Colorectal and other GI cancers:
Indications for: IMJUDO
In combination with durvalumab for the treatment of adults with unresectable hepatocellular carcinoma (uHCC).
Adult Dosage:
Give as IV infusion over 60mins. <30kg: 4mg/kg as a single dose, followed by durvalumab (20mg/kg) at Day 1 of Cycle 1; continue durvalumab (20mg/kg) as a single agent every 4 weeks. ≥30kg: 300mg as a single dose dose, followed by durvalumab (1500mg) at Day 1 of Cycle 1; continue durvalumab (1500mg) as a single agent every 4 weeks. Continue treatment until disease progression or unacceptable toxicity. Dose modifications: see full labeling. Refer to durvalumab full labeling for additional information.
Children Dosage:
Not established.
IMJUDO Warnings/Precautions:
Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related colitis, hepatitis (with or without tumor involvement), dermatologic reactions, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), pneumonitis, nephritis/renal dysfunction, pancreatitis, myocarditis, neurological toxicities, ophthalmologic, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain clinical chemistries including LFTs, creatinine, ACTH levels, and thyroid function at baseline and before each dose. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Monitor for infusion-related reactions; permanently discontinue if Grade 3 or 4 reaction; interrupt or slow infusion rate if Grade 1 or 2 reaction. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 3 months after final dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 months after final dose).
IMJUDO Classification:
Cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody.
Adverse Reactions:
Rash, diarrhea, fatigue, pruritus, musculoskeletal pain, abdominal pain, decreased appetite, pyrexia, hypothyroidism, lab abnormalities (eg, increased AST/ALT, increased bilirubin, increased alkaline phosphatase, decreased hemoglobin, decreased sodium, and decreased lymphocytes).
Drug Elimination:
Half-life: 16.9 days (19%) after a single dose; 18.2 days (19%) during steady state.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial (1.25mL, 15mL)—1
