Dostarlimab

Pronunciation: (JEM-per-lee).

Generic name
Dostarlimab
Brand names
Immunostar, Jemperli, Dostar
Drug class
Anti-PD-1 Monoclonal Antibody (Immune Checkpoint Inhibitor)

Availability and supply rules vary by country

Trade names by country: United States

Australia: · Full directory

What Dostarlimab is and how it works

Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.

Mechanism of action: how Dostarlimab works

Dostarlimab is a humanized IgG4 monoclonal antibody that binds to the programmed death receptor-1 (PD-1) on T cells. By blocking the interaction between PD-1 and its ligands (PD-L1 and PD-L2), dostarlimab prevents the inhibition of T-cell activity, thereby enhancing the immune system's ability to recognize and destroy tumor cells. (1)

What Dostarlimab is used for

Endometrial cancer (recurrent or advanced, mismatch repair deficient (dMMR))

Endometrial cancer (recurrent or advanced, mismatch repair deficient (dMMR)) (2)

Solid tumors (recurrent or advanced, dMMR, progressed on prior treatment)

These two entries are Jemperli's dMMR-specific monotherapy indications. Jemperli also has a separate, broader FDA-approved combination-therapy indication (see overview) not detailed here as a standalone dose regimen. (2)

Before taking Dostarlimab

Do not take / not appropriate for

  • Contraindicated in patients with a history of severe hypersensitivity to dostarlimab or any excipients. (Contraindication) (2)
  • Not recommended during pregnancy or breastfeeding due to potential fetal harm. (Contraindication) (2)

Tell your clinician about

(2)

How to take Dostarlimab

  • General Instructions: Jemperli is given as an intravenous (IV) infusion by a healthcare professional in a clinic or hospital setting. Do not self-administer.. Adult Dosing: The usual dose is 500 mg every 3 weeks for the first 4 doses, followed by 1000 mg every 6 weeks until disease progression or unacceptable toxicity.. Pediatric Dosing: Jemperli is not approved for use in children under 18 years of age.. Administration: Infused over 30 minutes through a vein. Pre-medication is not routinely required but may be considered if infusion reactions occur.. When To Stop: Treatment should be discontinued if you develop life-threatening side effects or if your doctor determines it is no longer effective.. Storage: Jemperli vials should be stored in a refrigerator (2°C–8°C/36°F–46°F) and protected from light. Do not freeze or shake.
  • This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
(2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)

Missed dose

If you miss an infusion appointment, contact your healthcare provider as soon as possible to reschedule. Do not try to make up the dose yourself.

Overdose

There is limited information on overdose. If overdose is suspected, seek immediate medical attention. Supportive care and monitoring for side effects are recommended. (2)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.

Fatigue

Incidence: Reported in the clinician-authored database; frequency not established

Nausea

Incidence: Reported in the clinician-authored database; frequency not established

Diarrhea

Incidence: Reported in the clinician-authored database; frequency not established

Anemia

Incidence: Reported in the clinician-authored database; frequency not established

Rash

Incidence: Reported in the clinician-authored database; frequency not established

Hypothyroidism

Incidence: Reported in the clinician-authored database; frequency not established

Colitis

Incidence: Reported in the clinician-authored database; frequency not established

Pneumonitis

Incidence: Reported in the clinician-authored database; frequency not established

Serious warnings

FDA BOXED WARNING — IMMUNE-MEDIATED ADVERSE REACTIONS — serious

Symptoms: FDA BOXED WARNING — IMMUNE-MEDIATED ADVERSE REACTIONS: this is the FDA's most prominent warning level, not a general precaution. Jemperli can cause severe or fatal immune-mediated adverse reactions in any organ or tissue, explicitly including immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies (hormone gland problems), nephritis with kidney dysfunction, skin reactions, and solid organ transplant rejection. Tell your care team promptly about any new or worsening symptoms so they can assess and manage these reactions.

Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)

Serious infusion reactions may occur during or after administration — serious

Symptoms: Serious infusion reactions may occur during or after administration. May cause fetal harm if used during pregnancy — effective contraception is recommended during treatment and for a period after the last dose; discuss timing with your care team. Use with caution in patients with autoimmune disorders. Monitor for signs of infection, as immune system changes may increase risk.

Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)

Contraindications recorded in the clinician database — serious

Symptoms: Contraindications recorded in the clinician database: Contraindicated in patients with a history of severe hypersensitivity to dostarlimab or any excipients. Use with caution in patients with pre-existing autoimmune diseases, as immune-related adverse events may be exacerbated. Not recommended during pregnancy or breastfeeding due to potential fetal harm. Monitor closely for immune-mediated adverse reactions.

Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)

Interactions

Medicine or testEffectAction
Recorded interactionsJemperli has a low potential for drug-drug interactions, but caution is advised with immunosuppressive therapies, corticosteroids, and live vaccines. Always inform your healthcare provider of all medications and supplements you are taking. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Jemperli may cause fetal harm and is not recommended during pregnancy. The FDA label recommends effective contraception during treatment and for a period after the last dose. Discuss pregnancy plans, contraception, and the exact recommended duration with your care team before and during treatment. (2)

Breastfeeding

Not recommended during breastfeeding due to potential harm to a nursing infant, per the clinician-authored record. Specific data on transfer into breast milk was not established in the sources reviewed for this page — discuss feeding options with your care team. (2)

Children

Frequency: Not applicable.. Weight Based: Not recommended for pediatric use.. Max Daily Dose: Not applicable.. Max Single Dose: Not applicable.. Age Restrictions: Safety not established in children. (2)

Renal_impairment

The FDA label reports no clinically significant pharmacokinetic differences for renal impairment down to an estimated glomerular filtration rate (eGFR) of 15 mL/min/1.73m² or for mild-to-moderate hepatic impairment, so no dose adjustment is recommended for these groups. Dostarlimab has not been formally studied in patients with severe renal impairment/end-stage renal disease or severe hepatic impairment (bilirubin >3x the upper limit of normal), and data in moderate hepatic impairment are limited — the treating cancer team will individualize monitoring for these patients. (2)

Hepatic_impairment

The FDA label reports no clinically significant pharmacokinetic differences for renal impairment down to an estimated glomerular filtration rate (eGFR) of 15 mL/min/1.73m² or for mild-to-moderate hepatic impairment, so no dose adjustment is recommended for these groups. Dostarlimab has not been formally studied in patients with severe renal impairment/end-stage renal disease or severe hepatic impairment (bilirubin >3x the upper limit of normal), and data in moderate hepatic impairment are limited — the treating cancer team will individualize monitoring for these patients. (2)

Monitoring

(2)

Storage

Jemperli is stored and handled by your clinic or hospital pharmacy, not by patients at home. Unopened vials are kept refrigerated at 2°C-8°C (36°F-46°F) in the original carton, protected from light, and must not be frozen or shaken.

Professional information

Clinician-facing context only. This section does not replace current product labeling.

General

Indication: Endometrial cancer (recurrent or advanced, mismatch repair deficient (dMMR))

Dose summary: 500 mg administered as an intravenous infusion over 30 minutes every 3 weeks for the first four doses, followed by 1,000 mg every 6 weeks.

Renal context: No dose adjustment is recommended for renal impairment down to an eGFR of 15 mL/min/1.73m² — the FDA label reports no clinically significant pharmacokinetic differences in this range. Dostarlimab has not been formally studied in severe renal impairment or end-stage renal disease/dialysis. (1) (2)

Mechanism of action

Hepatic guidance

No dose adjustment is recommended for mild-to-moderate hepatic impairment (total bilirubin from normal up to 3x the upper limit of normal, any AST) — the FDA label reports no clinically significant pharmacokinetic differences for mild impairment, though data in moderate impairment are limited. Dostarlimab has not been studied in severe hepatic impairment (total bilirubin greater than 3x the upper limit of normal); the oncology team will individualize monitoring for these patients.

Frequently asked questions

What types of cancer does Jemperli treat?

Jemperli is approved for certain types of endometrial cancer and solid tumors with mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H), especially when other treatments have not worked.

How is Jemperli administered?

Jemperli is given as an intravenous infusion by a healthcare professional, usually every 3 or 6 weeks depending on the treatment phase.

What are the most common side effects?

Common side effects include fatigue, nausea, diarrhea, constipation, decreased appetite, rash, cough, and joint pain.

Can I receive vaccines while on Jemperli?

You should avoid live vaccines during treatment. Inactivated vaccines may be given if necessary, but always consult your healthcare provider first.

Is Jemperli safe during pregnancy or breastfeeding?

Jemperli may harm an unborn baby and is not recommended during pregnancy or breastfeeding. Use effective contraception during treatment and for at least 4 months after the last dose.

What should I do if I experience severe side effects?

Contact your healthcare provider immediately if you develop severe symptoms such as persistent diarrhea, jaundice, chest pain, severe rash, or signs of infection.

How long will I need to take Jemperli?

Treatment duration depends on your response and tolerance. Your doctor will monitor your progress and decide when to stop or continue therapy.

What happens if I take too much Jemperli (Dostarlimab, anti-PD-1)?

Jemperli is administered intravenously by a healthcare professional, making overdose by self-administration unlikely. However, if an overdose were to occur, potential symptoms could include an exacerbation of known side effects. In such a scenario, immediate medical attention and supportive care would be crucial. Always seek emergency medical help if you suspect an overdose.

Can I drink alcohol while taking Jemperli (Dostarlimab, anti-PD-1)?

There are no specific contraindications regarding alcohol consumption while taking Jemperli. However, alcohol can exacerbate some common side effects of immune checkpoint inhibitors, such as fatigue and nausea, and may also impact liver function. It is always advisable to discuss alcohol intake with your healthcare provider to understand potential individual risks and recommendations.

Is Jemperli (Dostarlimab, anti-PD-1) safe during pregnancy?

Jemperli's pregnancy category requires consultation with a doctor. Animal studies have shown that immune checkpoint inhibitors can cause fetal harm. Therefore, Jemperli is generally not recommended during pregnancy due to potential risks to the developing fetus. It is essential for pregnant individuals or those planning pregnancy to discuss the risks and benefits with their healthcare provider.

What is the mechanism of action of Dostarlimab?

Dostarlimab is a humanized IgG4 monoclonal antibody that binds to the programmed death receptor-1 (PD-1) on T cells. By blocking the interaction between PD-1 and its ligands (PD-L1 and PD-L2), dostarlimab prevents the inhibition of T-cell activity, thereby enhancing the immune system's ability to recognize and destroy tumor cells. (1)

What is the generic name of Dostarlimab?

The generic name is Dostarlimab. It is sold under brand names including Immunostar, Jemperli, Dostar.

What class of drug is Dostarlimab?

Dostarlimab is classed as: Anti-PD-1 Monoclonal Antibody (Immune Checkpoint Inhibitor).

References

  1. Jemperli (Dostarlimab, anti-PD-1) clinician medicine recordMedGuideGlobal · International · accessed 2026-08-06 · source 1
  2. JEMPERLI (dostarlimab-gxly) prescribing informationU.S. Food and Drug Administration · United States · dated 2024 · accessed 2026-08-06 · source 2
  3. JEMPERLI (DOSTARLIMAB) INJECTION [GLAXOSMITHKLINE LLC] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 3
  4. Dostarlimab-gxly Injection — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 4
  5. Jemperli — FDA approval record (Drugs@FDA BLA761174)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 5
  6. Dostarlimab — RxNorm normalized drug concept (RXCUI 2539967)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 6

Brand names by country

Single-ingredient Dostarlimab names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Jemperli50 mg/mL · glaxosmithkline llc
View brands in additional countries.

General information only — not a diagnosis, prescription, or substitute for professional medical advice.

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