Scribd Logo
Upload

Welcome to Scribd!

  • Fexofenadine Sanofi

    Uploaded by

    dnbgzt
    34 views21 pages

    Original Title

    FEXOFENADINE SANOFI

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    34 views21 pages

    Fexofenadine Sanofi

    Uploaded by

    dnbgzt

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    of 21

    Fexofenadine:

    3rd Generation Antihistamine


    with 3-in-1 Benefit

    dr. Fatimah Pitaloca


    SwipeRx Webinar

    Jul 2024

    MAT-ID-2200317-V1.0 (03/2022)
    Internal

    Agenda

    01 History of Fexofenadine

    02 Clinical Pharmacology of
    Fexofenadine

    03 Fexofenadine Efficacy
    Studies

    04 3 in 1 Benefit of
    Fexofenadine

    05 Summary

    INTERNAL USE 3
    Internal

    01

    History of Fexofenadine
     Synthesized in 1993 by Sepracor, which then sold the
    development rights to Hoechst Marion Roussel (now part
    of Sanofi-Aventis)1
     First approved in the UK on 11 Mar 1996, now approved in 110
    countries worldwide2
     The total global cumulative exposure: 50.8 million patient years2
     Approved as OTC drug in the US in 20112, Indonesia in 2021 (for
    60mg)

    References:
    1. https://en.wikipedia.org/wiki/Fexofenadine#:~:text=Fexofenadine%20was%20originally%20synthesized%20in,Administration%20(FDA)%20in%201996
    Accessed on 10 March 2022
    2. Sanofi internal data.

    INTERNAL USE 4
    Internal

    02

    Clinical Pharmacology of Fexofenadine


     A third-generation histamine H1-receptor antagonist1
     Active metabolite of terfenadine1
     Retain all of the biological activity of terfenadine with fewer
    adverse reactions in patients, particularly cardiac arrhythmia1
     Does not cross the blood brain barrier3
     Rapidly absorbed into the body following oral administration
    with t-max occurring at 1-3 hours post dose3
     70-80% bound to plasma protein, 5% of the total dose are
    metabolized3
    References:
    1. https://en.wikipedia.org/wiki/Fexofenadine#:~:text=Fexofenadine%20was%20originally%20synthesized%20in,Administration%20(FDA)%20in%201996
    Accessed on 10 March 2022
    3. Fexofenadine Product Information

    INTERNAL USE 5
    Internal

    03

    Efficacy of Fexofenadine
    Fexofenadine showed a decrease in AR total symptoms score (TSS)

    Reference:
    1. Day JH, et al. Onset of action, efficacy, and safety of a single dose of fexofenadine hydrochloride for ragweed allergy using an
    environmental exposure unit. Ann Allergy Asthma Immunol 1997;79:533– 40.
    2. Simpson et al.
    INTERNAL USE 6
    6
    Internal

    03

    Efficacy of Fexofenadine

    1 out of 2 allergic rhinitis sufferers


    identified congestion as the most
    bothersome symptom, and 40%
    identify their congestion as severe1

    Fexofenadine + Pseudoephedrine
    is suitable for AR patients with
    nasal congestion2

    References:
    1. Stewart, M., Ferguson, B. and Fromer, L. (2010). Epidemiology and burden of nasal congestion.International Journal of General
    Medicine, 3, pp.37-45. INTERNAL USE 7
    2. Sussman GL, et al. J Allergy Clin Immunol. 1999; 104: 100–106.
    Internal

    03

    Efficacy of Fexofenadine
    Fexofenadine 180 mg QD Significantly Reduces Pruritus in CIU
    Double-blind, placebo-controlled,4- week study in 255 patients with CIU

    References: INTERNAL USE 8


    1. Kaplan AP, et al. Ann Allergy Asthma Immunol. 2005; 94: 662–669.
    Internal

    FEXOFENADINE

    INTERNAL USE 9
    Internal

    04

    Fexofenadine 3-in-1 Benefit: Bekerja Cepat


    Fexofenadine has Fast Onset of Action within 30-60 Minutes
    696 patients received Fexofenadine 120 mg to assess the relief of AR symptoms4

     Sneezing
     Rhinorrhea
     Itchy nose, palate and throat
     Itchy, watery or red eyes

    80% patients reported significant


    symptoms relief within

    94% patients reported significant


    symptoms relief within

    Reference:
    Potter PC, Schoeman HS. Brief Communication: Rapid Onset of Action
    INTERNAL USE 10
    of Fexofenadine (Telfast). Curr Allergy Clin Immunol. 2001; 14(2):14-16
    Internal

    04

    Fexofenadine 3-in-1 Benefit: Tanpa Kantuk


    Fexofenadine does not occupy H1
    Receptor in the Brain

    8% -8%

    H1RO (H1 Receptor Occupancy)


    -0.1% 26%
    Fexofenadine with -8% (60 mg) and -0.1% (120 mg) H1RO indicates that it does not occupy H1 receptors at all
    Reference
    1. Hiraoka. Expert Opin. Drug Saf. (2015)
    INTERNAL14(2)
    USE 11
    2. Tashiro et al. J Clin Pharmacol 2004;44:890-900
    Internal

    04

    Fexofenadine 3-in-1 Benefit: Tanpa Kantuk


    Fexofenadine

    Reference:
    Hindmarch et al. Clinical and Experimental Allergy,INTERNAL
    32:133-139
    USE 12
    Internal

    04

    Fexofenadine 3-in-1 Benefit: Tanpa Kantuk


    Fexofenadine 360 mg has no effect on cognitive and psychomotor function

    Reference:
    INTERNAL USE
    Hindmarch et al. Clinical and Experimental Allergy, 32:133-139 13
    Internal

    04

    Fexofenadine 3-in-1 Benefit: Efektif 24 Jam

    INTERNAL USE 14
    Internal

    Fexofenadine with 3-in-1 benefit


    Fast onset of action

    30-60 minutes

    Non drowsy
    No sedation
    No impairment

    24-hour coverage

    Referensi:
    4. Meltzer et al. Evaluation of the Optimal Oral Antihistamine for Patients With Allergic Rhinitis. Mayo Clin Proc. 2005;80(9):1170-1176

    6/11/2024
    15
    Internal

    Reference:
    INTERNAL USE
    Vachiano et al. Aviation, Space, and Environmental Medicine x Vol. 79, No. 8 x August 2008 16
    Efficacy vs loratadine Internal

    Fexofenadine provides better AR symptoms relief and


    quality of life (QoL) than Loratadine

    Fexofenadine was significantly better than loratadine Fexofenadine was significantly better than
    in improving 24-h reflective itchy/watery/red eyes loratadine (P≤0.03) and placebo (P≤0.005)
    and relieving nasal congestion (P≤0.05) in improving quality of life (QoL)

    17
    Safety vs 1st gen Internal

    Fexofenadine did not disturb normal sleep pattern


    compared to 1st gen AH

    18
    Internal

    Comparison

    Fexofenadine Diphen-
    Cetirizine Loratadine hydramine Desloratadine Levocetirizine Ebastine
    Relief

    Fast-acting ✓ ✓ ✓ ✓ ✓

    24-hour ✓ ✓ ✓ ✓ ✓

    Non-
    drowsy/ ✓ ✓ ✓
    non-
    sedating

    6/11/2024
    19
    Internal
    04

    Summary

    Fexofenadine is a third-generation histamine H1-receptor antagonist


    first approved in 1996

    Fexofenadine does not cross the blood brain barrier and rapidly
    absorbed into the body following oral administration

    Fexofenadine has 3 in 1 benefit: fast relief within 30-60 minutes, non-


    drowsy, 24-hour relief

    INTERNAL USE 20
    Thank You

    You might also like