Imfinzi Dosage/Direction for Use

The recommended dose of Durvalumab (IMFINZI) depends on the indication as presented in Table 12. Durvalumab (IMFINZI) is administered as an intravenous infusion over 1 hour. (See Table 12.)

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No dose reduction or escalation for Durvalumab (IMFINZI) is recommended. In general, withhold Durvalumab (IMFINZI) for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue Durvalumab (IMFINZI) for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating corticosteroids.
Immune-mediated adverse reactions requiring specific management are summarized in Table 13.
Refer to Precautions for further monitoring and evaluation information. (See Table 13.)

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For suspected immune-mediated adverse reactions, adequate evaluation should be performed to confirm etiology or exclude alternate etiologies.
For non-immune-mediated adverse reactions, withhold Durvalumab (IMFINZI) for Grade 2 and 3 adverse reactions until ≤ Grade 1 or baseline. Durvalumab (IMFINZI) should be discontinued for Grade 4 adverse reactions (with the exception of Grade 4 laboratory abnormalities, about which the decision to discontinue should be based on accompanying clinical signs/symptoms and clinical judgment).
Special patient populations: Based on a population pharmacokinetic analysis, no dose adjustment of Durvalumab (IMFINZI) is recommended based on patient age, body weight, gender and race (see Pharmacology: Pharmacokinetics under Actions).
Paediatric and adolescents: The safety and effectiveness of Durvalumab (IMFINZI) have not been established in children and adolescents aged less than 18 years.
Elderly (≥65 years): No dose adjustment is required for elderly patients (≥65 years of age) (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Renal impairment: Based on a population pharmacokinetic analysis, no dose adjustment of Durvalumab (IMFINZI) is recommended in patients with mild or moderate renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: Based on a population pharmacokinetic analysis, no dose adjustment of Durvalumab (IMFINZI) is recommended for patients with mild or moderate hepatic impairment. Durvalumab (IMFINZI) has not been studied in patients with severe hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Method of administration: For intravenous administration.
For metastatic NSCLC, during cycle 1, tremelimumab is to be followed by Durvalumab (IMFINZI) starting approximately 1 hour (maximum 2 hours) after the end of the tremelimumab infusion. Platinum-based chemotherapy infusion should start approximately 1 hour (maximum 2 hours) after the end of the Durvalumab (IMFINZI) infusion. If there are no clinically significant concerns during cycle 1, then at the physician's discretion, subsequent cycles of Durvalumab (IMFINZI) can be given immediately after tremelimumab and the time period between the end of the Durvalumab (IMFINZI) infusion and the start of chemotherapy can be reduced to 30 minutes.
For instructions on dilution of the medicinal product before administration, see Instructions for use, handling and disposal under Cautions for Usage.