Imjudo Concentrate for Solution for Intravenous Infusion 20 mg/mL

Manufacturer
AstraZeneca AB(SWEDEN)

Registraction Number
MAL24076003ACZ

Contents:

• Active Ingredient: Tremelimumab 20 mg/mL
• Excipients: Various inactive ingredients (specifics can be found in the package leaflet)

• Hepatocellular Carcinoma (HCC): Used in combination with durvalumab for the first-line treatment of adults with advanced or unresectable HCC.
• Non-Small Cell Lung Cancer (NSCLC): Used in combination with durvalumab and platinum-based chemotherapy for the first-line treatment of adults with metastatic NSCLC without sensitizing EGFR mutations or ALK positive mutations.

1. Preparation: Imjudo should be prepared and administered by a healthcare professional.
2. Administration: It is given as an intravenous infusion over 1 hour.
3. Dosage:
   • For HCC: A single dose of 300 mg of Imjudo followed by 1,500 mg of durvalumab at Day 1 of Cycle 1, then durvalumab 1,500 mg every 4 weeks.
   • For NSCLC: 75 mg of Imjudo in combination with durvalumab 1,500 mg and platinum-based chemotherapy every 3 weeks for 4 cycles, followed by durvalumab 1,500 mg every 4 weeks.