What are the precautions for Ofatumumab?

In clinical trials, warnings and precautions for Ofatumumab include infusion reactions, hepatitis B virus reactivation, hepatitis B virus infection, progressive multifocal leukoencephalopathy, tumor lysis syndrome, cytopenias, immunization, etc.

1. Infusion reaction: Ofatumumab can cause serious (including fatal) infusion reactions, manifested as bronchospasm, dyspnea, laryngeal edema, pulmonary edema, flushing, hypertension, and hypoemia. pressure, syncope, cardiac events (e.g., myocardial ischemia/infarction, acute coronary syndrome, arrhythmia, bradycardia), back pain, abdominal pain, pyrexia, rash, urticaria, angioedema, cytokine release syndrome, and anaphylactoid/anaphylactoid reactions. Infusion reactions were more frequent during the first two infusions. These reactions may result in temporary interruption or discontinuation of treatment. If an allergic reaction occurs, immediately and permanently discontinue ofatumumab and initiate appropriate medical treatment.

2. Reactivation of hepatitis B virus: Patients receiving ofatumumab have experienced reactivation of hepatitis B virus (HBV), which in some cases can lead to fulminant hepatitis, liver failure and death. PatientsScreen all patients for HBV infection by measuringHBsAg and anti-HBc before initiating treatment with ofatumumab; Monitor patients with evidence of current or past HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months after treatment. Patients who develop HBV reactivation while receiving ofatumumab treatment should immediately discontinue ofatumumab and any concomitant chemotherapy and initiate appropriate treatment.

3. Hepatitis B virus infection: Fatal infections due to hepatitis B have been observed in patients treated with ofatumumab in previously uninfected patients. Monitor patients for clinical and laboratory signs of hepatitis.

4. Progressive multifocal leukoencephalopathy (PML): Ofatumumab patients have developed PML leading to death. PML should be considered in any patient with new onset or changes in preexisting neurological signs or symptoms. If PML is suspected, discontinue ofatumumab and initiate evaluation for PML.

5. Tumor lysis syndrome (TLS):Patients receiving ofatumumab developed tumor lysis syndrome, including the need for hospitalization. Patients with high tumor burden and/or high circulating lymphocyte count (>25x109/L) are at greater risk of developing TLS. Tumor lysis prevention with antihyperuricemia and hydration was initiated 12-24 hours before ofatumumab infusion. For the treatment of TLS, aggressive intravenous hydration and antihyperuricemic drugs are administered, electrolyte abnormalities are corrected, and renal function is monitored.

6. Cytopenia: Severe cytopenias, including neutropenia, thrombocytopenia and anemia, may occur with ofatumumab. Monitor complete blood counts periodically during and after treatment and more frequently in patients who develop Grade 3 or 4 cytopenias.

7. Immunization: The safety of immunization with live virus vaccines during or after the use of ofatumumab has not been studied. Do not administer live virus vaccines to patients who have recently received ofatumumab. The ability of ofatumumab to elicit an immune response to any vaccine following administration of ofatumumab has not been studied.

The original drug of ofatumumab has been launched in China and has also been included in medical insurance. Only patients who meet the indications can be reimbursed. The price is around tens of thousands of yuan, and domestic purchase channels are relatively difficult. The European version of ofatumumab original drug specifications20mg/0.4mL each sold overseas may cost around RMB 16,000 (the price may fluctuate due to the exchange rate). It is expensive and there are currently no generics of ofatumumab. For more drug information and specific prices, please consult a medical consultant.