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 the 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 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:
For additional information, please see the full Prescribing Information including BOXED WARNING, and Medication Guide for BROVANA 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), 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.