QALSODY Solution for injection Ref.[110458] Active ingredients: Tofersen

Treatment with tofersen should only be initiated by a physician with experience in the management of ALS.

Qalsody should be administered by, or under the direction of, healthcare professionals experienced in performing lumbar punctures.

Posology

The recommended dose is 100 mg of tofersen per treatment.

Tofersen treatment should be initiated with 3 loading doses administered at 14-day intervals.

A maintenance dose should be administered once every 28 days thereafter.

Missed or delayed doses

If the second loading dose is delayed or missed, tofersen should be administered as soon as possible, and the third loading dose should be administered 14 days later.

If the third loading dose is delayed or missed, tofersen should be administered as soon as possible, and the first maintenance dose should be administered 28 days later.

If a maintenance dose is delayed or missed, tofersen should be administered as soon as possible. Subsequent maintenance doses should be administered every 28 days from the last dose.

Duration of treatment

The need for continuation of therapy should be reviewed regularly and considered on an individual basis depending on the patient’s clinical presentation and response to the therapy.

Special populations

Elderly

Experience with the use of tofersen in the elderly is limited. However, from the clinical data available, the efficacy and safety of tofersen are expected to be similar to that of other age groups studied. There is no evidence for special dose considerations based on age when tofersen is administered.

Renal impairment

Tofersen has not been studied in patients with renal impairment.

Hepatic impairment

Tofersen has not been studied in patients with hepatic impairment.

Paediatric population

The safety and efficacy of Qalsody in paediatric patients below the age of 18 years has not been established. No data are available.

Method of administration

Qalsody is for intrathecal use by lumbar puncture.

• It is recommended to ensure intrathecal access prior to removing the plastic cap from the vial and drawing up the tofersen dose.
• Just prior to administration, the plastic cap should be removed from the vial and a nonspinal anesthesia needle attached to the syringe for the purpose of withdrawing tofersen from the vial. The syringe needle is inserted into the vial through the center of the overseal to withdraw the required dose of 15 ml (equivalent to 100 mg) from the vial.
  • Qalsody must not be diluted.
  • External filters, including bacterial or particulate filters, are not required.
• It is recommended that approximately 10 ml of cerebrospinal spinal fluid (CSF) is removed using a lumbar puncture needle prior to administration of tofersen.
• Tofersen is administered as an intrathecal bolus injection using a lumbar puncture needle over 1 to 3 minutes.

Procedural preparation instruction:

• If indicated by the clinical condition of the patient, sedation can be considered.
• If indicated by the clinical condition of the patient, imaging to guide intrathecal administration of tofersen can be considered.
• Prior to removing the vial’s cap on the aluminium overseal, readiness of the patient should be confirmed. An unopened vial can be returned to the refrigerator; for total time permitted, see section 6.3.
• Patients should be evaluated prior to and after intrathecal injection for the presence of potential conditions related to lumbar puncture to avoid serious procedural complications.

Following injection, standard post-lumbar-puncture care is recommended.

No cases of overdose associated with tofersen were reported in clinical studies.

In the event of an overdose, supportive medical care should be provided including consulting with a healthcare professional and close observation of the clinical status of the patient.

30 months

Temporary storage conditions:

The vial of Qalsody in its original carton can be stored for up to 14 days at room temperature (store below 30°C).

Unopened vials of Qalsody can be removed from and returned to the refrigerator, if necessary. Unopened vials can be removed from the original carton for not more than 6 hours per day at room temperature for a maximum of 6 days.

Store in a refrigerator (2°C-8°C).

Do not freeze.

Store in the original package in order to protect from light.

For temporary storage conditions of unopened vials of the medicinal product, see section 6.3.

20 ml clear Type I glass vial with chlorobutyl rubber stopper and an aluminium overseal with flip-off plastic button.

Qalsody is available in a pack of 1 vial.

Aseptic technique must be used when preparing and administering tofersen intrathecally. For single use only.

Vial preparation instructions:

• The refrigerated vial should be allowed to warm to room temperature (25°C) prior to administration without external heat source.
• The vial should not be shaken.
• Qalsody contains no preservatives. Once drawn into the syringe, the solution should be administered immediately (within 4 hours since removal from refrigeration) at room temperature; otherwise, it must be discarded.
• The solution should be visually inspected prior to removal of the solution from the vial. The solution should be essentially free of visible particles. Only clear and colourless to slightly yellow solution should be administered. If not, the vial must not be used.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.