Qalsody Generic Name & Formulations
Single-dose vial (15mL)—1
Mechanism of Action
Tofersen causes degradation of SOD1 mRNA through binding to SOD1 mRNA, which results in a reduction of SOD1 protein synthesis.
Amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.
Qalsody Dosage and Administration
Remove ~10mL of CSF (via lumbar puncture needle) prior to administration. Give as an intrathecal bolus inj over 1–3mins (via lumbar puncture needle). Each dose is 100mg (15mL). Initiate with 3 loading doses given at 14-day intervals. Maintenance dose: give every 28 days thereafter.
Qalsody Boxed Warnings
Monitor for myelitis and/or radiculitis, papilledema, elevated intracranial pressure, aseptic meningitis; evaluate and treat accordingly if symptoms occur. Pregnancy. Nursing mothers.
Median time to maximum concentration (Tmax) plasma: range 2–6 hours.
Half-life: ~4 weeks.
Qalsody Adverse Reactions
Pain, fatigue, arthralgia, increased CSF white blood cell, myalgia, increased CSF protein, musculoskeletal stiffness, neuralgia.
Qalsody Clinical Trials
Qalsody Patient Counseling