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Qalsody Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose vial (15mL)—1
Manufacturer
Generic Availability
NO
Mechanism of Action
Tofersen causes degradation of SOD1 mRNA through binding to SOD1 mRNA, which results in a reduction of SOD1 protein synthesis.
Qalsody Indications
Indications
Amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.
Qalsody Dosage and Administration
Adult
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
Not established.
Qalsody Contraindications
Not Applicable
Qalsody Boxed Warnings
Not Applicable
Qalsody Warnings/Precautions
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 Pharmacokinetics
Absorption
Median time to maximum concentration (Tmax) plasma: range 2–6 hours.
Elimination
Half-life: ~4 weeks.
Qalsody Interactions
Qalsody Adverse Reactions
Adverse Reactions
Pain, fatigue, arthralgia, increased CSF white blood cell, myalgia, increased CSF protein, musculoskeletal stiffness, neuralgia.
Qalsody Clinical Trials
See Literature
Qalsody Note
Not Applicable
Qalsody Patient Counseling
See Literature
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