近日，美国食品和药物管理局（FDA）批准其用于BROVANA™（酒石酸阿福特罗）吸入溶液的新药（NDA）15 mcg（微克）作为长期，每日两次（早晚），维持治疗慢性阻塞性肺病（COPD）患者的支气管收缩，包括慢性支气管炎和肺气肿。
BROVANA仅供雾化使用。
BROVANA是第一种被批准用作雾化器的吸入溶液的长效β2-激动剂，雾化器是一种将液体药物转化为通过口罩或面罩吸入的细雾的机器.
Sepracor呼吸与免疫学副主席Rudolf A. Baumgartner博士说。 BROVANA是COPD患者唯一经FDA批准的雾化长效β2激动剂，我们期待为这些患者提供这种治疗支气管收缩的新治疗方案。
作用机制
福莫特罗是福莫特罗的（R，R）-对映异构体，是一种选择性长效β2-肾上腺素能受体激动剂（β2-激动剂），其效力比外消旋福莫特罗（含有（S，S）和两者）高两倍。 （R，R） - 对映体）。（S，S）-对映体作为β2-激动剂的效力比（R，R）-对映体低约1,000倍。虽然人们认识到β2受体是支气管平滑肌中的主要肾上腺素能受体，而β1受体是心脏中的主要受体，但数据表明，人心脏中也存在β2受体，包括10％至5​​0％的受体。总β-受体肾上腺素受体。这些受体的确切功能尚未确定，但它们提高了甚至高选择性β2-激动剂可能具有心脏作用的可能性。
β2-肾上腺素能受体激动剂药物（包括阿福特罗）的药理作用至少部分归因于细胞内腺苷酸环化酶的刺激，这种酶催化三磷酸腺苷（ATP）转化为环-3'，5'-腺苷一磷酸（环AMP）。增加的细胞内环AMP水平导致支气管平滑肌松弛并抑制细胞，特别是肥大细胞的即时超敏介质的释放。
适应症和用法
BROVANA（酒石酸阿福特罗）吸入溶液适用于长期，每日两次（早晚）维持治疗慢性阻塞性肺病（COPD）患者的支气管收缩，包括慢性支气管炎和肺气肿。 BROVANA仅供雾化使用。
禁忌症
BROVANA（酒石酸阿福特罗）吸入溶液禁用于对阿福特罗，外消旋福莫特罗或本产品的任何其他成分有过敏史的患者。
所有LABA，包括BROVANA，都禁用于哮喘患者，不使用长期哮喘控制药物（见警告） 。


BROVANA®(arformoterol tartrate) Inhalation Solution15 mcg*/2 mL
potency expressed as arformoterol
For oral inhalation only
IMPORTANT SAFETY INFORMATION AND INDICATION
IMPORTANT SAFETY INFORMATION
BROVANA has been approved for COPD only and is NOT indicated for the treatment of asthma. People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines such as BROVANA have an increased risk of death from asthma problems. It is not known if LABA medicines, such as BROVANA, increase the risk of death in people with COPD.
BROVANA does not relieve sudden symptoms of COPD and should not be used more than twice a day. Always have a short-acting beta2-agonist with you to treat sudden symptoms.
Use BROVANA exactly as your health care provider tells you to use it. Do not use BROVANA more often than it is prescribed for you or with other LABA medicines. Do not stop using BROVANA 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, if you need to use your rescue medication more often than usual, or if your rescue medication does not work as well to relieve your symptoms.
Do not use BROVANA if you are allergic to arformoterol tartrate, or any of the ingredients in BROVANA, or have asthma without using a long-term asthma control medicine. 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 heart problems
Have high blood pressure
Have seizures
Have thyroid problems
Have diabetes
Have liver problems
Are pregnant or planning to become pregnant
Are breastfeeding or plan to breastfeed
Are allergic to BROVANA or any of its ingredients, any other medicines, or food products.
Tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. BROVANA and certain other medicines may interact with each other. This may cause serious side effects.
Especially tell your health care provider if you take LABA medicines (including formoterol, salmeterol, vilanterol, indacaterol, olodaterol).
BROVANA can cause serious side effects, including:
Sudden shortness of breath immediately after use of BROVANA
Increased blood pressure
Fast or irregular heartbeat
Serious allergic reactions, including rash; hives; swelling of the tongue, lips, and face; and difficulties breathing or swallowing. Call your health care provider or get emergency medical care if you get any symptoms of a serious allergic reaction
Common side effects of BROVANA include: chest or back pain, diarrhea, sinus congestion, headache, tremor, nervousness, leg cramps, high blood potassium, shortness of breath, rash, fever, increased white blood cells, vomiting, tiredness, leg swelling, chest congestion or bronchitis.
These are not all the possible side effects with BROVANA. Tell your health care provider if you get any side effect that bothers you or that does not go away.
BROVANA should not be swallowed or injected. BROVANA is for inhalation only through a standard jet nebulizer connected to an air compressor. Do not mix other medicines in your nebulizer.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
This information is not comprehensive.
How to get more information:
Talk to your health care provider
Visit www.BROVANA.com to obtain the FDA-approved product labeling
Call 1-844-BROVANA (276-8262)
For additional information, please see the full Prescribing Information, including BOXED WARNING and Medication Guide for BROVANA or visit www.BROVANA.com.
INDICATION
BROVANA® (arformoterol tartrate) Inhalation Solution is a medicine called a long-acting beta2-adrenergic agonist, or LABA. BROVANA is used long term, twice a day (morning and evening), in controlling symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. BROVANA is for inhalation use only through a standard jet nebulizer connected to an air compressor and should not be swallowed or injected.
http://www.drugsdb.eu/drug.php?d=Brovana&m=Sunovion%20Pharmaceuticals%20Inc.&id=bd2c5d7a-e0fb-4f5d-aa20-8f70b47df656.xml