JEMPERLI

/ GSK

The recommended dose is 500 mg dostarlimab every 3 weeks in combination with carboplatin and paclitaxel every 3 weeks for 6 cycles followed by 1000 mg dostarlimab as monotherapy every 6 weeks for all cycles thereafter.
See prescribing information for full details.

In combination with carboplatin and paclitaxel, for the treatment of adult patients with mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer (EC) who are candidates for systemic therapy.
As monotherapy for the treatment of adult patients with dMMR/MSI-H recurrent or advanced EC that has progressed on or following prior treatment with a platinum-containing regimen.

Hypersensitivity to the active substance or to any of the excipients

Immune-related adverse reactions
Although immune-related adverse events typically develop during therapy with PD-1/PD-L1 inhibitors, such reactions may also present following treatment cessation. Immune-related adverse reactions may occur in any organ or tissue and may affect more than one body system simultaneously.
Symptoms and signs of immune-related adverse reactions should be monitored. Haematological and clinical chemistries, including liver, kidney and thyroid function tests, should be evaluated at baseline and periodically during treatment. For suspected immune-related adverse reactions, adequate evaluation including specialty consultation should be ensured.
Based on the severity of the adverse reaction, treatment with dostarlimab should be withheld or permanently discontinued and corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) or other appropriate therapy administered. Treatment with dostarlimab should be permanently discontinued for any grade 3 immune-related adverse reaction that recurs and for any grade 4 immune-related adverse reaction toxicity, except for endocrinopathies that are controlled with replacement hormones and unless otherwise specified
Examples of immune-related adverse events include pneumonitis, colitis, hepatitis, endocrinopathies (including hypothyroidism, hyperthyroidism, and adrenal insufficiency), nephritis, immune-mediated dermatologic reactions, and arthralgia.
Infusion-related reactions
For severe (grade 3) or life-threatening (grade 4) infusion-related reactions, the infusion should be stopped and treatment should be permanently discontinued.
See prescribing information for full details.

Dostarlimab in monotherapy
Very common: Anaemia, hypothyroidism, diarrhoea, nausea, vomiting, rash, pruritus, arthralgia, pyrexia, Transaminases increased.
Common: Hyperthyroidism, adrenal insufficiency, pneumonitis, colitis, pancreatitis, gastritis, hepatitis, myalgia, chills, infusion-related reaction.
Dostarlimab in combination with chemotherapy
Very common: Hypothyroidism, rash, dry skin, pyrexia, alanine aminotransferase increased, aspartate aminotransferase increased.
Common: Hyperthyroidism, adrenal insufficiency, pneumonitis, colitis.

No interaction studies have been performed. Monoclonal antibodies (mAb) such as dostarlimab are not substrates for cytochrome P450 or active substance transporters. Dostarlimab is not a cytokine and is unlikely to be a cytokine modulator. Additionally, pharmacokinetic (PK) interaction of dostarlimab with small molecule active substances is not expected. There is no evidence of interaction mediated by non-specific clearance of lysosome degradation for antibodies.

Women of childbearing potential/Contraception: There is a risk associated with the administration of dostarlimab to women of childbearing potential. Women of childbearing potential must use effective contraception during treatment with dostarlimab and until 4 months after the last dose of dostarlimab.
Pregnancy: There are no or limited amount of data on the use of dostarlimab in pregnant women. Based on its mechanism of action, dostarlimab can cause foetal harmful pharmacological effects when administered during pregnancy.
Lactation: It is unknown whether dostarlimab/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded.
Dostarlimab should not be used during breast-feeding and breast-feeding should be avoided for at least 4 months after the last dose of dostarlimab.

If overdose is suspected, the patient should be monitored for any signs or symptoms of adverse reactions or effects, and appropriate symptomatic treatment instituted.