187-0065-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE BRYHALI ® (halobetasol propionate) lotion, 0.01% is indicated for the topical treatment of plaque psoriasis in adults. BRYHALI lotion is a corticosteroid indicated for the topical treatment of plaque psoriasis in adults. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Apply a thin layer of BRYHALI Lotion to affected areas once daily. Rub in gently. Wash hands after each application, unless BRYHALI Lotion is for treatment of the hands.
BRYHALI Lotion treatment beyond 8 weeks is not recommended, and the total dosage should not exceed approximately 50 g per week. Discontinue treatment if control is achieved before 8 weeks. Do not use with occlusive dressings unless directed by a physician.
BRYHALI Lotion should not be used on the face, groin, or in the axillae. BRYHALI Lotion is not for oral, ophthalmic, or intravaginal use. • Apply a thin layer of BRYHALI Lotion to the affected areas once daily. ( 2 ) • Treatment beyond 8 weeks is not recommended.
Discontinue treatment if control is achieved before 8 weeks. ( 2 ) • Do not use with occlusive dressings unless directed by a physician. ( 2 ) • Avoid use on the face, groin, or axillae.
( 2 ) • Not for oral, ophthalmic, or intravaginal use. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Lotion, 0.01% Each gram of BRYHALI Lotion contains 0.1 mg (0.01%) halobetasol propionate in a white to off-white lotion. Lotion, 0.01% ( 3 ) Each gram of BRYHALI Lotion contains 0.1 mg (0.01%) halobetasol propionate. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None ( 4 ).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression was observed and may occur with the potential for glucocorticosteroid insufficiency during or after treatment. ( 5.1 ) • Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria. ( 5.1 ) • Systemic absorption may require evaluation for HPA axis suppression.
( 5.1 ) • Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure. ( 5.1 ) • Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. ( 5.1 , 8.4 ) • Local adverse reactions may include atrophy, striae, telangiectasias, hypopigmentation, and allergic contact dermatitis.
Some local adverse reactions may be irreversible. ( 5.2 ) • Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist for evaluation.
( 5.3 )
5.1Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression BRYHALI Lotion 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 with the topical corticosteroid.
The potential for hypothalamic-pituitary-adrenal (HPA) axis suppression with BRYHALI Lotion was evaluated in a study of 19 adult subjects with moderate to severe plaque psoriasis involving ≥20% of their body surface area (BSA). HPA axis suppression was reported for 1 (5.6%) subject at Week 4 and for 3 (15.8%) subjects at Week 8. All 3 subjects had normal HPA axis suppression test with discontinuation of treatment [see Clinical Pharmacology (12.2) ] .
Because of the potential for systemic absorption, use of topical corticosteroids, including BRYHALI 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 multiple corticosteroid-containing products, liver failure, and young age. An adrenocorticotropic hormone (ACTH) stimulation test may be helpful in evaluating patients for HPA axis suppression.
If HPA axis suppression is documented, attempt to gradually withdraw the drug, reduce the frequency of application, or substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.
Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria. Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure to corticosteroids. Pediatric patients may be more susceptible than adults to systemic toxicity from the use of topical corticosteroids due to their larger surface-to-body-mass ratios [see Use in Specific Populations (8.4) ] .
5.2Local Adverse Reactions Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. These may be more likely with occlusive use, prolonged use, or use of higher potency corticosteroids, including BRYHALI Lotion. Some local adverse reactions may be irreversible.
5.3Ophthalmic Adverse Reactions Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS • The most common adverse reactions (≥1%) were upper respiratory tract infection, application site dermatitis and hyperglycemia. ( 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, 426 adults with plaque psoriasis were treated with BRYHALI Lotion and had post-baseline safety data. Subjects applied BRYHALI Lotion once daily for up to 8 weeks.
Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with BRYHALI Lotion and more frequently than in vehicle-treated subjects. Table 1: Adverse Reactions Occurring in ≥1% of the Subjects Treated with BRYHALI Lotion through Week 8 BRYHALI Lotion (N=284) Vehicle Lotion (N=142) Adverse Reaction % % Upper Respiratory Tract Infection 2% 1% Application Site Dermatitis 1% 0 Hyperglycemia 1% 0
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on BRYHALI Lotion use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, increased malformations, including cleft palate and omphalocele, were observed after oral administration of halobetasol propionate during organogenesis to pregnant rats and rabbits. 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 BRYHALI Lotion.
The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data 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.
8.2Lactation Risk Summary There are no data on the presence of halobetasol propionate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production after treatment with BRYHALI Lotion. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for BRYHALI Lotion and any potential adverse effects on the breastfed child from BRYHALI Lotion. Clinical Considerations Advise breastfeeding women not to apply BRYHALI Lotion directly to the nipple and areola to avoid direct infant exposure.
8.4Pediatric Use Safety and effectiveness of BRYHALI 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 (5.1) ] . 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 (5.1) ] .
8.5Geriatric Use Of 284 subjects exposed to BRYHALI Lotion in clinical trials, 61 subjects were 65 years or older. Clinical trials of BRYHALI Lotion did not include sufficient numbers of subjects age 65 years and older to determine whether they respond differently from younger subjects.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on BRYHALI Lotion use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, increased malformations, including cleft palate and omphalocele, were observed after oral administration of halobetasol propionate during organogenesis to pregnant rats and rabbits. 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 BRYHALI Lotion.
The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data 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.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of BRYHALI 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 (5.1) ] . 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 (5.1) ] .
🧓 Geriatric Use ▾
8.5Geriatric Use Of 284 subjects exposed to BRYHALI Lotion in clinical trials, 61 subjects were 65 years or older. Clinical trials of BRYHALI 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.
12.2Pharmacodynamics Vasoconstrictor Assay A vasoconstrictor assay in healthy subjects with BRYHALI Lotion indicated that the formulation is in the potent to superpotent range of potency as compared to other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression The potential for HPA axis suppression was evaluated in 19 adult subjects with moderate to severe plaque psoriasis with at least 20% BSA involved.
An approximate dose of 7 g BRYHALI Lotion was applied once daily for 8 weeks. An abnormal HPA axis suppression test, as indicated by a 30-minute post-stimulation cortisol level ≤18 mcg/dL, was reported for 1 (5.6%) subject at Week 4 and for 3 (15.8%) subjects at Week 8. The subject suppressed at Week 4 was also suppressed at Week 8.
These effects were reversible as recovery of HPA axis function was generally prompt with the discontinuation of treatment. [See Warnings and Precautions (5.1) .]
12.3Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
In an open-label, randomized, pharmacokinetic study, 23 subjects aged 18 years and older with moderate to severe plaque psoriasis applied approximately 7 grams of BRYHALI Lotion to a mean BSA of 27.7±11.3% once daily for 28 days. Systemic concentrations were at steady state by Day 14. Only 5 out of 20 subjects had one or more quantifiable systemic concentrations of halobetasol propionate on Day 14.
The mean ± SD for maximum systemic concentration (C max ) on Day 14 was 31.2±62.2 pg/mL. The mean area under the concentration versus time curve (AUC) could not be reliably estimated due to insufficient number of quantifiable timepoints.
🧬 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING BRYHALI (halobetasol propionate) lotion, 0.01% is a white to off-white lotion supplied in a white aluminum tube as follows: • 60 g (NDC 0187-0002-60) • 100 g (NDC 0187-0002-01) 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 BRYHALI (halobetasol propionate) lotion contains a corticosteroid, halobetasol propionate, as the active ingredient 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 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20 –dione, 17-propionate.
Halobetasol propionate is a white to off-white crystalline powder with a molecular weight of 484.96 and a molecular formula of C 25 H 31 ClF 2 O 5 . It is practically insoluble in water and freely soluble in dichloromethane and in acetone. The structural formula for halobetasol propionate is represented below: Each gram of BRYHALI Lotion contains 0.1 mg (0.01%) halobetasol propionate 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%. description.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 BRYHALI Lotion of the following information and instructions: Important Administration Instructions Instruct patients to discontinue BRYHALI Lotion when psoriasis is controlled. Inform patients that BRYHALI Lotion is to be used as directed by the physician and should not be used for longer than the prescribed time period. 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 BRYHALI Lotion is for external use only.
Advise patients that BRYHALI Lotion is not for oral, ophthalmic, or intravaginal use [see Dosage and Administration (2) ] . Breastfeeding women should not apply BRYHALI Lotion directly to the nipple and areola to avoid directly exposing the infant [see Use in Specific Populations (8.2) ] . Effects on Endocrine System BRYHALI Lotion may cause HPA axis suppression.
Advise patients that use of topical corticosteroids, including BRYHALI 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 (5.1) ] .
Local Adverse Reactions Inform patients that BRYHALI Lotion may cause local adverse reactions. These reactions may be more likely to occur with occlusive use or prolonged use of BRYHALI Lotion [see Warnings and Precautions (5.2) ] . 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: 8,809,307 and 10,478,502 BRYHALI is a trademark of Bausch Health Companies Inc. or its affiliates. © 2020 Bausch Health Companies Inc. or its affiliates 9652104 TEAR HERE (Patient Information)
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
In an open-label, randomized, pharmacokinetic study, 23 subjects aged 18 years and older with moderate to severe plaque psoriasis applied approximately 7 grams of BRYHALI Lotion to a mean BSA of 27.7±11.3% once daily for 28 days. Systemic concentrations were at steady state by Day 14. Only 5 out of 20 subjects had one or more quantifiable systemic concentrations of halobetasol propionate on Day 14.
The mean ± SD for maximum systemic concentration (C max ) on Day 14 was 31.2±62.2 pg/mL. The mean area under the concentration versus time curve (AUC) could not be reliably estimated due to insufficient number of quantifiable timepoints.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Vasoconstrictor Assay A vasoconstrictor assay in healthy subjects with BRYHALI Lotion indicated that the formulation is in the potent to superpotent range of potency as compared to other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression The potential for HPA axis suppression was evaluated in 19 adult subjects with moderate to severe plaque psoriasis with at least 20% BSA involved.
An approximate dose of 7 g BRYHALI Lotion was applied once daily for 8 weeks. An abnormal HPA axis suppression test, as indicated by a 30-minute post-stimulation cortisol level ≤18 mcg/dL, was reported for 1 (5.6%) subject at Week 4 and for 3 (15.8%) subjects at Week 8. The subject suppressed at Week 4 was also suppressed at Week 8.
These effects were reversible as recovery of HPA axis function was generally prompt with the discontinuation of treatment. [See Warnings and Precautions (5.1) .]
🔬 Clinical Studies ▾
14 CLINICAL STUDIES BRYHALI Lotion was evaluated for the treatment of moderate to severe plaque psoriasis in two prospective, multicenter, randomized, double-blind clinical trials (Trial 1 [NCT02514577] and Trial 2 [NCT02515097]). These trials were conducted in 430 subjects 18 years of age and older with moderate to severe plaque psoriasis that covered a body surface area (BSA) between 3% and 12% excluding the face, scalp, palms, soles, axillae, and intertriginous areas. Disease severity was determined by a 5-grade Investigator’s Global Assessment (IGA).
Subjects applied BRYHALI Lotion or vehicle to all affected areas once daily for up to 8 weeks. Subjects had a follow-up visit 4 weeks after the end of treatment (Week 12) where safety and efficacy were evaluated. The primary efficacy endpoint was the proportion of subjects with treatment success at Week 8, where treatment success was defined as at least a 2-grade improvement from baseline in IGA score and an IGA score equating to “clear” or “almost clear”.
Table 2 lists the primary efficacy results for Trials 1 and 2. The secondary efficacy endpoints evaluated treatment success sequentially at Weeks 12, 6, 4, and 2. Figure 1 shows the primary and secondary efficacy results over time.
Table 2: Primary Efficacy Results at Week 8 in Subjects with Moderate to Severe Plaque Psoriasis Trial 1 Trial 2 BRYHALI Vehicle BRYHALI Vehicle N=143 N=74 N=142 N=71 IGA Treatment Success at Week 8 Treatment success was defined as at least a 2-grade improvement from baseline in IGA score and an IGA score equating to “clear” or “almost clear”. Clear = no evidence of scaling, no evidence of erythema, no evidence of plaque elevation above normal skin level. Almost clear = some plaques with fine scales, faint pink/light red erythema on most plaques, slight or barely perceptible elevation of plaques above normal skin level.
37% 8% 38% 12% * The treatment difference at Week 2 in Trial 2 was not statistically significant. Figure 1: Efficacy Results* over Time
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate. Halobetasol propionate was not genotoxic in the Ames assay, in the sister chromatid exchange test in Chinese hamster somatic cells, in chromosome aberration studies of germinal and somatic cells of rodents, or in a mammalian spot test. Positive mutagenicity effects were observed in a mouse lymphoma gene mutation assay in vitro and in a Chinese hamster micronucleus test.
Studies in rats following oral administration of halobetasol propionate at dose levels up to 0.05 mg/kg/day indicated no impairment of fertility or general reproductive performance.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate. Halobetasol propionate was not genotoxic in the Ames assay, in the sister chromatid exchange test in Chinese hamster somatic cells, in chromosome aberration studies of germinal and somatic cells of rodents, or in a mammalian spot test. Positive mutagenicity effects were observed in a mouse lymphoma gene mutation assay in vitro and in a Chinese hamster micronucleus test.
Studies in rats following oral administration of halobetasol propionate at dose levels up to 0.05 mg/kg/day indicated no impairment of fertility or general reproductive performance.
📄 Patient Package Insert ▾
Patient Package Insert PATIENT INFORMATION BRYHALI ® (bry-HAL-ee) (halobetasol propionate) Lotion Important: BRYHALI is for use on the skin only. Do not apply BRYHALI in your mouth, eyes, or vagina. What is BRYHALI?
BRYHALI is a prescription corticosteroid medicine used on the skin (topical) to treat adults with plaque psoriasis. It is not known if BRYHALI is safe and effective in children under 18 years of age. Before using BRYHALI, tell your doctor about all of your medical conditions, including if you: • have had irritation or other skin reaction to a steroid medicine in the past. • have a skin infection.
You may need medicine to treat the skin infection before using BRYHALI. • have diabetes. • have adrenal gland problems. • have liver problems. • are pregnant or plan to become pregnant. It is not known if BRYHALI will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if BRYHALI passes into your breast milk.
If you use BRYHALI and breastfeed, do not apply BRYHALI to your nipple or areola to avoid getting BRYHALI into your baby’s mouth. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroids medicines by mouth, or injection, or use other products on your skin that contain corticosteroids.
How should I use BRYHALI? • Use BRYHALI exactly as your doctor tells you to use it. • Apply a thin layer of BRYHALI to the affected areas 1 time each day and rub in gently. • You should not use more than 50 g of BRYHALI in 1 week. • Do not bandage, wrap, or cover the treated skin area(s) unless your doctor tells you to. • Avoid using BRYHALI on your face, groin, or underarms (armpits). • Talk to your doctor if your skin does not improve after 8 weeks of treatment with BRYHALI. • You should not use BRYHALI longer than 8 weeks unless your doctor tells you to. • Wash your hands after using BRYHALI unless you are using the medicine to treat your hands.
What are the possible side effects of BRYHALI? BRYHALI may cause serious side effects, including: • BRYHALI can pass through your skin. Too much BRYHALI passing through your skin can cause adrenal glands to stop working. • Cushing’s syndrome , a condition that happens when your body is exposed to too much of the hormone cortisol. • High blood sugar (hyperglycemia). • Skin reactions at the treated skin site.
Tell your doctor if you get any skin reactions or skin infections. • Vision problems. BRYHALI may increase your chance of developing cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with BRYHALI. • Effects on growth and weight in children.
The most common side effects of BRYHALI include burning, stinging, itching, dryness (application site dermatitis), upper respiratory tract infection and high blood sugar (hyperglycemia). These are not all the possible side effects of BRYHALI. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088. How should I store BRYHALI? • Store BRYHALI at room temperature between 68° to 77°F (20° to 25°C). • Protect from freezing. Keep BRYHALI and all medicines out of the reach of children.
General information about the safe and effective use of BRYHALI. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BRYHALI for a condition for which it was not prescribed.
Do not give BRYHALI to other people, even if they have the same condition you have. It may harm them. You can ask your pharmacist or doctor for information about BRYHALI that is written for health professionals.
What are the ingredients in BRYHALI? Active ingredients: halobetasol propionate Inactive ingredients: carbomer copolymer type B, carbomer homopolymer type A, diethyl sebacate, edetate disodium dihydrate, light mineral oil, methylparaben… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0187-0002-01 For Topical Use Only Not for Eye Use BRYHALI ® (halobetasol propionate) Lotion, 0.01% Rx only Net Wt. 100 g Ortho Dermatologics carton