How to use Gefituzumab Injection

Glofitamab (Glofitamab) is an innovative bispecific antibody drug with the trade name Columvi. It was developed by Roche Pharmaceuticals and launched into the global market. It is mainly suitable for the treatment of relapsed or refractory large B-cell lymphoma (DLBCL) and other non-Hodgkin lymphoma. Its unique pharmacological mechanism is to simultaneously combine CD3 on the surface of T cells and CD20 on the surface of tumor B cells, thereby activating the human immune system to eliminate malignant B cells in a targeted manner. As a highly active immunotherapy drug, its usage, dosage, administration procedures and adverse reaction management must be highly standardized.

Graftuzumab is an intravenous infusion drug, and the entire treatment process is divided into "pretreatment phase", "dose escalation phase" and "maintenance treatment phase". This design aims to reduce the first dose effect and slow down immune overactivation, thereby reducing the risk of serious immune side effects such as cytokine release syndrome (CRS).

A key step before treatment is pretreatment with obinutuzumab (Obinutuzumab). This drug is an anti-CD20 monoclonal antibody, which is mainly used to deplete some normal B cells in the body and reduce the intensity of immune system activation. It is recommended to give 1000 mg of otuzumab intravenously 7 days before starting treatment with gaffetuzumab, that is, day 1 of cycle 1. This can significantly reduce the risk of CRS in the initial medication stage and is a core safety protection measure in the entire treatment plan.

After officially entering gratinumab treatment, the recommended medication regimen adopts an ascending dose strategy: Inject 2.5 mg intravenously on the 8th day of cycle 1, and increase to 10 mg on the 15th day; starting from the second cycle, each 21-day cycle is a cycle, and a maintenance dose of 30 mg is given on the first day of each cycle until the prescribed course of treatment is reached or treatment is interrupted due to disease progression. This staged medication approach is optimized based on pharmacokinetic studies and clinical trial data, aiming to minimize immune-related toxicity while ensuring efficacy.

Because gaffetuzumab may induce severe immune reactions, especially when first used, patients must be treated in a medical institution experiencedin the management of CRS. During the dose-increasing phase (especially when infusing 2.5 mg and 10 mg), it is recommended that patients be hospitalized for at least 24 hours of observation so that symptomatic treatment, such as tocilizumab and corticosteroids, can be given promptly when symptoms of CRS such as fever, hypotension, and dyspnea occur. At the same time, preventive drugs, including antihistamines, antipyretic analgesics, glucocorticoids, etc., are also needed to reduce the severity of infusion reactions.

Before use, gaffetuzumab injection needs to be diluted and prepared by a professional pharmacy and should not be operated by yourself. The drug solution is a colorless to light yellow clear liquid and must undergo strict drug quality inspection. If turbidity, particles or abnormal color are found, use is strictly prohibited. The medicinal solution should be injected intravenously at a constant speed through an infusion pump, and the entire infusion time is usually controlled within a few hours, which is adjusted according to the patient's weight and tolerance.

In addition, gaffetuzumab is an immune-activating drug, and its efficacy may be delayed, and there may be temporary decreases in B cells or fluctuations in T cell activation-related indicators during the treatment process. Therefore, throughout the treatment cycle, dynamic hematology examinations, infection screening and tumor burden assessment should be performed to ensure that drug safety and efficacy evaluation are carried out simultaneously.

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