Transcription of JEMPERLI (dostarlimab-gxly) injection
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JEMPERLI (dostarlimab-gxly) injection
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use JEMPERLI saf ely an d ef f ectively. S ee f u ll p rescrib in g in f ormation f or JEMPERLI . JEMPERLI (dostarlimab-gxly) injection , for intravenous use Initial Approval: 2021 ------------------------------- RECENT MAJOR CHANGES------------------------------ Indications and Usage (1) 8/2021 Dosage and Administration, Patient Selection ( ) 8/2021 Dosage and Administration, Dosage Modifications for Adverse Reactions ( ) 8/2021 Warnings and P recautions, S evere and F atal Immune-Mediated Adverse Reactions ( ) 8/2021 Warnings and Precautions, Infusion-R elated R eactions (5. 2) 8/2021 -------------------------------- INDICATIONS AND USAGE ------------------------------ JEMPERLI is a programmed death receptor-1 (P D-1) blocking antibody indicated for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced: endometrial cancer, as determined by an F DA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen, or solid tumors, as determined by an F
• Complications of allogeneic hematopoietic stem cell transplantation (HSCT): Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1–blocking antibody. (5.3) • Embryo-fetal toxicity: Can cause fetal harm. Advise females of
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