Dostarlimab
Dostarlimab is an anti-PD-1 monoclonal antibody immunotherapy used to treat certain cancers by helping the immune system recognize and attack tumor cells. It is primarily indicated for endometrial cancer and solid tumors with mismatch repair deficiency (dMMR). The drug works by blocking the PD-1 checkpoint pathway, which tumors often exploit to evade immune detection.
Dostarlimab is an immunotherapy drug that blocks the PD-1 pathway to help the immune system fight cancer cells, primarily used for endometrial cancer and dMMR solid tumors.
Key facts at a glance
- ATC
- L01FF07
- RxNorm
- 2539967
- Generic
- Dostarlimab
- Class
- atc-l01
- Brands
- Jemperli
- 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
12 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks; discontinue therapy if pregnancy occurs
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 unless benefits outweigh risks; consider risks to mother and fetus
regular fetal monitoring, ultrasound for fetal growth
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use during pregnancy; discontinue therapy if pregnancy occurs
regular fetal monitoring, assessment of fetal well-being
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingdo not breastfeed
women should not breastfeed during treatment and for at least 4 months after the last dose due to potential serious adverse reactions in infants
monitor breastfed infants for signs of adverse reactions
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderlyno dose adjustment required
no overall differences in efficacy observed; monitor for immune-related adverse reactions
regular monitoring for adverse reactions, renal and hepatic function
Use with caution and monitor for adverse effects.
pediatric_age
children adolescentsnot recommended
safety and efficacy not established in patients under 18 years of age; use in pediatric patients not recommended
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
renal_impairment
mildno dose adjustment required
no clinically significant effect on exposure; standard dosing recommended
routine renal function monitoring
renal_impairment
moderateno dose adjustment required
no clinically significant effect on exposure based on population PK analysis; standard dosing recommended
routine renal function monitoring
renal_impairment
severeuse with caution
limited data available; use with caution and monitor closely
close monitoring of renal function
Use with caution and monitor for adverse effects.
hepatic_impairment
mildno dose adjustment required
no clinically significant effect on exposure; standard dosing recommended
routine hepatic function monitoring
hepatic_impairment
moderateuse with caution
limited data available; use with caution
close hepatic function monitoring
Use with caution and monitor for adverse effects.
hepatic_impairment
severeuse with caution
limited data available; use with caution
close hepatic function monitoring
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Anti-PD-1 monoclonal antibody immunotherapy drug
FDA approval year
First FDA approval date for Jemperli
Primary indication
Primary therapeutic indication approved by FDA
Mechanism of action
Pharmacological mechanism of action
Dostarlimab is indicated for the treatment of adult patients with advanced or recurrent endometrial cancer that has progressed on or after platinum-containing chemotherapy, as well as for solid tumors with mismatch repair deficiency (dMMR) that have progressed following prior treatment.
Dostarlimab is a programmed death receptor-1 (PD-1) inhibitor. It binds to the PD-1 receptor on T cells, blocking interaction with PD-L1 and PD-L2 ligands that are often upregulated in tumors. This removes the brake on T-cell activity, allowing the immune system to recognize and destroy cancer cells.
Common adverse reactions include fatigue, nausea, diarrhea, and rash. Immune-related adverse events can affect any organ system including colitis, hepatitis, pneumonitis, and endocrine disorders. Patients require monitoring for these complications and may need corticosteroids or immunosuppression for management. Use during pregnancy is contraindicated.
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