Obinutuzumab
Obinutuzumab is a monoclonal antibody medication used to treat certain cancers of the blood and immune system. It works by targeting the CD20 protein on the surface of B-cells, leading to their destruction through immune-mediated mechanisms. This drug is primarily prescribed for chronic lymphocytic leukemia (CLL) and follicular lymphoma.
Obinutuzumab is a monoclonal antibody that targets and destroys B-cells to treat certain blood cancers.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- L01FA03
- RxNorm
- 974779
- Generic
- Obinutuzumab
- Class
- atc-l01
- Brands
- Gazyva
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 100mg on day 1, then 900mg on day 2, then 1000mg on day 8 and day 15 of cycle 1; subsequent cycles: 1000mg on day 1
- Maximum
- consult physician
- Frequency
- every 28 days
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- safety and efficacy not established in pediatric patients
- Maximum
- consult physician
- Frequency
- not applicable
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 100mg on day 1, then 900mg on day 2, then 1000mg on day 8 and day 15 of cycle 1; subsequent cycles: 1000mg on day 1
- Maximum
- consult physician
- Frequency
- every 28 days
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
9 groupspregnancy
overallavoid if possible
avoid use during pregnancy unless benefits outweigh risks to the fetus
regular fetal monitoring including ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
first trimesteravoid
avoid use during first trimester due to critical organ development period
comprehensive fetal monitoring if exposure occurs
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
overalldiscontinue breastfeeding or avoid drug
discontinue breastfeeding during treatment and for at least 6 months after last dose
monitor infant for signs of infection or immunosuppression
geriatric
overallno specific adjustment required
use with caution due to increased susceptibility to infections and comorbidities
close monitoring for infusion-related reactions and infections
Use with caution and monitor for adverse effects.
pediatric_age
overallnot established
safety and efficacy not established in pediatric patients
no specific pediatric monitoring guidelines available
renal_impairment
mild to moderateno dose adjustment required
no formal dose adjustment needed for mild to moderate renal impairment
monitor renal function during treatment
Use with caution and monitor for adverse effects.
renal_impairment
severeuse with caution
limited data for severe renal impairment use with caution
close monitoring of renal function and for infusion reactions
Use with caution and monitor for adverse effects.
hepatic_impairment
mild to moderateno specific adjustment
no formal dose adjustment recommended for mild to moderate hepatic impairment
monitor liver function tests
Use with caution and monitor for adverse effects.
hepatic_impairment
severeinsufficient data
use with caution due to limited data
frequent monitoring of liver function and clinical status
Statistics and clinical data
FDA approval year
Initial FDA approval date for Obinutuzumab (Gazyva)
Drug class
Therapeutic classification of Obinutuzumab
Primary indications
FDA-approved therapeutic uses
Mechanism of action
Pharmacological mechanism
Chronic lymphocytic leukemia (CLL) and follicular lymphoma (a type of non-Hodgkin lymphoma). Often used in combination with other chemotherapy agents.
Binds to the CD20 antigen on pre-B and mature B lymphocytes, triggering cell destruction through immune effector cell recruitment and direct intracellular signaling pathways.
Requires infusion monitoring due to potential infusion-related reactions. May increase risk of infections due to B-cell depletion. Administered intravenously by healthcare professionals in clinical settings.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy