Active Ingredient and Strength	TREMELIMUMAB - 20 MG/ML
Dosage Form	INFUSION, SOLUTION CONCENTRATE
Manufacturer and Country	VETTER PHARMA-FERTIGUNG GMBH & CO. KG - GERMANY
Registration Number	SIN16845P
Licence Holder	ASTRAZENECA SINGAPORE PTE LTD
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	L01FX20

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.

Non-Small Cell Lung Cancer (NSCLC)

IMJUDO in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of patients with metastatic NSCLC with no sensitising epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumour aberrations.

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.

For use in combination with other therapeutic agents, refer to Prescribing Information of the therapeutic agents for further information.

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 management recommendations, monitoring and evaluation information – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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 intravenous 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.

IMJUDO in combination with durvalumab and platinum-based chemotherapy

For metastatic NSCLC, during cycle 1, IMJUDO is to be followed by durvalumab starting approximately 1 hour (maximum 2 hours) after the end of the IMJUDO infusion. Platinum-based chemotherapy infusion should start approximately 1 hour (maximum 2 hours) after the end of the durvalumab infusion. If there are no clinically significant concerns during cycle 1, then at the physician’s discretion, subsequent cycles of durvalumab can be given immediately after IMJUDO and the time period between the end of the durvalumab infusion and the start of chemotherapy can be reduced to 30 minutes.

IMJUDO, durvalumab, and platinum-based chemotherapy are administered as separate intravenous infusions.

IMJUDO in combination with durvalumab

For uHCC, when IMJUDO is administered in combination with durvalumab, administer IMJUDO prior to durvalumab on the same day. IMJUDO and durvalumab are administered as separate intravenous infusions.

4.3 Contraindications

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