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Tremelimumab(Imjudo)

Acetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine Injection

Reference price:

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INJECTION

Validity period:

Not specified in the specification.

Reminder: The outer packaging is for reference only, please purchase and use under the guidance of a pharmacist. For read by medical and pharmaceutical professionals only.

IMJUDO (tremelimumab-actl) is a fully human monoclonal antibody that targets cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), a key negative regulator of T-cell activation. By binding to CTLA-4, IMJUDO blocks its interaction with ligands CD80 and CD86, thereby enhancing T-cell mediated immune responses against tumor cells. This immunotherapeutic mechanism is leveraged in combination with durvalumab, a PD-L1 inhibitor, to provide a synergistic effect in the management of unresectable hepatocellular carcinoma.

Administered as a single intravenous infusion, IMJUDO is used in conjunction with durvalumab, which is continued as monotherapy every four weeks following the initial combination dose. The regimen is specifically designed for adult patients with uHCC who are not candidates for surgical resection. The clinical benefit of this combination has been demonstrated in the HIMALAYA study, showing improved overall survival compared to standard therapy. Use in other indications, pediatric populations, or in combination with other agents is not specified in the specification.

Generic name

Tremelimumab(Imjudo)

English name

Tremelimumab

Alternative Names

Imjudo

Drug prices

Indications

IMJUDO, in combination with durvalumab, is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).

Therapeutic Target

Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4).

Active Ingredients

Tremelimumab-actl, a human IgG2 monoclonal antibody.

Dosage form

INJECTION

specifications

25 mg/1.25 mL (20 mg/mL) single-dose vial 300 mg/15 mL (20 mg/mL) single-dose vial

Description

Tremelimumab-actl is a CTLA-4 blocking human IgG2 monoclonal antibody produced by recombinant DNA technology in NS0 cell suspension culture. The solution is clear to slightly opalescent, colorless to slightly yellow, and preservative-free.

Dosage and Administration

For patients ≥30 kg: IMJUDO 300 mg as a single intravenous dose, followed by durvalumab 1,500 mg on the same day (Cycle 1, Day 1).

For patients <30 kg: IMJUDO 4 mg/kg as a single dose, followed by durvalumab 20 mg/kg.

After Cycle 1, durvalumab is continued as monotherapy every 4 weeks.

IMJUDO must be diluted and administered over 60 minutes.

Dose modifications for adverse reactions are specified; no dose reductions are recommended.

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