All Names: dostarlimab
Indications:1. endometrial cancer (EC); 2. solid tumors
Manufacturer:GSK
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INDICATIONS AND USAGE
JEMPERLI is indicated for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced:
•endometrial cancer (EC), as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen, or
•solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options [see Dosage and Administration (2.1)].
These indications are approved under accelerated approval based on tumor response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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
Administer JEMPERLI as an intravenous infusion over 30 minutes. Treat patients until disease progression or unacceptable toxicity.
ADVERSE REACTIONS
Severe and fatal immune-mediated adverse reactions
Infusion-related reactions
For full information, please refer to:
https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/095eab9f-545a-4f12-bfb7-19477fb901a5/spl-doc?hl=dostarlimab
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