Imfinzi Dosage/Direction for Use

MMR testing for patients with endometrial cancer: Patients with endometrial cancer should be evaluated for treatment based on tumour MMR status confirmed by a validated test (see Pharmacology: Clinical Studies under Actions).
Posology: The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with chemotherapy are presented in Table 9 [see Pharmacology: Clinical Studies under Actions].
IMFINZI is administered as an intravenous infusion over 60 minutes. (See Table 9.)

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Dosage Modifications for Adverse Reactions: No dose reductions are recommended. In general, withhold or discontinue 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.
Immune-mediated adverse reactions requiring specific management are summarized in Table 10. Refer to Precautions for further management monitoring, monitoring, and evaluation information. (See Table 10.)

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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, USP or 5% Dextrose Injection, USP. 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 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); 12 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 drug products as separate infusions.
Do not co-administer other 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.