•输液相关反应：根据反应的严重程度中断、减慢输液速度或永久停止JEMPERLI。
•异基因造血干细胞移植（HSCT）的并发症：在接受PD-1/PD-L1阻断抗体治疗之前或之后接受异基因HSCT的患者可能会出现致命和其他严重并发症。
•胚胎-胎儿毒性：可能对胎儿造成伤害。建议有生育潜力的女性注意对胎儿的潜在风险，并采取有效的避孕措施。
不良反应
dMMR实体瘤患者最常见的不良反应（≥20%）是疲劳/乏力、贫血、腹泻和恶心。最常见的3级或4级实验室异常（≥2%）是淋巴细胞减少、钠减少、碱性磷酸酶增加和白蛋白减少。
要报告疑似不良反应，请致电1-888-825-5249与葛兰素史克联系，或致电1-800-FDA-1088与美国食品药品监督管理局联系，或拨打WWW.FDA.GOV/MEDWATCH与美国食品和药物管理局联系。
在特定人群中使用
哺乳期：建议不要母乳喂养。
包装供应/储存和处置
JEMPERLI（dostarimab-gxly）注射剂是一种透明至微乳白色、无色至黄色的溶液，装在一个纸箱中，该纸箱含有一个500 mg/10mL（50mg/mL）的单剂量小瓶（NDC 0173-0898-03）。
将小瓶在2°C至8°C（36°F至46°F）的温度下冷藏保存在原始纸箱中，以防光线照射。不要冻结或摇晃。
请参阅随附的JAYPIRCA完整处方信息：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095eab9f-545a-4f12-bfb7-19477fb901a5
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FDA grants accelerated approval for GSK's JEMPERLI(dostarlimab-gxly)for women with recurrent or advanced dMMR endometrial cancer
US Food and Drug Administration(FDA)has approved JEMPERLI (dostarlimab-gxly), a programmed death receptor-1(PD-1)blocking antibody, based on the company's Biologics License Application. JEMPERLI is indicated for the treatment of adult patients with mismatch repair-deficient(dMMR)recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that have progressed on or following prior treatment with a platinum-containing regimen.
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 benefit in a confirmatory trial(s).
PRINCIPAL DISPLAY PANEL
NDC 0173-0898-03
Jemperli(dostarlimab-gxly) Injection
500mg/10 mL
(50mg/mL)
gsk
For Intravenous Infusion after Dilution
Single-Dose Vial
Dosage: See Prescribing Information.
Storage: Refrigerate at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
Do not freeze or shake.
Discard unused portion.
Do not accept if plastic overseal is missing or not securely fitted.
©2020 GSK group of companies or its licensor.
Rev. 10/20
PCR-700-13182 |
