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 The leading web portal for pharmacy resources, news, education and careers November 20, 2009

Special Announcement

Brovana
 New  New


Brovana™ (arfomoterol tartrate) Inhalation Solution, the first and only approved nebulized long-acting bronchodilator for chronic obstructive pulmonary disease, was launched on April 11, 2007. BROVANA is an important new option for patients who currently use nebulized bronchodilator therapy for COPD.

Healthcare professionals may choose to prescribe BROVANA for patients with COPD who:
  • Currently use nebulizer therapy and would benefit from the addition of a nebulized long-acting bronchodilator†
  • Are not adequately controlled and who overuse short-acting beta-agonists†
  • Prefer nebulized treatments
  • Are candidates for initiating nebulizer therapy
    • Those who have progressed to moderate severity level or above
    • Those who have trouble using metered-dose or dry-powder inhalers

†BROVANA should not be used in conjunction with other inhaled long-acting beta2-agonists or with other medications containing long-acting beta2-agonists.  Patients who have been taking inhaled short-acting beta2-agonists on a regular basis should be instructed to discontinue their regular use and to use them only for symptomatic relief of acute respiratory symptoms.

Indications and Usage:
  • Brovana™ (arformoterol tartrate) Inhalation Solution is indicated for the long term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.  BROVANA is for use by nebulization only.
Clinical Highlights:
  • BROVANA provided rapid onset1 of bronchodilation
    • Median time to onset was 6.7 minutes when defined as a 15% increase in FEV1, and 20 minutes when defined as a 12% and 200 mL increase in FEV1 after the first dose.  Peak bronchodilator effect was generally seen within 1 to 3 hours of dosing1
    • BROVANA is not indicated for the treatment of acute episodes of bronchospasm
  • BROVANA provided sustained bronchodilation over the 12-hour dosing interval throughout the 12-week study period1
  • BROVANA decreased the use of rescue albuterol and supplemental ipratropium bromide vs placebo1
  • BROVANA 15 mcg was well tolerated1
    • The percentages of patients who reported adverse events were comparable in the BROVANA 15 mcg BID and placebo groups 
    • BROVANA, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms
  • BROVANA (15 mcg/2 mL) provides twice-daily dosing by jet nebulizer

1BROVANA prescribing information

Important Safety Information:

    Long acting beta2- adrenergic agonists may 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 may apply to arfomoterol (a long-acting beta-adrenergic agonist), the active ingredient in BROVANA.
  • BROVANA should not be used in conjunction with other inhaled, long-acting beta2-agonists.  BROVANA should not be used with other medications containing long-acting beta2-agonists.
  • As with other inhaled beta2-agonists, BROVANA can produce paradoxical bronchospasm occurs, BROVANA should be discontinued immediately and alternative therapy instituted.
  • BROVANA should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with conclusive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines.
  • BROVANA, as with other beta-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents.
  • Overall efficacy of BROVANA was maintained throughout the 12-week trial duration.  Some tolerance to the bronchodilator effect of BROVANA was observed after 6 weeks of dosing (at the end of the dosing interval), although the FEV1 improvement remained statistically significant.  This was not accompanied by other clinical manifestations of tolerance.
  • The most common adverse events reported in patients taking BROVANA, and occuring more frequently than in patients taking placebo, were pain (8% vs 5%), chest pain (7% vs 6%), back pain (6% vs 2%), diarrhea (6% vs 4%), and sinusitis (5% vs 4%).
Dosing & Strength:
  • 15 mcg twice daily by jet nebulizer. Brovana 15mcg/2mL can be nebulized in only 5-10 minutes.
Storage:
  • Store BROVANA in the protective foil pouch under refrigeration at 36°-46°F (2°-8°C).  Protect from light and excessive heat.  Once the foil pouch is opened, the contents of the vial should be used immediately.  Discard any vial if the solution is not colorless.  Unopened foil pouches of BROVANA can also be stored at room temperature 68°-77°F, (20°-25°C) for up to 6 weeks. If stored at room temperature, discard if not used after 6 weeks or if past the expiration date, whichever is sooner.
NDC:
  • 63402-911-30

Wholesale Acquisition Cost:

  • $4.61 per vial
Package Size:
  • 30 unit-dose individually pouched vials
PIC:
  • Company Item
    AmeriSourceBergen Corp. 752586
    Bellco Drug Corp. 220071
    Cardinal Health Corp. 3950227
    DIK Drug Company 286955
    FW Kerr Company O83824
    Harvard Drug- Livonia 743000
    HD Smith Company 2047611
    King Drug 169680
    Kinray Inc. O96149
    McKesson Corp 116270
    McQueary Brothers Inc. 746746
    Miami Luken Inc. 69005
    Morris & Dickson 727693
    NC Mutual Wholesale Drug Company 601542
    Pharmacy Buying Association 63402091130
    Prescription Supply 413294
    QK Healthcare 78768
    Rochester Drug 10149144
    Valley Wholesale Drug Company 359547
    Value Drug Company 591628

Click here to see complete BROVANA Prescribing Information including Boxed Warning



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