Duobrii

Duobrii is a prescription medicine used on the skin (topical) to treat adults with plaque psoriasis.

Duobrii is a combination product with halobetasol propionate and tazarotene. Halobetasol belongs to a group of drugs called corticosteroids. These drugs work by blocking chemical reactions that cause inflammation and by tempering the action of certain immune cells and preventing tissue damage that excessive inflammation can cause. Tazarotene belongs to a class of drugs called retinoids. These drugs help treat plaque psoriasis by reducing inflammation and by reducing the rate at which the skin cells develop plaques.

Duobrii comes as a lotion. It is applied in a thin layer to the affected area once daily.

Common side effects include skin redness, itching, swelling, burning and stinging.

Duobrii is a prescription medicine used on the skin (topical) to treat adults with plaque psoriasis. It is not known if Duobrii is safe and effective in children under 18 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Duobrii. See the "Duobrii Precautions" section.

The most common side effects of Duobrii include: redness, itching, swelling, burning, stinging, application site pain, inflamed hair follicles (folliculitis), thinning of the skin (atrophy), peeling and rash.

This is not a complete list of Duobrii side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take corticosteroids by mouth, or injection, or use other products on your skin that contain corticosteroids.

Certain medicines may make your skin more sensitive to sunlight. Ask your healthcare provider for a list of these medicines if you are not sure.

Serious side effects have been reported with Duobrii including the following:

• Duobrii may cause birth defects if used during pregnancy. Females must not be pregnant when they start using Duobrii or become pregnant during treatment with Duobrii. 

For females who are able to get pregnant:

• Your healthcare provider will order a pregnancy test for you within 2 weeks before you begin treatment with Duobrii to be sure that you are not pregnant. Your healthcare provider will decide when to do the test.
• Begin treatment with Duobrii during a normal menstrual period.
• Use an effective form of birth control during treatment with Duobrii. Talk with your healthcare provider about birth control options that may be used to prevent pregnancy during treatment with Duobrii.
• Stop using Duobrii and tell your healthcare provider right away if you become pregnant during treatment with Duobrii.
• Duobrii can pass through your skin. Too much Duobrii 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).
• Effects of growth and weight in children.
• Skin irritation. Duobrii may cause increased skin irritation. Tell your healthcare provider if you develop any skin irritation during your treatment with Duobrii. If you develop skin irritation, your healthcare provider may tell you to interrupt or stop using Duobrii, or tell you to use Duobrii less often.
• Sensitivity to light and risk of sunburn. Avoid sunlight, including sunlamps and tanning beds during your treatment with Duobrii. Duobrii can make your skin more sensitive to the sun and the light from sunlamps and tanning beds. You could get severe sunburn. Use sunscreen, and wear a hat and clothes that cover your skin if you have to be in sunlight. Talk to your healthcare provider if you get sunburn during treatment with Duobrii. If you do get sunburn, do not use Duobrii until your sunburn is healed.
• Vision problems. Duobrii may increase your chance of developing cataract(s) and glaucoma. Tell your healthcare provider if you have blurred vision or other vision problems during your treatment with Duobrii.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Duobrii, there are no specific foods that you must exclude from your diet when receiving this medication.

Before using Duobrii, tell your healthcare provider about all of your medical conditions, including if you:

• have eczema or any other skin problems.
• have a skin infection. You may need medicine to treat the skin infection before using Duobrii.
• have diabetes.
• have adrenal gland problems.
• have liver problems.
• are breastfeeding or plan to breastfeed. It is not known if Duobrii passes into your breast milk. If you use Duobrii and breastfeed, do not apply Duobrii to your nipple or areola to avoid getting Duobrii into your baby’s mouth.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take corticosteroids by mouth, or injection, or use other products on your skin that contain corticosteroids.

Certain medicines may make your skin more sensitive to sunlight. Ask your healthcare provider for a list of these medicines if you are not sure.

Do not use Duobrii if you are pregnant.

Duobrii may cause birth defects if used during pregnancy.

Females must not be pregnant when they start using Duobrii or become pregnant during treatment with Duobrii. 

For females who are able to get pregnant:

• Your healthcare provider will order a pregnancy test for you within 2 weeks before you begin treatment with Duobrii to be sure that you are not pregnant. Your healthcare provider will decide when to do the test.
• Begin treatment with Duobrii during a normal menstrual period.
• Use an effective form of birth control during treatment with Duobrii. Talk with your healthcare provider about birth control options that may be used to prevent pregnancy during treatment with Duobrii.
• Stop using Duobrii and tell your healthcare provider right away if you become pregnant during treatment with Duobrii.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Duobrii passes into your breast milk. If you use Duobrii and breastfeed, do not apply Duobrii to your nipple or areola to avoid getting Duobrii into your baby’s mouth.

• Use Duobrii exactly as your healthcare provider tells you to use it.
• If you shower or bathe before applying Duobrii, your skin should be dry before applying the lotion.
• Apply a thin layer of Duobrii to the affected areas 1 time each day and rub in gently.
• You should not use more than 50 grams of Duobrii in 1 week.
• Avoid using Duobrii on your face, groin, or underarms (armpits).
• Do not bandage, wrap, or cover the treated skin area(s) unless your healthcare provider tells you to.

Take this medication exactly as prescibed by your doctor. Follow the directions on your prescription label carefully. 

Recommended dosage: Apply a thin layer of Duobrii Lotion once daily to cover only affected areas and rub in gently. If a bath or shower is taken prior to application, the skin should be dry before applying the lotion. The total dosage should not exceed approximately 50 g per week.

If you think you have applied too much Duobrii lotion, call your healthcare provider or local poison control center, or seek emergency medical attention right away.

• Store Duobrii at room temperature between 68°F to 77°F (20°C to 25°C).
• Protect from freezing. 
• Keep Duobrii and all medicines out of the reach of children.