Product image of Imjudo (Tremelimumab) supplied by GNH India

Imjudo

Active Ingredient:
Tremelimumab
Origin:
EU

Imjudo (Tremelimumab)

Tremelimumab, the active ingredient in Imjudo, is a monoclonal antibody presented as an intravenous formulation for infusion use. It is indicated for the treatment of urothelial carcinoma in combination with durvalumab, acting as an immune checkpoint inhibitor to enhance antitumor T‑cell activity.

GNH India supplies Imjudo as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres, hospitals and pharmacies worldwide. The company follows European Union quality standards and provides cold‑chain logistics for biologic products, ensuring timely delivery to clinical sites across multiple continents.

Manufacturer / TM Owner

Astrazeneca Ab

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Indications & Clinical Uses

  • Imjudo is employed in the management of urothelial carcinoma, an advanced bladder cancer, as part of an immune checkpoint inhibition strategy.
  • Locally advanced urothelial carcinoma: used with durvalumab to boost immune activation and improve surgical outcomes.
  • Metastatic urothelial carcinoma: combined therapy aims to extend survival and delay disease progression in patients with disseminated disease.
  • Bladder cancer recurrence prevention: in selected patients, the regimen may reduce the risk of tumor recurrence after initial treatment.
  • High‑risk urothelial carcinoma post‑cystectomy: administered as adjuvant therapy to lower the chance of relapse.

How It Works

  • Tremelimumab is a fully human IgG2 monoclonal antibody that binds to the cytotoxic T‑lymphocyte‑associated protein 4 (CTLA‑4) receptor on activated T cells. By blocking CTLA‑4 interaction with its ligands CD80 and CD86, the drug prevents inhibitory signaling, thereby sustaining T‑cell proliferation and cytokine production. This enhanced immune activation promotes recognition and destruction of tumor cells, forming the basis of its activity as an immune checkpoint inhibitor in cancer therapy. The blockade results in a broader repertoire of tumor‑specific T‑cell responses.

Side Effects

Tremelimumab may cause a range of immune‑related adverse reactions, varying from mild to severe.

Common Side Effects

  • Fatigue: persistent tiredness affecting daily activities.
  • Skin rash: erythematous or maculopapular eruptions.
  • Diarrhea: mild to moderate loose stools.
  • Nausea: occasional queasiness or upset stomach.

Serious or Rare Side Effects

  • Colitis: severe inflammation of the colon that may lead to perforation.
  • Hepatitis: elevated liver enzymes indicating liver inflammation.
  • Endocrinopathies: dysfunction of thyroid, pituitary or adrenal glands requiring hormone replacement.

Precautions & Warnings

Prior to initiating Tremelimumab therapy, clinicians should evaluate patients for factors that may increase the risk of adverse events.

  • Monitor immune‑related adverse events: assess organ function regularly throughout treatment.
  • Screen for active autoimmune disease: avoid use in patients with uncontrolled autoimmune disorders.
  • Evaluate hepatic function: baseline liver enzymes should be measured and monitored.
  • Avoid live vaccines during therapy: immunosuppression may cause severe infection.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Tremelimumab can interact with other agents that modify immune function or affect safety profiles.

Major Interactions (Avoid)

  • Concurrent use with other immune checkpoint inhibitors: heightened risk of severe immune‑mediated toxicity.
  • High‑dose systemic steroids: may diminish therapeutic efficacy of Tremelimumab.
  • Live attenuated vaccines: increased risk of infection due to immunosuppression.

Moderate Interactions (Monitor Closely)

  • Immunosuppressive chemotherapy: may alter immune activation and require dose adjustments.
  • Anticoagulants: monitor for bleeding complications during infusion reactions.
  • Drugs affecting cytokine release: observe for additive inflammatory responses.

Frequently Asked Questions

Imjudo, containing the monoclonal antibody Tremelimumab, is approved for the treatment of urothelial carcinoma, including locally advanced and metastatic bladder cancer, when used in combination with durvalumab as part of an immune checkpoint inhibition regimen.

Tremelimumab binds to the CTLA‑4 receptor on activated T cells, blocking its interaction with CD80/CD86. This inhibition lifts the brake on T‑cell activation, leading to sustained proliferation and cytokine release that enhances the immune system’s ability to recognize and destroy cancer cells.

The dosing regimen for Imjudo is determined by the prescribing oncologist based on the patient’s clinical condition, body weight, and treatment protocol. Specific dose amounts and infusion schedules are outlined in the product’s prescribing information and should not be altered without medical guidance.

Safety data for Tremelimumab in pregnancy and lactation are limited. The drug is classified as contraindicated or to be used only if the potential benefit justifies the potential risk to the fetus or infant. Women of child‑bearing potential should discuss contraception and risk with their healthcare provider.

To request Imjudo, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain handling) and any necessary import documentation.

Imjudo (Tremelimumab) targets CTLA‑4, whereas agents such as pembrolizumab or nivolumab target PD‑1, and ipilimumab also targets CTLA‑4 but differs in antibody subclass and dosing. Clinical outcomes, safety profiles, and approved indications vary, so selection depends on tumor type, prior therapies, and physician judgment.

Imjudo must be stored refrigerated at 2‑8 °C. It should be kept in its original container, protected from light, and must not be frozen or shaken. Proper cold‑chain management is essential to maintain product stability and efficacy.

Imjudo is given as an intravenous infusion under the supervision of a qualified healthcare professional. The infusion is typically administered over a set period according to the prescribing information, with patients monitored for infusion‑related reactions during and after the procedure.

Serious adverse events include immune‑mediated colitis, hepatitis, and endocrinopathies such as thyroiditis or adrenal insufficiency. These conditions can be life‑threatening and require prompt recognition, laboratory monitoring, and appropriate medical management, often including corticosteroids.

Imjudo is contraindicated in patients with active, uncontrolled autoimmune diseases, those receiving live attenuated vaccines, and individuals with known hypersensitivity to Tremelimumab or any excipients. Caution is also advised for patients with severe organ dysfunction or a history of severe immune‑related toxicities.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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