- Store Brovana in a refrigerator between 36° to 46°F (2° to 8°C) in the 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 68º to 77ºF (20º to 25ºC) 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 solution should be colorless. Discard Brovana solution if it is not colorless.
- Keep Brovana and all medicines out of the reach of children.
WARNING: ASTHMA RELATED DEATH
Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including arformoterol, the active ingredient in BROVANA Inhalation Solution. The safety and efficacy of BROVANA Inhalation Solution in patients with asthma have not been established. All LABA, including BROVANA Inhalation Solution, are contraindicated in patients with asthma without use of a long-term asthma control medication.
Use Brovana exactly as prescribed. One ready-to-use vial of Brovana is one dose. Do not use more than 2 ready-to-use vials of Brovana Inhalation Solution a day.
- Do not swallow or inject Brovana Inhalation Solution.
- 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 the Medication Guide that comes with this medicine 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 each 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 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.
- Do not use Brovana:
- more often than prescribed
- more medicine than prescribed to you
- 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
Before taking 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 breastfeeding
Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements.
Brovana can cause serious side effects, including:
- See “Drug Precautions” section
- 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:
- 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
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.
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
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.
- have asthma without using a long-term asthma control medicine.
Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:
- diuretics such as furosemide (Lasix), hydrochlorothiazide (HydroDiuril), metolazone (Zaroxolyn) and others
- beta blockers such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol XL), propranolol (Inderal) and others
- antidepressants such as notriptyline (Pamelor), and MAO inhibitors
- other long-acting beta agonists such as formoterol (Foradil, Perforomist), salmeterol (Serevent) and others
- oral steroids such as prednisone (Deltasone), dexamethasone (Decadron, Dexone) methylprednisolone (Medrol) and others
- QT-prolonging medications
This is not a complete list of Brovana drug interactions. Ask your healthcare provider or pharmacist for more information.
Active ingredient: arformoterol tartrate
Inactive ingredients: anhydrous citric acid, trisodium citrate dihydrate, sodium chloride, water
If you take too much Brovana, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Brovana there are no specific foods that you must exclude from your diet when receiving Brovana.
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.
Brovana Inhalation Solution is a prescription medication used in adults to prevent symptoms of chronic obstructive pulmonary disease (COPD) such as wheezing, cough, chest tightness and shortness of breath. COPD is a lung disease that includes both chronic bronchitis and emphysema.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Brovana (generic: arformoterol) is a prescription medication used long-term to prevent breathing difficulties (wheezing, cough, chest tightness and shortness of breath) caused by chronic obstructive pulmonary disease (COPD). Brovana belongs to a group of medications called long acting beta agonists (LABA). It works by helping the muscles in your lungs to stay relaxed, opening up the airways, making it easier to breathe.
This medicine comes in a liquid form to be used in a nebulizer, twice daily; once in the morning and once in the evening.
Common side effects of Brovana include diarrhea, headache, and nervousness.
Tell your healthcare provider if you are breastfeeding. It is not known if Brovana passes into your milk and if it can harm your baby.
Tell your healthcare provider if you are pregnant or planning to become pregnant. It is not known if Brovana can harm your unborn baby.