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Dosing and administration

Intrathecal administration allows QALSODY to be distributed from the CSF to central nervous system tissues1

After an initial dosing period, QALSODY is administered once every 28 days1

QALSODY should be administered intrathecally by healthcare professionals experienced in performing lumbar punctures1

Managing missed doses

Missed second dose:

If the second loading dose is missed, administer QALSODY as soon as possible, and give the third loading dose 14 days later.1

Missed third dose:

If the third loading dose is missed, administer QALSODY as soon as possible, and give the next dose 28 days later.1

Missed maintenance dose:

If a maintenance dose is missed, administer QALSODY as soon as possible, and give the next dose 28 days later.1

Preparation and administration instructions1

Use aseptic technique when preparing and administering QALSODY intrathecally. Prepare and administer QALSODY according to the following steps:

Preparation

Vial preparation instructions
  • Allow refrigerated QALSODY to warm to room temperature (25°C/77°F) prior to administration, without using external heat sources
  • Inspect the solution in the QALSODY vial prior to administration. Do not administer if particles are observed or the liquid in the vial is not clear and colorless to slightly yellow
  • Do not shake the vial
Procedural preparation instructions
  • If indicated by the clinical condition of the patient, consider sedation
  • If indicated by the clinical condition of the patient, consider imaging to guide intrathecal administration of QALSODY
  • Prior to removing the vial’s cap on the aluminum overseal, confirm readiness of the patient. An unopened QALSODY vial can be returned to the refrigerator
  • Evaluate patients prior to and after intrathecal injection for the presence of potential conditions related to lumbar puncture, to avoid serious procedural complications

Administration1

Please click for full Prescribing
Information for complete preparation and
administration details. 

Storage and handling

Vials of QALSODY should be stored refrigerated, at a temperature between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze.1

If no refrigeration is available, QALSODY may be stored in its original carton, protected from light at or below 30°C (86°F) for up to 14 days.1

If removed from the original carton, unopened vials of QALSODY can be removed from and returned to the refrigerator, if necessary, for not more than 6 hours per day at or below 30°C (86°F) for a maximum of 6 days (36 hours).1

Please click for full Prescribing Information
for complete preparation, storage, and
handling details.

Find out more about SOD1 genetic ALS and NfL

INDICATION

QALSODY® (tofersen) 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 reduction in plasma neurofilament light chain (NfL) observed in patients treated with QALSODY. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Myelitis and/or Radiculitis

Serious adverse reactions of myelitis and radiculitis have been reported in patients treated with QALSODY. Six patients treated with QALSODY experienced myelitis or radiculitis in the clinical studies. Two patients discontinued treatment with QALSODY and required symptomatic management with full resolution of symptoms. In the remaining 4 patients, symptoms resolved without discontinuation of QALSODY. If symptoms consistent with myelitis or radiculitis develop, diagnostic workup and treatment should be initiated according to the standard of care. Management may require interruption or discontinuation of QALSODY.

Papilledema and Elevated Intracranial Pressure

Serious adverse reactions of papilledema and elevated intracranial pressure have been reported in patients treated with QALSODY. Four patients developed elevated intracranial pressure and/or papilledema. All patients received treatment with standard of care with resolution of symptoms, and no events led to discontinuation of QALSODY. If symptoms consistent with papilledema or elevated intracranial pressure develop, diagnostic workup and treatment should be initiated according to the standard of care.

Aseptic Meningitis

Serious adverse reactions of aseptic meningitis (also called chemical meningitis or drug-induced aseptic meningitis) have been reported in patients treated with QALSODY. One patient experienced a serious adverse reaction of chemical meningitis, which led to discontinuation of QALSODY. One patient experienced a serious adverse reaction of aseptic meningitis, which did not lead to discontinuation of QALSODY. In addition, nonserious adverse drug reactions of CSF white blood cell increased, and CSF protein increased have also been reported with QALSODY. If symptoms consistent with aseptic meningitis develop, diagnostic workup and treatment should be initiated according to the standard of care.

Adverse Reactions

The most common adverse reactions (≥10% of patients treated with QALSODY and greater than placebo) were pain, fatigue, arthralgia, cerebrospinal fluid white blood cell increased, and myalgia.

Please click for full Prescribing Information.

Reference: 1. QALSODY Prescribing Information, Cambridge, MA: Biogen.

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