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obinutuzumab

Gazyvaro · ATC code L01FA03

Key facts
Active substance
obinutuzumab
ATC code
L01FA03
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Gazyvaro 1 000 mg concentrate for solution for infusion
Marketing authorisation holder
Roche Registration GmbH
Information as of
2026-10-27

Key facts

Obinutuzumab (Gazyvaro) is an anti-CD20 monoclonal antibody. It is used in chronic lymphocytic leukaemia, follicular lymphoma and lupus nephritis, each in combination with other medicines.

What it is used for

  • Previously untreated CLL in adults unsuitable for full-dose fludarabine-based therapy (with chlorambucil)
  • Previously untreated advanced follicular lymphoma (with chemotherapy, then maintenance in responders)
  • Follicular lymphoma not responding to or progressing after rituximab-containing treatment (with bendamustine, then maintenance)
  • Active Class III or IV lupus nephritis in adults (with mycophenolate mofetil)

Dosing

  • Intravenous infusion under close supervision of an experienced physician with resuscitation facilities available
  • CLL: cycle 1 1,000 mg over Day 1 and Day 2 (100 mg Day 1, 900 mg Day 2), plus 1,000 mg on Day 8 and Day 15; cycles 2–6 1,000 mg on Day 1; six 28-day cycles
  • Follicular lymphoma: induction with chemotherapy, then in responders 1,000 mg maintenance every 2 months for 2 years or until progression
  • Lupus nephritis: 1,000 mg initially, at Week 2, Week 24 and Week 26, then every 6 months
  • Premedication against infusion reactions (corticosteroid, analgesic/anti-pyretic, antihistamine) and TLS prophylaxis in at-risk patients; details in the full text
  • No dose adjustment in mild to moderate renal impairment; not established in severe renal or in hepatic impairment

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Infusion-related reactions, mainly with the first infusion; withholding antihypertensives around the infusion should be considered
  • Tumour lysis syndrome in patients with high tumour burden, high lymphocyte count or renal impairment
  • Severe and life-threatening neutropenia, and thrombocytopenia
  • Serious, including fatal, infections; not to be given in active infection
  • Hepatitis B reactivation; HBV screening before treatment
  • Progressive multifocal leukoencephalopathy (PML) has been reported

Side effects

  • Most frequent: infusion-related reactions, predominantly during the first infusion
  • Neutropenia, thrombocytopenia and infections
  • Serious: tumour lysis syndrome, hepatitis B reactivation, PML

Interactions

  • No pharmacokinetic interactions expected via CYP450, UGT or P-glycoprotein
  • Combination with chlorambucil, bendamustine, CHOP or CVP may increase the risk of neutropenia
  • Live virus vaccines not recommended during treatment and until B-cell recovery

Pregnancy and breastfeeding

  • Women of childbearing potential must use effective contraception during and for 18 months after treatment; not to be given in pregnancy unless the benefit outweighs the risk
  • Breast-feeding should be discontinued during therapy and for 18 months after the last dose

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • GazyvaroRoche Registration GmbH · EMEA/H/C/002799

Source: European Medicines Agency (EMA), product information

Turkey

  • GazyvaROCHE MÜSTAHZARLARI SAN.A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Gazyvaro
Liechtenstein
Gazyvaro
Norway
Gazyvaro

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Gazyvaro – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/gazyvaro-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.