Tislelizumab
Tislelizumab is a monoclonal antibody immunotherapy that works by blocking the PD-1 receptor on T cells, preventing tumor cells from evading immune detection. It is used to treat various advanced solid tumors and hematologic malignancies by restoring T-cell immune function against cancer cells.
Tislelizumab is an anti-PD-1 immunotherapy that helps the immune system recognize and attack cancer cells by blocking an inhibitory signaling pathway.
Key facts at a glance
- ATC
- L01FF09
- RxNorm
- 2677426
- Generic
- Tislelizumab
- Class
- atc-l01
- Brands
- Tevimbra
- 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
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
9 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks; discontinue therapy if pregnancy occurs
regular fetal monitoring including ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second third trimesteravoid
avoid use during second and third trimester; consider risks vs benefits carefully
detailed fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingdiscontinue breastfeeding
discontinue breastfeeding during treatment and for at least 4 months after last dose
monitor infant for immune-related effects
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
children adolescentsnot established
safety and efficacy not established in pediatric patients; use only in clinical trials
close monitoring in pediatric clinical trials
geriatric
elderly 65 yearsno specific dose adjustment required
use with caution; monitor for adverse reactions; no overall differences in efficacy observed
regular monitoring of immune-related adverse events
Use with caution and monitor for adverse effects.
renal_impairment
mild moderateno dose adjustment needed
no clinically significant effect on pharmacokinetics; no dose adjustment required
routine renal function monitoring
renal_impairment
severeuse with caution
limited data available; use with caution and close monitoring
close monitoring of renal function
Use with caution and monitor for adverse effects.
hepatic_impairment
mild moderateno dose adjustment needed
no clinically significant effect observed; no dose adjustment required
routine liver function monitoring
Use with caution and monitor for adverse effects.
hepatic_impairment
severeuse with caution
limited data available; use only if benefits outweigh risks
close monitoring of liver function and hepatic adverse events
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
Initial FDA approval date for Tislelizumab (Tevimbra)
Drug class
Monoclonal antibody immunotherapy classification
Therapeutic use
FDA-approved indications for Tevimbra
Approved for treatment of various advanced solid tumors including non-small cell lung cancer, esophageal squamous cell carcinoma, and other malignancies where PD-1/PD-L1 pathway involvement has been demonstrated.
Tislelizumab is a monoclonal antibody that binds to the PD-1 receptor on T lymphocytes, blocking interaction with PD-L1 and PD-L2 ligands expressed on tumor cells. This prevents inhibitory signaling and restores T-cell proliferation and cytokine production, enabling effective anti-tumor immune responses.
As an immunotherapy, tislelizumab may cause immune-related adverse events affecting various organ systems. Patients should be monitored for pneumonitis, colitis, hepatitis, and endocrine disorders. Treatment should be administered by healthcare professionals experienced in cancer immunotherapy management.
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