Gazyva 1 000 mg Concentrate solution for infusion

    Gazyva 1 000 mg Concentrate solution for infusion

    S4
    PDF Leaflet Revision Date: 29 July 2025

    API: Obinutuzumab | Company: Roche Products

    Clinical Summary

    Quick overview from the medicine insert

    Indication

    Treatment of chronic lymphocytic leukaemia and follicular lymphoma.

    Dosage (summary)

    1,000 mg IV on Day 1, 8, 15 of Cycle 1; then 1,000 mg IV on Day 1 of subsequent cycles.

    Special Populations

    • Elderly
    • Renal impairment
    • Hepatic impairment

    Pregnancy & Breastfeeding

    Avoid in pregnancy; use contraception during and for 18 months after treatment. Discontinue breastfeeding during therapy.

    Key Drug Interactions

    • Bendamustine
    • CHOP
    • Chlorambucil

    Contraindications

    • Hypersensitivity to obinutuzumab
    • Active infections
    • Active hepatitis B
    • Live vaccines
    • Pregnancy

    Common side effects

    • Infusion related reactions
    • Neutropenia
    • Thrombocytopenia
    • Infections
    • Fatigue

    Counselling Points

    • Monitor for infusion reactions
    • Hydration and prophylaxis for TLS
    • Avoid live vaccines
    • Report any signs of infection

    Serious warnings

    • Severe infusion related reactions
    • Tumour lysis syndrome
    • Hepatitis B reactivation
    • Progressive multifocal leukoencephalopathy
    Important Disclaimer

    The Gazyva 1 000 mg Concentrate solution for infusion professional information leaflet below is the property of Roche Products 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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