Bryhali 0.01% Lotion 100gm
It is used to treat plaque psoriasis.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Not available
FDA Approved
Jul 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Bryhali is a strong steroid lotion used on the skin to treat plaque psoriasis in adults. It helps reduce redness, scaling, and itching caused by psoriasis.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Continue using the medication as directed, even if your symptoms improve.
Applying the Medication
Do not take this medication by mouth. It is for use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply the medication to the vagina.
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 Instructions
Do not apply the medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Avoid using bandages or dressings to cover the treated area unless your doctor advises you to do so.
Storing and Disposing of Your Medication
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 by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in a drug take-back program in your area.
Missing a Dose
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 safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Continue using the medication as directed, even if your symptoms improve.
Applying the Medication
Do not take this medication by mouth. It is for use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply the medication to the vagina.
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 Instructions
Do not apply the medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Avoid using bandages or dressings to cover the treated area unless your doctor advises you to do so.
Storing and Disposing of Your Medication
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 by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in a drug take-back program in your area.
Missing a Dose
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
- Apply a thin layer to the affected skin areas once daily.
- Wash your hands thoroughly before and after applying the lotion.
- Do not use more than 50 grams (one 100gm tube used halfway) per week.
- Do not use for longer than 8 weeks unless directed by your doctor.
- Do not use on your face, groin, or armpits, or for diaper rash.
- Avoid getting the lotion in your eyes, mouth, or nose. If it gets into your eyes, rinse thoroughly with water.
- Do not cover the treated area with bandages or other dressings unless your doctor tells you to, as this can increase absorption and side effects.
- Inform your doctor if your condition worsens or does not improve after 8 weeks.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas once daily for up to 8 weeks. Do not exceed 50 grams per week.
Condition-Specific Dosing:
plaquePsoriasis:
Apply a thin layer to affected areas once daily for up to 8 weeks. Do not exceed 50 grams per week.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in patients under 18 years of age.)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but use with caution if extensive systemic absorption is anticipated.
Moderate:
No specific adjustment recommended, but use with caution if extensive systemic absorption is anticipated.
Severe:
No specific adjustment recommended, but use with caution if extensive systemic absorption is anticipated.
Dialysis:
Considerations: Systemic absorption can occur; monitor for signs of systemic corticosteroid effects if used extensively.
Hepatic Impairment:
Mild:
No specific adjustment recommended, but use with caution if extensive systemic absorption is anticipated.
Moderate:
No specific adjustment recommended, but use with caution if extensive systemic absorption is anticipated.
Severe:
No specific adjustment recommended, but use with caution if extensive systemic absorption is anticipated.
Pharmacology
Mechanism of Action
Halobetasol propionate is a synthetic corticosteroid. Like other topical corticosteroids, it has anti-inflammatory, antipruritic, and vasoconstrictive properties. These effects are thought to be mediated by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. Lipocortins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Pharmacokinetics
Absorption:
Bioavailability:
Varies; systemic absorption can occur, especially with prolonged use, large surface areas, occlusive dressings, or impaired skin barrier.
Tmax:
Not typically reported for topical corticosteroids.
FoodEffect:
Not applicable
Distribution:
Vd:
Not well-quantified for topical application.
ProteinBinding:
Not well-quantified for topical application.
CnssPenetration:
Limited (primarily local action, systemic effects are due to absorption into the bloodstream).
Elimination:
HalfLife:
Not typically reported for topical corticosteroids.
Clearance:
Not well-quantified for topical application.
ExcretionRoute:
Primarily renal, with some biliary excretion.
Unchanged:
Not well-quantified for topical application.
Pharmacodynamics
OnsetOfAction:
Within days (reduction in inflammation and pruritus).
PeakEffect:
Not precisely defined for topical corticosteroids; depends on severity and duration of use.
DurationOfAction:
Not precisely defined for topical corticosteroids; effects persist as long as treatment continues and for some time after discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some individuals may experience severe and potentially life-threatening side effects while taking this medication. If you exhibit any of the following symptoms, contact your doctor or seek medical help right away:
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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation at the site of application
Thinning of the skin
Changes in eyesight
Other Possible Side Effects
As with any medication, you may experience side effects. While many people have no 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 guidance:
Burning or stinging
Dry skin
* Itching
This is not an exhaustive list of potential side effects. If you have questions or concerns, don't hesitate to reach out to 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 individuals may experience severe and potentially life-threatening side effects while taking this medication. If you exhibit any of the following symptoms, contact your doctor or seek medical help right away:
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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation at the site of application
Thinning of the skin
Changes in eyesight
Other Possible Side Effects
As with any medication, you may experience side effects. While many people have no 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 guidance:
Burning or stinging
Dry skin
* Itching
This is not an exhaustive list of potential side effects. If you have questions or concerns, don't hesitate to reach out to 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:
- Signs of skin thinning (e.g., easy bruising, shiny skin, stretch marks)
- Worsening of your skin condition or new skin problems (e.g., acne, hair growth, skin discoloration)
- Signs of skin infection (e.g., increased redness, swelling, pus, warmth)
- Unusual tiredness or weakness
- Weight gain, especially in the face or upper back (signs of Cushing's syndrome)
- Increased thirst or frequent urination (signs of high blood sugar)
- Blurred vision or eye pain (possible cataracts or glaucoma)
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 treatment, it is crucial to disclose all of your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all of your other medications and health problems.
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 treatment, it is crucial to disclose all of your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all of your other medications and health problems.
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 to ensure safe use.
Precautions for Application
Do not apply this medication to cuts, scrapes, or damaged skin. When applying to a large area of skin or near open wounds, exercise caution and consult with your doctor.
Duration of Use
Do not use this medication for longer than prescribed by your doctor. Additionally, do not use this medication to treat acne, rosacea, or rashes around the mouth, as it may increase the risk of cataracts or glaucoma. Discuss any concerns with your doctor.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult with your doctor to discuss the benefits and risks to you and your baby. If breastfeeding, avoid applying this medication directly to the nipple or surrounding area.
Special Considerations for Children
Not all products are suitable for use in children. Before giving this medication to a child, consult with your doctor to determine the appropriate use. 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. Consult with your doctor to discuss any concerns.
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 to ensure safe use.
Precautions for Application
Do not apply this medication to cuts, scrapes, or damaged skin. When applying to a large area of skin or near open wounds, exercise caution and consult with your doctor.
Duration of Use
Do not use this medication for longer than prescribed by your doctor. Additionally, do not use this medication to treat acne, rosacea, or rashes around the mouth, as it may increase the risk of cataracts or glaucoma. Discuss any concerns with your doctor.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult with your doctor to discuss the benefits and risks to you and your baby. If breastfeeding, avoid applying this medication directly to the nipple or surrounding area.
Special Considerations for Children
Not all products are suitable for use in children. Before giving this medication to a child, consult with your doctor to determine the appropriate use. 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. Consult with your doctor to discuss any concerns.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic corticosteroid effects, including suppression of the hypothalamic-pituitary-adrenal (HPA) axis, Cushing's syndrome, hyperglycemia, and glucosuria.
What to Do:
If you suspect an overdose or significant systemic absorption, contact your doctor or poison control center immediately. Call 1-800-222-1222. Management is supportive and may involve gradual withdrawal of the medication under medical supervision.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition (extent and severity of psoriasis)
Rationale: To establish baseline for efficacy assessment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, burning, itching, irritation)
Frequency: Regularly during treatment, especially with prolonged use.
Target: Absence or minimal signs of adverse reactions.
Action Threshold: If severe or persistent, consider discontinuation or alternative therapy.
Signs of HPA axis suppression (e.g., fatigue, weakness, weight gain, moon face)
Frequency: Periodically, especially with extensive use, large surface areas, or occlusive dressings.
Target: Normal HPA axis function.
Action Threshold: If suspected, perform appropriate tests (e.g., ACTH stimulation test) and consider gradual withdrawal or alternative therapy.
Efficacy (reduction in redness, scaling, thickness, itching)
Frequency: Regularly during treatment.
Target: Improvement in psoriatic lesions.
Action Threshold: If no improvement after 8 weeks, re-evaluate diagnosis and treatment.
Symptom Monitoring
- Worsening of skin condition
- Signs of skin infection (redness, warmth, pus)
- Unusual fatigue or weakness
- Weight gain or swelling (especially in face/neck)
- Increased thirst or urination (signs of hyperglycemia)
- Blurred vision (possible cataracts/glaucoma with prolonged use)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of halobetasol propionate lotion in pregnant women. Based on animal reproduction studies, corticosteroids may cause fetal harm when administered to pregnant animals. Bryhali should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Animal studies show corticosteroids can be teratogenic (e.g., cleft palate, skeletal abnormalities). Risk in humans is not well-established for topical use.
Second Trimester:
Risk of fetal harm from systemic absorption is generally low with appropriate topical use, but caution is advised.
Third Trimester:
Risk of fetal harm from systemic absorption is generally low with appropriate topical use, but caution is advised. Monitor for signs of HPA axis suppression in the neonate if used extensively.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Caution should be exercised when Bryhali is administered to a nursing woman. Avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low risk with limited, appropriate use. Potential for systemic effects in infant if significant maternal absorption occurs or if applied directly to breast.
Pediatric Use
Safety and effectiveness of Bryhali in pediatric patients (under 18 years of age) have not been established. Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids due to their larger skin surface area to body mass ratio.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects. However, elderly patients may have thinner skin and be more susceptible to local adverse reactions.
Clinical Information
Clinical Pearls
- Bryhali 0.01% Lotion is a super-high potency topical corticosteroid. Use with caution and strictly adhere to prescribed duration and quantity.
- It is specifically formulated as a lotion for plaque psoriasis and may be preferred for larger or hairy areas compared to creams/ointments.
- Limit treatment duration to 8 weeks to minimize risk of local and systemic adverse effects.
- Do not exceed 50 grams per week to reduce the risk of HPA axis suppression.
- Not indicated for use on the face, groin, or axillae due to increased risk of skin atrophy and other side effects in these sensitive areas.
- Patients should be advised to wash hands after application to avoid accidental transfer to eyes or other sensitive areas.
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol propionate, betamethasone dipropionate, fluocinonide)
- Topical vitamin D analogs (e.g., calcipotriene, calcitriol)
- Topical retinoids (e.g., tazarotene)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus - off-label for psoriasis)
- Coal tar preparations
- Anthralin
- Systemic therapies for psoriasis (e.g., methotrexate, cyclosporine, biologics, oral retinoids)
- Phototherapy (UVB, PUVA)
Cost & Coverage
Average Cost:
Check current pricing per 100gm tube
Insurance Coverage:
Tier 2 or 3 (Specialty)
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's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to 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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.