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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