Duobrii: Uses, Side Effects and Dosage

What is DUOBRII used for?

• DUOBRII is a lotion used on the skin to improve the signs and symptoms of psoriasis in adults.

How does DUOBRII work?

DUOBRII contains 2 types of medicine:

• Halobetasol propionate is a corticosteroid. It reduces inflammation.
• Tazarotene is a retinoid. It is not known exactly how it works but it is believed to help with the normal growth of skin cells and by reducing inflammation.

What are the ingredients in DUOBRII?

Medicinal ingredients: halobetasol propionate and tazarotene.

Non-medicinal ingredients: 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%.

DUOBRII comes in the following dosage forms:

Lotion: halobetasol propionate 0.01% w/w and tazarotene 0.045% w/w.

Do not use DUOBRII:

• If you are allergic to halobetasol propionate, tazarotene or any of the other ingredients found in DUOBRII.
• If you are allergic to other corticosteroids or retinoic compounds.

• On some other skin conditions. DUOBRII can cause more irritation if used on them. These include:

  • Dermatitis which is red itchy or scaly patches and dandruff.
  • Skin reaction after a vaccine.
  • Infection from a parasite, bacteria, fungus or a virus. These include herpes, chicken pox, tuberculosis or syphilis.

• If you are pregnant or if you think you might be pregnant. DUOBRII may harm your unborn baby.

  • If you are a woman who is able to get pregnant, you should use an appropriate method of birth control while you are using DUOBRII.
  • You should take a pregnancy test 2 weeks before you start using DUOBRII to make sure you are not pregnant.
  • You should start using DUOBRII during your period to make sure you are not pregnant.
  • STOP using DUOBRII and tell your healthcare professional right away if you become pregnant.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DUOBRII. Talk about any health conditions or problems you may have, including if you:

• Have eczema.
• Are thinking of becoming pregnant or think you might be pregnant.
• Have hormonal problems.
• Have glaucoma.
• Have a condition for which you were previously or are currently taking other corticosteroid drugs.
• Have other inflammatory skin diseases caused by poor circulation such as stasis dermatitis or chronic ulcers in the legs.
• Have a reduced ability to fight infections.
• Are taking medicines that suppress your immune system.
• Have diabetes.
• Have problems with your kidney or liver.
• Are breastfeeding. You and your healthcare professional should decide if the benefits of breastfeeding outweigh any possible harm to the baby. It is not known if it is safe to use DUOBRII and breastfeed. If you breastfeed, do not apply DUOBRII to your nipples or areola (dark part around the nipple). This will help decrease direct exposure of the baby to DUOBRII.
• Take medications or use skin products that increase your chances of getting sunburns (example: certain antibiotics).
• Use skin products that can dry or irritate your skin.
• Are older than 65 years.

Other warnings you should know about:

• DUOBRII can increase your chances of having sunburns. If you are going to be exposed to sunlight, you should use sunscreen with a minimum SPF of 15 and wear clothes that can protect you from the sun. This includes sunlamps. If you already have a sunburn, wait until it has healed before using DUOBRII.
• DUOBRII can make the wind, and very hot or very cold weather more irritating for your skin.
• DUOBRII can cause abnormal blood and urine test results. Your healthcare professional will decide when to perform blood and urine tests and will interpret the results. They may monitor how your liver is working and the levels of your blood sugar and hormones. They will also check to see how your adrenal glands are working. Monitoring the health of your adrenal glands is especially important if you are taking DUOBRII for 8 weeks or longer without a break
• Tell your healthcare professional if your psoriasis is not healing.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with DUOBRII:

• Other corticosteroid containing products applied to your skin or taken by mouth.
• Drugs that make your skin more sensitive to the sun such as thiazides, tetracyclines, fluoroquinolones, phenothiazines or sulfonamides.
• Immunosuppressants. They are drugs which lower your body’s ability to fight infection.

How to use DUOBRII:

• ONLY use DUOBRII on dry skin.
• ONLY use DUOBRII on skin affected with psoriasis plaques.
• After a bath or shower, make sure your skin is dry before using DUOBRII.
• You can apply a cream or lotion to soften or moisten your skin as often as you wish after using DUOBRII.
• A QR link to a video is on the carton label to show how to apply DUOBRII.

Usual adult dose:

Apply a thin layer, once a day to affected skin. Rub in gently. Once your psoriasis is better, stop using DUOBRII. It may then be used on and off as necessary.

If you get redness, peeling, or discomfort you can stop or reduce how often you apply DUOBRII. For example, you can try only applying DUOBRII every second or third day until the area is better and then return to using DUOBRII as prescribed by your healthcare professional.

Do NOT do the following when using DUOBRII:

• Do NOT apply to normal skin areas or broken skin such as ulcers, open sores, wounds.
• Do NOT apply on skin with eczema because it can cause severe irritation.
• Do NOT apply to areas where two skin areas touch or rub together. For example, do not put DUOBRII on armpits, genitals, groin, anal area, skin folds of the breast and between your fingers.
• Do NOT get DUOBRII in your eyes, nose, mouth or other mucous membranes. If you get DUOBRII in your eye, flush it with cold water.
• Do NOT apply a bandage or wrap your skin after applying DUOBRII.
• Do NOT share your medicine.

• Do NOT use on children under 18 years old.

• Do NOT use DUOBRII in ways that are not indicated by your healthcare professional.
• Do NOT use more than 50 g of DUOBRII in one week.

Overdose:

If you think you have used too much DUOBRII, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose: Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.

What are possible side effects from using DUOBRII?

These are not all the possible side effects you may feel when taking DUOBRII. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• Dermatitis: skin rash or sores.
• Red, sore, itchy, blisters or oozing
• Itching of the skin
• Redness, rash, tears or scrapes
• Application site pain or burning/stinging sensation
• Skin Atrophy: thinning or wasting of the skin.
• Folliculitis: inflammation or infection of a hair follicle. It looks like a small yellow or white lump with a red ring. It usually happens on the face, arms, or legs or parts not usually covered by clothing.
• Stretch Marks: a band, line, streak or stipe that starts out pink or purple but turns white later on. They are due to weak elastic tissues in the skin. They can occur on the breasts, thighs, abdomen, and buttocks.
• Telangiectasia: small red areas caused by dilation of the blood vessels in the skin.
• Worsening of psoriasis
• Swelling
• Skin dryness and flaking
• Increased risk of skin infections

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store at room temperature (15-30°C).

Keep out of reach and sight of children.

If you want more information about DUOBRII:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); by contacting the sponsor: Bausch Health, Canada Inc., 2150 St-Elzéar Blvd. West, Laval, (Quebec) H7L 4A8; or by calling 1-800-361-4261.

Last Revised: June 17, 2022