Miscellaneous neurodegenerative disorders:
Indications for: QALSODY
Amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.
Adult Dosage:
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.
Children Dosage:
Not established.
QALSODY Warnings/Precautions:
Monitor for myelitis and/or radiculitis, papilledema, elevated intracranial pressure, aseptic meningitis; evaluate and treat accordingly if symptoms occur. Pregnancy. Nursing mothers.
QALSODY Classification:
Antisense oligonucleotide.
Adverse Reactions:
Pain, fatigue, arthralgia, increased CSF white blood cell, myalgia, increased CSF protein, musculoskeletal stiffness, neuralgia.
Drug Elimination:
Half-life: ~4 weeks.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial (15mL)—1
