Glofitamab
Glofitamab is a bispecific monoclonal antibody used to treat certain B-cell cancers by simultaneously binding to CD20 on malignant B cells and CD3 on T cells. This dual binding brings T cells into proximity with cancer cells, triggering immune-mediated destruction of the B cells. It is indicated for adult patients with relapsed or refractory B-cell non-Hodgkin lymphomas who have received prior therapies.
Glofitamab is a bispecific antibody that recruits T cells to attack and destroy CD20-expressing B cells, used to treat certain relapsed or refractory B-cell lymphomas.
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
- L01FX28
- RxNorm
- 2639782
- Generic
- Glofitamab
- Class
- atc-l01
- Brands
- Columvi
- 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
- 30mg
- Maximum
- consult physician
- Frequency
- every 21 days (after step-up dosing)
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- not established
- Maximum
- consult physician
- Frequency
- not established
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 30mg
- Maximum
- consult physician
- Frequency
- every 21 days (after step-up dosing)
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
7 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks; women of childbearing potential should use effective contraception during treatment and for 18 months after last dose
regular fetal monitoring and ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteravoid if possible
avoid use during pregnancy; if treatment is absolutely necessary, discuss risks with patient
regular fetal monitoring including ultrasound
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingnot recommended
discontinue breastfeeding during treatment and for at least 18 months after last dose
no specific monitoring required
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderly 65 and olderno specific dose adjustment required
use with caution; monitor closely for adverse reactions including cytokine release syndrome and neutropenia
close monitoring of vital signs and blood counts; assess for infections
Use with caution and monitor for adverse effects.
pediatric_age
children and adolescentsnot established
safety and efficacy not established in patients under 18 years of age
not applicable
renal_impairment
severe renal impairmentno dose adjustment recommended
use with caution; monitor renal function closely; monoclonal antibodies are not significantly renally excreted
monitor renal function regularly before and during treatment
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate to severe hepatic impairmentno specific dose adjustment established
use with caution; limited clinical data available; monitor hepatic function
regular monitoring of liver function tests including ALT, AST, bilirubin
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
FDA approval for relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
Drug class
Mechanism of action classification
Target
Molecular targets of the bispecific antibody
Route of administration
Method of drug delivery
Glofitamab is indicated for the treatment of adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL), who have received two or more prior lines of systemic therapy.
Glofitamab is a bispecific antibody that simultaneously binds to CD20 antigen on the surface of malignant B cells and the CD3 receptor on T cells. This cross-linking redirects and activates T cells, leading to T-cell proliferation, cytokine secretion, and targeted lysis of CD20-expressing B cells.
Administered as an intravenous infusion using a step-up dosing schedule to reduce the risk of cytokine release syndrome (CRS), which is a common and potentially serious adverse effect. Requires pre-medication and close monitoring during treatment, particularly for the first dose. May increase risk of infections due to B-cell depletion and can cause tumor lysis syndrome. Patients should be vaccinated against encapsulated bacteria prior to treatment initiation.
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