IMJUDO

What it is

IMJUDO (tremelimumab) is an injection concentrate . Each mL contains 20 mg of tremelimumab. The product is supplied in vials of 1.25 mL containing 25 mg, or 15 mL containing 300 mg . It is a sterile, preservative-free, clear to slightly opalescent, colourless to slightly yellow solution .

Approved indications

— Treatment of adult patients with unresectable hepatocellular carcinoma (uHCC) who have not received prior treatment with a PD-1/PD-L1 inhibitor, in combination with durvalumab .

Dosing overview

IMJUDO is administered as an intravenous infusion over 1 hour in combination with durvalumab for the treatment of unresectable hepatocellular carcinoma . The HIMALAYA study evaluated STRIDE dosing, which comprises IMJUDO 300 mg as a single priming dose followed by durvalumab 1500 mg, then durvalumab 1500 mg every 4 weeks . Refer to the Product Information for durvalumab for its recommended dosing information .

Key safety warnings

Immune-mediated pneumonitis or interstitial lung disease has occurred in patients receiving IMJUDO in combination with durvalumab. Patients should be monitored for signs and symptoms of pneumonitis, which should be confirmed with radiographic imaging and other infectious and disease-related aetiologies excluded . Immune-mediated hepatitis has occurred in patients receiving IMJUDO in combination with durvalumab. Patients should be monitored for abnormal liver tests prior to and periodically during treatment . Immune-mediated colitis or diarrhoea has occurred in patients receiving IMJUDO in combination with durvalumab. Intestinal perforation and large intestine perforation were reported. Patients should be monitored for signs and symptoms of colitis, diarrhoea and intestinal perforation . Immune-mediated hypothyroidism, hyperthyroidism or thyroiditis have occurred in patients receiving IMJUDO in combination with durvalumab. Patients should be monitored for abnormal thyroid function tests prior to and periodically during treatment . Immune-mediated myocarditis, which can be fatal, has occurred in patients receiving IMJUDO in combination with durvalumab. Patients should be monitored for signs and symptoms of immune-mediated myocarditis . Severe infusion-related reactions have been reported in patients receiving IMJUDO in combination with durvalumab .

Contraindications

IMJUDO is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients .

PBS listing

IMJUDO 300 mg in 15 mL solution concentrate for intravenous infusion is listed on the PBS with 2 items under streamlined authority restriction. The ex-manufacturer price is A$16,560.18 .

Regulatory history

IMJUDO tremelimumab 25 mg/1.25 mL concentrated injection vial (ARTG 387299) and IMJUDO tremelimumab 300 mg/15 mL concentrated injection vial (ARTG 387300) were first listed on the ARTG on 23 June 2023 .