DOSTARLIMAB 500 MG/10 ML INJECTION
JEMPERLI (dostarlimab-gxly) is a programmed death receptor-1 (PD-1)–blocking IgG4 humanized monoclonal antibody. JEMPERLI (dostarlimab-gxly) injection is a sterile, clear to slightly opalescent, colorless to yellow solution essentially free from visible particles. It is supplied as single-dose vials.Each vial contains 500 mg of JEMPERLI in 10 mL of solution. Each mL of solution contains 50 mg of dostarlimab-gxly, citric acid monohydrate (0.48 mg), L-arginine hydrochloride (21.07 mg), polysorbate 80 (0.2 mg), sodium chloride (1.81 mg), trisodium citrate dihydrate (6.68 mg), and Water for Injection, USP.
JEMPERLI (dostarlimab-gxly) Injection: 500 mg/10 mL (50 mg/mL) solution in a single-dose vial.
Recommended Dosage 1 through 4: 500 mg every 3 weeks. Subsequent dosing beginning 3 weeks after Dose 4 (Dose 5 onwards): 1,000 mg every 6 weeks • Administer as an intravenous infusion over 30 minutes.
1. JEMPERLI (dostarlimab-gxly) is a programmed death receptor-1 (PD-1)–blocking antibody indicated for the treatment of adult patients with mismatch repair deficient 5.2) (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test that has progressed on or following prior treatment with a platinum-containing regimen.
2. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical contraception benefits in a confirmatory trial.
