Product Details

IMJUDO 25 MG/1.25 ML VIAL

Manufacturer: Astra

MFG#: 00310-4505-25

NDC: 00310-4505-25

PID: 639455

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Additional Information

Product NameImjudo 25 mg/1.25 mL Vial
Active IngredientTremelimumab-actl
Drug ClassImmune Checkpoint Inhibitor (Anti-CTLA-4 Monoclonal Antibody)
Mechanism of ActionBlocks CTLA-4 to enhance T-cell activation and promote antitumor immunity
Strength25 mg per 1.25 mL
Volume1.25 mL
Route of AdministrationIntravenous infusion
Side EffectsFatigue, rash, pruritus, diarrhea, elevated liver enzymes
PrecautionsRisk of immune-mediated colitis, hepatitis, endocrinopathies, pneumonitis
StorageRefrigerate at 2°C to 8°C; protect from light; do not freeze
PackagingSingle-use vial containing sterile, preservative-free solution
UsesUsed in combination therapy for unresectable hepatocellular carcinoma and selected cancers

Description

Imjudo 25 mg/1.25 mL vial contains tremelimumab-actl, a fully human monoclonal antibody that targets cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4). It functions as an immune checkpoint inhibitor by blocking CTLA-4, a negative regulator of T-cell activation. This blockade enhances T-cell proliferation and immune response against tumor cells.

The agent is indicated for use in combination with durvalumab for the treatment of unresectable hepatocellular carcinoma and other selected advanced malignancies. By modulating the immune system, Imjudo promotes antitumor activity, contributing to improved clinical outcomes in patients with limited treatment options.

Common side effects include fatigue, rash, pruritus, and gastrointestinal disturbances. Serious immune-mediated events may involve colitis, hepatitis, endocrinopathies, and pneumonitis. Regular monitoring of liver function, endocrine parameters, and immune status is essential during therapy. The product must be stored refrigerated at 2°C to 8°C, protected from light, and should not be frozen. 


 

Frequently Asked Questions (FAQs)

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IMJUDO 25 MG/1.25 ML VIAL is manufactured by Astra.

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