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第一款银屑病组合乳液halobetasol propionate/tazarotene(商品名 Duobrii)获FDA批准上市(二)
2019-04-27 15:00:22 来源: 作者: 【 】 浏览:2439次 评论:0
oid with synergistic efficacy. Combination therapy is the mainstay of topical treatment for plaque psoriasis, making DUOBRII an important new option," said Linda Stein Gold, M.D., director, Dermatology Clinical Research, Henry Ford Health System. "Although effective, topical retinoids have had limited use as monotherapy due to tolerability concerns. DUOBRII provides improved local tolerability, allowing patients to benefit from an extended duration of use."
DUOBRII Comprehensive Clinical Data
A Phase 2 study demonstrated DUOBRII Lotion was consistently more effective than its individual agents and vehicle in achieving treatment success (defined as at least a two-grade improvement from baseline in an Investigator Global Assessment (IGA) score, and 'clear' or 'almost clear' skin) and reducing psoriasis signs of erythema, plaque elevation, and scaling at the target lesion.6 In addition, a post-hoc analysis of the data, in which the vehicle effect was removed, showed that the efficacy of DUOBRII was superior to the aggregated results of the individual agents, supporting the synergy of the two ingredients when combined in one lotion formulation.
Important Safety Information for DUOBRII™ (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%
What is DUOBRII™ Lotion?
DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, is a prescription medicine used on the skin (topical) to treat adults with plaque psoriasis. It is not known if DUOBRII Lotion is safe and effective in children.
Important Safety Information
DUOBRII Lotion is for use on the skin only; do not use it in your mouth, eyes, or vagina.
What is the most important Information I should know about DUOBRII Lotion?
DUOBRII Lotion may cause birth defects if used during pregnancy.
A negative pregnancy test must be obtained before females of child-bearing age start using DUOBRII Lotion and they must use effective birth control during treatment. Begin treatment during a normal menstrual period.
Stop using DUOBRII Lotion and tell your healthcare provider right away if you become pregnant while using DUOBRII Lotion.
Before you use DUOBRII Lotion, tell your healthcare provider if you:
have eczema or any other skin problems, including skin infections, which may need to be treated before using DUOBRII.
have diabetes, adrenal gland problems or liver problems.
are breastfeeding or plan to breastfeed. If you use DUOBRII and breastfeed, do not apply DUOBRII to your nipple area.
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 skin products that contain corticosteroids.
Ask your healthcare provider for a list of medicines that may make your skin more sensitive to sunlight.
What should I avoid during treatment with DUOBRII?
To avoid a severe sunburn, avoid sunlight, including sunlamps and tanning beds, as much as possible, and use sunscreen, protective clothing and a hat while in sunlight. Talk to your healthcare provider if you get sunburn, and do not use DUOBRII Lotion until your sunburn is healed.
Avoid using DUOBRII on skin with eczema because it may cause severe irritation.
DUOBRII may cause side effects, including:
If too much DUOBRII passes through your skin it can cause adrenal glands to stop working
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