What are the side effects of tisagenlecleucel?

Silevermin (Tisagenlecleucel), made from the patient's own white blood cells, is a prescription cancer treatment used in patients younger than 25 years old with acute lymphoblastic leukemia (ALL It is also used in patients with large B-cell lymphoma or follicular lymphoma (FL), two types of non-Hodgkin lymphoma, who have relapsed or been refractory after receiving at least two other types of treatment.

Serifamine may cause serious or life-threatening side effects, such as cytokine release syndrome (CRS) and neurotoxicity. Symptoms of CRS include general malaise (high fever, chills, fatigue, myalgia and arthralgia), gastrointestinal discomfort (anorexia, nausea, vomiting), Neurological symptoms (encephalopathy, headache), respiratory complaints (dyspnea, tachypnea, hypoxia), elevated laboratory markers of inflammation (ferritin, LDH, and CRP), and organ system dysfunction manifesting as hyperbilirubinemia, transaminasitis, renal injury, transient left ventricular dysfunction, coagulopathy, and hypotension. Significant proliferation of histiocytes and high disease burden at the time of treatment are major risk factors for severe CRS reactions. Neurologic events are also common, with reported symptoms ranging from delirium to global encephalopathy, including aphasia, confusion, hallucinations, tremors, agitation, and seizures.

At leastOther serious adverse events occurred in at least 5% of patients, including cytopenias, electrolyte and liver function test abnormalities, pyrexia, anorexia, hypotension, hypoxia, pulmonary edema, acute kidney injury, and fluid overload. Coagulopathy is considered a late effect that occurs in many cases after remission of CRS, with elevated prothrombin and partial thromboplastin times, and hypofibrinogenemia in patients who develop severe CRS. Acute infusion reactions, including fever, chills, and nausea, can also occur.