Tremelimumab-actl, a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking human IgG2
monoclonal antibody, is produced by recombinant DNA technology in NS0 cell suspension culture and
has a molecular weight of 149 kDa.
IMJUDO (tremelimumab-actl) injection is a sterile, preservative-free, clear to slightly opalescent,
colorless to slightly yellow solution in a single-dose vial for intravenous infusion after dilution. IMJUDO
contains tremelimumab-actl at a concentration of 20 mg/mL in either a 25 mg/1.25 mL or a 300 mg/15
mL single-dose vial.
Each mL contains 20 mg of tremelimumab-actl, and edetate disodium (0.09 mg), histidine (0.68 mg),
L-histidine hydrochloride monohydrate (3.3 mg), polysorbate 80 (0.2 mg), trehalose (76 mg), and Water
for Injection, USP.
Injection: 25 mg/1.25 mL (20 mg/mL) solution in a single-dose vial. Injection: 300 mg/15 mL (20 mg/mL) solution in a single-dose vial
Weight 30 kg and more: IMJUDO 300 mg as a single dose in combination with durvalumab 1,500 mg at Cycle 1/Day 1, followed by durvalumab as a single agent every 4 weeks (2.1) o Weight less than 30 kg: IMJUDO 4 mg/kg as a single dose in combination with durvalumab 20 mg/kg at Cycle 1/Day 1, followed by durvalumab as a single agent every 4 week
IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma