Brovana

Brovana is a prescription medication used to used to control wheezing, shortness of breath, coughing, and chest tightness caused by chronic obstructive pulmonary disease, or COPD. Brovana belongs to a group of drugs called long-acting beta agonists (LABAs). These work by relaxing and opening air passages in the lungs, making it easier to breathe.

This medication comes in oral inhalational form and is taken twice a day, 12 hours apart, with a nebulizer machine.

Common side effects of Brovana include chest or back pain, diarrhea, and sinus congestion.

Brovana is a prescription medication used to used to control wheezing, shortness of breath, coughing, and chest tightness caused by chronic obstructive pulmonary disease, or COPD.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Sunovion Pharmaceuticals Inc.

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.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• theophylline (Theocron, Theolair)
• diuretics such as
  • acetazolamide (Diamox)
  • amiloride (Midamor)
  • bumetanide (Bumex)
  • chlorothiazide (Diuril)
  • chlorthalidone (Thalitone)
  • ethacrynic acid (Edecrin)
  • furosemide (Lasix)
  • hydrochlorothiazide (Microzide, HCTZ)
  • metolazone (Zaroxolyn)
  • torsemide (Demadex)
  • triamterene (Dyrenium, Dyazide, Maxzide)
• steroids such as prednisone (Cortan, Deltasone, Orasone, Sterapred), budesonide (Entocort), dexamethasone (Decadron), triamcinolone (Kenacort, Aristocort), flunisolide (AeroBid, Aerospan), ciclesonide (Alvesco), mometasone (Asmanex, Dulera), fluticasone (Flovent), methylprednisolone (Medrol, Solu-Medrol), fludrocortisone (Florinef), and hydrocortisone (Cortef, Hydrocortone)
• tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)
• beta blockers such as
  • metoprolol (Toprol XL, Lopressor)
  • carvedilol (Coreg)
  • bisoprolol (Zebeta)
  • betaxolol (Kerlone)
  • nebivolol (Bystolic)
  • propranolol (Inderal)
• Monoamine oxidase inhibitors such as
  • isocarboxazid (Marplan)
  • phenelzine (Nardil)
  • tranylcypromine (Parnate)
  • selegiline (Emsam, Eldepryl, Zelapar)
  • rasagiline (Azilect)

This is not a complete list of Brovana drug interactions. Ask your doctor or pharmacist for more information.

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

• 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
  • You experience a 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.

Brovana can cause serious side effects, including:

• 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.

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

Do not use Brovana if you:

• have had a serious allergic reaction to Brovana, 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.

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

It is not known if Brovana is safe and effective in people with asthma.

Medications 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 this medication.

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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.
 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Brovana crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Brovana.

• 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.
• 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

Take Brovana exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Brovana is one 15 mcg unit-dose vial taken twice daily (morning and evening) with a nebulizer. A total daily dose of greater than 30 mcg (15 mcg twice daily) is not recommended.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

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 Brovana, the active ingredient in Brovana. The safety and efficacy of Brovana in patients with asthma have not been established. All LABA, including Brovana, are contraindicated in patients with asthma without use of a long-term asthma control medication.