Imjudo Dosage/Direction for Use

The recommended dose of IMJUDO is presented in Table 2.
IMJUDO is administered as an intravenous infusion over 1 hour. (See Table 2.)

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Dose reduction or escalation is not recommended during treatment with IMJUDO in combination with durvalumab. Treatment withholding or discontinuation may be required based on individual safety and tolerability.
Immune-mediated adverse reactions requiring specific treatment modification and management are summarized in Table 3. Refer to Precautions for further monitoring and evaluation information. (See Table 3.)

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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, withhold IMJUDO and/or durvalumab for Grade 2 and 3 adverse reactions until ≤ Grade 1 or return to baseline. IMJUDO and durvalumab 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 IMJUDO is recommended based on patient age, body weight, gender and race (see Pharmacology: Pharmacokinetics under Actions).
Paediatric and adolescents: The safety and effectiveness of IMJUDO have not been established in children and adolescents aged less than 18 years.
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 IMJUDO is recommended in patients with mild to moderate renal impairment. IMJUDO has not been studied in patients with severe renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic Impairment: Based on a population pharmacokinetic analysis, no dose adjustment of IMJUDO is recommended for patients with mild or moderate hepatic impairment. IMJUDO has not been studied in patients with severe hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Method of Administration: For instructions on dilution of the medicinal product before administration, see Instructions for use, handling and disposal under Cautions for Usage.