Prescription medicine
Dostarlimab Brand names: Jemperli
Dostarlimab (Jemperli) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the dostarlimab FDA label on DailyMed (effective September 2, 2025); every dostarlimab label on DailyMed.
Highlights of the record
FDA label of September 2, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageJEMPERLI is a programmed death receptor-1 (PD-1)–blocking antibody indicated: Endometrial Cancer
in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC).
Forms and strengths
- 50 mg/ml
Injection.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,264 through July 30, 2026
What is dostarlimab used for?
From the label: indications and usageJEMPERLI is a programmed death receptor-1 (PD-1)–blocking antibody indicated: Endometrial Cancer
in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC). ( 1.1 )
as a single agent for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced EC, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. […]
FDA pharmacologic class: Programmed Death Receptor-1 Blocking Antibody.
Source: FDA drug label (Jemperli), GlaxoSmithKline LLC, effective September 2, 2025 (SPL set 095eab9f-545a-4f12-bfb7-19477fb901a5), via openFDA; the full label on DailyMed
What does the patient leaflet for dostarlimab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about JEMPERLI?JEMPERLI is a medicine that may treat certain cancers by working with your immune system. JEMPERLI can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems. • cough • shortness of breath • chest pain Intestinal problems. • diarrhea or more bowel movements than usual • stools that are black, tarry, sticky, or have blood or mucus • severe stomach-area (abdomen) pain or tenderness Liver problems. […] These are not all of the signs and symptoms of immune system problems that can happen with JEMPERLI. Call or see your healthcare provider right away for any new or worse signs or symptoms. • chest pain, irregular heartbeat, shortness of breath, swelling of ankles • confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs • double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight • persistent or severe muscle pain or weakness, muscle cramps • low red blood cells, bruising Infusion reactions that can sometimes be severe or life-threatening. […]
Source: FDA drug label (Jemperli), GlaxoSmithKline LLC, effective September 2, 2025 (SPL set 095eab9f-545a-4f12-bfb7-19477fb901a5), via openFDA; the full label on DailyMed
Is there a generic for dostarlimab (Jemperli)?
No generic dostarlimab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the dostarlimab label say about other medicines?
The dostarlimab label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carboplatin | warnings and precautions | JEMPERLI in Combination with Carboplatin and Paclitaxel: Hypophysitis (Grade 3) occurred in 0.4% (1/241) of patients receiving JEMPERLI in combination with carboplatin and paclitaxel. Systemic corticosteroids were required, and the event resolved. JEMPERLI was withheld and the patient reinitiated treatment. |
| Paclitaxel | warnings and precautions | JEMPERLI in Combination with Carboplatin and Paclitaxel: Hypophysitis (Grade 3) occurred in 0.4% (1/241) of patients receiving JEMPERLI in combination with carboplatin and paclitaxel. Systemic corticosteroids were required, and the event resolved. JEMPERLI was withheld and the patient reinitiated treatment. |
| Prednisone | warnings and precautions | In general, if JEMPERLI requires interruption or discontinuation, administer systemic corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. |
Source: FDA drug label (Jemperli), GlaxoSmithKline LLC, effective September 2, 2025 (SPL set 095eab9f-545a-4f12-bfb7-19477fb901a5), via openFDA; the full label on DailyMed
What do FAERS reports show for dostarlimab?
The FDA Adverse Event Reporting System holds 2,264 reports that list dostarlimab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 274 are coded as a death and 878 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other programmed death receptor-1 blocking antibodys
- the pharmacologic class, with prices and generics
- Dostarlimab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other