Jemperli
Jemperli (dostarlimab-gxly or dostarlimab) is FDA approved to treat adults with endometrial cancer, or uterine cancer. This medication can also treat certain types of cancers that have specific abnormalities called dMMR. Jemperli (dostarlimab) is an immunotherapy medication called a PD-1 inhibitor. It’s given as an infusion through the vein every 3 weeks at first and then every 6 weeks. Some side effects include fatigue, nausea, and rash.
What is Jemperli (dostarlimab)?
What is Jemperli (dostarlimab) used for?
Advanced or recurrent endometrial cancer, including those that are mismatch repair deficient (dMMR)
Advanced or recurrent dMMR solid tumors, when previous treatment no longer works and no other alternative options are available
How Jemperli (dostarlimab) works
In your body, the immune system acts as a defense system to protect you from harm. It uses a protein called PD-1 to tell apart normal cells from abnormal cells, like cancer cells. When it detects a normal cell, PD-1 acts like “brakes” and stops the immune system from attacking. And when the immune system detects an abnormal cell, it knows to attack the cell to get rid of it from the body.
But some cancer cells can hide from your immune system. They’re able to make your immune system think that they’re “normal.” When this happens, your immune system can’t find and attack the cancer cells as well. This allows the cancer to grow.
Jemperli (dostarlimab) is an immunotherapy medication that blocks PD-1. It’s called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. By blocking PD-1, Jemperli (dostarlimab) helps the immune system find, detect, and attack cancer cells better. This helps stop the cancer from growing.
Drug Facts
What are the side effects of Jemperli (dostarlimab)?
Common Side Effects
- Fatigue or feeling very tired (49%)
- Low white blood cell count (up to 46%)
- Anemia (low red blood cell count; 35%)
- Higher creatinine levels (33%)
- Nausea (32%)
- Elevated liver enzyme levels (up to 31%)
- Diarrhea (29%)
- Constipation (23%)
- Vomiting (23%)
- Rash (21%)
Other Side Effects
- Low appetite
- Cough
- Muscle ache
- Itching
- Changes in the electrolyte levels in the blood
Serious Side Effects
- Immune-related side effects: trouble breathing, cough, diarrhea, mucus or blood in the stool, stomach pain or cramps, rash
- Reaction during the infusion: shortness of breath, itching, chills, flushing, upset stomach, chest discomfort
Source: FDA
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Dry cough, shortness of breath or trouble breathing
- Eye pain, redness, irritation, or discharge with blurry or decreased vision
- Heart muscle inflammation—unusual weakness or fatigue, shortness of breath, chest pain, fast or irregular heartbeat, dizziness, swelling of the ankles, feet, or hands
- Hormone gland problems—headache, sensitivity to light, unusual weakness or fatigue, dizziness, fast or irregular heartbeat, increased sensitivity to cold or heat, excessive sweating, constipation, hair loss, increased thirst or amount of urine, tremors or shaking, irritability
- Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
- Kidney injury (glomerulonephritis)—decrease in the amount of urine, red or dark brown urine, foamy or bubbly urine, swelling of the ankles, hands, or feet
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
- Rash, fever, and swollen lymph nodes
- Redness, blistering, peeling, or loosening of the skin, including inside the mouth
- Sudden or severe stomach pain, bloody diarrhea, fever, nausea, vomiting
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Bone, joint, or muscle pain
- Diarrhea
- Fatigue
- Loss of appetite
- Nausea
- Skin rash
Pros and cons of Jemperli (dostarlimab)
Pros
Only need an infusion every 3 or 6 weeks
Infusion time is relatively short (takes about 30 minutes)
Helps your own immune system work better to fight the cancer
Cons
Given as an infusion through the vein (IV)
Commonly causes fatigue
Can cause immune-related side effects, such as rash, which might require additional treatment
Pharmacist tips for Jemperli (dostarlimab)
During your treatment with Jemperli (dostarlimab), keep track of how you’re feeling and tell your care team if you feel anything out of the ordinary, such as shortness of breath, rash, or diarrhea. It could be a sign of an immune-related side effect. These side effects can happen when the medication makes your immune system become too active. You might need additional treatment for these side effects.
Your care team will help manage any immune-related side effects you might have from Jemperli (dostarlimab). They’ll probably recommend steroids for you to take to relieve your symptoms and to calm down the immune system. For more severe immune-related side effects, you might need to take a break from your Jemperli (dostarlimab) infusions or stop treatment altogether.
In addition to keeping your care team aware of how you’re feeling, it’s important to get blood tests done as instructed. These blood tests help your care team check for possible immune-related side effects that you might not feel, such as liver, kidney, or thyroid problems.
Tell your care team right away if you feel short of breath, itchy, feverish, chilly, nauseous, or flushed during your Jemperli (dostarlimab) infusion. Although rare, it’s possible to have an allergic reaction to the infusion (called infusion-related reactions).
Talk with your oncologist before you start Jemperli (dostarlimab) if you’re pregnant or if you’re planning to become pregnant. This medication can potentially harm an unborn baby if it’s given during pregnancy. If you’re able to become pregnant, be sure to use effective birth control to prevent pregnancy while you’re taking Jemperli (dostarlimab) and for 4 months after your last dose. Contact your care team right away if you become pregnant during treatment.
Don’t breastfeed while you’re taking Jemperli (dostarlimab) and for 4 months after your last dose. Although it’s not known, it’s possible for the medication to cause serious side effects in a breastfed baby. Speak with a healthcare professional about safer ways to feed your baby.
Frequently asked questions about Jemperli (dostarlimab)
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What are the risks and warnings for Jemperli (dostarlimab)?
Jemperli (dostarlimab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Immune-related side effects
Jemperli (dostarlimab) works by taking the “brakes” off the immune system to help the immune system attack cancer cells better. But sometimes, the immune system becomes too active, leading to immune-related side effects. These side effects can happen at any time during Jemperli (dostarlimab) treatment and sometimes even after you stop the medication. Immune-related side effects can range from being mild to very serious.
In studies, these immune reactions happen most often in the lungs, digestive system, liver, and skin. But the reactions can happen anywhere in the body. Some of these immune-related side effects, like liver or kidney problems, don’t cause noticeable symptoms but are instead found on your lab test results. So be sure to get your blood work done when instructed so your care team can check for side effects. Tell your care team if you notice any new or worsening shortness of breath, diarrhea, or rash. These could be symptoms of more noticeable immune-related side effects.
Getting treatment for immune-related side effects quickly is key to preventing serious or irreversible damage. Your oncologist will probably pause additional treatment with Jemperli (dostarlimab) to manage the side effects. Your oncologist might also prescribe medications like steroids to lower inflammation in the body caused by the overactive immune system.
Infusion-related reactions
Some people can have reactions to the Jemperli (dostarlimab) infusion. In rare situations, these reactions can be severe or life-threatening. Your care team will watch for signs and symptoms of an infusion reaction during your infusion. Be sure to also let your care team know right away if you notice new chills, flushing, trouble breathing, itching, or dizziness during your infusion.
Most of the time, your care team will pause the infusion to help manage your symptoms. Once your symptoms get better, your team might restart your infusion at a slower speed to lower the risk of reactions. But for more severe reactions, your care team might stop treatment altogether.
Complications from stem cell transplants
Risk factors: People who’ve had an allogeneic stem cell transplant before or after starting Jemperli (dostarlimab) treatment
It’s possible for serious and sometimes fatal complications to happen if you get a stem cell transplant from a stem cell donor (allogeneic stem cell transplant) before or after treatment with an immunotherapy medication like Jemperli (dostarlimab). These complications can include graft-versus-host disease, veno-occlusive disease, and fevers that aren’t caused by infection.
Before you start Jemperli (dostarlimab), talk with your oncology care team if you’ve had a stem cell transplant before or are considering getting one. Also tell them if you have a stem cell transplant planned at any time after you’ve completed treatment. Because of the risk for serious complications, your care team will discuss with you about the safest treatment options for you. They’ll also follow up with you very closely to check for signs and symptoms of complications.
Harm to an unborn baby
Jemperli (dostarlimab) hasn’t been studied in human pregnancy. But based on results from animal studies, there’s a risk that the medication can cause harm to an unborn baby or cause pregnancy loss if it’s given during pregnancy.
If you’re able to become pregnant, your oncologist will ask for you to take a pregnancy test before you start your treatment with Jemperli (dostarlimab). Then, use birth control during treatment and for 4 months after you stop taking the medication. This helps lower your risk for pregnancy and potential harm to the unborn baby. Let your oncology care team know right away if you become pregnant while you’re taking Jemperli (dostarlimab).
Jemperli (dostarlimab) dosage forms
Typical dosing for Jemperli (dostarlimab)
Jemperli (dostarlimab) is given by a healthcare professional as an infusion through the vein (IV) over a 30-minute period. The dose depends on your cancer and your specific treatment regimen.
Endometrial cancer that’s not mismatch repair deficient (dMMR): The typical dose of Jemperli (dostarlimab) is 500 mg IV every 3 weeks for the first 6 doses, given together with carboplatin and paclitaxel. After that, the typical dose of Jemperli (dostarlimab) is 1,000 mg IV every 6 weeks.
dMMR endometrial cancer or dMMR solid tumor: The typical dose of Jemperli (dostarlimab) is 500 mg IV every 3 weeks for the first 4 doses, then 1,000 mg IV every 6 weeks.
What are alternatives to Jemperli (dostarlimab)?
Advanced or recurrent endometrial cancer, including those that are mismatch repair deficient (dMMR)
Advanced or recurrent dMMR solid tumors, when previous treatment no longer works and no other alternative options are available
Non-small cell lung cancer (NSCLC)
Renal cell carcinoma (kidney cancer)
Endometrial carcinoma (uterine cancer)
Cancers with high tumor mutation burden (TMB-H), high microsatellite instability (MSI-H), or deficient mismatch repair (dMMR)
What is the latest news about Jemperli (dostarlimab)?
Jemperli (dostarlimab) images
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References
Best studies we foundAmerican Cancer Society. (2019). What is endometrial cancer?
American Cancer Society. (2023). How is a biopsy done?
American Cancer Society. (2024). Infusion or immune reactions.
André, T., et al. (2023). Antitumor activity and safety of dostarlimab monotherapy in patients with mismatch repair deficient solid tumors: A nonrandomized controlled trial. Journal of the American Medical Association Network Open.
GlaxoSmithKline LLC. (2024). Jemperli (dostarlimab-gxly) injection, for intravenous use [package insert]. U.S. Food and Drug Administration.
Mirza, M. R., et al. (2023). Dostarlimab for primary advanced or recurrent endometrial cancer. The New England Journal of Medicine.
National Cancer Institute. (n.d.). Allogeneic stem cell transplant.
National Cancer Institute. (n.d.). dMMR.
National Cancer Institute. (n.d.). Hepatic veno-occlusive disease.
National Cancer Institute. (n.d.). PD-1.
National Cancer Institute. (2022). Immune checkpoint inhibitors.
National Comprehensive Cancer Network. (n.d.). Understanding immunotherapy side effects.
National Comprehensive Cancer Network. (2023). Uterine cancer: Endometrial cancer uterine sarcoma.
National Comprehensive Cancer Network. (2024). Immunotherapy side effects: Immune checkpoint inhibitors.
National Marrow Donor Program. (n.d.). What is graft-versus-host disease (GVHD)?
U.S. Food and Drug Administration. (2021). Patient-friendly language for cancer clinical trials.
Zhao, P., et al. (2019). Mismatch repair deficiency/microsatellite instability-high as a predictor for anti-PD-1/PD-L1 immunotherapy efficacy. Journal of Hematology & Oncology.
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