Brovana

Generic name: arformoterol inhalation
Drug class: Adrenergic bronchodilators

Medically reviewed by  A Ras MD.

What is Brovana?

Brovana is for long-term use and should be taken 2 times each day (morning and evening), to help control the symptoms of chronic obstructive pulmonary disease (COPD) for better breathing. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. Brovana is only for use with a nebulizer.

Long acting beta2 adrenergic agonist (LABA) medicines, such as Brovana, help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath. Brovana is not used to treat sudden symptoms of COPD. Always have a short-acting beta2-agonist medicine (rescue inhaler) with you to treat sudden symptoms of COPD. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.

Brovana is not for the treatment of asthma. It is not known if Brovana is safe and effective in people with asthma. Brovana should not be used in children. It is not known if Brovana is safe and effective in children

Description

BROVANA (arformoterol tartrate) Inhalation Solution is a sterile, clear, colorless, aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol.

Arformoterol is a selective beta2-adrenergic bronchodilator. The chemical name for arformoterol tartrate is formamide, N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]-, (2R,3R)-2,3-dihydroxybutanedioate (1:1 salt), and its established structural formula is as follows:

The molecular weight of arformoterol tartrate is 494.5 g/mol, and its empirical formula is C19H24N2O4•C4H6O6 (1:1 salt). It is a white to off-white solid that is slightly soluble in water.

Arformoterol tartrate is the United States Adopted Name (USAN) for (R,R)-formoterol L-tartrate.

BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate.

BROVANA Inhalation Solution requires no dilution before administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend upon patient factors, the nebulizer used, and compressor performance. Using the PARI LC® Plus nebulizer (with mouthpiece) connected to a PARI DURA NEB™ 3000 compressor under in vitro conditions, the mean delivered dose from the mouthpiece (% nominal) was approximately 4.1 mcg (27.6%) at a mean flow rate of 3.3 L/min. The mean nebulization time was 6 minutes or less. BROVANA Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via face mask or mouthpiece.

Patients should be carefully instructed on the correct use of this drug product (please refer to the accompanying Patient Information).

Mechanism of Action

Arformoterol, the (R,R)-enantiomer of formoterol, is a selective long-acting beta2-adrenergic receptor agonist (beta2-agonist) that has two-fold greater potency than racemic formoterol (which contains both the (S,S) and (R,R)-enantiomers). The (S,S)-enantiomer is about 1,000-fold less potent as a beta2-agonist than the (R,R)-enantiomer. While it is recognized that beta2-receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-receptors are the predominant receptors in the heart, data indicate that there are also beta2-receptors in the human heart comprising 10% to 50% of the total beta-adrenergic receptors. The precise function of these receptors has not been established, but they raise the possibility that even highly selective beta2-agonists may have cardiac effects.

The pharmacologic effects of beta2-adrenoceptor agonist drugs, including arformoterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3′,5′-adenosine monophosphate (cyclic AMP). Increased intracellular cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.

In vitro tests show that arformoterol is an inhibitor of the release of mast cell mediators, such as histamine and leukotrienes, from the human lung. Arformoterol also inhibits histamine-induced plasma albumin extravasation in anesthetized guinea pigs and inhibits allergen-induced eosinophil influx in dogs with airway hyper-responsiveness. The relevance of these in vitro and animal findings to humans is unknown.

Who should not take Brovana?

Do not use Brovana if you:

• are allergic to arformoterol, racemic formoterol, or any of the ingredients in Brovana. Ask your healthcare provider if you are not sure. See the end of this guide for a complete list of ingredients in Brovana.
• have asthma.

What should I tell my healthcare provider before taking Brovana?

Before you use Brovana, tell your healthcare provider about all of your medical conditions, including if you:

• have heart problems
• have high blood pressure
• have seizures
• have thyroid problems
• have diabetes
• have liver problems
• are pregnant or plan to become pregnant. It is not known if Brovana can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if the arformoterol or any other ingredients in Brovana passes into your milk and if it can harm your baby. You and your healthcare provider should decide if you will take Brovana or breastfeed.

Tell your healthcare provider about all the medicines you take including prescription and over-the-counter 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.

How should I take Brovana?

Read the step-by-step Instructions for Use that comes with Brovana.

• Use Brovana exactly as prescribed. Do not use Brovana more often than prescribed.
• One unit dose vial of Brovana is 1 dose. The usual dose of Brovana is 1 unit dose vial, 2 times a day (morning and evening) breathed in through your nebulizer machine. The 2 doses should be taken about 12 hours apart. Do not use more than 2 unit dose 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 that come with Brovana before starting Brovana.
• Do not mix other medicines with Brovana in your nebulizer machine.
• 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.

Call your healthcare provider or get emergency medical care right away if your breathing problems worsen with Brovana, you need to use your rescue medicine more often than usual, or your rescue inhaler medicine does not work as well for you at relieving symptoms.

What are the possible side effects of Brovana?

Brovana can cause serious side effects, including:

• people with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as arformoterol (the medicine in Brovana), without also using a medicine called an inhaled corticosteroid have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death.
  • Call your healthcare provider if breathing problems worsen over time while using Brovana. You may need a different treatment.
  • Get emergency medical care if:
    • your breathing problems worsen quickly.
    • you use a rescue inhaler medicine, but it does not relieve your breathing problems.
• COPD symptoms that get worse over time. If your COPD symptoms worsen over time, do not increase your dose of Brovana, instead call your healthcare provider.
• using too much of a LABA medicine may cause:
  • chest pain
  • fast and irregular heartbeat
  • tremor
  • increased blood pressure
  • headache
  • nervousness
• sudden shortness of breath immediately after use of Brovana. Sudden shortness of breath may be life threating. If you have sudden breathing problems immediately after inhaling your medicine, stop taking Brovana and call your healthcare provider or go to the nearest hospital emergency room right away.
• effects on the heart which may include:
  • increased blood pressure
  • a fast or irregular heartbeat, awareness of a heartbeat
  • chest pain
• 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.
• Changes in laboratory levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia).

Common side effects of Brovana include:

• pain
• chest or back pain
• diarrhea
• sinus congestion
• leg cramps
• trouble breathing
• rash
• flu-like symptoms
• swelling in your legs
• 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 possible side effects of Brovana. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Brovana

Medicines are sometimes prescribed for purposes not mentioned in this Patient Information leaflet. Do not use Brovana for a condition for which it was not prescribed. Do not give Brovana to other people, even if they have the same symptoms that you may have. It may harm them.

You can ask your pharmacist or healthcare provider for information about Brovana that was written for health professionals.

How should I store Brovana?

• 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 unit dose vials should be returned to, and stored in, the pouch. An opened unit dose vial should be used right away.
• 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 unit dose vial.
• Brovana should be colorless. Throw away (discard) Brovana if it is not colorless.
• Keep Brovana and all medicines out of the reach of children.

What are the ingredients in Brovana?

Active ingredient: arformoterol

Inactive ingredients: citric acid and sodium citrate

Label

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 VIAL CARTON

• NDC 63402-911-30
• 30x 2mL Sterile Unit-Dose Vials
• KEEP REFRIGERATED OR STORE AT ROOM TEMPERATURE
  FOR UP TO 6 WEEKS.
• Brovana®
• (arformoterol tartrate)
• Inhalation Solution
• 15 mcg* / 2 mL
• * Potency expressed as arformoterol
• For Oral Inhalation Only.
• Rx Only