Generic Name: dostarlimab-gxly
Dosage Form: injection

Jemperli is a prescription medicine used to treat adults with a kind of uterine cancer called endometrial cancer. Jemperli may be used when:

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

It is not known if this medicine is safe and effective in children.

Important information

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. 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 symptoms of the following problems or if these symptoms get worse:

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

  • new or worsening cough
  • chest pain
  • shortness of breath

Intestinal problems (colitis) that 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
  • 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
  • extreme weakness
  • dizziness and fainting
  • vision changes
  • rapid heartbeat
  • increased sweating
  • weight gain or weight loss
  • feeling more hungry or thirsty than usual
  • changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
  • hair loss
  • constipation
  • your voice gets deeper
  • very low blood pressure
  • urinating more often than usual
  • nausea and vomiting
  • stomach-area (abdomen) pain
  • feeling cold

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

Problems in other organs. Signs and symptoms of these problems may include:

  • headache
  • tiredness or weakness
  • sleepiness
  • changes in heartbeat, such as beating fast, or seeming to skip a beat, or pounding sensation
  • confusion, fever, muscle weakness, balance problems, nausea, vomiting, stiff neck, memory problems, or seizures (encephalitis)
  • swollen lymph nodes, rash or tender lumps on skin, cough, shortness of breath, vision changes, or eye pain (sarcoidosis)
  • seeing or hearing things that are not there (hallucinations)
  • severe or persistent muscle pain
  • severe muscle weakness
  • low red blood cells (anemia)
  • bruises on the skin or bleeding
  • changes in eyesight

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

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

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. Your healthcare provider may also need to delay or completely stop treatment, if you have severe side effects.

Before receiving Jemperli

Before you receive Jemperli, tell your healthcare provider if you have any medical conditions, including if you:

  • have immune system problems.
  • have lung or breathing problems.
  • 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.
  • 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.

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 of them to show your healthcare provider and pharmacist when you get a new medicine.

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 for the first 4 doses, and then 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 side effects

Jemperli can cause serious side effects.

The most common side effects include: tiredness and weakness, nausea, diarrhea, low red blood count (anemia), and constipation.

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. 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. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider for information 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.