Jul 26, 2022

Generic name:  dostarlimab-gxly
Dosage form: injection
Drug class:  Anti-PD-1 monoclonal antibodies

What is Jemperli?

Jemperli is a prescription medicine used to treat adults with certain cancers that have 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). Jemperli may be used when:

  • you have a kind of uterine cancer called endometrial cancer, and you have received chemotherapy that contains platinum and it did not work or is no longer working.
  • you have a solid tumor that progressed during treatment or after treatment, and you have no satisfactory treatment options.

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)
  • low white blood cell counts
  • 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.

Detailed Jemperli dosage information

Jemperli side effects

Get emergency medical help if you have signs of an allergic reaction to Jemperli (hives, difficult 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 or feverish, itchy, or short of breath.

Dostarlimab 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.

Jemperli may cause serious side effects. Call your doctor at once if you have:

  • new or worsening cough, shortness of breath;
  • chest pain, irregular heartbeats;
  • a light-headed feeling, like you might pass out;
  • a seizure;
  • confusion, hallucinations, eye pain or redness, vision problems;
  • severe stomach pain, nausea>, vomiting, diarrhea, bloody or tarry stools;
  • low red blood cells (anemia)–pale skin, tiredness, cold hands and feet;
  • low white blood cell counts–fever, mouth sores, skin sores, sore throat, cough;
  • kidney problems – swelling in your ankles, blood in your urine, little or no urination;
  • liver problems – right-sided upper stomach pain, loss of appetite, bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes); or
  • signs of a hormonal disorder – frequent or unusual headaches, dizziness, feeling very weak, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation hair loss, sweating, feeling cold, weight gain or loss.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Jemperli side effects may include:

  • abnormal liver function tests;
  • nausea, diarrhea, constipation;
  • low white blood cell counts, anemia; or
  • feeling weak or tired.

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

Jemperli side effects  (more detail)

What other drugs will affect Jemperli?

Other drugs may interact with dostarlimab, including prescription and over-the-counter medicines,  vitamins , and  herbal products . Tell your doctor about all other medicines you use.

Jemperli drug interactions  (more detail)

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.

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