近日，美国FDA已批准DUOBRII（halobetasol propionate/tazarotene.中文译名：卤倍他索丙酸酯/他扎罗汀）乳液0.01％/0.045％，用于斑块型银屑病成人患者的治疗，该药是一种局部外用药物，每日涂抹患处一次。
DUOBRII是第一个也是唯一一个将卤倍他索丙酸酯和他扎罗汀独特组合融入一个配方的局部乳液。银屑病患者连续使用了DUOBRII长达24周，并且在需要时可以使用长达52周。
批准日期：2019年4月27日   公司：Bausch Health Americas, Inc
DUOBRII（卤倍他索丙酸酯/他扎罗汀[halobetasol propionate/tazarotene]）0.01％/0.045％乳液，用于局部使用
美国最初批准：2019年
作用机制
皮质类固醇在细胞信号传导，免疫功能，炎症和蛋白质调节中发挥作用; 然而，斑块状银屑病中作用的精确机制尚不清楚。
他扎罗汀是一种类视黄醇前药，通过酯化作用转化为其活性形式，他扎罗汀，他扎罗汀的羧酸。Tazarotenic acid与视黄酸受体（RAR）家族的所有三个成员结合：RARα，RARβ和RARγ，但显示对RARβ和RARγ的相对选择性并且可以修饰基因表达。 这些发现用于治疗斑块状银屑病的临床意义尚不清楚。
适应症和用法
DUOBRII乳液是指用于局部治疗成人斑块状银屑病的卤代甲酸丙酸酯和他扎罗汀的组合。
剂量和给药
•每天一次在受影响的区域涂上一层薄薄的DUOBRII乳液。
•不适用于口服，眼科或阴道内使用。
剂量形式和强度
乳液，0.01％/0.045％
每克DUOBRII洗剂含有0.1mg（0.01％）卤代甜油酸丙酸酯和0.45mg（0.045％）他扎罗汀。
禁忌症
DUOBRII乳液在怀孕期间禁用。
警告和注意事项
•胚胎风险：DUOBRII乳液含有他扎罗汀，这是一种致畸物质。在具有生殖潜力的女性中，在开始治疗前2周内进行阴性妊娠试验，并建议患者在治疗期间使用有效的避孕方法。
•可逆性下丘脑-垂体 -肾上腺（HPA）轴抑制可能发生，并且在治疗后可能存在糖皮质激素不足。
•局部皮质类固醇的全身作用还可能包括库欣综合征，高血糖和糖尿。
•系统吸收可能需要评估HPA轴抑制。
•在大面积使用强效皮质类固醇，持续时间较长，敷贴不足或皮肤屏障改变可能会增加系统暴露。
•局部不良反应：局部不良反应可能包括萎缩，皮纹，毛细血管扩张和毛囊炎。如果出现这些影响，请至少停止，直到皮肤的完整性恢复。 DUOBRII乳液不应用于湿疹皮肤，因为它可能会引起严重的刺激。
•光敏性和晒伤风险：避免暴露在阳光，太阳灯和极端天气下。如果患者还服用已知为光敏剂的药物，则应谨慎使用DUOBRII乳液。
•眼科不良反应：使用外用皮质类固醇可能会增加后囊下白内障和青光眼的风险。如果出现视觉症状，请考虑转诊给眼科医生。
不良反应
•最常见的不良反应是接触性皮炎（7％），应用部位疼痛（3％），毛囊炎（2％），皮肤萎缩（2％），抗氧化（2％）。
要报告疑似不良反应，请致电1-800-321-4576联系BauschHealth US，LLC或致电1-800-FDA-1088或www.fda.gov/medwatch联系FDA。
包装提供/存储和处理
DUOBRII（halobetasol丙酸盐和他扎罗汀）乳液，0.01％/ 0.045％是白色至灰白色乳液，在白色铝管中供应如下：
•100克（NDC 0187-0653-01）
储存和处理条件
储存在20°至25°C（68°至77°F）; 允许偏移15°至30°C（59°至86°F）[见USP受控室温]。
防止冻结。
完整说明资料附件：https://www.bauschhealth.com/Portals/25/Pdf/PI/Duobrii-PI.pdf
FDA Approves Bausch Health's DUOBRII™ (Halobetasol Propionate And Tazarotene) Lotion 0.01%/0.045% For Plaque Psoriasis In Adults
U.S. Food and Drug Administration (FDA) has approved the New Drug Application for DUOBRII™ (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, indicated for the topical treatment of plaque psoriasis in adults.
DUOBRII is the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation. In a year-long safety study, patients used DUOBRII Lotion for up to 24 weeks of continuous use and up to 52 weeks of as-needed use.
"With today's approval of DUOBRII, patients suffering from plaque psoriasis now have an innovative topical treatment option that uniquely combines two well-known ingredients, halobetasol propionate and tazarotene, with established safety profiles, into a single lotion featuring dual mechanisms of action," said Bill Humphries, president, Ortho Dermatologics. "Since psoriasis is a chronic skin disease, patients require continuous treatment in order to achieve optimal control of their symptoms.
"DUOBRII provides the known benefits of a potent topical corticosteroid and a topical retinoid 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
Cushing's syndrome, a condition from too much exposure to the hormone cortisol
High blood sugar (hyperglycemia)
Effects of growth and weight in children
Skin irritation. If you get too much skin irritation at the site of application, your healthcare provider may tell you to interrupt or stop using DUOBRII or to use it less often.
Vision problems, including an increased chance of developing cataracts and glaucoma. Tell your healthcare provider about any vision problems during treatment.
The most common side effects of DUOBRII Lotion include: redness, itching, swelling, burning, stinging, application site pain, inflamed hair follicles (folliculitis), thinning of the skin (atrophy), peeling and rash.