What are the precautions for using gaffetomab?

In the clinical study of Glofitamab (Glofitamab) in the treatment of diffuse large B-cell lymphoma (non-Hodgkin lymphoma), warnings and precautions such as cytokine release syndrome , neurotoxicity, severe infection, tumor outbreak, embryonic-fetal toxicity have emerged. Discontinue and resume at reduced dose upon recovery, or permanently discontinue based on severity.

1. Cytokine release syndrome (CRS): The most common manifestations of CRS include fever, tachycardia, hypotension, chills and hypoxia. Among patients treated with gaffetuzumab, the incidence of CRS was 70%. Administer geffirumab in a facility equipped to monitor and manage CRS. Initiate treatment according to an escalating dose regimen of gaffetuzumab to reduce the risk of CRS, administer pretreatment medications, and ensure adequate hydration.

Patients should be hospitalized during and within 24 hours of completing the 2.5 mg escalating dose infusion. Patients who develop any grade of CRS during the 2.5 mg escalating dose should be hospitalized during and within 24 hours of completion of the 10 mg escalating dose. For subsequent doses, patients who develop ≥Grade 2 CRS with a previous infusion should be hospitalized during and for 24 hours after their next column infusion. At the first sign of CRS, assess the patient immediately for hospitalization, manage according to current practice guidelines, and implement supportive care.

2. Neurotoxicity: Gerfituzumab can cause severe and fatal neurotoxicity, including immune effector cell-associated neurotoxicity (ICANS). The most common neurotoxicities of any grade in patients treated with gaffetuzumab were headache, peripheral neuropathy, dizziness or vertigo, and mental status changes (including confusional states, cognitive impairment, disorientation, somnolence, and delirium).

Concomitant use of gaffetuzumab with other products that cause dizziness or changes in mental status may increase the risk of neurotoxicity. Optimize concomitant medications and hydration to avoid dizziness or changes in mental status. Have appropriate fall prevention measures in place. Monitor patients for signs and symptoms of neurotoxicity, perform evaluation, and provide supportive care. Evaluate patients who develop neurotoxicity (such as tremor, dizziness, or adverse effects that may immediately impair cognition or consciousness), including potential neurological evaluation. Advise affected patients to avoid driving and/or engaging in hazardous occupations or activities, such as operating heavy or potentially hazardous machinery, until the neurotoxicity is completely resolved.

3. Serious infection: Gerfituzumab can cause serious or fatal infection. Higher-grade infections are COVID-19 infections, including COVID-19 pneumonia and sepsis, which can also occur with febrile neutropenia. Gerfituzumab should not be used in patients with active infection. Use antimicrobial prophylaxis according to guidelines. Monitor patients for infections before and during treatment with gaffetuzumab and initiate appropriate treatment.

4. Tumor outbreak: Gerfituzumab can cause severe tumor progression, with symptoms including local pain and swelling at the lymphoma lesion and/or dyspnea caused by new pleural effusion. Patients with large tumors or disease located near the airways or vital organs should be closely monitored during initial treatment. Monitor for signs and symptoms of compression or obstruction due to mass effect secondary to tumor eruption, and initiate appropriate treatment. This product should not be used until the tumor has receded.

5. Embryo-fetal toxicity: According to its mechanism of action, gaffetuzumab may cause harm to the fetus when used by pregnant women. Inform pregnant women of potential risks to the fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with gaffetuzumab and for 1 month after the last dose.

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