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Bezlotoxumab

Published: July 26, 2026Updated: July 26, 2026

Bezlotoxumab is a monoclonal antibody used to prevent recurrence of Clostridioides difficile (C. diff) infection in adults at high risk for recurrence. It is administered as a single intravenous infusion alongside standard antibiotic treatment for C. diff infection. This medication does not treat active C. diff infection but helps reduce the risk of the infection coming back.

Quick summary

A monoclonal antibody that prevents C. difficile infection recurrence by neutralizing toxin B.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 2026Editorial policy

Key facts at a glance

ATC
J06BC03
RxNorm
1855048
Generic
Bezlotoxumab
Class
atc-j06
Brands
Zinplava
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

adult (standard)tablet
Usual dose
500mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
250mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
400mg daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Single dose exceeding 10 grams may cause serious toxicity; bezlotoxumab is typically administered as 10 mg/kg IV infusion
Chronic overdose: Cumulative dosing data limited; no established chronic toxicity threshold as drug is administered as single infusion
Immediate actions
Discontinue infusion immediately, maintain airway and ventilation, establish IV access, monitor vital signs continuously, consider activated charcoal if within 1 hour of ingestion
Antidote
No specific antidote exists for bezlotoxumab overdose(Supportive care is primary treatment; no specific antidote proven effective)
Poison Control: 1-800-222-1222

Special Populations

9 groups
?

pregnancy

general
unknown
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

use only if potential benefits justify potential risks to fetus; insufficient data available

Monitor

standard prenatal monitoring

?

pregnancy

first trimester
unknown
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use unless benefits outweigh risks

Monitor

regular fetal monitoring

?

lactation

general
unknown
FDA Category
N
Dose Adjustment

no adjustment

Key Recommendations

breastfeeding not recommended during treatment and for 6 months after; decision should consider infant benefits and mother benefits

Monitor

monitor infant for adverse effects

✓

geriatric

over 65
safe
FDA Category
N
Dose Adjustment

no adjustment

Key Recommendations

no dose adjustment required for patients over 65 years; efficacy and safety consistent with younger adults

Monitor

standard clinical monitoring

✗

pediatric_age

under 18 years
unsafe
FDA Category
N
Dose Adjustment

not recommended

Key Recommendations

not approved for patients under 18 years of age; safety and efficacy not established

Monitor

not applicable

Use of this medication in this population requires careful consideration of risks and benefits.

✓

renal_impairment

mild to moderate
safe
FDA Category
N
Dose Adjustment

no adjustment

Key Recommendations

no dose adjustment required for mild to moderate renal impairment based on pharmacokinetic characteristics

Monitor

standard clinical monitoring

?

renal_impairment

severe
unknown
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

use with caution; limited clinical data available

Monitor

close clinical monitoring recommended

?

hepatic_impairment

mild to moderate
unknown
FDA Category
N
Dose Adjustment

no adjustment

Key Recommendations

no dose adjustment anticipated based on monoclonal antibody metabolism

Monitor

standard clinical monitoring

?

hepatic_impairment

severe
unknown
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

use with caution; not studied in severe hepatic impairment

Monitor

close clinical monitoring recommended

Statistics and clinical data

drug_classFDA
2023

Drug class

Value:Monoclonal antibody

Bezlotoxumab is a fully human monoclonal antibody

usageFDA
2023

Common uses

Value:Prevention of Clostridioides difficile infection recurrence

Indicated to reduce recurrence of C. difficile infection in high-risk patients

prescribingFDA
2023

FDA approval year

Value:2016

Initial FDA approval date for Bezlotoxumab (Zinplava)

mechanismFDA
2023

Mechanism of action

Value:Binds to Clostridioides difficile toxin B, neutralizing its effects

Monoclonal antibody that neutralizes C. difficile toxin B

Prevention of recurrence of Clostridioides difficile infection in adults at high risk for recurrence, given as adjunct to antibacterial therapy.

Human monoclonal antibody that binds specifically to C. difficile toxin B, neutralizing its effects and preventing toxin-mediated damage to cells.

Administered as a single 60-minute intravenous infusion. Does not have antibacterial activity and is not indicated for treatment of active C. diff infection. Heart failure has been observed as a potential adverse reaction in clinical trials; use with caution in patients with known heart failure.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

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.

Medical Disclaimer

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