Registered Kenya · PPB

GAZYVARO 1,000MG CONCENTRATE FOR SOLUTION FOR INFUSION

OBINUTUZUMAB

What it does

Obinutuzumab is a medicine used to treat certain types of blood cancers.

Commonly used for: chronic lymphocytic leukaemia (CLL), follicular lymphoma

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2026/CTD11487/23551
Registration date
-
Expiry date
2031 March 30
Status
Registered
Active ingredient
OBINUTUZUMAB
Strength
-
Pack size
40 ML CONCENTRATE IN A 50 ML VIAL (CLEAR TYPE I GLASS) WITH STOPPER (BUTYL RUBBER) PLACED IN OUTER CARTON BOX
Therapeutic class
NEW/INNOVATOR
Manufacturer / MAH
Roche
Applicant / LTR
F. HOFFMANN-LA ROCHE LTD
Country of origin
FOREIGN
Manufacturer location
Chaka Rd, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-06-28 19:41:47 · updated 2026-09-25 02:03:30

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Obinutuzumab is a medicine used to treat certain types of blood cancers.

What it treats

  • chronic lymphocytic leukaemia (CLL)
  • follicular lymphoma

How it works

It works by targeting and destroying cancerous B cells, which are a type of white blood cell involved in the immune system.

Who it's for

This medicine is for adults diagnosed with specific blood cancers.

Cautions

  • • Be cautious if you are taking other medicines that affect bone marrow function.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Obinutuzumab

BNF-referenced

Obinutuzumab is a monoclonal antibody that targets the CD20 antigen on B-lymphocytes, leading to their destruction. It is primarily used in the treatment of certain hematological malignancies, particularly chronic lymphocytic leukemia (CLL) and follicular lymphoma, especially in patients who have not responded adequately to previous therapies.

Indications

  • Chronic lymphocytic leukemia (CLL)
  • Follicular lymphoma
  • Other CD20-positive B-cell malignancies

Dosage

Children: Refer to the BNF for Children for appropriate dosing guidance in paediatric patients, as specific doses may vary based on age and condition.

Adults: Refer to the BNF for specific dosing recommendations, particularly for combination therapies or when managing specific patient populations.

Mechanism of action

Obinutuzumab selectively binds to the CD20 antigen on B cells, leading to B cell lysis through multiple mechanisms, including antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and induction of apoptosis. This action results in the depletion of B cells, which play a crucial role in the pathogenesis of several B-cell malignancies.

Pharmacodynamics

The pharmacodynamics of obinutuzumab involves the modulation of immune response through the direct targeting of B cells. The binding to CD20 enhances the immune system's ability to target and destroy malignant B cells while sparing normal B cells during the initial phases of treatment, although long-term effects on the immune system must be monitored.

Pharmacokinetics

Obinutuzumab has a half-life of approximately 14 days, with pharmacokinetics influenced by the patient's body weight and the presence of anti-drug antibodies. It is administered via intravenous infusion. The peak concentration occurs at the end of the infusion, and it is primarily cleared from the body through a combination of metabolism and immunogenic clearance.

Contra-indications

  • Active hepatitis B infection
  • Severe hypersensitivity to obinutuzumab or any of its excipients

Adverse effects

  • Infusion-related reactions
  • Nausea
  • Hypotension
  • Angina
  • Skin reactions
  • Tumour lysis syndrome
  • Reactivation of infections

Interactions

  • Monoclonal antibodies
  • Corticosteroids may be used for premedication to reduce infusion-related reactions

Precautions

  • Monitor for signs of active hepatitis B infection during and up to a year after treatment
  • Monitor for infusion-related reactions
  • Use effective contraception during and for 18 months after treatment

Pregnancy

Avoid unless potential benefit outweighs risk due to risk of B-lymphocyte depletion in fetus.

Breast-feeding

Avoid breastfeeding during and for 18 months after treatment as it is present in milk in animal studies.

Storage

Store in a refrigerator (2°C to 8°C). Do not freeze. Protect from light.

Formulations

  • Solution for infusion
BNF 85 (British National Formulary) p.983 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.