Brovana is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.

Brovana inhalation solution is used to prevent bronchoconstriction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Brovana will not treat a bronchospasm attack that has already begun.

Brovana is for use only in people with chronic obstructive pulmonary disease (COPD) and should not be used to treat asthma.

Brovana is not a rescue medicine. It will not work fast enough to treat a bronchospasm attack.

Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Before taking this medicine

You should not use Brovana if you are allergic to arformoterol. Brovana is for use only in people with COPD and should not be used to treat asthma.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure;

• a seizure;

• diabetes;

• liver disease; or

• a thyroid disorder.

Tell your doctor if you are pregnant or breastfeeding.

Brovana is not approved for use by anyone younger than 18 years old.

Use Brovana inhalation solution exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides. Use the medicine exactly as directed. Using too much of this medicine can cause life-threatening side effects.

Brovana is not a rescue medicine for bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Brovana solution for inhalation is for use only with a standard jet nebulizer machine connected to an air compressor. Do not mix with other medicines in the nebulizer. Do not take this medicine by mouth or swallow it.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Store this medicine in the refrigerator, protected from light and heat.

Keep each vial in the foil pouch until you are ready to use the medicine. Once a vial is opened, you must use the medicine right away. Throw the empty vial away where children and pets cannot get to it.

You may store an unopened foil pouch at room temperature but you must use it within 6 weeks or throw it away. Protect from heat and light.

Do not use Brovana if it does not look clear and colorless in the vial. Do not use after the expiration date on the label has passed.

You should not stop using this medicine suddenly. Stopping suddenly may make your condition worse.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

15 mcg inhaled by nebulization twice daily (morning and evening).

Maximum Daily Dose: 30 mcg

Comments:
-Not for use to treat acute deteriorations of COPD.

Use: Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

You should not use Brovana if you are allergic to arformoterol. Brovana is for use only in people with COPD and should not be used to treat asthma.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure;

• a seizure;

• diabetes;

• liver disease; or

• a thyroid disorder.

Tell your doctor if you are pregnant or breastfeeding.

Brovana is not approved for use by anyone younger than 18 years old.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of arformoterol inhalation can be fatal.

Overdose symptoms may include chest pain, fast or irregular heartbeats, nervousness, tremor, muscle cramps, feeling light-headed, and fainting.

Do not use a second inhaled bronchodilator that contains arformoterol or a similar medicine (such as formoterol, indacaterol, olodaterol, salmeterol, or vilanterol).

Get emergency medical help if you have signs of an allergic reaction to Brovana: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have;

• tremors, nervousness, chest pain, fast or pounding heartbeats;

• wheezing, choking, or other breathing problems after using this medicine;

• worsening breathing problems;

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor; or

• low potassium level - leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling.

Common Brovana side effects may include:

• chest pain, trouble breathing;

• back pain;

• diarrhea;

• leg cramps;

• skin rash;

• swelling in your legs;

• stuffy nose; or

• flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If you also use a short-acting bronchodilator, do not use it daily while you are using Brovana. Use the short-acting bronchodilator only for a sudden bronchospasm attack.

Other drugs may interact with arformoterol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.