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 Table 15. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 16 and 17.
Administer IMFINZI as an intravenous infusion after dilution as recommended.
IMFINZI is administered as an intravenous infusion over 60 minutes.
When IMFINZI is administered in combination with other therapeutic agents, refer to the Prescribing Information of the therapeutic agents for further information. (See Table 15.)

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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 NSCLC are provided in Tables 16 and 17.
Weigh patients prior to each infusion.
Calculate the appropriate dose using Table 17 as follows based on the patient's weight and tumor histology. (See Tables 16 and 17.)

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Dosage Modifications for Adverse Reactions: 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 or IMFINZI in combination with tremelimumab or chemotherapy for adverse reactions that require management different from these general guidelines are summarized in Table 18. (See Table 18.)

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For non-immune-mediated adverse reactions, withhold 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 patient 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).
Paediatric and adolescents: The safety and effectiveness of IMFINZI have not been established in children and adolescents aged less than 18 years. Currently available data of IMFINZI in combination with tremelimumab are described in Adverse Reactions, and Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions, but no recommendation on a posology can be made.
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 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 IMFINZI is recommended for patients with mild or moderate hepatic impairment. IMFINZI has not been studied in patients with severe hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Method of administration: 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.
IMFINZI in combination with chemotherapy: For resectable NSCLC, ES-SCLC, BTC and endometrial cancer, when IMFINZI is administered in combination with chemotherapy, administer IMFINZI prior to chemotherapy on the same day.
IMFINZI in combination with tremelimumab and platinum-based chemotherapy: For metastatic NSCLC, during cycle 1, tremelimumab is to be followed by 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 IMFINZI infusion. If there are no clinically significant concerns during cycle 1, then at the physician's discretion, subsequent cycles of IMFINZI can be given immediately after tremelimumab and the time period between the end of the IMFINZI infusion and the start of chemotherapy can be reduced to 30 minutes.
IMFINZI in combination with tremelimumab: For uHCC, when IMFINZI is administered in combination with tremelimumab, administer tremelimumab prior to IMFINZI on the same day. IMFINZI and tremelimumab are administered as separate intravenous infusions.