What does the instructions for Tremelimumab contain?

1. Name

Generic name:Tremelimumab

Product name:Imjudo

Other names: temtumumab, cetumumab, tremelimumab, tremelimumab

Tremelimumab is a new type of immunotherapy drug that belongs to the monoclonal antibody class and helps the body recognize and attack cancer cells by inhibiting the immune system. Imjudo, its trade name, is gradually gaining recognition in the market and becoming an important option for treating certain types of cancer.

2. Indications

1. Hepatocellular carcinoma: Testumumab combined with durvalumab (durvalumab) is used for adult patients with unresectable hepatocellular carcinoma (uHCC). This combination therapy helps patients resist the growth and spread of tumors by boosting their immune response.

2. Non-small cell lung cancer : Temtumumab is used in combination with durvalumab and platinum-based chemotherapy. It is suitable for adult patients with metastatic non-small cell lung cancer (NSCLC) without sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor abnormalities. This combination provides patients with a wider range of treatment options and helps improve outcomes.

3. Usage and dosage

1. Hepatocellular carcinoma:

For patients with body weight≥30kg, the treatment plan is a single intravenous dose of temsilimumab 300 mg on day 1 of cycle 1, followed by intravenous injection of 1500 mg of durvalumab, and maintenance of 1500 mg of durvalumab every 4 weeks.

For weightFor patients <30 kg, 4 mg/kg of tesseltum and 20 mg/kg of durvalumab were administered intravenously on day 1 of cycle 1, and then 20 mg/kg of durvalumab was continued every 4 weeks until disease progression or intolerable toxicity. This treatment usually does not require hospitalization.

2. Non-small cell lung cancer:

For patients with body weight ≥30kg, 75 mg of temsilimumab was administered first, followed by intravenous injection of 1500 mg of durvalumab; if the weight was <30kg, 1 mg/kg of temsilimumab and 20 mg/kg of durvalumab were administered. The first to fourth cycles of treatment are once every three weeks, and the dosing interval can be adjusted according to the patient's condition in the later period.

4. Adverse reactions

In clinical studies, common adverse reactions of temsitumumab include but are not limited to nausea, decreased appetite, and fatigue. In addition,Grade 3 or 4 laboratory abnormalities include neutropenia, leukopenia, anemia, and hyponatremia. These adverse reactions require close monitoring during treatment and timely treatment to ensure patient safety.

5. Storage

Tistumumab injection should be stored in a refrigerator at 2°C to 8°CAvoid freezing and shaking. Once the drug is ready for infusion, it should be administered as soon as possible. If temporary storage is required, the total time from preparation to the start of administration should not exceed 24 hours, and it should be used within 24 hours at room temperature not exceeding 30°C.

6. Mechanism of action

The mechanism of action of temsitumumab mainly involves the antagonism of CTLA-4. As a negative regulator of T cell activity, CTLA-4 inhibits T cell activation by interacting with CD80 and CD86. As a monoclonal antibody, temsitumumab binds to CTLA-4 and blocks its binding to ligands, thereby releasing the inhibition of T cells and promoting the proliferation and activation of T cells. In mouse tumor models, blocking CTLA-4 activity showed reduced tumor growth and increased T cell proliferation, demonstrating its potential value in tumor immunotherapy.

Reference: https://www.drugs.com/mtm/tremelimumab.html