Bryhali 0.01% Lotion 60gm
It is used to treat plaque psoriasis.
Drug Class
Anti-inflammatory
Pharmacologic Class
Topical Corticosteroid, Super-High Potency
Pregnancy Category
Category C
FDA Approved
Aug 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Bryhali is a strong steroid lotion used on the skin to treat plaque psoriasis. It helps reduce redness, thickness, and scaling of the skin. Use it exactly as prescribed by your doctor, usually once a day, and only for the recommended time.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply the medication to the vaginal area.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Precautions
Unless directed by your doctor, do not apply the medication to your face, underarms, or groin area.
Do not cover the treated area with bandages or dressings unless instructed to do so by your doctor.
Storage and Disposal
Store the medication at room temperature and do not freeze it.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of medications, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular application schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply the medication to the vaginal area.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Precautions
Unless directed by your doctor, do not apply the medication to your face, underarms, or groin area.
Do not cover the treated area with bandages or dressings unless instructed to do so by your doctor.
Storage and Disposal
Store the medication at room temperature and do not freeze it.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of medications, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular application schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Wash your hands before and after applying the lotion.
- Apply a thin layer of the lotion to the affected skin areas only.
- Do not cover the treated area with bandages or other dressings unless directed by your doctor, as this can increase absorption and side effects.
- Avoid applying the lotion to the face, groin, or armpits unless specifically instructed by your doctor, as these areas are more susceptible to side effects.
- Do not use Bryhali for longer than prescribed, typically up to 8 weeks, without consulting your doctor.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Keep out of reach of children.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas once daily.
Condition-Specific Dosing:
plaquePsoriasis:
Apply a thin layer to affected areas once daily for up to 8 weeks. Treatment beyond 8 weeks may be warranted for patients with more than 20% body surface area (BSA) involvement, provided the patient is tolerating the treatment and has not experienced HPA axis suppression.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for patients under 12 years of age due to potential for systemic absorption and HPA axis suppression.
Adolescent:
Not recommended for patients under 12 years of age. For adolescents 12 years and older, use with caution and consider the potential for systemic absorption and HPA axis suppression.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended due to minimal systemic absorption.
Moderate:
No specific dose adjustment recommended due to minimal systemic absorption.
Severe:
No specific dose adjustment recommended due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended due to minimal systemic absorption.
Moderate:
No specific dose adjustment recommended due to minimal systemic absorption.
Severe:
No specific dose adjustment recommended due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Halobetasol propionate is a synthetic corticosteroid. Corticosteroids diffuse across cell membranes and bind to specific cytoplasmic receptors. These complexes then enter the nucleus, bind to DNA (chromatin), and stimulate the transcription of messenger RNA (mRNA) and subsequent protein synthesis of various enzymes thought to be responsible for the anti-inflammatory effects. These effects include the inhibition of prostaglandin and leukotriene synthesis by inhibiting the release of arachidonic acid from membrane phospholipids via phospholipase A2. They also suppress the migration of polymorphonuclear leukocytes and reverse increased capillary permeability.
Pharmacokinetics
Absorption:
Bioavailability:
Not well-quantified for topical application; systemic absorption is minimal but can occur, especially with prolonged use, large surface areas, occlusive dressings, or compromised skin barrier.
Tmax:
Not typically reported for topical application; systemic levels are generally low.
FoodEffect:
Not applicable
Distribution:
Vd:
Not typically reported for topical application; systemically absorbed corticosteroids are widely distributed.
ProteinBinding:
Approximately 90% for systemically absorbed corticosteroids.
CnssPenetration:
Limited for topical application; systemic penetration is low.
Elimination:
HalfLife:
Not typically reported for topical application; systemic half-life of corticosteroids varies.
Clearance:
Not typically reported for topical application.
ExcretionRoute:
Primarily renal excretion of metabolites; some biliary excretion.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Anti-inflammatory effects may be observed within days.
PeakEffect:
Full therapeutic effect for plaque psoriasis may take several weeks (e.g., 8 weeks in clinical trials).
DurationOfAction:
Varies depending on application frequency and individual response.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Drowsiness
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or abdomen
+ Moon face
+ Severe headache
+ Slow wound healing
Signs of a weak adrenal gland, including:
+ Severe nausea or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Extreme fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Acne
+ Stretch marks
+ Slow wound healing
+ Excessive hair growth
Irritation at the application site
Thinning of the skin
Changes in vision
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Burning or stinging sensations
Dry skin
* Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Drowsiness
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or abdomen
+ Moon face
+ Severe headache
+ Slow wound healing
Signs of a weak adrenal gland, including:
+ Severe nausea or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Extreme fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Acne
+ Stretch marks
+ Slow wound healing
+ Excessive hair growth
Irritation at the application site
Thinning of the skin
Changes in vision
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Burning or stinging sensations
Dry skin
* Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Increased redness, itching, or burning at the application site
- Signs of skin infection (e.g., pus, spreading redness, fever)
- Thinning of the skin, easy bruising, or stretch marks (striae) in treated areas
- Changes in skin color (lightening)
- Acne-like breakouts or increased hair growth in treated areas
- Symptoms of systemic steroid absorption, such as unusual tiredness, weight gain (especially in the face or trunk), muscle weakness, or mood changes (rare with proper use).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
The presence of an infection at the site where this medication will be administered.
To ensure safe use, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any health problems you have, as this medication may interact with other drugs or health conditions.
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions or adverse effects.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
The presence of an infection at the site where this medication will be administered.
To ensure safe use, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any health problems you have, as this medication may interact with other drugs or health conditions.
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions or adverse effects.
Precautions & Cautions
Important Warnings and Cautions for Patients Taking This Medication
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists. Before using any other medications or skin products, such as soaps, consult with your doctor.
Precautions for Application
Do not apply this medication to cuts, scrapes, or damaged skin. Exercise caution when applying it to a large area of skin or near open wounds, and discuss this with your doctor.
Duration of Use and Indications
Use this medication only for the duration prescribed by your doctor. Do not use it to treat acne, rosacea, or rashes around the mouth, as this may not be an approved indication.
Potential Eye Risks
This medication may increase the risk of cataracts or glaucoma. Discuss this potential risk with your doctor.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult with your doctor to weigh the benefits and risks to you and your baby. When breastfeeding, avoid applying this medication directly to the nipple or surrounding area.
Special Considerations for Children
Not all formulations of this medication are suitable for all children. Consult with your doctor before administering this medication to a child. When using this medication in children, exercise caution, as the risk of certain side effects may be higher. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss this with your doctor.
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists. Before using any other medications or skin products, such as soaps, consult with your doctor.
Precautions for Application
Do not apply this medication to cuts, scrapes, or damaged skin. Exercise caution when applying it to a large area of skin or near open wounds, and discuss this with your doctor.
Duration of Use and Indications
Use this medication only for the duration prescribed by your doctor. Do not use it to treat acne, rosacea, or rashes around the mouth, as this may not be an approved indication.
Potential Eye Risks
This medication may increase the risk of cataracts or glaucoma. Discuss this potential risk with your doctor.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult with your doctor to weigh the benefits and risks to you and your baby. When breastfeeding, avoid applying this medication directly to the nipple or surrounding area.
Special Considerations for Children
Not all formulations of this medication are suitable for all children. Consult with your doctor before administering this medication to a child. When using this medication in children, exercise caution, as the risk of certain side effects may be higher. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss this with your doctor.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use of topical corticosteroids can lead to systemic effects, including suppression of the hypothalamic-pituitary-adrenal (HPA) axis, Cushing's syndrome, hyperglycemia, and glucosuria. Symptoms may include fatigue, weakness, nausea, vomiting, weight gain, moon face, central obesity, and high blood sugar.
What to Do:
If systemic effects are suspected due to overdose or prolonged extensive use, contact a healthcare professional immediately. Management may involve gradual withdrawal of the corticosteroid, symptomatic treatment, and supportive care. For immediate concerns, call 911 or a poison control center (1-800-222-1222).
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of plaque psoriasis and identify any pre-existing skin infections or conditions.
Timing: Prior to initiation of therapy
Body Surface Area (BSA) involvement
Rationale: To guide treatment duration and assess potential for systemic absorption.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical efficacy (reduction in psoriasis signs/symptoms)
Frequency: Periodically, e.g., at 4 and 8 weeks
Target: Improvement in erythema, induration, scaling
Action Threshold: Lack of improvement or worsening may indicate need for re-evaluation or alternative therapy.
Local skin reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation)
Frequency: At each follow-up visit
Target: Absence or minimal reactions
Action Threshold: Persistent or severe reactions may require discontinuation or reduction in frequency.
Signs of skin infection
Frequency: At each follow-up visit
Target: Absence of infection
Action Threshold: Presence of infection requires appropriate antimicrobial therapy; consider discontinuing Bryhali until infection is controlled.
Signs/symptoms of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension)
Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings
Target: Absence of symptoms
Action Threshold: If suspected, perform HPA axis evaluation (e.g., ACTH stimulation test). Discontinue or gradually withdraw if suppression is confirmed.
Symptom Monitoring
- Burning
- Stinging
- Itching
- Dryness
- Folliculitis
- Hypertrichosis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Maceration of the skin
- Secondary infection
- Skin atrophy
- Striae
- Miliaria
- Signs of Cushing's syndrome (e.g., moon face, central obesity, buffalo hump)
- Hyperglycemia
- Glucosuria
Special Patient Groups
Pregnancy
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Corticosteroids have been shown to be teratogenic in animals. Bryhali should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity observed in animal studies with systemic corticosteroids. Use with caution.
Second Trimester:
Use with caution; systemic absorption is minimal but possible.
Third Trimester:
Use with caution; potential for systemic effects in the mother and fetus, including HPA axis suppression in the neonate, though rare with topical use.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when Bryhali is administered to a nursing woman. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with appropriate use (minimal systemic absorption), but potential for growth suppression or other adverse effects if significant systemic absorption occurs in the mother and transfers to the infant via breast milk. Avoid direct contact with infant's skin.
Pediatric Use
Safety and effectiveness in pediatric patients under 12 years of age have not been established. Due to a larger skin surface area to body weight ratio, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when treated with topical corticosteroids. Use in children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
Geriatric Use
Clinical studies of Bryhali did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients may have thinner skin and be more susceptible to local adverse effects like skin atrophy.
Clinical Information
Clinical Pearls
- Bryhali is a super-high potency topical corticosteroid; use with caution and for limited durations to minimize systemic absorption and local side effects.
- Educate patients on proper application technique: thin layer, once daily, and avoid occlusive dressings unless specifically instructed.
- Monitor for signs of HPA axis suppression, especially in patients using the lotion on large body surface areas, for prolonged periods, or under occlusion.
- Not for use on the face, groin, or axillae unless specifically directed by a dermatologist due to increased risk of skin atrophy and other side effects in these sensitive areas.
- If no improvement is seen after 8 weeks, re-evaluate the diagnosis and treatment plan.
- Patients should be advised to report any signs of local irritation, infection, or systemic side effects promptly.
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol propionate, betamethasone dipropionate, fluocinonide, triamcinolone acetonide, hydrocortisone)
- Topical vitamin D analogs (e.g., calcipotriene, calcitriol)
- Topical retinoids (e.g., tazarotene)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus - off-label for psoriasis)
- Systemic therapies for moderate to severe psoriasis (e.g., methotrexate, cyclosporine, biologics, oral small molecules like apremilast)
- Phototherapy (UVB, PUVA)
Cost & Coverage
Average Cost:
$700 - $1000+ per 60gm tube
Insurance Coverage:
Tier 2 or Tier 3 (Specialty/Non-Preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the medication taken, the amount, and the time it occurred.