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Imfinzi Full Prescribing Information

US-56097 HIGHLIGHTS OF Prescribing INFORMATIONT hese highlights do not include all the Information needed to use Imfinzi safely and effectively. See full Prescribing Information for (durvalumab) injection, for intravenous use Initial Approval: 2017--------------------------------- RECENT MAJOR CHANGES--------------------------------- Indications and Usage, Urothelial Carcinoma Accelerated ApprovalIndication Removed (1) 02/2021 Dosage and Administration ( ) 02/2021 Dosage and Administration, Dosage Modifications ( ) 11/2020 Dosage and Administration ( ) 07/2021 Warnings and Precautions ( , ) 11/2020 Warnings and Precautions ( ) 07/2021--------------------------------- INDICATIONS AND USAGE --------------------------------- Imfinzi is a programmed death-ligand 1 (PD-L1) blocking antibody indicated.

Weight 30 kg and more: 10 mg/kg every 2 weeks or 1500 mg every 4 weeks (2.1) ° Weight less than 30 kg: 10 mg/kg every 2 weeks (2.1) • ES-SCLC: ° Weight 30 kg and more: With etoposide and either carboplatin or cisplatin, administer IMFINZI 1500 mg every 3 weeks in combination with chemotherapy, and then 1500 mg every 4 weeks as a single ...

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