What are the precautions for vepotuzumab (POLIVY)?

Patients should pay attention to the occurrence of peripheral neuropathy, infusion-related reactions, bone marrow suppression, severe and opportunistic infections, progressive multifocal leukoencephalopathy, tumor lysis syndrome, hepatotoxicity and other events during and after treatment with vepotuzumab (POLIVY).

1. Peripheral neuropathy: Vepotuzumab can cause peripheral neuropathy, including severe cases. Peripheral neuropathy appears as early as the first cycle of treatment and is a cumulative effect that may also exacerbate preexisting pathology, such as hypoesthesia, hyperesthesia, paresthesia, dysesthesia, neuropathic pain, burning sensation, weakness, or gait disturbance. Patients who develop new or worsening peripheral neuropathy may need to delay, reduce the dose, or discontinue vepotuzumab.

2. Infusion-related reactions: Delayed infusion-related reactions occurred within 24 hours after receiving vepotuzumab . More than 1% of patients experienced symptoms including chills, dyspnea, fever, itching, rash and chest discomfort. Administer an antihistamine and antipyretic drug before taking velpotuzumab and monitor the patient closely throughout the infusion. If an infusion-related reaction occurs, interrupt the infusion and initiate appropriate medical management.

3. Myelosuppression: including neutropenia, thrombocytopenia and anemia, monitor complete blood count throughout the treatment process. Cytopenia may require delay, dose reduction, or discontinuation of vepotuzumab. For the prophylactic use of G-CSF for the treatment of neutropenia in patients receiving velpotuzumab plus R-CHP, consider the prophylactic administration of G-CSF in patients receiving velpotuzumab plus bendamustine and rituximab products.

4. Severe and opportunistic infections: including opportunistic infections, such as sepsis, pneumonia (including Pneumocystis jiroveci and other fungal pneumonia), herpes virus infection and cytomegalovirus infection. During the treatment process, patients should be closely monitored for signs of infection to prevent Pneumocystis pneumonia and herpes virus. Use prophylactic G-CSF for neutropenia as recommended.

5. Progressive multifocal leukoencephalopathy (PML): In studies, PML has been reported after treatment with vepotuzumab plus bendamustine and obinutuzumab (0.6%). Monitor for new or worsening neurological, cognitive, or behavioral changes. If PML is suspected, withhold vepotuzumab and any concomitant chemotherapy and, if confirmed, permanently discontinue use.

6. Tumor lysis syndrome: Patients with high tumor burden and rapidly proliferating tumors may be at increased risk for tumor lysis syndrome. Monitor closely and take appropriate measures, including prevention of tumor lysis syndrome.

7. Hepatotoxicity: In patients treated with velpotuzumab, severe cases of hepatotoxicity consistent with hepatocellular injury have occurred, including transaminases and /or elevated bilirubin. Preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase the risk of hepatotoxicity. Monitor liver enzyme and bilirubin levels.