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.


Exonuclease (3'- and 5')-mediated hydrolysis.

Drug Elimination:

Half-life: ~4 weeks.

Generic Drug Availability:


How Supplied:

Single-dose vial (15mL)—1