Generic Name: arformoterol (AR-for-MOE-ter-ol)
Brand Name: Brovana
Long-acting beta-agonists such as Brovana have been rarely associated with an increased risk of asthma-related death. Long-acting beta-agonists should not be used in asthma patients without another long-term asthma-control medicine (eg, inhaled corticosteroids). Brovana has not been approved to treat asthma. Safety and effectiveness of Brovana in patients with asthma have not been confirmed.
Brovana is used for:
Long-term treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It may also be used for other conditions as determined by your doctor.
Brovana is a long-acting beta-agonist bronchodilator. It works by widening the airways in the lungs, which helps you breathe more easily.
Do NOT use Brovana if:
- you are allergic to any ingredient in Brovana or to formoterol
- you are using another medicine that has a long-acting beta-agonist (eg, salmeterol) in it
- you are having severe breathing problems (eg, sudden, severe onset or worsening of COPD symptoms such as chest tightness, cough, shortness of breath, wheezing)
- you have asthma and you are not currently using a long-term asthma-control medicine (eg, inhaled corticosteroids) or if you have asthma that is already well controlled with the use of a long-term asthma-control medicine
Contact your doctor or health care provider right away if any of these apply to you.
Before using Brovana:
Some medical conditions may interact with Brovana. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- you have a history of other breathing problems (eg, asthma), diabetes, heart problems (eg, fast or irregular heartbeat, heart blood vessel problems), liver problems, high blood pressure, low blood potassium levels, seizures, or thyroid problems
- if you have high blood or urine ketone levels
- if you have recently been to an emergency room for breathing problems, have a history of frequent hospitalizations for breathing problems, or have ever had life-threatening breathing problems
- if you have had an unusual reaction to a sympathomimetic medicine (eg, albuterol, pseudoephedrine), such as fast or irregular heartbeat, overexcitement, or severe trouble sleeping
- if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or a tricyclic antidepressant (eg, amitriptyline) or you have taken either of these medicines within the last 14 days
- if you are taking any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat.
Some MEDICINES MAY INTERACT with Brovana. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), or xanthines (eg, theophylline) because the risk of low blood potassium or irregular heartbeat may be increased
- Linezolid, long-acting beta-agonists (eg, salmeterol), MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Brovana's side effects
- Beta-blockers (eg, propranolol) because they may decrease Brovana's effectiveness or worsen your condition
This may not be a complete list of all interactions that may occur. Ask your health care provider if Brovana may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Brovana:
Use Brovana as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Brovana comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Brovana refilled.
- Be sure to use Brovana exactly as prescribed by your doctor. Space doses about 12 hours apart unless your doctor tells you otherwise. Do not use more than 2 vials in 1 day.
- Brovana should only be inhaled using a nebulizer. Do not inject or swallow it.
- A health care provider will teach you how to use the nebulizer. Be sure you know what type of nebulizer to use with Brovana and how to use it. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Store Brovana in the original foil pouch in a dry place. Do not remove from the foil pouch or the vial until right before use.
- Do not use Brovana if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Do not mix Brovana with other medicines in your nebulizer machine.
- To use Brovana, twist open the top of the vial and pour the entire contents into the nebulizer reservoir.
- Connect the nebulizer reservoir to the mouthpiece or face mask. Connect the nebulizer to the compressor.
- Sit in a comfortable, upright position. Place the mouthpiece in your mouth (or put on the face mask) and turn on the nebulizer.
- Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 10 minutes).
- Clean the nebulizer according to the instructions. Failure to properly clean the nebulizer could lead to bacteria entering the medicine. This may lead to an infection. To avoid bacteria entering the medicine, use the entire contents right after opening the vial for the first time.
- Continue to use Brovana even if you feel well. Do not miss any doses.
- If you miss a dose of Brovana, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Brovana.
Important safety information:
- Brovana may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Brovana with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Brovana will not stop sudden symptoms of COPD once they have already started. Be sure to carry a short-acting bronchodilator inhaler (eg, albuterol) with you at all times to treat any breathing problems that may occur between doses of Brovana (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop sudden symptoms, check with your doctor or pharmacist.
- If you have been regularly using a short-acting bronchodilator inhaler, talk with your doctor about how to use it with Brovana. Short-acting bronchodilators are normally used with Brovana to treat breathing problems that may occur between doses.
- The risk of serious heart problems (eg, irregular heartbeat) may be greater if you use Brovana in high doses. Do NOT use more than recommended dose or use more often than prescribed.
- Tell your doctor at once if you notice that your short-acting bronchodilator inhaler does not work as well, if you need to use it often, or if your breathing problems get worse.
- Contact your doctor or seek medical care right away if you have breathing problems that worsen quickly, or if you use your short-acting bronchodilator and do not get relief.
- Talk with your doctor or pharmacist about all of your breathing medicines and how to use them. Do not start, stop, or change the dose of any breathing medicine unless your doctor tells you to.
- The medicine may sometimes cause severe breathing problems right after you use a dose. If this happens, use your short-acting bronchodilator. Contact your doctor or seek other medical care at once.
- Brovana may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Lab tests, including lung function and blood potassium levels, may be performed while you use Brovana. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Brovana should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Brovana while you are pregnant. It is not known if Brovana is found in breast milk. If you are or will be breast-feeding while you use Brovana, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Brovana:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; diarrhea; dry mouth; headache; nausea; nervousness; stuffy nose; tiredness; tremor; trouble sleeping; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness); chest pain; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; leg swelling; muscle pain, weakness, or cramps; new or worsening breathing problems (eg, increased chest tightness, coughing, shortness of breath, wheezing); severe or persistent headache, dizziness, light-headedness, tremor, or nervousness; severe or persistent nausea or vomiting; sluggishness; symptoms of high blood sugar (eg, increased thirst, urination, or hunger; unusual weakness or drowsiness; confusion); trouble speaking.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; fainting; fast breathing; fast or irregular heartbeat; muscle pain, weakness, or cramps; severe or persistent dizziness, dry mouth, fatigue, headache, light-headedness, nausea, nervousness, trouble sleeping, tremors, or vomiting; severe or unusual drowsiness; shortness of breath; sluggishness; symptoms of high blood sugar (eg, increased thirst, urination, or hunger; drowsiness; flushing of the skin; confusion; fruit-like breath odor).Proper storage of Brovana:
Store Brovana in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Unopened pouches may be stored at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), for up to 6 weeks. If Brovana is stored at room temperature, throw it away after 6 weeks. Do not use Brovana if it is past the expiration date on the container. Store Brovana away from heat, moisture, and light. Keep Brovana out of the reach of children and away from pets.
- If you have any questions about Brovana, please talk with your doctor, pharmacist, or other health care provider.
- Brovana is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Brovana or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Brovana. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Brovana. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Brovana.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.