Even though Duobrii is a medicine used on the skin, it is highly potent. Excessive doses can pass through your skin and into your bloodstream, which may lead to serious side effects like suppression of your natural cortisol production, Cushing syndrome, high blood sugar or vision problems. Follow your doctor’s dosing instructions exactly.

• Do not use more than 50 grams of Duobrii per week (or as prescribed by your doctor). Duobrii Lotion is applied as a thin layer to the affected areas once daily.
• Serious side effects like suppression of the hypothalamic-pituitary-adrenal (HPA) axis and reduction of your natural cortisol production, Cushing syndrome, high blood sugar (glucose) levels, type 2 diabetes, or vision problems (glaucoma, cataracts) can occur if you use too much Duobrii.

Other side effects like skin irritation, redness, peeling, dry skin, burning, and itching can also occur, especially when applied in large amounts.

What’s in Duobrii?

Duobrii (generic name: halobetasol 0.01% / tazarotene 0.045%) is a topical prescription lotion that combines two skin medicines: the corticosteroid halobetasol with the retinoid tazarotene. It is applied once-daily to the skin to treat plaque psoriasis in adults.

• Topical corticosteroids like halobetasol are used in many skin conditions to help decrease inflammation, redness or itching. They work by mimicking our own steroid hormones and prevent the release of substances in the body that cause these side effects. They also suppress the immune response, reduce cell turnover, and narrow blood vessels.
• Retinoids such as tazarotene are derived from or similar to vitamin A. Retinoids also have an anti-inflammatory action and slow down skin cell overgrowth in psoriasis.

Before you start treatment, be sure to tell your doctor if you use any other products that contain corticosteroids or tazarotene, including skin creams, lotions, foams or ointments, pills or injections. If you are not sure, ask your pharmacist or doctor.

Does Duobrii contain steroids?

Duobrii contains two active ingredients: halobetasol, a potent topical corticosteroid (or “steroid”), and tazarotene, a retinoid vitamin A derivative. These skin medicines work together to treat psoriasis but can still cause side effects or be absorbed into your bloodstream.

Long-term or excessive use of potent topical corticosteroids, such as halobetasol, may suppress the HPA axis and reduce cortisol production in your body.

• Cortisol is the natural stress hormone found in humans. It is made by your adrenal glands, the endocrine glands found on top of your kidneys.
• Cortisol is needed by your body to help you respond to stressful events, like illness or surgery, and helps to control metabolism, blood pressure, and sleep patterns.
• Suppression of cortisol may also increase your risk for infections.

Other side effects from excessive corticosteroid use may include high blood sugar levels (hyperglycemia), sugar in the urine (glycosuria), Cushing syndrome, onset of type 2 diabetes, and rarely, the development of glaucoma or cataracts.

Cushing syndrome is a condition when your body is exposed to too much of the hormone cortisol over a long time. Using too much corticosteroid may affect the body the same way as having excessive cortisol in your bloodstream. The primary symptoms of Cushing syndrome are abnormal fat deposits between the shoulders, a rounded face, purple stretch marks on the skin, high blood pressure, type 2 diabetes or bone loss.

Tell your doctor if you develop blurry vision or other vision problems during treatment with Duobrii as that may be a sign of cataracts or glaucoma. This is not a common side effect with Duobrii, but can occur with excessive use of corticosteroids.

Let your doctor know if you have type 2 diabetes, adrenal gland problems, or any liver disease.

Does Duobrii cause HPA axis suppression?

Yes, studies have shown that Duobrii used once daily may cause reversible HPA axis suppression in some patients.

• Duobrii applied once daily was evaluated in an 8-week study in 20 adults with moderate to severe plaque psoriasis involving 20% or more of their body surface area.
• Certain tests can measure cortisol levels in the body to look for HPA axis suppression.
• In the study, HPA axis suppression occurred in 3 out of 20 (15%) subjects at Week 4 and none (0%) of these 20 subjects at Week 8.

How can I prevent HPA axis suppression?

To hekp prevent HPA axis suppression avoid use of potent corticosteroids like halobetasol on large areas, for a long period of time, under any type of occlusive dressing, or on skin that is broken, infected, sunburned or irritated. Follow your healthcare providers directions exactly.

Duobrii may be absorbed to a greater extent if you cover up the area with occlusive dressings (like bandages, wraps or coverings), which can increase your risk for side effects. Do not use Duobrii with an occlusive dressing unless directed by your doctor.

Avoid use in areas where there are skin folds (where skin rubs against skin), unless directed to apply there by your doctor, as increased absorption may occur.

Avoid application of Duobrii Lotion on the face, groin, or in the axillae (underarm or armpit area). These areas have thinner skin and may be subject to greater side effects, like skin thinning (atrophy), inflamed hair follicles, stretch marks (striae) or visible broken capillaries like spider veins (telangiectasias). Call your doctor right away if you develop these side effects.

Duobrii Lotion is not to be used in the mouth, eyes or vagina. Do not apply it to skin that has eczema or an infection.

It is not known if Duobrii is safe and effective for people under the age of 18 years. It should only be used by adults.

Other side effects with Duobrii

The most common side effects that occur with the use of Duobrii are:

• redness
• itching
• swelling
• burning
• stinging
• pain at the application site
• inflamed hair follicles (folliculitis)
• thinning of the skin (atrophy)
• skin peeling
• skin rash

Duobrii may also cause skin sensitivity, sensitivity to light and a risk for a sunburn, which could be severe, on your skin. Avoid sunlight, sunlamps and tanning beds during use. Apply sunscreen and wear a hat and protective clothing when outside.

If you get a sunburn, contact your doctor for further instructions. Do not apply Duobrii to the sunburned area until it is healed.

Excessive use of tazarotene may lead to skin irritation, peeling, dry skin, burning, and itching.

Can you use Duobrii if you are pregnant?

No, Duobrii lotion cannot be used during pregnancy as it may cause birth defects due to the tazarotene ingredient, a vitamin A retinoid.

• Your doctor will order a pregnancy test for you before you start treatment
• Use an effective form of birth control during treatment and discuss contraceptive options with your healthcare provider.
• Stop using Duobrii and call your doctor right away if you become pregnant during treatment.

This is not a complete list of side effects or warnings and is not all the information you need to know about Duobrii (halobetasol 0.01% / tazarotene 0.045%) for safe and effective use. It does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.