Pronunciation: jem-PER-lee
Generic name: dostarlimab-gxly
Dosage form: injection for intravenous infusion 500 mg/10 mL (50 mg/mL)
Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)

Medically reviewed by Melisa Puckey, BPharm. Last updated on Aug 7, 2024.

What is Jemperli?

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

Jemperli (dostarlimab-gxly) is given as an intravenous infusion into your vein over 30 minutes every 3 to 6 weeks, depending on your treatment regime. Jemperli can be used as a single medicine or used with carboplatin and paclitaxel to treat certain cancers.

Jemperli is FDA-approved to treat adult patients with:

• Primary advanced or recurrent endometrial cancer, regardless of biomarker status. To be used in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent.
• Mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has been confirmed with an FDA-approved test. Endometrial cancer must have progressed on or following prior treatment with a platinum-containing regimen in any setting, and patients are not candidates for curative surgery or radiation. It is to be used as a single agent.
• Mismatch repair deficient (dMMR) recurrent or advanced solid tumors confirmed with an FDA-approved test. Solid tumors must have progressed on or following prior treatment, and there are no satisfactory alternative treatment options. It is to be used as a single agent.

Jemperli side effects

Common Jemperli side effects

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 Jemperli common 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.

Important information

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 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, 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 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 you, 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 receiving Jemperli

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 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 are able to 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 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.

How will I receive Jemperli?

• 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.
• 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 Dosing information

Usual adult Jemperli dose for primary advanced or recurrent endometrial cancer.

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

Usual adult dose for dMMR recurrent or advanced endometrial cancer

Dose: Jemperli (as a single agent) 500 mg every 3 weeks for 4 cycles followed by 1,000 mg every 6 weeks for all cycles thereafter.

Usual adult dose for dMMR recurrent or advanced solid tumors

Dose: Jemperli (as a single agent) 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.
• Click on the link below for more detailed dosing information.

What other drugs will affect Jemperli?

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

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

Related/similar drugs

methotrexate, Keytruda, pembrolizumab, megestrol, medroxyprogesterone, Provera, Enhertu, Lenvima, dabrafenib, Mekinist

Jemperli Package Insert

Review the Jemperli Package Insert for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

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

Company

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

Distributed by: GlaxoSmithKline, Durham, NC 27701.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer