IMJUDO CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML

4.1 Therapeutic indications

Hepatocellular Carcinoma (HCC)

IMJUDO in combination with durvalumab is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC) who have not received prior systemic therapy.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

4.2 Posology and method of administration

The recommended dose of IMJUDO is presented in Table 1.

IMJUDO is administered as an intravenous infusion over 1 hour.

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 2. Refer to section 4.4 for further monitoring and evaluation information – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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 section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 sections 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of Administration

For instructions on dilution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.