Instructions for use of datopotamab for injection

Datopotomab is an innovative anti-cancer drug that targets Trop-2 by conjugating an antibody with a topoisomerase inhibitor. Trop-2 (tumor-associated calmodulin 2) is a receptor expressed on the surface of various tumor cells and plays an important role in the growth, proliferation and survival of cancer cells. By targeting Trop-2, dabrotuzumab can effectively target tumor cells and release drugs to treat targeted cancers.

1. Indications

Dabrotuzumab is indicated for the treatment of the following two diseases:

1. Breast cancer : For adult patients with unresectable or metastatic, hormone receptor-positive (HR+), HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer, and these patients have previously received endocrine therapy and chemotherapy, their disease still progresses.

2. Non-small cell lung cancer (NSCLC): patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have received EGFR targeted therapy and platinum-based chemotherapy.

2. Usage and dosage

Dedabrotuzumab is for intravenous infusion only, and the following medication guidelines must be strictly followed:

1. Recommended dose: For the vast majority of patients, the recommended dose is6 mg/kg, once every three weeks (i.e. every 21 days per cycle). If the patient weighs more than 90 kg, the maximum dose should not exceed 540 mg. The dose of dabrotuzumab should be calculated based on the patient's weight and administered at this recommended dose.

2. Route of administration: The drug can only be given by intravenous infusion, not intravenous push or rapid infusion. To avoid causing discomfort, the infusion must be administered at the recommended rate and time.

3. Pre-infusion treatment: To reduce the occurrence of infusion reactions and nausea and vomiting, patients should receive appropriate treatment before receiving dabrotuzumab infusion. These preventive medications may include antihistamines, corticosteroids, and antiemetics.

4. Infusion process: Each infusion should be strictly controlled according to the dosage and time recommended in the instructions, and avoid instilling too quickly. The patient's reaction should be monitored throughout the infusion process. If there are serious adverse reactions, the infusion should be stopped immediately and necessary first aid measures should be taken.

5. Treatment cycle: dabrotomab is usually administered everyInfusion is performed once every 3 weeks (21 days), and treatment continues until any of the following occurs: the patient's condition progresses, or the patient develops unacceptable toxicity. During the course of treatment, doctors will regularly evaluate the patient's condition and treatment effects, and decide whether to continue treatment based on the patient's resistance or tolerance.

3. Precautions

1. Infusion reaction: Dedabrotomab may cause certain infusion reactions during administration. Common symptoms include fever, chills, nausea, vomiting, rash, hypotension, etc. Patients require close monitoring during treatment, especially during the initial infusion, as more serious reactions may occur. For this reason, medical staff need to give appropriate preventive drugs before treatment to reduce the occurrence of adverse reactions

2. Allergic reaction: If the patient experiences severe allergic reaction (such as dyspnea, angioedema, etc.), the drug needs to be stopped immediately and emergency treatment is required.

3. Liver function monitoring: During treatment, the patient's liver function should be checked regularly to ensure that the drug will not cause liver damage. Especially when patients develop symptoms such as jaundice and liver pain during use, timely intervention should be carried out.

4. Immune system suppression: As a targeted drug, dabrotomab may suppress immune system function, so patients may be more susceptible to infection during treatment. Clinicians should assess the patient's immune status and take appropriate preventive measures based on the patient's specific situation.

Reference materials:https://www.google.com.hk/