Chinese instructions for Lisocabtagene maraleucel (Beryanzi)

Part 1: Indications

Lisocabtagene maraleucel (Beryanzi) is a CAR-T cell therapy indicated for adults with refractory or relapsed large B cell lymphoma (DLBCL). DLBCL is a subtype of non-Hodgkin lymphoma that usually presents with symptoms such as swollen lymph nodes, fever, night sweats, fatigue, and weight loss. Lisocabtagene maraleucel provides a new treatment option for patients with DLBCL who are ineffective or resistant to traditional treatments.

Part 2: Mechanism of Action

Lisocabtagene maraleucel's mechanism of action is to attack cancer cells by improving the patient's own immune system. Here are the key steps in its mechanism of action:

1.Tcell collection: First, the patient's T cells (a type of immune cell) are collected, usually from blood. TheseT cells will be used for subsequent treatments.

2.CARDesign: Scientists design CAR (chimeric antigen receptor) in the laboratory, a protein receptor that recognizes cancer cells. CARis designed to bind to specific antigens on DLBCL cells.

3.TCell engineering: The patient's T cells are modified through genetic engineering technology to implant CAR. This process gives TT cells the ability to recognize and attack cancer cells.

4.Amplification and activation: engineeredCAR-TCells are massively expanded to increase their numbers. They are then activated and ready to attack cancer cells.

5.Patient reinfusion:CAR-T cells are re-infused into the patient. Once inside the patient's body, these CAR-T cells seek out and destroy DLBCL cells.

Lisocabtagene maraleucel’s mechanism of action enables it to precisely attack cancer cells, thus providing hope for treatment.

Part 3: Pharmacology

The pharmacology of lisocabtagene maraleucel primarily involves its metabolism and effects in patients. It includes information on:

1.Absorption and distribution:Lisocabtagene maraleucelis reinjected into the patient in the form of in vitro engineered T cells. Once injected, the CAR-T cells will seek out and attack cancer cells in the body.

2.Metabolism and excretion: There is limited information on the metabolism and excretion of Lisocabtagene maraleucel because it is an engineered form of the patient's own T cells rather than a traditional drug molecule.

3.Pharmacokinetics:Lisocabtagene maraleucel has had limited pharmacokinetic studies, but its therapeutic effects are usually apparent within weeks of treatment and may last for months or longer.

Part 4: Dosage and Usage

Lisocabtagene maraleucelThe dosage and usage should be determined by professional medical personnel based on the patient's specific situation and disease state. Generally speaking, the following is the general usage:

1.Dosage: The dosage of Lisocabtagene maraleucel is usually determined based on the patient's weight and disease status, so it should be accurately calculated by the doctor.

2.Usage: This drug is usually given to patients via intravenous injection. Treatment needs to be done under professional medical supervision as serious side effects may occur.

3.Treatment cycle: The duration of a treatment cycle can vary depending on the patient's disease state, but usually takes weeks or months. The doctor will adjust the treatment plan based on the patient's response.

Part 5: Side Effects

Lisocabtagene maraleucelmay cause a series of side effects, including but not limited to the following:

1.Cytokine release syndrome (CRS): CRS is a potentially serious side effect that usually manifests as high fever, low blood pressure, shortness of breath, and multiple organ dysfunction. It requires urgent treatment.

2.Neurological toxicity: Some patients may experience neurological toxicity manifesting as neurological symptoms such as headache, ataxia, and coma.

3.Infection:CAR-Tcell therapy may cause damage to the immune system, making patients susceptible to infection.

4.Blood problems: Treatment may cause blood problems such as anemia, thrombocytopenia, and leukopenia.

5.Other side effects: There are other possible side effects, such as nausea, vomiting, fatigue, and lung problems.

Part 6: Warnings and Precautions

UseWhen using Lisocabtagene maraleucel, be aware of the following warnings and precautions:

1.Close monitoring: Patients need to be closely monitored during treatment to detect and deal with any side effects in a timely manner.

2.CRSManagement: Physicians need to be prepared to deal with CRS, which may require the use of anti-inflammatory drugs and other treatments.

3.Risk of infection: Due to a compromised immune system, patients are susceptible to infections. Therefore, steps should be taken to prevent infection and to treat infection quickly when it occurs.

4.Post-treatment follow-up: Regular follow-up is required after treatment to monitor the efficacy and side effects, and adjust the treatment plan as needed.

Part 7: Contraindications

The use of lisocabtagene maraleucel may be limited by a number of contraindications, including but not limited to the following:

1.An allergic reaction or serious adverse reaction to the drug.

2.Suffering from severe immune system disease or autoimmune disease.

3.Suffering from serious cardiovascular or respiratory diseases.

4.Pregnant or breastfeeding women may require additional caution.

Part 8: Drug Interactions

There is limited information about the interactions of Lisocabtagene maraleucel with other drugs because it is a special type of treatment. Patients should provide their doctor with a list of all medications and supplements they are taking so that the doctor can evaluate potential interactions.

Part 9: Medication for Special Populations

Special populations, such as children, elderly patients, and pregnant women, require special caution when usingLisocabtagene maraleucel. Doctors will decide whether this drug is suitable for use and adjust the medication regimen based on each patient's specific circumstances.

In summary,Lisocabtagene maraleucel(Beryanzi) is a CAR-T cell therapy for the treatment of refractory or relapsed large Bcell lymphoma (DLBCL). It works by modifying the patient's own immune system to attack cancer cells, but can also cause serious side effects. Treatment should be supervised by a medical professional and individualized to the patient's specific circumstances. Patients and doctors should work closely together to ensure safe and effective treatment. Please read and follow your doctor's recommendations and prescriptions carefully before use.