Jemperli

About Jemperli (Dostarlimab-gxly)

• Dostarlimab, marketed as Jemperli, initially received accelerated approval from the US Food and Drug Administration (FDA) in April 2021 for treating adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors. 
• It gained full approval in February 2023 for the same indication. Jemperli, a programmed death receptor-1 (PD-1)–blocking antibody, is prescribed for adults diagnosed with endometrial cancer (EC). 
• It may be used in combination with chemotherapy drugs like carboplatin and paclitaxel, followed by Jemperli alone, under specific circumstances: when a laboratory test confirms dMMR or microsatellite instability-high (MSI-H) status, and the cancer has progressed beyond the uterus or has recurred. 
• Additionally, it may be administered independently if the tumor is dMMR, and the cancer has recurred or advanced (advanced EC) after platinum-based chemotherapy has ceased to be effective, and surgery or radiation is not feasible. 
• Dostarlimab, a PD-1 blocking monoclonal antibody, works by altering the immune system’s action to target and eliminate cancer cells. By binding to PD-1, dostarlimab aids in unleashing the immune response against tumor cells, contributing to their destruction. 
• The GARNET trial revealed an objective response rate of 41.6% among dMMR solid tumors treated with dostarlimab, with an impressive 95% of responders maintaining a response duration of six months or more. This trial encompassed patients with dMMR recurrent or advanced non-endometrial cancers, with a particular focus on colorectal, small intestine, and stomach cancers. 
• Efficacy outcomes included objective response rate and duration of response.

Strength: 

A single-dose vial contains 500 mg/10 mL (50 mg/mL) of Dostarlimab-gxly in solution. 

Recommended Dosage:

Prepare Jemperli for intravenous infusion by visually inspecting for particles or discoloration. Dilute 500 mg in 10 mL or 1,000 mg in 20 mL from 2 vials, into an infusion bag with 0.9% Sodium Chloride or 5% Dextrose to a concentration of 2 to 10 mg/mL. Gently mix, discard unused portion, and store at room temperature for up to 6 hours or refrigerated for up to 24 hours. Do not freeze.

It is administered intravenously over 30 minutes using specific equipment including tubing and fittings made of polyvinyl chloride or polycarbonate, along with a sterile, non-pyrogenic, low-protein binding, 0.2-micron, in-line or add-on filter.

• For monotherapy in dMMR recurrent or advanced endometrial cancer or solid tumors, the recommended dosage is 500 mg every 3 weeks for 4 doses, followed by 1000 mg every 6 weeks for all subsequent doses. 
• In combination with carboplatin and paclitaxel for dMMR or MSI-H primary advanced or recurrent endometrial cancer, the dosage is 500 mg every 3 weeks for 6 doses, followed by 1000 mg monotherapy every 6 weeks. 

Important:

Your healthcare provider may modify your Jemperli treatment if severe side effects occur, potentially involving the suspension or postponement of treatment, or adjustments to the dosage. Regular blood tests will be administered to monitor for any potential side effects. 

The duration of treatment needed will be decided based on how you respond individually to therapy. Prior to initiating treatment, ensure to inform your doctor about your pregnancy status, pregnancy plans, or breastfeeding, as well as all current medications and medical conditions. This enables your doctor to evaluate potential interactions and tailor your treatment plan accordingly.

Warnings & Precautions

• Severe immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, and organ rejection, can occur with Jemperli treatment. Regular monitoring for signs and symptoms is crucial, alongside assessing clinical chemistries. 
• Adjustments to Jemperli administration, including withholding or discontinuation and corticosteroid use, may be necessary based on reaction severity. Additionally, infusion-related reactions should prompt rate adjustments or discontinuation. 
• Patients should exercise caution when driving or operating vehicles or potentially dangerous machinery while on Jemperli
• Patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) before or after PD-1/PD-L1 blockade face serious complications, including fatal outcomes. 
• Moreover, due to embryo-fetal toxicity, females of reproductive potential should use effective contraception during the treatment to mitigate fetal risk. Consult your doctor for more information. 

Common Jemperli Side Effects:

In Combination with Carboplatin and Paclitaxel for dMMR/MSI-H EC:

• Rash
• Diarrhea
• Hypothyroidism
• Hypertension

With Jemperli as a Single Agent in dMMR Solid Tumors:

• Fatigue/Asthenia
• Anemia
• Diarrhea
• Nausea

Laboratory abnormalities 

• Decreased lymphocytes
• Decreased sodium
• Increased alkaline phosphatase
• Decreased albumin
• Decreased neutrophils
• Decreased hemoglobin
• Decreased white blood cell count
• Increased glucose
• Decreased platelets

Use in Specific Population

• Due to its mechanism of action, Jemperli can potentially harm a fetus if administered to a pregnant woman. There are no available data on its use in pregnant women. It’s essential to verify the pregnancy status of females of reproductive potential before starting treatment. Women should be advised to use effective contraception during the treatment and for 4 months after the final dose.
• There is no information on the presence of dostarlimab-gxly (Jemperli) in human milk or its effects on the breastfed child. Because of potentially serious adverse reactions, women should be advised not to breastfeed during treatment and for 4 months after the last dose.
• The safety and efficacy of the medicine have not been established in pediatric patients. 
• No significant differences in safety or effectiveness were observed between geriatric  patients and younger patients.

Storage and Handling

• Keep Jemperli stored in its original carton in a refrigerator at a temperature between 2°C to 8°C (36°F to 46°F) to shield it from light exposure. 
• Avoid freezing the medication.
• Do not freeze the medicine. 
• Keep the medicine away from pets and children.