IMPORTANT SAFETY INFORMATION
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.
Take BROVANA only as directed by your health care provider. If your COPD symptoms worsen over time, do not increase your dose of BROVANA. Instead, call your health care professional.
Get emergency medical care if your breathing problems worsen quickly or if you use your rescue inhaler medicine and it does not relieve your breathing problems.
Do not use BROVANA if:
- You have had a serious allergic reaction to arformoterol, formoterol, or any of the ingredients in BROVANA. Ask your health care provider if you are not sure
- You have asthma without using a long-term asthma control medicine
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
Tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. BROVANA and certain other medicines may interact with each other. This may cause serious side effects.
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 face, mouth, and tongue; and breathing problems. 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 side effects with BROVANA. Tell your health care provider if you get any side effect that bothers you or that does not go away.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visitwww.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
For additional information, please see the full Prescribing Information including Boxed Warning, and Medication Guide for BROVANA (arformoterol tartrate) Inhalation Solution, or visit www.BROVANA.com.
BROVANA® (arformoterol tartrate) Inhalation Solution is a medicine called a long-acting beta2-agonist or LABA. BROVANA is used long term, twice a day (morning and evening), in controlling symptoms of chronic obstructive pulmonary disease (COPD) in adults with COPD. BROVANA is for inhalation use only through a standard jet nebulizer connected to an air compressor and should not be swallowed or injected.