Imfinzi Dosage/Direction for Use

Treatment must be initiated and monitored by an experienced oncologist.
To ensure traceability of biotechnically manufactured medicinal treatment, it is recommended to keep record of brand name and batch number from each treatment.
Posology: The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Tables 9, 10 and 11.
IMFINZI is administered as an intravenous infusion over 60 minutes. (See Table 9.)

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IMFINZI in Combination with Tremelimumab and Platinum-Based Chemotherapy: The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic non-small cell lung cancer (NSCLC) are provided in Tables 10 and 11.
Weigh patients prior to each infusion.
Calculate the appropriate dose using Table 11 as follows based on the patient's weight and tumor histology. (See Tables 10 and 11.)

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Instructions for use: For intravenous administration.
For instructions on dilution of the medicinal product before administration, see "Special precautions for disposal and other handling" under Cautions for Usage.
No dose reduction for IMFINZI is recommended. In general, withhold IMFINZI for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue 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.
Dosage modifications for IMFINZI for adverse reactions that require management different from these general guidelines are summarized in Table 12. Refer to Precautions for further monitoring and evaluation information. (See Table 12.)

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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, consider withholding IMFINZI for Grade 2 and 3 adverse reactions until ≤ Grade 1 or baseline. 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 populations: Based on a population pharmacokinetic analysis, no dose adjustment of IMFINZI is recommended based on patient age, body weight, gender and race (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: Safety and efficacy of IMFINZI have not been studied in patients with renal impairment. Based on the population pharmacokinetic (PK) results, no dose adjustment of IMFINZI is recommended in patients with mild or moderate renal impairment (see Pharmacology: Pharmacokinetics under Actions). Data from patients with severe renal impairment are too limited to draw conclusions on this population.
Hepatic impairment: Safety and efficacy of IMFINZI have not been studied in patients with hepatic impairment. Based on a population pharmacokinetic analysis, no dose adjustment of IMFINZI is recommended for patients with mild or moderate hepatic impairment. IMFINZI has not been studied in patients with moderate or severe hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Elderly (≥65 years): Based on a population PK analysis, no dose adjustment is required for elderly patients (≥65 years of age) (see Pharmacology: Pharmacodynamics under Actions). Of the 476 patients with locally advanced, unresectable NSCLC (primary efficacy population) treated with IMFINZI, 215 patients were 65 years or older. No overall clinically meaningful differences in safety were reported between patients ≥65 years of age and younger patients. Data from patients 75 years of age or older in the Pacific Study (7.6%) are too limited to draw conclusions on this population.
Of the 265 patients with ES-SCLC treated with IMFINZI in combination with chemotherapy, 101 (38%) patients were 65 years or older and 19 (7.2%) patients were 75 years or older. There were no clinically meaningful differences in safety or efficacy between patients 65 years or older and younger patients.
Paediatric population: Safety and efficacy of IMFINZI have not been established in children and adolescents aged less than 18 years. No data are available.