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Basiliximab

Published: July 26, 2026Updated: August 24, 2026

Basiliximab is a monoclonal antibody immunosuppressant used to prevent acute organ rejection in patients receiving kidney transplants. It works by blocking the activation of T-lymphocytes, which are key players in the immune response that can attack transplanted organs. This medication is typically administered as part of a multi-drug immunosuppressive regimen around the time of transplantation.

Quick summary

Basiliximab is an immunosuppressant monoclonal antibody used to prevent kidney transplant rejection by blocking T-cell activation.

Medically reviewed by WellAlly Editorial TeamLast reviewed August 24, 2026Editorial policy
BOXED WARNING

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
L04AC02
RxNorm
196102
Generic
Basiliximab
Class
atc-l04
Brands
—
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: Consult local poison control center for specific information
Chronic overdose: Varies by patient
Immediate actions
Call poison control center: 1-800-222-1222
Poison Control: 1-800-222-1222

Special Populations

7 groups
✗

pregnancy

first trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless benefits outweigh risks; consider alternative immunosuppression

Monitor

regular fetal monitoring including ultrasound assessments

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

⚠

pregnancy

second third trimester
caution
FDA Category
C
Dose Adjustment

use only if clearly needed

Key Recommendations

use only if benefits outweigh potential risks to fetus; consider timing of last dose before delivery

Monitor

fetal growth monitoring and standard prenatal care

Use with caution and monitor for adverse effects.

✗

lactation

nursing mothers
unsafe
FDA Category
C
Dose Adjustment

discontinue breastfeeding

Key Recommendations

do not breastfeed during treatment and for at least 4 months after last dose

Monitor

inform patients about infant immune system monitoring

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

⚠

pediatric_age

children 2 17 years
caution
FDA Category
C
Dose Adjustment

weight-based dosing

Key Recommendations

approved for pediatric patients 2 years and older for renal transplant prophylaxis; follow pediatric dosing protocol

Monitor

monitor for infections and immune suppression complications

Use with caution and monitor for adverse effects.

✓

renal_impairment

severe renal impairment
safe
FDA Category
C
Dose Adjustment

no adjustment needed

Key Recommendations

no dose adjustment required for any degree of renal impairment; monitor renal function as appropriate

Monitor

standard renal function monitoring

⚠

hepatic_impairment

moderate to severe
caution
FDA Category
C
Dose Adjustment

limited data available

Key Recommendations

use with caution; limited clinical data on hepatic impairment; consider clinical judgment

Monitor

monitor liver function tests and clinical response

Use with caution and monitor for adverse effects.

⚠

geriatric

elderly 65 years and older
caution
FDA Category
C
Dose Adjustment

no specific adjustment

Key Recommendations

use with caution; no specific dose adjustment required but monitor closely for infections

Monitor

increased vigilance for infections, malignancies, and cardiovascular events

Use with caution and monitor for adverse effects.

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:1998

Initial FDA approval for prevention of acute organ rejection

drug_classWHO
2023

Drug class

Value:Immunosuppressant (Monoclonal antibody)

Pharmacological classification as IL-2 receptor antagonist

mechanismFDA
2023

Mechanism of action

Value:IL-2 receptor antagonist (CD25)

Blocks interleukin-2 receptor on activated T-lymphocytes

usageMedical guidelines
2023

Common uses

Value:Prevention of acute rejection in kidney and liver transplantation

Primary therapeutic indication in organ transplantation

Basiliximab is indicated for the prophylaxis of acute organ rejection in patients undergoing renal (kidney) transplantation. It is used as part of an immunosuppressive regimen that typically includes cyclosporine and corticosteroids, particularly in first-time transplant recipients.

Basiliximab is a chimeric monoclonal antibody that binds specifically to the CD25 alpha subunit of the interleukin-2 (IL-2) receptor on the surface of activated T-lymphocytes. By blocking this receptor, it prevents IL-2 from binding and activating T-cells, thereby inhibiting the immune response that would otherwise attack the transplanted organ.

Basiliximab is administered intravenously, usually in two doses—one before transplant surgery and one 4 days after. Common side effects may include gastrointestinal symptoms and fever. Due to its immunosuppressive effects, patients are at increased risk for infections and require careful monitoring. It should not be used in patients with known hypersensitivity to the drug. Women of childbearing potential should use effective contraception during and for 4 months after treatment.

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 August 24, 2026. · Read our editorial policy