QALSODY™ requires careful monitoring for serious adverse events related to the procedure and potential complications of intrathecal injection.

Warnings and Precautions  

Serious adverse events have been reported in some patients, including myelitis, radiculitis, papilledema, and elevated intracranial pressure. It is crucial to monitor patients closely for any symptoms related to these conditions. If any symptoms arise, prompt diagnostic workups and appropriate treatments should be initiated according to standard care protocols. Additionally, aseptic meningitis has also been observed, necessitating further monitoring. Any patients undergoing intrathecal injection must be evaluated for potential lumbar puncture-related complications, and sedation or imaging may be required based on individual patient conditions.

Tofersen(QALSODY)
Adults with amyotrophic lateral sclerosis (ALS) who have a mutation in the SOD1 gene.
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