Imfinzi Dosage/Direction for Use

Patient Selection: Advanced or Recurrent dMMR Endometrial Cancer: Select patients for treatment based on the presence of dMMR in tumor specimens [see Pharmacology: Pharmacodynamics: Clinical Studies under Actions].
Recommended Dosage: The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 8. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 9 and 10 [see Indications/Uses].
Administer IMFINZI as an intravenous infusion after dilution as recommended [see Dosage Modifications for Adverse Reactions as follows]. (See Table 8.)

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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 9 and 10. (See Tables 9 and 10.)
Weigh patients prior to each infusion.
Calculate the appropriate dose using Table 10 as follows based on the patient's weight and tumor histology.

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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 11. (See Table 11.)

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Preparation and Administration: Preparation: Visually inspect drug product for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the vial if the solution is cloudy, discolored, or visible particles are observed.
Do not shake the vial.
Withdraw the required volume from the vial(s) of IMFINZI and transfer into an intravenous bag containing 0.9% Sodium Chloride Injection or 5% Dextrose Injection. Mix diluted solution by gentle inversion. Do not shake the solution. The final concentration of the diluted solution should be between 1 mg/mL and 15 mg/mL.
Discard partially used or empty vials of IMFINZI.
Storage of Infusion Solution: IMFINZI does not contain a preservative.
Administer infusion solution immediately once prepared. If the infusion solution is not administered immediately and needs to be stored, the time from preparation until the completion of the infusion should not exceed: 28 days in a refrigerator at 2°C to 8°C (36°F to 46°F); 8 hours at room temperature up to 25°C (77°F).
Do not freeze.
Do not shake.
Administration: Administer infusion solution intravenously over 60 minutes through an intravenous line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
Use separate infusion bags and filters for each drug product.
IMFINZI in Combination with Other Products: Administer all intravenous drug products as separate infusions.
Do not co-administer other intravenous drugs through the same infusion line.
For platinum-based chemotherapy, refer to Prescribing Information for administration information.
For pemetrexed therapy, refer to Prescribing Information for administration information.
Combination Regimens: Order of Infusions: IMFINZI in Combination with Tremelimumab: Infuse tremelimumab first, followed by IMFINZI on the same day of dosing.
IMFINZI in Combination with Tremelimumab and Platinum-Based Chemotherapy: Infuse tremelimumab first, followed by IMFINZI and then platinum-based chemotherapy on the day of dosing.
IMFINZI in Combination with Tremelimumab and Pemetrexed Therapy: Infuse tremelimumab first, followed by IMFINZI and then pemetrexed therapy on the day of dosing.
IMFINZI in Combination with Carboplatin and Paclitaxel: Infuse IMFINZI first and then carboplatin and paclitaxel on the same day of dosing.
Combination Regimens: Infusion Instructions: IMFINZI in Combination with Tremelimumab: Administer tremelimumab over 60 minutes followed by a 60 minute observation period. Then administer IMFINZI as a separate intravenous infusion over 60 minutes.
IMFINZI in Combination with Tremelimumab and Platinum-Based Chemotherapy/Pemetrexed Therapy: Cycle 1: Infuse tremelimumab over 1 hour. One to two hours after completion of tremelimumab infusion, infuse IMFINZI over 1 hour. One to two hours after completion of IMFINZI infusion, administer platinum-based chemotherapy.
Subsequent Cycles: If there are no infusion reactions during cycle 1, subsequent cycles of IMFINZI can be given immediately after tremelimumab. The time between the end of the IMFINZI infusion and the start of chemotherapy can be reduced to 30 minutes.