Tofersen(QALSODY)
Acetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine Injection
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QALSODY™ (tofersen) is an innovative treatment specifically developed for patients suffering from amyotrophic lateral sclerosis (ALS) with SOD1 gene mutations. This drug works by targeting and reducing the harmful SOD1 protein, which is believed to play a significant role in the neurodegenerative process of ALS. It is administered intrathecally via a lumbar puncture, requiring careful dosing and preparation.
The therapeutic effect of QALSODY™ has been demonstrated in clinical trials, showing promising results in reducing neurofilament light chain (NfL) levels, an important biomarker in ALS. It is approved under accelerated approval due to its potential to slow disease progression. Ongoing trials will further validate the long-term clinical benefits, making QALSODY™ a crucial option for ALS patients with this specific genetic mutation.
Generic name
Tofersen(QALSODY)
Alternative Names
QALSODY
Indications
QALSODY is 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 the reduction in plasma neurofilament light chain (NfL) levels observed in patients treated with QALSODY. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.
Therapeutic Target
The therapeutic target of QALSODY is the SOD1 gene mutation, which is implicated in a subset of ALS cases.
Active Ingredients
Tofersen (an antisense oligonucleotide).
specifications
QALSODY is provided in single-dose vials with a concentration of 100 mg/15 mL (6.7 mg/mL) solution.
Description
QALSODY is an antisense oligonucleotide designed for intrathecal administration. It is indicated for the treatment of ALS patients with SOD1 gene mutations, aiming to reduce the accumulation of toxic SOD1 proteins in the nervous system. The reduction in neurofilament light chain (NfL) levels in plasma serves as a biomarker of neuronal damage, which may correlate with clinical benefits. This drug is administered via intrathecal injection and requires careful monitoring during treatment.
Dosage and Administration
Recommended Dose: 100 mg (15 mL) per administration.
Loading Doses: Three loading doses should be administered at 14-day intervals.
Maintenance Doses: Administered once every 28 days thereafter.
Preparation Instructions:
Allow the vial to warm to room temperature before administration.
Administer within 4 hours of removing the solution from the vial.
Prior to administration, remove approximately 10 mL of cerebrospinal fluid (CSF).
Administer as an intrathecal bolus injection over 1 to 3 minutes.
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