Jemperli

Jemperli is a cancer immunotherapy used to treat certain types of endometrial cancer, locally advanced rectal cancer, and other solid tumors. Jemperli belongs to a class of drugs called programmed death receptor-1 (PD-1) blocking antibodies. In tumors, a protein called PD-1 on immune cells (T-cells) makes them inactive, which prevents them from killing cancer cells. Jemperli works by binding to PD-1, which reactivates the T-cells so they can find, attack, and kill cancer cells.

Jemperli (dostarlimab-gxly) is given as an intravenous infusion into a vein over 30 minutes every 3 to 6 weeks, depending on your treatment regimen. Jemperli can be used on its own or in combination with the chemotherapy medicines carboplatin and paclitaxel, depending on the type of cancer being treated.

Jemperli is FDA-approved to treat adults with:

• Primary advanced or recurrent endometrial cancer, regardless of biomarker status. It is used in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent.
• Mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer confirmed with an FDA-approved test. The cancer must have progressed on or after prior treatment with a platinum-containing regimen in any setting, and the patient is not a candidate for curative surgery or radiation. It is used as a single agent.
• Microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) locally advanced rectal cancer that is Stage II or III, confirmed with an FDA-approved test for solid tumors. It is used as a single agent. This use was approved in October 2026 under accelerated approval based on a sustained clinical complete response lasting at least 12 months. The long-term risk of the cancer returning is not yet known.
• Mismatch repair deficient (dMMR) recurrent or advanced solid tumors confirmed with an FDA-approved test. The tumors must have progressed on or after prior treatment, and there are no satisfactory alternative treatment options. It is used as a single agent.

Jemperli (dostarlimab-gxly) first received FDA approval on April 22, 2021.

• Your healthcare provider will give you Jemperli into your vein through an intravenous (IV) line over 30 minutes.
• When Jemperli is used in combination with carboplatin and paclitaxel, Jemperli is usually given every 3 weeks for the first 6 doses. Beginning 3 weeks later, it is usually given alone every 6 weeks.
• When Jemperli is used alone to treat dMMR recurrent or advanced endometrial cancer and dMMR recurrent or advanced solid tumors, it is usually given every 3 weeks for the first 4 doses. Beginning 3 weeks later, it is usually given every 6 weeks.
• When Jemperli is used alone to treat MSI-H or dMMR locally advanced rectal cancer, it is given every 3 weeks for 9 doses (cycles), which is about 6 months of treatment.
• 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.

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. These problems may happen anytime during treatment or even after your treatment with Jemperli has ended.

Call or see your healthcare provider right away if you develop any symptoms of the following problems or if these symptoms get worse:

Lung problems (pneumonitis). Symptoms of pneumonitis may include:

• cough
• chest pain
• shortness of breath

Intestinal problems (colitis) can lead to tears or holes in your intestine. Signs and symptoms of colitis may include:

• 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, including hepatitis. Signs and symptoms of liver problems may include:

• 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 normal

Hormone gland problems (especially the adrenal glands, pituitary, thyroid, and pancreas). Signs and symptoms that your hormone glands are not working properly may include:

• 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 hungrier or thirstier 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, including nephritis and kidney failure. Signs of kidney problems may include:

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

Skin problems. Signs of skin problems may include:

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

Problems in other organs and tissues. These are not all of the signs and symptoms of immune system problems. Call or see your healthcare provider right away for any new or worse signs or symptoms. Signs and symptoms of these problems may include:

• chest pain, irregular heartbeat, shortness of breath, swelling of the 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 and life-threatening. Signs and symptoms of infusion reactions may include:

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

Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor, depending on the type of organ 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 severe 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 the following signs and symptoms: skin rash, liver inflammation, stomach area (abdominal) pain, and diarrhea.

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. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. If you have severe side effects, your healthcare provider may also need to delay or completely stop treatment.

Before you receive Jemperli, tell your healthcare provider if you have any 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 a 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.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. Jemperli can harm your unborn baby.

Females who can become pregnant:

• Your healthcare provider will do a pregnancy test before you start treatment.
• You should use effective birth control during treatment and for 4 months after your last dose. Talk to your healthcare provider about birth control methods that you can use during this time.
• Tell your healthcare provider right away if you think you may be pregnant or if you become pregnant during treatment with Jemperli.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Jemperli passes into your breast milk.

• Do not breastfeed during treatment and for 4 months after your last dose.

Common Jemperli side effects

Common Jemperli side effects when used alone in people with MSI-H or dMMR locally advanced rectal cancer (LARC) include:

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

Common Jemperli side effects when used alone in people with dMMR solid tumors (including endometrial cancer) include:

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

The most common Jemperli side effects when given with carboplatin and paclitaxel in people with endometrial cancer include:

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

Serious Jemperli side effects

Get emergency medical help if you have signs of an allergic reaction to Jemperli (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may occur during the injection. Tell your caregiver if you feel light-headed, chilled, feverish, itchy, or short of breath.

Jemperli strengthens your immune system to help it attack cancer cells, but it may also attack healthy cells, and you could develop serious or fatal side effects.

Also, see the Important Information section.

This is not a complete list of Jemperli's side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Dose for primary advanced or recurrent endometrial cancer:

In combination with carboplatin and paclitaxel: Jemperli 500 mg every 3 weeks for 6 cycles, followed by 1,000 mg monotherapy every 6 weeks for all cycles thereafter.

Dose for dMMR recurrent or advanced endometrial cancer:

Single agent: Jemperli 500 mg every 3 weeks for 4 cycles, followed by 1,000 mg every 6 weeks for all cycles thereafter.

Dose for MSI-H or dMMR locally advanced rectal cancer:

Single agent: Jemperli 500 mg every 3 weeks for 9 cycles.

Dose for dMMR recurrent or advanced solid tumors:

Single agent: Jemperli 500 mg every 3 weeks for 4 cycles, followed by 1,000 mg every 6 weeks for all cycles thereafter.

General Dosing Information

• Jemperli is given as an intravenous infusion over 30 minutes.

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

Jemperli’s prescribing information lists no formal drug interactions and has no dedicated interactions section, but that does not rule interactions out.

Because Jemperli works by activating your immune system, tell your provider about any medicine that suppresses it, such as corticosteroids. When combined with carboplatin and paclitaxel for endometrial cancer, dostarlimab levels stay similar to using it alone, so no dose change is needed. In high-grade glioma, dMMR testing should be done before temozolomide treatment begins.

Know the medicines you take. Keep a list to show your healthcare provider and pharmacist when you get a new medicine.

Jemperli is usually stored and prepared by your healthcare provider. Unopened vials are stored in a refrigerator at 36 degrees F to 46 degrees F (2 degrees C to 8 degrees C) in the original carton to protect from light. Do not freeze and do not shake the vial.

Active ingredient: dostarlimab-gxly

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