imjudo 300 mg/15 ml

Imjudo (Tremelimumab) is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellowish solution. It is a concentrate that must be diluted before administration. The active substance is Tremelimumab, a fully human monoclonal antibody.

2. Mechanism of Action:
Imjudo is a type of immunotherapy known as an immune checkpoint inhibitor. Specifically, it is a CTLA-4 (Cytotoxic T-Lymphocyte-Associated protein 4) blocker. It works by targeting and blocking the activity of CTLA-4, a protein on T-cells (a type of immune cell) that normally helps keep the immune system in check. By blocking CTLA-4, Imjudo unleashes the immune system, promoting the activation and proliferation of T-cells to attack cancer cells.

3. Therapeutic Indications (Uses):
Imjudo is used in combination with another immunotherapy medicine called Durvalumab (Imfinzi) for the treatment of adults with:

• Liver Cancer (Hepatocellular Carcinoma – HCC): It is indicated for the treatment of patients with unresectable (cannot be removed by surgery) or advanced hepatocellular carcinoma. This combination is often used as a first-line treatment.

4. Warnings and Precautions:
Imjudo can cause serious and potentially fatal immune-mediated side effects. These occur when the immune system attacks healthy organs and tissues. It is critical to be vigilant and report any new or worsening symptoms to your healthcare team immediately.

• Immune-Mediated Reactions (Inflammation of healthy organs):

  • Lung Problems (Pneumonitis/Interstitial Lung Disease): New or worsening cough, chest pain, or shortness of breath.

  • Intestinal Problems (Colitis/Diarrhea): Diarrhea (watery, loose, or soft stools), severe stomach pain, blood or mucus in your stool.

  • Liver Problems (Hepatitis): Yellowing of the skin or the whites of the eyes (jaundice), dark urine, severe nausea or vomiting, bleeding or bruising more easily, pain on the right side of the stomach.

  • Hormonal Gland Problems (Endocrinopathies): Inflammation of the pituitary, thyroid, or adrenal glands. Symptoms can include persistent or unusual headaches, extreme tiredness, weight changes, changes in mood or behavior, dizziness or fainting, hair loss, feeling cold, constipation, and deepened voice.

  • Kidney Problems (Nephritis): Inflammation of the kidneys, which can cause changes in urine output or blood in urine.

  • Skin Problems (Dermatitis/Rash): Severe rash, itching, blistering, or peeling skin, mouth sores.

  • Pancreas Problems (Pancreatitis): Severe stomach pain that may move to the back.

• Infusion-Related Reactions: Symptoms during or after the infusion may include fever, chills, shaking, flushing, difficulty breathing, or rash.

• Complications of Stem Cell Transplant: Severe and fatal complications have occurred in patients who receive a stem cell transplant before or after being treated with Imjudo.

• Pregnancy and Contraception: Imjudo can cause fetal harm. Women of childbearing potential must use effective contraception during treatment and for at least 3 months after the last dose. Do not breastfeed while taking this medication.

5. Administration:
Imjudo must be diluted by a healthcare professional and administered as an intravenous (IV) infusion over 60 minutes. It is typically given in combination with Imfinzi (Durvalumab) every 4 weeks for the first 4 doses, then Imfinzi alone is continued every 4 weeks.

6. Storage:
Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Keep the vial in the outer carton to protect from light.