Indacaterol

Indacaterol
Names
Trade namesArcapta, Onbrez, others
Other namesIndacaterol maleate
IUPAC name
  • 5-[2-[(5,6-Diethyl-2,3-dihydro-1H-inden-2-yl)amino]-1-hydroxyethyl]-8-hydroxyquinolin-2(1H)-one
Clinical data
Drug classLong-acting beta-adrenoceptor agonist (LABA)[1]
Main usesChronic obstructive pulmonary disease (COPD)[1]
Side effectsUpper respiratory tract infection, chest pain, cough[2]
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Pregnancy
category
  • AU: B3
    Routes of
    use
    Inhalation
    Typical dose75 to 300 mg OD[1][2]
    External links
    AHFS/Drugs.comMonograph
    Legal
    License data
    Legal status
    Chemical and physical data
    FormulaC24H28N2O3
    Molar mass392.499 g·mol−1
    3D model (JSmol)
    SMILES
    • O=C4/C=C\c1c(c(O)ccc1[C@@H](O)CNC3Cc2cc(c(cc2C3)CC)CC)N4
    InChI
    • InChI=1S/C24H28N2O3/c1-3-14-9-16-11-18(12-17(16)10-15(14)4-2)25-13-22(28)19-5-7-21(27)24-20(19)6-8-23(29)26-24/h5-10,18,22,25,27-28H,3-4,11-13H2,1-2H3,(H,26,29)/t22-/m0/s1 checkY
    • Key:QZZUEBNBZAPZLX-QFIPXVFZSA-N checkY

    Indacaterol, sold under the brand name Onbrez among others, is a medication used to treat chronic obstructive pulmonary disease (COPD).[1] Is is used by dry powder inhaler once per day.[1]

    Common side effects include upper respiratory tract infection, chest pain, and cough.[2] In those with asthma it may increase the risk of death.[1] It is a long-acting beta-adrenoceptor agonist (LABA).[1]

    Indacaterol was approved for medical use in Europe in 2009 and the United States in 2011.[2][1] In the United Kingdom it costs the NHS about £32 a month as of 2021.[7] In the United States this amount costs about 260 USD.[8]

    Medical uses

    A Cochrane review found benefit in lung function in people with COPD at least as good as that seen with twice-daily long-acting beta2-agonists.[9]

    Dosage

    It is used at a dose of 75 to 300 mg once per day.[1][2]

    History

    It was approved by the European Medicines Agency (EMA) under the brand name Onbrez Breezhaler on November 30, 2009,[10] and by the United States Food and Drug Administration (FDA), under the brand name Arcapta Neohaler, on July 1, 2011.[11][12] In 2016, Novartis licensed its U.S. commercial rights for Arcapta Neohaler to Sunovion Pharmaceuticals.[13]

    References

    1. 1 2 3 4 5 6 7 8 9 "Indacaterol Monograph for Professionals". Drugs.com. Archived from the original on 22 January 2021. Retrieved 26 November 2021.
    2. 1 2 3 4 5 "Onbrez Breezhaler". Archived from the original on 28 January 2021. Retrieved 26 November 2021.
    3. "Arcapta Neohaler (indacaterol) inhalation powder Initial U.S. Approval: 2011". DailyMed. 1 April 2020. Archived from the original on 15 June 2021. Retrieved 14 June 2021.
    4. "Onbrez Breezhaler EPAR". European Medicines Agency (EMA). Archived from the original on 28 January 2021. Retrieved 20 January 2021.
    5. "Oslif Breezhaler EPAR". European Medicines Agency (EMA). Archived from the original on 28 January 2021. Retrieved 20 January 2021.
    6. "Hirobriz Breezhaler EPAR". European Medicines Agency (EMA). Archived from the original on 28 January 2021. Retrieved 20 January 2021.
    7. BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 267. ISBN 978-0857114105.
    8. "Indacaterol Prices, Coupons & Savings Tips - GoodRx". GoodRx. Retrieved 26 November 2021.
    9. Geake, James B (2015). "Indacaterol, a once-daily beta2-agonist, versus twice-daily beta2-agonists or placebo for chronic obstructive pulmonary disease". Reviews. 1: CD010139. doi:10.1002/14651858.CD010139.pub2. PMC 6464646. PMID 25575340.
    10. European Public Assessment Report for Onbrez Breezhaler EPARs for authorised medicinal products for human use - Onbrez Breezhaler at the Wayback Machine (archived 2010-01-16)
    11. "FDA approves Arcapta Neohaler to treat chronic obstructive pulmonary disease" (Press release). U.S. Food and Drug Administration. 2011-07-01. Archived from the original on 2011-07-03. Retrieved 2011-07-02.
    12. "Drug Approval Package: Arcapta Neohaler (indacaterol maleate) NDA #022383". U.S. Food and Drug Administration. 13 August 2013. Archived from the original on 7 April 2021. Retrieved 14 June 2021.
    13. Faulkner, Sarah (22 December 2016). "Sunovion, Novartis ink licensing deal for inhaled COPD drugs". Drug Delivery Business. Archived from the original on 31 October 2021. Retrieved 15 June 2021.
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