新型慢性阻塞性肺病吸入剂LONHALA MAGNAIR（glycopyrrolate）是第一个在美国批准用于治疗COPD的雾化长效毒蕈碱拮抗剂（LAMA）

批准日期：2018年4月3日 公司：Sunovion Respiratory Development Inc.,

LONHALA MAGNAIR（格隆溴铵 glycopyrrolate）吸入溶液，用于口服吸入

初始美国批准：1961年

作用机制

格隆溴铵是一种长效毒蕈碱拮抗剂，通常被称为抗胆碱能药。 它与毒蕈碱受体M1至M5的亚型具有相似的亲和力。 在气道中，它通过抑制平滑肌上的M3受体导致支气管扩张而表现出药理作用。 用人和动物来源受体和分离的器官制剂显示出拮抗作用的竞争性和可逆性。 在临床前体外和体内研究中，预防乙酰甲胆碱和乙酰胆碱诱导的支气管收缩作用是剂量依赖性的并且持续超过24小时。 这些发现的临床相关性尚不清楚。 吸入格隆溴铵后的支气管扩张主要是位点特异性作用。

适应症和用法

LONHALA MAGNAIR是一种抗胆碱能药，适用于慢性阻塞性肺病（COPD）患者气流阻塞的长期维持治疗。

剂量和用量

仅用于口服吸入。不要吞下LONHALA解决方案。只能使用带有MAGNAIR的LONHALA小瓶。

COPD的维持治疗：每天两次LONHALA小瓶的内容物。

剂量形式和强度

LONHALA吸入溶液作为无菌溶液提供，可在一次性使用的低密度聚乙烯（LDPE）小瓶中进行吸入。每个1mL小瓶含有25mcg格隆溴铵。

禁忌症

LONHALA MAGNAIR禁用于对格隆溴铵或任何成分过敏的患者。

警告和注意事项

不要急性恶化COPD或治疗急性症状。

如果出现反常的支气管痉挛，立即停用LONHALA MAGNAIR并进行替代治疗。

可能会出现窄角型青光眼的恶化。对于患有窄角型青光眼的患者慎用，并指导患者在出现症状时立即与医生联系。

可能发生尿潴留恶化。前列腺增生或膀胱颈梗阻患者慎用，并指导患者在出现症状时立即就医。

不良反应

最常见的不良反应（发生率大于或等于2.0％且高于安慰剂）是呼吸困难和尿路感染。

要报告疑似不良反应，请致电1-877-737-7226联系Sunovion制药公司或1-800-FDA-1088或www.fda.gov/medwatch联系FDA。

药物相互作用

抗胆碱能药：可以与伴随使用的抗胆碱能药物相互作用。避免使用含有其他抗胆碱能药物的LONHALA MAGNAIR。

用于特定人群

如果治疗的潜在益处超过风险，应考虑用于严重肾功能不全的患者。

如何提供/存储和处理

如何提供

LONHALA MAGNAIR以1 mL无菌，透明，无色的水溶液形式提供，采用低密度聚乙烯（LDPE）单位剂量小瓶包装。 LONHALA MAGNAIR有一个入门套件，包含60个单位剂量的小瓶，其中包含一个MAGNAIR和FDA批准的患者标签。 LONHALA MAGNAIR还提供一个补充套件，其中包含60个单位剂量的小瓶，其中包含MAGNAIR替换手机和FDA批准的患者标签。

包装配置剂量强度NDC

提供30天的入门套件（30个铝箔袋，每袋2个样品瓶）和完整的MAGNAIR雾化器系统25 mcg NDC：63402-201-00

30天供应的补充套件（30个铝箔袋，每袋2个样品瓶）和MAGNAIR替换手机25 mcg NDC：63402-301-01

存储和处理

将LONHALA吸入溶液储存在20°-25°C（68°-77°F）的保护性铝箔袋中[参见USP Controlled Room Temperature]。

LONHALA样品瓶只能与MAGNAIR一起使用。不要将MAGNAIR与任何其他样品瓶一起使用。

将LONHALA样品瓶存放在保护膜袋中。打开箔袋后，应将未使用的单位剂量小瓶放回并存放在铝箔袋中。打开铝箔袋后，如果在7天内未使用，则丢弃样品瓶。应立即使用打开的单位剂量小瓶。如果溶液不是无色，则丢弃任何单位剂量的小瓶。

始终使用每个LONHALA MAGNAIR笔芯处方随附的MAGNAIR替换手机。

放在儿童接触不到的地方。
------------------------------------------------------------------------------------------------------------------------------------
LONHALA MAGNAIR REFILL 25 MCG-ML VL 60 GLYCOPYRROLATE/NEB.ACCESSORIES SUNOVION PHARMACEUTICALS INC 63402030101
LONHALA MAGNAIR STARTER 25 MCG-ML VL 60 GLYCOPYRROL/NEBULIZER/ACCESSOR SUNOVION PHARMACEUTICALS INC 63402020100 
-------------------------------------------------------------------------------------------------------------------------------------

完整资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=78166def-5e2f-42a6-a1f1-0253e5765632

Sunovion Receives FDA Approval for Lonhala™ Magnair™ Inhalation Solution to Treat COPD 

- LONHALA MAGNAIR is the first nebulized long-acting muscarinic antagonist (LAMA) approved for the treatment of COPD in the U.S. - 

U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA) for Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution (25 mcg twice daily), also known as SUN-101/eFlow®, for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Sunovion expects LONHALA MAGNAIR to be available in U.S. pharmacies in early 2018. 

LONHALA MAGNAIR is the first nebulized long-acting muscarinic antagonist (LAMA) approved for the treatment of COPD in the U.S. and the first use of the MAGNAIR, which is based on the closed eFlow® technology system, developed by PARI Pharma GmbH, to treat COPD. This technology is a virtually silent, portable, closed system nebulizer that is designed to deliver the drug in two to three minutes and allows people to breathe normally while using the device. 

“We are proud that the FDA has approved LONHALA MAGNAIR as the first nebulized, long-acting muscarinic antagonist treatment option for people in the U.S. living with COPD,” said David Frawley, Executive Vice President and Chief Commercial Officer at Sunovion. “The approval of LONHALA MAGNAIR underscores our leadership in nebulization and the value we place on providing innovative treatment options for people living with COPD. LONHALA MAGNAIR is an important addition to our portfolio of approved COPD therapies for people at various stages of COPD, providing the flexibility to choose handheld or nebulized products based on individual needs.” 

“Despite the availability of several therapies, many people still struggle to control their COPD – a challenge that may be affected by the delivery method used to administer a medication,” said Gary Ferguson, M.D., Pulmonary Research Institute of Southeast Michigan, Farmington Hills, Michigan. “LONHALA MAGNAIR offers an important new option that combines the efficacy of a proven medication for COPD with the attributes of a unique handheld nebulizer that allows a person to breathe normally while taking their medication.” 

Approximately 15.7 million adults in the U.S. report they have been diagnosed with COPD, a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or lung abnormalities usually caused by significant exposure to toxic particles or gases.
The main risk factor for COPD is tobacco smoking, but other environmental exposures may contribute.The disease makes it hard for people to breathe and subsequently may limit their ability to perform some routine activities, including the proper inhalation of medication.
This improper medication technique may impact treatment over time and may also result in an inadequate amount of the drug reaching the lungs, potentially worsening a person’s COPD.For people with moderate-to-very-severe COPD, nebulized treatments offer an alternative to inhalers, allowing a person to breathe normally while taking their medicine. 

The approval is based on data from the clinical trials in the Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer (GOLDEN) program, which included GOLDEN-3 and GOLDEN, two Phase , 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, efficacy and safety trials comparing LONHALA MAGNAIR with placebo in adults with moderate-to-very-severe COPD. At study endpoints, individuals treated with LONHALA MAGNAIR demonstrated statistically significant and clinically important changes from baseline in trough forced expiratory volume in one second (FEV1) at Week 12 versus placebo. An additional study, GOLDEN-5, was a Phase, 48-week, randomized, open-label, active-controlled, parallel-group, multicenter safety trial designed to eva luate the long-term safety and tolerability of LONHALA MAGNAIR in adults with moderate-to-very-severe COPD and included the active comparator Spiriva® (tiotropium bromide) delivered by the HandiHaler® device. LONHALA MAGNAIR was generally well-tolerated in clinical studies, with the most common side effects being exacerbations and cough. The overall treatment emergent adverse events (TEAE) incidences were similar for glycopyrrolate and tiotropium groups over 48 weeks. 

About Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution 

LONHALA MAGNAIR (glycopyrrolate) Inhalation Solution, also known as SUN-101/eFlow®, is the first long-acting muscarinic antagonist (LAMA) bronchodilator delivered via the MAGNAIR, which is based on the closed eFlow® technology system, developed by PARI Pharma GmbH. The MAGNAIR nebulizer is a virtually silent, portable delivery device that reduces the amount of time required to deliver the drug to two to three minutes and allows people to breathe normally while using the device. LONHALA MAGNAIR is approved for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. 

Important Safety Information for LONHALA MAGNAIR (glycopyrrolate) Inhalation Solution 

INDICATION 

LONHALA™ MAGNAIR™ (glycopyrrolate) is a medicine called an anticholinergic. LONHALA MAGNAIR is used long term, twice each day (morning and evening), for maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. 

IMPORTANT SAFETY INFORMATION 

LONHALA MAGNAIR does not relieve sudden symptoms of COPD and should not be used more than twice daily. Always have a short-acting beta2-agonist with you to treat sudden symptoms. 

Do not use LONHALA MAGNAIR unless your health care provider has taught you how to use the device and you understand how to use it correctly. Use LONHALA MAGNAIR exactly as your health care provider tells you to use it. 

Do not use LONHALA MAGNAIR more often than is prescribed for you. Do not stop using LONHALA MAGNAIR or other medicines to control or treat your COPD unless told to do so by your health care provider because your symptoms might get worse. Your health care provider will change your medicines as needed. 

Get emergency medical care if your breathing problems worsen quickly, you need to use your rescue medication more often than usual, or your rescue medication does not work as well to relieve your symptoms. 

Do not use LONHALA MAGNAIR if you are allergic to glycopyrrolate or to any of the ingredients in LONHALA MAGNAIR. Ask your health care provider if you are not sure. 

Tell your health care provider about all of your health conditions, including if you: 

• have kidney problems 

• have eye problems such as glaucoma 

• have prostate or bladder problems, or problems passing urine 

• have any other medical conditions 

• are pregnant or plan to become pregnant 

• are breastfeeding or plan to breastfeed 

• are allergic to LONHALA MAGNAIR or any of its ingredients, or to any other medicines or food products 

Tell your health care provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. LONHALA MAGNAIR and certain other medicines may interact with each other. This may cause serious side effects. 

Especially tell your health care provider if you take anticholinergics (including umeclidinium, tiotropium, ipratropium, aclidinium, glycopyrrolate). 

LONHALA MAGNAIR can cause serious side effects, including: 

• sudden shortness of breath (that may be life-threatening) immediately after use of LONHALA MAGNAIR 

• serious allergic reactions, including: rash; hives; swelling of the tongue, lips, and face; and difficulty breathing or swallowing. Call your health care provider or get emergency medical care if you get any symptoms of a serious allergic reaction 

• new or worsened eye problems, including acute narrow-angle glaucoma (symptoms may include eye pain or discomfort, blurred vision, red eyes, nausea or vomiting, seeing halos or bright colors around lights) 

• new or worsened urinary retention (symptoms may include difficulty urinating, urinating frequently, painful urination, urination in a weak stream or drips) 

Common side effects of LONHALA MAGNAIR include shortness of breath and urinary tract infection. 

These are not all of the possible side effects with LONHALA MAGNAIR. Tell your health care provider about any side effect that bothers you or that does not go away. 

LONHALA solution is for oral inhalation only and should not be injected or swallowed. LONHALA vials should only be administered with MAGNAIR.