Imjudo

Imjudo

tremelimumab

Manufacturer:

AstraZeneca

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Tremelimumab
Indications/Uses
In combination w/ durvalumab for the treatment of adult patients w/ unresectable hepatocellular carcinoma (uHCC). In combination w/ durvalumab & platinum-based chemotherapy for the treatment of adult patients w/ metastatic NSCLC w/ no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
Dosage/Direction for Use
Administer as an IV infusion over 60 min after dilution. uHCC Patient weighing ≥30 kg 300 mg as a single dose in combination w/ durvalumab 1,500 mg at day 1 of cycle 1, followed by durvalumab as a single agent every 4 wk, <30 kg 4 mg/kg as a single dose in combination w/ durvalumab 20 mg/kg at day 1 of cycle 1, followed by durvalumab as a single agent every 4 wk. Metastatic NSCLC Patient weighing ≥30 kg 75 mg every 3 wk in combination w/ durvalumab 1,500 mg & platinum-based chemotherapy for 4 cycles, & then administer durvalumab 1,500 mg every 4 wk as a single agent w/ histology-based pemetrexed therapy every 4 wk, & a 5th dose of Imjudo 75 mg in combination w/ durvalumab dose 6 at wk 16, <30 kg 1 mg/kg every 3 wk in combination w/ durvalumab 20 mg/kg & platinum-based chemotherapy for 4 cycles, & then administer durvalumab 20 mg/kg every 4 wk as a single agent w/ histology-based pemetrexed therapy every 4 wk, & a 5th dose of Imjudo 1 mg/kg in combination w/ durvalumab dose 6 at wk 16.
Special Precautions
Risk of immune-mediated adverse reactions &/or infusion-related reactions. Evaluate clinical chemistries including liver enzymes, creatinine, ACTH level, & thyroid function at baseline & before each dose. W/hold or permanently discontinue treatment depending on the severity of reactions. Can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use effective contraception during treatment & for 3 mth after the last dose. Women should not breastfeed during treatment & for 3 mth after the last dose. Safety & effectiveness have not been established in ped patients.
Adverse Reactions
Rash, diarrhea, fatigue, musculoskeletal pain. uHCC: Pruritus, abdominal pain. Metastatic NSCLC: Nausea, decreased appetite.
MIMS Class
Targeted Cancer Therapy / Cancer Immunotherapy
ATC Classification
L01FX20 - tremelimumab ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.
Presentation/Packing
Form
Imjudo conc for soln for infusion 25 mg/1.25 mL
Packing/Price
1's
Form
Imjudo conc for soln for infusion 300 mg/15 mL
Packing/Price
1's
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