Imjudo Dosage/Direction for Use

Recommended Dosage: The recommended dosages of IMJUDO are presented in Tables 3, 4 and 5.
Administer IMJUDO as an intravenous infusion after dilution as recommended [see Administration as follows].
IMJUDO in Combination with Durvalumab: See Table 3.

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IMJUDO in Combination with Durvalumab and Platinum-Based Chemotherapy: The recommended dosage schedule and regimens for IMJUDO for the treatment of metastatic non-small cell lung cancer (NSCLC) are provided in Tables 4 and 5. (See Tables 4 and 5.)
Weigh patients prior to each infusion.
Calculate the appropriate dose using Table 5 as follows based on the patient's weight and tumor histology.

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Dosage Modifications for Adverse Reactions: No dose reduction for treatment is recommended. In general, withhold treatment regimen for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue treatment regimen 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.
Recommended treatment modifications are presented in Table 6. (See Table 6.)

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Administration: Administer IMJUDO infusion solution intravenously over 60 minutes through an intravenous line containing a sterile, low-protein binding 0.2 or 0.22 micron filter.
Use separate infusion bags and filters for each drug product.
IMJUDO In Combination with Other Products: Administer all drug products as separate intravenous 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 treatment, refer to Prescribing Information for administration information.
Combination Regimens - Order of Infusions: IMJUDO in Combination with Durvalumab: Infuse IMJUDO, followed by durvalumab on the same day of dosing.
IMJUDO in Combination with Durvalumab and Platinum-based Chemotherapy: Infuse IMJUDO first, followed by durvalumab and then platinum-based chemotherapy on the day of dosing.
IMJUDO in Combination with Durvalumab and Pemetrexed Therapy: Infuse IMJUDO first, followed by durvalumab and then pemetrexed treatment on the day of dosing.
Combination Regimens - Infusion Instructions: IMJUDO in Combination with Durvalumab: Observe patient for 60 minutes following completion of IMJUDO infusion [see Infusion-Related Reactions under Precautions]. Then administer durvalumab as a separate intravenous infusion over 60 minutes.
IMJUDO in Combination with Durvalumab and Platinum-based Chemotherapy/Pemetrexed Therapy: Cycle 1: Infuse IMJUDO over one hour. One to two hours after completion of IMJUDO infusion, infuse durvalumab over one hour. One to two hours after completion of durvalumab infusion, administer platinum-based chemotherapy.
Subsequent Cycles: If there are no infusion reactions during cycle 1, subsequent cycles of durvalumab can be given immediately after IMJUDO. The time between the end of the durvalumab infusion and the start of chemotherapy can be reduced to 30 minutes.