- Drug Name: Qalsody
- Active Pharmaceutical Ingredient: Tofersen
- Dosage Forms and Strengths: Injection: 100 mg/15 mL (6.7 mg/mL) in a single-dose vial
- Manufactured by: Biogen
QALSODY is an antisense oligonucleotide indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain observed in patients treated with QALSODY. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).
Dosage And Administration
QALSODY is administered intrathecally
- Dosing Information
- Recommended dose: 100 milligrams (15 mL) per administration
- Initiate QALSODY treatment with 3 loading doses administered at 14-day intervals. A maintenance dose should be administered once every 28 days thereafter.
- Preparation and Administration Instructions
- Allow to warm to room temperature prior to administration
- Administer within 4 hours of removal from vial
- Prior to administration, remove approximately 10 mL of cerebrospinal fluid
- Administer as an intrathecal bolus injection over 1 to 3 minutes
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