Bryhali

Bryhali is a high-potency, Class I corticosteroid lotion that may be used by adults to reduce inflammation and itching caused by plaque psoriasis. It contains 0.01% halobetasol propionate.

Bryhali was approved on November 6, 2018. It contains a lower concentration than other halobetasol propionate lotions which limits its risk of side effects.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Bryhali (halobetasol propionate 0.01% lotion) is a highly potent, Class I corticosteroid that can be absorbed through the skin into the bloodstream and cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency, including Cushing’s syndrome, hyperglycemia, and glucosuria. Do not use for longer than 2 weeks and do not exceed the recommended dose. Periodic monitoring for HPA suppression may be required.

You should not use halobetasol topical if you are allergic to it.

Bryhali should not be applied to lesions that are exuding serum or to skin folds (where two areas of skin touch each other).

Tell your doctor if you have ever had:

• any type of skin infection;
• a skin reaction to any steroid medicine;
• liver disease; or
• an adrenal gland disorder.

Topical corticosteroids can increase the glucose (sugar) levels in your blood or urine. Tell your doctor if you have diabetes.

Children are more susceptible to systemic absorption of topical corticosteroids. Bryhali is not approved for use by anyone younger than 18 years old.

It is not known whether halobetasol topical will harm an unborn baby. Tell your doctor if you are pregnant. If you are instructed to use Bryhali, use only a small amount for the shortest time possible.

It may not be safe to breastfeed while using this medicine. If you are instructed to use Bryhali, use only a small amount for the shortest time possible. Do not apply to the breasts.

Get emergency medical help if you have signs of an allergic reaction to Bryhali such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• worsening of your skin condition;
• redness, warmth, swelling, oozing, or severe irritation of any treated skin;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor; or
• possible signs of absorbing this medicine through your skin - weight gain (especially in your face or your upper back and torso), slow wound healing, thinning or discolored skin, increased body hair, muscle weakness, nausea, diarrhea, tiredness, mood changes, menstrual changes, sexual changes.

Common Bryhali side effects may include:

• upper respiratory tract infection
• burning, stinging, itching, or dryness of treated skin
• high blood sugar levels.

Other side effects that may occur with topical corticosteroids include:

• acne
• discoloration of the skin where the tape has been applied
• dryness
• excessive hair growth
• miliaria
• ophthalmic side effects such as cataracts or glaucoma
• perioral dermatitis and allergic contact dermatitis
• redness or crusting around your hair follicles (folliculitis)
• skin thinning
• spider veins
• stretch marks.

Topical corticosteroids can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency.

If you develop a skin infection while using Bryhali your doctor may give you an antimicrobial cream to use as well. If this does not resolve the infection, your doctor may discontinue the tape until the infection has cleared.

If irritation develops, stop using Bryhali.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Apply Bryhali exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Do not take it by mouth or use it intravaginally. Topical medicine is for use only on the skin. Do not use on open wounds or sunburned, windburned, dry, or irritated skin. Rinse with water if Bryhali gets in your eyes or mouth.

• Wash your hands before and after using Bryhali, unless you are using this medicine to treat the skin on your hands.
• Apply a thin layer of Bryhali lotion to the affected areas once daily. Rub in gently and completely. Do not apply this medicine over a large area of skin unless your doctor has told you to.

Do not cover the treated skin area with a bandage or other covering unless your doctor tells you to. Covering treated areas can increase the amount of medicine absorbed through your skin and may cause harmful effects.

Bryhali lotion is for short-term use only (up to 8 weeks). Follow your doctor's dosing instructions very carefully. Clinical trials have shown Bryhali continues to provide relief from psoriasis for up to 4 weeks after stopping using it.

Call your doctor if your symptoms do not improve after 8 weeks, or if they get worse. Stop using the product if your symptoms improve sooner.

Apply the product as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

High doses or long-term use of Bryhali lotion can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

• Avoid applying Bryhali to your face, scalp, underarms, or groin area. Do not use it to treat any skin condition that has not been checked by your doctor.
• Avoid using other topical steroid medications on the areas you treat with Bryhali unless your doctor tells you to.
• Do not use more than 50 grams per week.

Bryhali is unlikely to interact with other medications you may take. But you should not use it with other topical or oral corticosteroids, because they may have an additive effect.

Tell your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Store at room temperature 20°C – 25°C (68°F – 77°F). Do not freeze.

Keep out of reach of children.

Active: halobetasol propionate 0.01%

Inactive: carbomer copolymer type B and type A, diethyl sebacate, edetate disodium, light mineral oil, methylparaben, propylparaben, water, sodium hydroxide, sorbitan monooleate, sorbitol.

Supplied as 45-gram, 60-gram, and 100-gram aluminum tubes.

Valeant Pharmaceuticals North America LLC.