Dostarlimab-gxly

What is Dostarlimab-gxly?

• Dostarlimab-gxly (Jemperli) is a programmed death receptor-1 (PD-1)–blocking antibody used to treat adults with a kind of uterine cancer called endometrial cancer.

What are the uses of this medicine?

This medicine is 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.

How does this medicine work?

• Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells inhibits T-cell proliferation and cytokine production.
• Upregulation of PD-1 ligands occurs in some tumors, and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors.
• Dostarlimab-gxly is a humanized monoclonal antibody of the IgG4 isotype that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
• In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

Is this medicine FDA approved?

• It was approved for use in the United States in 2021.

How should this medicine be used?

• Select patients with recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen for treatment with Jemperli based on the presence of dMMR in tumor specimens.

Recommended dosage The recommended dosage of Jemperli is:

• Dose 1 through Dose 4: 500 mg every 3 weeks
• Subsequent dosing beginning 3 weeks after Dose 4 (Dose 5 onwards): 1,000 mg every 6 weeks

Administration

• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Injection: 500 mg/10 mL (50 mg/mL) solution in a single-dose vial.

This medicine is available in fallowing brand namesː

• Jemperli

What side effects can this medication cause?

The most common side effects of this medicine include:

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

Jemperli may cause some serious side effects:

• Lung problems (pneumonitis)
• Intestinal problems (colitis) that can lead to tears or holes in your intestine
• Liver problems, including hepatitis
• Hormone gland problems (especially the adrenal glands, pituitary, thyroid, and pancreas)
• Kidney problems, including nephritis and kidney failure
• Skin problems
• Problems in other organs
• Infusion reactions that can sometimes be severe and life-threatening

What special precautions should I follow?

• immune‑mediated pneumonitis, immune‑mediated colitis, immune-mediated hepatitis, immune‑mediated endocrinopathies, immune-mediated nephritis, and immune-mediated dermatologic adverse reactions. Monitor for signs and symptoms of immune-mediated adverse reactions. Evaluate clinical chemistries, including liver and thyroid function, at baseline and periodically during treatment. Withhold or permanently discontinue Jemperli and administer corticosteroids based on the severity of reaction
• Interrupt, slow the rate of infusion, or permanently discontinue Jemperli based on severity of infusion-related reaction.
• Follow patients closely for evidence of transplant-related complications and intervene promptly.
• This medicine may Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on the use of Jemperli in pregnant women.

Can this medicine be used in children?

• The safety and efficacy of Jemperli have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

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

Who manufactures and distributes this medicine?

Manufactured by: GlaxoSmithKline LLC, Philadelphia, PA 19112 Distributed by: GlaxoSmithKline, Research Triangle Park, NC 27709

What should I know about storage and disposal of this medication?

• Store vial refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
• Do not freeze or shake.

• Dailymed label info on Dostarlimab-gxly
• FDA Dostarlimab-gxly

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