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Jemperli (Dostarlimab): Uses, Side Effects and Dosage

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Prescription (Rx)
Strength:
50 mg/mL
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Jemperli

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 (loose stools) or more frequent bowel movements than usual
  • stools that are black, tarry, sticky, or have blood or mucus
  • severe stomach-area (abdomen) pain or tenderness

Liver problems.

  • yellowing of your skin or the whites of your eyes
  • severe nausea or vomiting
  • pain on the right side of your stomach-area (abdomen)
  • dark urine (tea colored)
  • bleeding or bruising more easily than usual

Hormone gland problems.

  • headaches that will not go away or unusual headaches
  • eye sensitivity to light
  • eye problems
  • rapid heartbeat
  • increased sweating
  • extreme tiredness
  • weight gain or weight loss
  • feeling more hungry or thirsty than usual
  • urinating more often than usual
  • hair loss
  • feeling cold
  • constipation
  • your voice gets deeper
  • dizziness or fainting
  • changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems.

  • change in the amount or color of your urine
  • blood in your urine
  • swelling in your ankles
  • loss of appetite

Skin problems.

  • rash
  • itching
  • skin blistering or peeling
  • swollen lymph nodes
  • painful sores or ulcers in your mouth or in your nose, throat, or genital area
  • fever or flu-like symptoms

Problems can also happen in other organs and tissues. 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 worsening signs or symptoms, which may include.

  • chest pain, irregular heartbeat, shortness of breath, swelling of ankles
  • persistent or severe muscle pain or weakness, muscle cramps
  • 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, drooping eyelids, sensitivity to light, eye pain, changes in eyesight
  • low red blood cells, bruising

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

  • chills or shaking
  • itching or rash
  • flushing
  • shortness of breath or wheezing
  • dizziness
  • feel like passing out
  • fever
  • back or neck pain

Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ or tissue transplant that you have had.

Complications, including graft‑versus‑host‑disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with JEMPERLI. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious.

Your healthcare provider will check you for these problems during treatment with JEMPERLI. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with JEMPERLI, if you have severe side effects.

What is JEMPERLI?

JEMPERLI is a prescription medicine used to treat adults with:

  • a kind of uterine cancer called endometrial cancer (EC)

    • JEMPERLI may be used in combination with the chemotherapy medicines carboplatin and paclitaxel, and then after that, JEMPERLI may be used alone:

      • when your cancer has spread outside your uterus (advanced) or,
      • your cancer has returned.

    • JEMPERLI may be used alone:

      • when a laboratory test shows that your tumor is mismatch repair deficient (dMMR), and
      • your cancer has returned, or it has spread (advanced EC), and
      • you have received chemotherapy that contains platinum, and it did not work or is no longer working, and
      • your cancer cannot be treated by surgery or radiation.

  • a kind of cancer called rectal cancer. JEMPERLI may be used alone to treat rectal cancer that:

    • is Stage II or III and has spread to nearby tissues (locally advanced) but not to other parts of the body, and
    • is shown by a laboratory test to be microsatellite instability-high (MSI-H) or dMMR

  • a kind of cancer that is shown by laboratory test to be dMMR solid tumor. JEMPERLI may be used alone to treat:

    • cancer that has returned or has spread (advanced cancer) and,
    • has progressed during treatment or after treatment, and you have no satisfactory treatment options.

It is not known if JEMPERLI is safe and effective in children.

Before receiving JEMPERLI, tell your healthcare provider about all of your medical conditions, including if you:

  • have immune system problems, such as Crohn’s disease, ulcerative colitis, or lupus.
  • have received an organ or tissue transplant, including corneal transplant.
  • have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic).
  • have received radiation treatment to your chest area.
  • have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.

  • are pregnant or plan to become pregnant. JEMPERLI can harm your unborn baby.

  • Females who are able to become pregnant:

    1. o Your healthcare provider will do a pregnancy test before you start treatment with JEMPERLI.
    2. o Use an effective method of birth control during your treatment and for 4 months after your last dose of JEMPERLI. Talk to your healthcare provider about birth control methods that you can use during this time.
    3. o Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JEMPERLI.
  • are breastfeeding or plan to breastfeed. It is not known if JEMPERLI passes into your milk. Do not feed with your own milk during treatment and for 4 months after your last dose of JEMPERLI.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive JEMPERLI?

  • Your healthcare provider will give you JEMPERLI into your vein through an intravenous (IV) line over 30 minutes.
  • JEMPERLI is usually given every 3 weeks or 6 weeks, depending on your type of cancer, the dose you are receiving, whether it is used alone
  • or used
  • with other cancer medicines.
  • Your healthcare provider will decide how many treatments you need.
  • Your healthcare provider will do blood tests to check you for side effects.
  • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What are the possible side effects of JEMPERLI?

JEMPERLI can cause serious side effects.

  • See “What is the most important information I should know about JEMPERLI?”

The most common side effects of JEMPERLI when given with carboplatin and paclitaxel in people with EC include:

  • nerve problems in your arms, hands, legs, and feet
  • tiredness
  • nausea
  • hair loss
  • joint pain
  • rash
  • constipation
  • diarrhea
  • stomach area (abdomen) pain
  • shortness of breath
  • decreased appetite
  • urinary tract infections
  • vomiting

The most common side effects of JEMPERLI in people with MSI‑H or dMMR locally advanced rectal cancer (LARC) when used alone include:

  • tiredness
  • rash
  • diarrhea
  • itchy skin (pruritus)

The most common side effects of JEMPERLI in people with dMMR solid tumors (including EC) when used alone include:

  • tiredness and weakness
  • low red blood cell count (anemia)
  • diarrhea
  • nausea

These are not all of the possible side effects of JEMPERLI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA 1088.

General information about the safe and effective use of JEMPERLI.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about JEMPERLI that is written for healthcare professionals.

What are the ingredients in JEMPERLI?

Active ingredient: dostarlimab-gxly

Inactive ingredients: citric acid monohydrate, L-arginine hydrochloride, polysorbate 80, sodium chloride, trisodium citrate dihydrate, and Water for Injection.

Trademarks are owned by or licensed to the GSK group of companies.

Manufactured by:

GlaxoSmithKline LLC, Philadelphia, PA 19104, U.S. License No. 1727

Distributed by:

GlaxoSmithKline, Durham, NC 27701

©2026 GSK group of companies or its licensor.

JMP:6MG

For more information, call 1‑888‑825‑5249 or go to www.gsk.com

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: October 2026

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: BLA 761174 · View the label on DailyMed

Revision date stated in the text: October 2026

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Jemperli

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Programmed Death Receptor-1 Blocking Antibody
Active ingredient Dostarlimab 50 mg/mL
Dosage form Injection
Route Intravenous
Marketing status not in the current FDA NDC Directory
Company (applicant) GLAXOSMITHKLINE
FDA approval BLA 761174Biologics License Application (BLA) Approved April 22, 2021
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
50 mg/mL – 10 ml in 1 vial / 1 in 1 carton NDC 0173-0898-03

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.