What is the most important information I should know about BROVANA?

BROVANA can cause serious side effects, including:

• 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 chronic obstructive pulmonary disease (COPD).
• Get emergency medical care if:
  • breathing problems worsen quickly
  • you use your rescue inhaler medicine, but it does not relieve your breathing problems

back to top

What is BROVANA?

BROVANA is used long term, 2 times each day (morning and evening), in controlling symptoms of chronic obstructive pulmonary disease (COPD) in adults with COPD.

BROVANA is only for use with a nebulizer.

LABA medicines such as BROVANA help the muscles around the airways in your lungs stay relaxed to help control symptoms, such as wheezing, cough, chest tightness, and shortness of breath.

BROVANA should not be used in children. It is not known if BROVANA is safe and effective in children.

It is not know if BROVANA is safe and effective in people with asthma.

back to top

What's the recommended daily dose of BROVANA?

The recommended daily dose of BROVANA for COPD patients is 15 mcg (1 unit-dose vial) twice daily (morning and evening) by nebulization. A total daily dose greater than 30 mcg (15 mcg twice daily) is not recommended. BROVANA is for use by nebulization only. Of course, you should follow your healthcare provider’s specific prescription for taking BROVANA.

back to top

What are the possible side effects with BROVANA?

BROVANA can cause serious side effects, including:

• See "What is the most important information I should know about BROVANA?"
• Sudden shortness of breath immediately after use of BROVANA.
• If your COPD symptoms worsen over time, do not increase your dose of BROVANA, instead, call your healthcare provider.
• 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 healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction.

Common side effects of BROVANA include:

Tell your healthcare provider if you get any side effect that bothers you or that does not go away.

These are not all the side effects with BROVANA. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

back to top

How should I use BROVANA?

• Read the step-by-step instructions for using BROVANA at the end of this Medication Guide.
• Use BROVANA exactly as prescribed. One ready-to-use vial of BROVANA is one dose. The usual dose of BROVANA is 1 ready-to-use vial, twice a day (morning and evening) breathed in through your nebulizer machine. The 2 doses should be about 12 hours apart. Do not use more than 2 ready-to-use vials of BROVANA a day.
• Do not swallow or inject BROVANA.
• BROVANA is for use with a standard jet nebulizer machine connected to an air compressor. Read the complete instructions for use at the end of this Medication Guide before starting BROVANA.
• Do not mix other medicines with BROVANA in your nebulizer machine.
• If you miss a dose of BROVANA, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at one time.
• While you are using BROVANA 2 times a day:
  • do not use other medicines that contain a long-acting beta₂-agonist (LABA) for any reason.
  • do not use your short-acting beta₂-agonist medicine on a regular basis (four times a day).
• Brovana does not relieve sudden symptoms of COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a rescue inhaler medicine, call your healthcare provider to have one prescribed for you.
• Do not stop using BROVANA or other medicines to help control or treat 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
• Do not use:
  • BROVANA more often than prescribed
  • more BROVANA than prescribed to you
  • BROVANA with other LABA medicines
• Call your healthcare provider or get emergency medical care right away if:
  • your breathing problems worsen with BROVANA
  • you need to use your rescue inhaler medicine more often than usual
  • your rescue inhaler medicine does not work as well for you at relieving symptoms

back to top

How long does BROVANA last?

BROVANA is expected to last up to 12 hours per dose. BROVANA is taken by nebulizer twice daily (morning and evening).

back to top

What should I tell my healthcare provider 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 planning to become pregnant. It is not known if BROVANA can harm your unborn baby.
• Are breastfeeding. 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 non-prescription 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.

back to top

Is BROVANA covered by my insurance?

BROVANA is covered for patients with COPD, chronic bronchitis, or emphysema by most insurance plans, including commercial insurers (like HMOs or PPOs), Medicare, and Medicaid.

Coverage policies may vary by insurer, by state, or even between plans offered by the same insurer. You should always check with your insurance company, Medicare, or Medicaid about reimbursement for BROVANA. Click here to find out.

Your healthcare provider can also help you determine if you meet coverage requirements.

back to top

Can BROVANA be diluted?

No, BROVANA cannot be diluted. Use BROVANA exactly as prescribed. One unit-dose vial of BROVANA is one dose. The dose of BROVANA is 1 vial twice a day (morning and evening) breathed in through your nebulizer machine.

back to top

Can BROVANA be mixed with other drugs?

BROVANA should not be mixed with other medications in a nebulizer machine.

back to top

How should I store BROVANA?

• Store BROVANA in a refrigerator between 36°F-46°F (2°C-8°C) in a protective foil pouch. Protect from light and excessive heat. Do not open a sealed pouch until you are ready to use a dose of BROVANA. After opening the pouch, unused ready-to-use vials should be returned to, and stored in, the pouch. An opened ready-to-use vial should be used right away. BROVANA may be used directly from the refrigerator.
• BROVANA may also be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 6 weeks (42 days). If stored at room temperature, discard BROVANA if it is not used after 6 weeks or if past the expiration date, whichever is sooner. Space is provided on the packaging to record room temperature storage times.
• Do not use BROVANA after the expiration date provided on the foil pouch and ready-to-use vial.
• BROVANA should be colorless. Discard BROVANA if it is not colorless.
• Keep BROVANA and all medicines out of the reach of children.

back to top

Who should not use BROVANA?

Do not use BROVANA if you:

• Have had a serious allergic reaction to arformoterol, formoterol, or any of the ingredients in BROVANA. Ask your healthcare provider if you are not sure. See the end of this Medication Guide for a complete list of ingredients in BROVANA.
• Have asthma without using a long-lasting asthma control medicine.

back to top

Please click here for Important Patient Information.