Imjudo Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Tremelimumab

Indications/Uses

In combination w/ durvalumab for 1st-line treatment of adults w/ advanced or unresectable hepatocellular carcinoma (uHCC). In combination w/ durvalumab & platinum-based chemotherapy for 1st-line treatment of adults w/ metastatic NSCLC w/ no sensitising epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) +ve mutations.

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Dosage/Direction for Use

Administer as IV infusion over 60 min after dilution. uHCC Patient ≥30 kg 300 mg as single dose followed by durvalumab 1,500 mg at day 1 of cycle 1, continue durvalumab as single agent every 4 wk, <30 kg 4 mg/kg as single dose followed by durvalumab 20 mg/kg at day 1 of cycle 1, continue durvalumab as single agent every 4 wk. Metastatic NSCLC Patient ≥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 single agent w/ pemetrexed therapy every 4 wk from wk 12 & 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 single agent w/ pemetrexed therapy every 4 wk from wk 12 & 5th dose of Imjudo 1 mg/kg in combination w/ durvalumab dose 6 at wk 16.

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Overdosage

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Special Precautions

Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis w/ renal dysfunction, dermatology reactions, pancreatitis & other immune-mediated adverse reactions. Infusion-related reactions. Monitor for signs & symptoms of underlying immune-mediated adverse & infusion-related reactions. Evaluate clinical chemistries eg, liver enzymes, creatinine, ACTH level, thyroid function at baseline & before each dose. Women of childbearing potential should use effective contraception during & for 3 mth after last dose. Pregnancy. Not to be used during lactation & for 3 mth after last dose. Ped patients.

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Use In Pregnancy & Lactation

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Adverse Reactions

Nausea, diarrhea; hypothyroidism; rash, pruritus; decreased appetite; fatigue/asthenia, pyrexia; musculoskeletal pain. uHCC: Abdominal pain; insomnia. Metastatic NSCLC: Cough/productive cough; constipation, vomiting, stomatitis; alopecia; edema; pneumonia, URTI; headache.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Imjudo detailed prescribing information

Storage

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Description

View Imjudo description for details of the chemical structure and excipients (inactive components).

Action

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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.

Regulatory Classification

Presentation/Packing

Form

Imjudo infusion conc (vial) 25 mg/1.25 mL

Packing/Price

1's

Form

Imjudo infusion conc (vial) 300 mg/15 mL

Packing/Price

1's

Imjudo

tremelimumab

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma