Summary of Important Information for BROVANA
BROVANA® [brō vă nah] (arformoterol tartrate) Inhalation Solution
This summary does not include all information about BROVANA and is not meant to take the place of discussions with your healthcare provider about your treatment. Please read this important information carefully before you start taking BROVANA. Discuss any questions about BROVANA with your healthcare provider.
What is BROVANA?
BROVANA is a prescription, long-acting beta2-agonist (LABA) medicine, used long term and twice each day (morning and evening), to help control symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults with COPD. COPD is a long-term (chronic) lung disease that includes chronic bronchitis, emphysema, or both.
LABA medicines such as BROVANA help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, coughing, chest tightness, and shortness of breath.
BROVANA must only be used with a nebulizer.
Who should not use BROVANA?
Do not use BROVANA if you:
- have sudden symptoms of COPD. BROVANA should not be used as rescue therapy. Always have a short-acting beta2-agonist medicine (rescue inhaler) with you to treat sudden symptoms of COPD. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed.
- are allergic to arformoterol, racemic formoterol, or any of the ingredients in BROVANA (see below). Ask your healthcare provider if you are not sure.
- Active ingredient: arformoterol
- Inactive ingredients: citric acid, and sodium citrate
- have asthma. It is not known if BROVANA is safe and effective for people with asthma.
- BROVANA should not be used by children. It is not known if BROVANA is safe and effective for children.
What warnings should I know about BROVANA?
BROVANA can cause serious side effects, including:
- people with asthma, who take LABA medicines, such as arformoterol (the medicine in BROVANA), without also using a medicine called an inhaled corticosteroid have an increased risk of serious problems from asthma, including hospitalization, needing a tube placed in their airway to help them breathe, or death.
- It is not known if LABA medicines, such as BROVANA, increase the risk of death in people with COPD.
Get emergency medical care if:
- breathing problems worsen quickly.
- you use your rescue inhaler medicine, but it does not relieve your breathing problems.
- sudden shortness of breath immediately after use. Sudden shortness of breath may be life-threatening. If you have sudden breathing problems immediately after inhaling your medicine, stop using BROVANA. Call your healthcare provider or go to the nearest hospital emergency room right away.
- life-threatening paradoxical bronchospasm, which means your airway passages may narrow and breathing may become difficult. Stop using BROVANA immediately.
- Serious allergic reactions. Stop using BROVANA if you get any of the following symptoms:
- swelling of the tongue, lips and face
- difficulty breathing or swallowing
- effects on your heart. Symptoms may include:
- fast or irregular heartbeat (awareness of a heartbeat)
- increased blood pressure
- chest pain
- changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia)
If you have these side effects, stop taking BROVANA and call your healthcare provider or get emergency medical treatment right away before taking another dose.
Do not exceed the recommended dose. Excessive use of BROVANA, or use with other LABAs or anticholinergic medications, can result in undesirable increase in anticholinergic activity. If your COPD symptoms worsen over time, do not increase your dose of BROVANA. Call your healthcare provider.
What should I tell my healthcare provider before using BROVANA?
Before using BROVANA, tell your healthcare 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 plan to become pregnant. It is not known if BROVANA can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if BROVANA passes into your milk and if it can harm your baby.
Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements. BROVANA and certain other medicines may interact with each other. This may cause serious side effects.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.
How should I use BROVANA?
Read the step-by-step instructions for using BROVANA found in the Prescribing Information.
- Use BROVANA exactly as prescribed.
- The usual dose of BROVANA is 1 ready-to-use vial, twice a day (morning and evening) breathed in through your nebulizer.
- Do not swallow or inject BROVANA.
- If you miss a dose of BROVANA, just skip that dose. Take the next dose at your usual time. Do not use 2 vials at 1 time. Do not use more than 2 vials in a day.
- Do not stop using BROVANA or other medicines to control or treat your COPD unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
- If your COPD symptoms worsen over time, do not increase your dose of BROVANA; instead call your healthcare provider.
- Do not open a sealed pouch until you are ready to use a dose of BROVANA. After opening the pouch, unused vials should be returned to, and stored in, the pouch. An opened vial should be used right away. BROVANA can be stored in the refrigerator until its expiration date or can be stored at room temperature for up to 6 weeks.
- Do not use BROVANA after the expiration date provided on the foil pouch and vial.
- BROVANA should be colorless. Discard BROVANA if it is not colorless.
- Keep BROVANA and all medicines out of the reach of children.
- Do not use BROVANA:
- more often than prescribed.
- at higher dose than prescribed.
- with other LABA medicines.
What are the possible side effects with BROVANA?
- See “What warnings should I know about BROVANA?”
Common side effects of BROVANA include: pain, chest or back pain, diarrhea, sinus congestion, leg cramps, trouble breathing, rash, flu-like symptoms, swelling in legs, chest congestion or bronchitis.
These are not all the possible side effects of BROVANA. Tell your healthcare provider about any side effect that bothers you or that does not go away. Ask your healthcare provider or pharmacist for more information. You are encouraged to report negative side effects of prescription drugs to 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 healthcare provider or pharmacist.
- Visit www.brovana.com to obtain the FDA-approved product labeling.
- Call Sunovion at 1-888-394-7377.
For additional information, please see the full Prescribing Information and Patient Information for BROVANA.