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全球首款腋下多汗症新药:glycopyrronium（商标名:Qbrexza）为数百万慢性皮肤病患者提供新疗法

近日,Dermira宣布，美国FDA批准glycopyrronium（商标名:Qbrexza）适用于罹患原发性腋窝多汗症的9岁及以上儿童和成人患者的局部治疗。

原发性腋窝多汗症，通常也称为过度腋下出汗，是一种慢性皮肤病，会导致出汗超出正常体温调节所需的量。导致该病的确切病因尚不清楚，但它影响了美国近1000万人，男性和女性的患病率相似。这一疾病不仅为患者带来身体上的不适，也为他们的日常生活带来负担和耻辱感。

Qbrexza作为一种抗胆碱能药，有望为这些患者带来治疗希望。它可以直接应用于皮肤，能通过抑制汗腺活化来阻止汗液的产生。

批准日期:2018年6月30日 公司:Dermira

QBREXZA（格隆铵 glycopyrronium）粉/溶液，2.4％，局部使用

美国最初批准：2018年

作用机制

Glycopyrronium是乙酰胆碱受体的竞争性抑制剂，它存在于某些外周组织上，包括汗腺。在多汗症中，格隆铵抑制其作用。

汗腺上的乙酰胆碱，减少出汗。

适应症和用法

Qbrexza是用于成人和儿童患者9年ageand年长primaryaxillary多汗症的局部治疗所指示的抗胆碱。

剂量和用量

仅限局部使用。每天使用单布将Qbrexza一次涂抹于两个腋窝。

剂量形式和强度

布料：预先用2.4％格隆铵溶液润湿的一次性布料。

禁忌症

Qbrexza是患者的医疗条件canbe由Qbrexza（例如，青光眼，麻痹性肠梗阻，在急性心血管不稳定状态的抗胆碱能作用加剧禁忌

出血，严重的溃疡性结肠炎，中毒性巨结肠并发溃疡性结肠炎，重症肌无力，干燥综合征（Sjogren's syndrome）。

警告和注意事项

•尿潴留恶化：有史以来或有尿潴留记录的患者慎用。

•控制体温：在高环境温度的情况下，可能会发生热病;如果患者在暴露于炎热或非常温暖时会出现普遍缺乏出汗的情况，请避免使用环境温度。

•操作机械或汽车:短暂视力模糊mayoccur利用Qbrexza的如果出现视力模糊，停止useof Qbrexza直到症状缓解;避免驾驶机动车或其他机器，直到症状消退。

不良反应

最常见的不良反应（发生率≥2％）有口干，瞳孔散大，口咽部疼痛，头痛，尿犹豫，visionblurred，鼻腔干燥，咽喉干燥，眼干，皮肤干燥，便秘。

本地皮肤反应，包括红斑，灼热/刺痛和瘙痒也很常见（> 5％）。

药物相互作用

与添加剂相互作用，导致增加anticholinergicadverse效果mayresult抗胆碱药物Qbrexza合用，避免与其他Qbrexza合用含抗胆碱能药物。

要报告疑似不良反应，请联系Dermira at1-877-337-5553或FDA 1-800-FDA-1088 orwww.fda.gov/medwatch。

用于特定人群

•儿科用途：9岁以下的患者未建立安全性和有效性。

包装提供/存储和处理

提供

Qbrexza提供：

一次性布料，在袋中预先用2.4％格隆铵溶液润湿

纸箱30个小袋NDC 70428-011-12

存储和处理

在室温20° - 25°C（68° - 77°F）下储存;允许偏移15° - 30°C（59° - 86°F）[参见USP受控室温] .Qbrexza易燃; 来自热或火焰。

患者咨询信息

建议患者阅读FDA批准的患者标签（患者信息）。

尿潴留恶化使患者警惕尿潴留的症状和体征（例如，肌肉紊乱，膀胱膨胀）。

如果出现任何这些体征或症状，指导患者停止使用并立即咨询医生。

控制体温（过热或热病的风险）在高环境温度的情况下，使用抗胆碱能药物如Qbrexza可以发生由于出汗减少引起的热病。

使用Qbrexza towatch为患者提供建议

因为在炎热或非常温暖的环境温度下普遍缺乏出汗

如果不在这些条件下出汗，请避免使用。

操作机械或汽车

Qbrexza可能会出现短暂的视力模糊。如果发生这种情况，请指导患者联系其医疗保健提供者，停止使用Qbrexza并避免操作机动车辆或其他机械，或在症状消退前进行危险工作。

 

ABOUT QBREXZAWhat is Qbrexza?

Qbrexza is a topical prescription anticholinergic medicine used on the skin to treat excessive underarm sweating (primary axillary hyperhidrosis) in adults and children 9 years of age and older.

It is not known if Qbrexza is safe and effective in children under 9 years of age.

How does Qbrexza work?

The main active ingredient in Qbrexza, glycopyrronium, is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including sweat glands. This means Qbrexza blocks the “sweat signals” sent to certain sweat glands, inhibiting the action of acetylcholine on those glands and thereby reducing the extent of sweating.

Who should not use Qbrexza?

Do not use Qbrexza if you have certain medical conditions that can be made worse by taking an anticholinergic medicine, such as glaucoma, severe ulcerative colitis, or certain other serious bowel problems associated with severe ulcerative colitis, myasthenia gravis, or Sjogren’s syndrome.

Talk to your healthcare provider if you are not sure if you have a medical condition that can be made worse by taking an anticholinergic medicine. Please ask your healthcare provider for more information.

What should I tell my healthcare provider before using Qbrexza?

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

· have prostate or bladder problems, or problems passing urine

· have kidney problems

· are pregnant or plan to become pregnant. It is not known if Qbrexza will harm your unborn baby

· are breastfeeding or plan to breastfeed. It is not known if Qbrexza passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Qbrexza

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

Qbrexza may affect the way other medicines work, causing side effects. Especially tell your healthcare provider if you take anticholinergic medicines.

Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of Qbrexza?

Qbrexza can cause serious side effects, including:

New or worsened urinary retention. People who use Qbrexza may develop new or worse urinary retention. Urinary retention can be caused by a blockage in your bladder. Urinary retention can also happen in men who have a larger-than-normal prostate. Symptoms of urinary retention may include:

· difficulty urinating

· urinating frequently

· urination in a weak stream or drips

· full bladder or difficulty emptying your bladder (distended bladder)

If you have these symptoms, stop using Qbrexza and call your healthcare provider right away.

Problems with control of your body temperature. Qbrexza can cause you to have decreased sweating in areas other than the underarm area which could cause you to become overheated and to develop heat illness. When in hot or very warm temperatures, watch for lack of sweating on your body (generalized) and stop using Qbrexza if you develop lack of sweating on your body.

Stop using Qbrexza and call your healthcare provider right away if you develop any of these symptoms of heat illness:

· hot, red skin

· decreased alertness or passing out (unconsciousness)

· fast, weak pulse

· fast, shallow breathing

· increased body temperature (fever)

Blurred vision. If you develop blurred vision during treatment with Qbrexza, call your healthcare provider, stop using Qbrexza, and do not drive, operate machinery, or do hazardous work until your vision is clear.

The most common side effects of Qbrexza include:

· dry mouth

· dilation of the pupils of your eyes (mydriasis)

· sore throat

· skin redness, burning/stinging or itching in underarm area

· headache

· problems with urination

· blurred vision

· nasal dryness

· throat, eye, and skin dryness

· constipation

These are not all of the possible side effects of Qbrexza. Please see the Patient Product Information for additional side effect information.

What are the ingredients of Qbrexza?

The active ingredient in Qbrexza is glycopyrronium tosylate. The inactive ingredients are citric acid, dehydrated alcohol, purified water, and sodium citrate.

How do I know if Qbrexza is right for me?

Only your healthcare provider can tell you if Qbrexza is right for you. If you think you sweat more than normal under your arms, or if your underarm sweating is bothersome and/or interferes with daily activities, ask your healthcare professional about options for treating it, including Qbrexza.

USING QBREXZAHow should I use Qbrexza?

How should I use Qbrexza?

· Use Qbrexza exactly as your healthcare provider tells you to use it

· Qbrexza comes as a single-use pre-moistened cloth in individual pouches

· Qbrexza should be applied to the clean, dry, intact skin of your underarm areas only. Do not apply Qbrexza to broken skin. Do not cover the treated area with a plastic (occlusive) dressing

· Apply Qbrexza to both underarm areas with 1 cloth, 1 time every 24 hours

Applying Qbrexza:

· Carefully tear open the pouch to avoid tearing the Qbrexza cloth

· Unfold the Qbrexza cloth and apply Qbrexza by wiping across 1 entire underarm 1 time. Using the same Qbrexza cloth, wipe across the other underarm 1 time

· Throw away (discard) the used Qbrexza cloth in the trash

· Wash your hands right away after you apply Qbrexza and have thrown away the cloth. It is important that you wash your hands because the Qbrexza that is still on your hands can cause you to have blurred vision if you touch your eyes

· Do not reuse the Qbrexza cloth.

What should I avoid while using Qbrexza?

Qbrexza may cause you to have blurred vision that is temporary. If you develop blurred vision, call your healthcare provider, stop using Qbrexza and do not drive, operate machinery, or do hazardous work until your vision is clear.

Qbrexza is flammable. Avoid heat and flame while applying Qbrexza to your skin.

Do I need to use Qbrexza on both underarms?

Most people should use it under both underarms since axillary hyperhidrosis usually occurs equally under both arms. However, you should always consult with your healthcare professional about how to use Qbrexza.

How often should I use Qbrexza?

You should use Qbrexza once a day, or as directed by your doctor.

Is there a recommended time I should use Qbrexza?

There is no recommended time of day to use Qbrexza. However, in order to help you remember to use it every day, it’s best to make it part of your daily routine. For example, add it to your “washing up” routine before going to bed each night.

What do I do with the towelette after I’m done?

It is important that you throw the towelette away immediately after use and wash your hands with soap and water. If any medication is left on your hands and comes in contact with your eyes, blurred vision could result.

How does Qbrexza work with other antiperspirants?

Qbrexza is not meant to take the place of deodorants or antiperspirants. Talk to your healthcare professional for more specifics on using Qbrexza with your current deodorant or antiperspirant.

Does Qbrexza expire?

Please check the carton your Qbrexza pouches come in for an expiration date.

How should I store Qbrexza?

· Store Qbrexza at room temperature between 68°F and 77°F (20°C and 25°C)

· Qbrexza is flammable. Keep Qbrexza away from heat and flame

Keep Qbrexza and all medicines out of the reach of children.