Qalsody

— THERAPEUTIC CATEGORIES —
  • Miscellaneous neurodegenerative disorders

Qalsody Generic Name & Formulations

General Description

Tofersen 6.7mg/mL; soln for intrathecal inj; preservative-free.

Pharmacological Class

Antisense oligonucleotide.

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.

Metabolism

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

Elimination

Half-life: ~4 weeks.

Qalsody Interactions

Not Applicable

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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