What are the main contents of the instructions for greffitomab?

Glofitumab is an innovative bispecific antibody drug specifically designed to treat relapsed or refractory large B-cell lymphoma (DLBCL, NOS; non-Hodgkin lymphoma) and large B-cell lymphoma (LBCL) transformed from follicular lymphoma. It represents a cutting-edge T cell engagement therapy that induces tumor cell lysis by precisely activating T cells and targeting B cells.

[1. Description of indications]

Gefituzumab is mainly used for adult patients who have received two or more systemic therapies, especially those who have poor response to standard chemotherapy and immunotherapy;

Applicable to diffuse large cell lymphomaB-cell lymphoma (DLBCL), NOS type;

Also suitable for patients with follicular lymphoma (FL) transformed into large B-cell lymphoma;

The instructions clearly stipulate that it is used in "relapsed or refractory" scenarios and cannot be used as a first-line drug.

[2. Pharmacological mechanism and principle of action]

Gerfitolumab is aCD20×CD3 bispecific antibody; one end targets the CD20 antigen on the surface of B cells, and the other end targets the CD3 receptor on the surface of T cells. Through this structure, T cells and B cells are bridged, allowing T cells to accurately attack tumor B cells. It belongs to T cell engager (TCE)* therapy and is an emerging direction in today's immuno-oncology treatment. It can activate T cells to release effector molecules such as perforin and granzymes to induce tumor apoptosis.

[3. Usage, dosage and treatment cycle]

Gerfituzumab is an intravenous infusion drug;

Before using gratinuzumab7 days (day 1 of cycle 1), 1000 mg obinutuzumab needs to be intravenously injected as pretreatment to reduce the risk of adverse reactions;

The starting dose escalation schedule is as follows: Day 8 of cycle 1: 2.5 mg intravenously; Day 15 of cycle 1: 10 mg intravenously;

Maintenance dose phase: Starting from cycle 2, every 21 days, 30mg is injected intravenously on the first day of each cycle; treatment can last for several cycles, which will be evaluated by the clinician based on the condition.

[4. Pretreatment and safety monitoring requirements]

Ingredients may induce cytokine release syndrome (CRS), and treatment must be carried out in medical institutions with advanced monitoring conditions;

During the first dose increase (2.5mg), patients need to be hospitalized for at least 24 hours of observation; in subsequent courses of treatment, if the risk of CRS still exists, hospitalization is also recommended; preventive drugs, such as corticosteroids, antihistamines and antipyretics, are recommended to prevent CRS and other allergic reactions; the medical team needs to be familiar with the CRS scoring standards and processing procedures, such as using Tocilizumab and other drugs for symptomatic management.

[5. Common adverse reactions and management]

Common adverse reactions listed in the instructions include: cytokine release syndrome (the most common); fever, chills, fatigue; hematological toxicity: such as neutropenia; abnormal liver function indicators; regular monitoring of blood routine, liver function, electrolytes and other indicators is required; if severe toxicity occurs, doctors may consider delaying or terminating treatment and using symptomatic drugs.

【6. Contraindications and Medication Precautions】

It is contraindicated for those with a history of allergy to greffitumab or its excipients;

Not recommended for use by pregnant or lactating women as it may affect the fetus or milk;

It is not recommended to use it in combination with other strong immunosuppressants unless specifically directed by a doctor;

It is recommended to avoid live vaccines during treatment;

If the patient has an active infection or immune system disease, careful evaluation should be made before deciding whether to initiate treatment.

Reference materials:https://www.drugs.com/glofitamab.html