Infigratinib

Infigratinib
Names
Trade namesTruseltiq
Other namesBGJ-398
Clinical data
Drug classTyrosine kinase inhibitor
Main usesCholangiocarcinoma (bile duct cancer)[1]
Side effectsFinger nail problems, mouth inflammation, dry eyes, tiredness, hair loss, joint pain, constipation, abdominal pain, eye problems.[1]
Pregnancy
category
    Routes of
    use    		By mouth
    External links
    AHFS/Drugs.comMonograph
    US NLMInfigratinib
    Legal
    License data
    Legal status
    Chemical and physical data
    FormulaC26H31Cl2N7O3
    Molar mass560.48 g·mol−1
    3D model (JSmol)
    SMILES
    • CCN1CCN(c2ccc(Nc3cc(N(C)C(=O)Nc4c(Cl)c(OC)cc(OC)c4Cl)ncn3)cc2)CC1
    InChI
    • InChI=1S/C26H31Cl2N7O3/c1-5-34-10-12-35(13-11-34)18-8-6-17(7-9-18)31-21-15-22(30-16-29-21)33(2)26(36)32-25-23(27)19(37-3)14-20(38-4)24(25)28/h6-9,14-16H,5,10-13H2,1-4H3,(H,32,36)(H,29,30,31)
    • Key:QADPYRIHXKWUSV-UHFFFAOYSA-N

    Infigratinib, sold under the brand name Truseltiq, is a medication used to treat cholangiocarcinoma (bile duct cancer).[1] Specifically it is used for advanced disease with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement that has failed other treatments.[1] It is taken by mouth.[1]

    Common side effects include finger nail problems, mouth inflammation, dry eyes, tiredness, hair loss, joint pain, constipation, abdominal pain, and eye problems.[1] Common lab abnormalities include kidney problems, low phosphate, high calcium, low potassium, and low sodium.[1] Use in pregnancy may harm the baby.[1] It is a kinase inhibitor of fibroblast growth factor receptors FGFR1, FGFR2 and FGFR3.[1]

    Infigratinib was approved for medical use in the United States in 2021.[1] As of 2022 it is not approved in the United Kingdom or Europe, though has orphan status.[6] In the United States it costs about 10,700 USD per 4 week cycle.[7]

    Medical uses

    Infigratinib is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (bile duct cancer) with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.[5]

    Dosage

    It is generally used at a dose of 125 mg once per day for 21 days followed by 7 days off, which is than repeated.[1] A lower dose is used in people with kidney or liver problems.[1]

    History

    It was designated an orphan drug by the U.S. Food and Drug Administration (FDA) in 2019.[8]

    References

    1. 1 2 3 4 5 6 7 8 9 10 11 12 "DailyMed - TRUSELTIQ- infigratinib capsule". dailymed.nlm.nih.gov. Archived from the original on 10 June 2021. Retrieved 29 October 2022.
    2. 1 2 "Truseltiq". Therapeutic Goods Administration (TGA). 22 November 2021. Retrieved 28 December 2021.
    3. ↑ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 12 May 2022. Archived from the original on 3 April 2022. Retrieved 13 May 2022.
    4. ↑ "Summary Basis of Decision (SBD) for Truseltiq". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
    5. 1 2 "Truseltiq- infigratinib capsule". DailyMed. Archived from the original on 10 June 2021. Retrieved 10 June 2021.
    6. ↑ "Infigratinib". SPS - Specialist Pharmacy Service. 14 January 2020. Archived from the original on 2 December 2021. Retrieved 29 October 2022.
    7. ↑ "Truseltiq". Archived from the original on 29 October 2022. Retrieved 29 October 2022.
    8. ↑ "Infigratinib Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 11 September 2019. Archived from the original on 28 October 2022. Retrieved 30 May 2021.
    External sites:
    Identifiers:
    • Clinical trial number NCT02150967 for "A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma" at ClinicalTrials.gov


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