Vativio 10 mg/400 mg FC tablets

    Vativio 10 mg/400 mg FC tablets

    S4
    PDF Leaflet Revision Date: 16 September 2024


    Clinical Summary

    Quick overview from the medicine insert

    Indication

    Treatment of various hematological malignancies including CML and Ph+ ALL.

    Dosage (summary)

    400 mg/day for chronic phase CML; 600 mg/day for accelerated phase or blast crisis; 800 mg/day for DFSP.

    Special Populations

    • Hepatic impairment
    • Renal impairment
    • Elderly patients

    Pregnancy & Breastfeeding

    Contraindicated in pregnancy and lactation due to potential fetal harm.

    Key Drug Interactions

    • CYP3A4 inducers (e.g., rifampicin)
    • CYP3A4 inhibitors (e.g., ketoconazole)
    • Warfarin

    Contraindications

    • Hypersensitivity to imatinib
    • Pregnancy
    • Lactation

    Common side effects

    • Neutropenia
    • Thrombocytopenia
    • Anemia
    • Headache
    • Nausea

    Counselling Points

    • Take with food and a large glass of water
    • Monitor for signs of liver dysfunction
    • Report any rapid weight gain

    Serious warnings

    • Hepatitis B reactivation
    • Severe fluid retention
    • Hepatotoxicity
    • Cardiac failure
    Important Disclaimer

    The Vativio 10 mg/400 mg FC tablets professional information leaflet below is the property of Novartis South Africa and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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