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Imjudo Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose vial (1.25mL, 15mL)—1
Manufacturer
Generic Availability
NO
Mechanism of Action
Tremelimumab-actl is a monoclonal antibody that binds to CTLA-4 and blocks the interaction with its ligands CD80 and CD86, releasing CTLA-4-mediated inhibition of T-cell activation. In synergistic mouse tumor models, blocking CTLA-4 activity resulted in decreased tumor growth and increased proliferation of T cells in tumors.
Imjudo Indications
Indications
In combination with durvalumab for the treatment of adults with unresectable hepatocellular carcinoma (uHCC).
Imjudo Dosage and Administration
Adult
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, 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
Not established.
Imjudo Contraindications
Not Applicable
Imjudo Boxed Warnings
Not Applicable
Imjudo Warnings/Precautions
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 Pharmacokinetics
Distribution
Geometric mean (% coefficient of variation [CV%]) of tremelimumab-actl for central (V1) and peripheral (V2) volume of distribution was 3.45 (24%) and 2.66 (34%) L, respectively.
Elimination
Half-life: 16.9 days (19%) after a single dose; 18.2 days (19%) during steady state.
Imjudo Interactions
Not Applicable
Imjudo Adverse Reactions
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).
Imjudo Clinical Trials
See Literature
Imjudo Note
Not Applicable
Imjudo Patient Counseling
See Literature
Imjudo Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose vial (1.25mL, 15mL)—1
Manufacturer
Generic Availability
NO
Mechanism of Action
Tremelimumab-actl is a monoclonal antibody that binds to CTLA-4 and blocks the interaction with its ligands CD80 and CD86, releasing CTLA-4-mediated inhibition of T-cell activation. In synergistic mouse tumor models, blocking CTLA-4 activity resulted in decreased tumor growth and increased proliferation of T cells in tumors.
Imjudo Indications
Indications
In combination with durvalumab and platinum-based chemotherapy for the treatment of adults with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.
Imjudo Dosage and Administration
Adult
Give as IV infusion over 60mins. Metastatic NSCLC: non-squamous or squamous: (<30kg): 1mg/kg every 3 weeks (with durvalumab 20mg/kg and platinum-based chemotherapy) for 4 cycles, followed by durvalumab 20mg/kg every 4 weeks as a single agent (with histology-based pemetrexed therapy), and a 5th dose of tremelimumab-actl 1mg/kg (with durvalumab dose 6) at week 16. (≥30kg): 75mg every 3 weeks (with durvalumab 1500mg and platinum-based chemotherapy) for 4 cycles, followed by durvalumab 1500mg every 4 weeks as a single agent (with histology-based pemetrexed therapy), and a 5th dose of tremelimumab-actl 75mg (with durvalumab dose 6) at week 16. Continue durvalumab until disease progression or intolerable toxicity. In combination with durvalumab and chemotherapy: give tremelimumab-actl first, followed by durvalumab and then platinum-based chemotherapy on the day of dosing (see full labeling). If patients receive fewer than 4 cycles of chemotherapy, give remaining tremelimumab-actl cycles (up to a total of 5) after chemotherapy phase, in combination with durvalumab, every 4 weeks. For patients with non-squamous disease who received pemetrexed and carboplatin/cisplatin: optional pemetrexed therapy from week 12 until disease progression or intolerable toxicity. Dose modifications: see full labeling. Refer to durvalumab full labeling for additional information.
Children
Not established.
Imjudo Contraindications
Not Applicable
Imjudo Boxed Warnings
Not Applicable
Imjudo Warnings/Precautions
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 Pharmacokinetics
Distribution
Geometric mean (% coefficient of variation [CV%]) of tremelimumab-actl for central (V1) and peripheral (V2) volume of distribution was 3.45 (24%) and 2.66 (34%) L, respectively.
Elimination
Half-life: 16.9 days (19%) after a single dose; 18.2 days (19%) during steady state.
Imjudo Interactions
Not Applicable
Imjudo Adverse Reactions
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).
Imjudo Clinical Trials
See Literature
Imjudo Note
Not Applicable
Imjudo Patient Counseling
See Literature
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