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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