QALSODY Solution for injection Ref.[107302] Active ingredients: Tofersen

2.1. Dosing Information

Recommended Dosage

Administer QALSODY intrathecally using a lumbar puncture by, or under the direction of, healthcare professionals experienced in performing lumbar punctures.

The recommended dosage is 100 mg (15 mL) of QALSODY per administration.

Initiate QALSODY treatment with three (3) loading doses administered at 14-day intervals.

Administer a maintenance dose every 28 days thereafter.

Missed Dose

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

If the third loading dose or a maintenance dose is missed, administer QALSODY as soon as possible, and administer the next dose 28 days later.

2.2. Preparation and Administration Instructions

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 vial to warm to room temperature (25°C/77°F) prior to administration without using external heat sources [see Storage and Handling (16.2)].
• 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 QALSODY 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 [see Storage and Handling (16.2)].
• Evaluate patients prior to and after intrathecal injection for the presence of potential conditions related to lumbar puncture, to avoid serious procedural complications.

Administration

Prior to administration, remove approximately 10 mL of cerebrospinal spinal fluid (CSF) using a lumbar puncture needle.

Prior to administration, remove the plastic cap and attach a needle to the syringe, for the purpose of withdrawing QALSODY from the vial. Insert the needle into the vial through the center of the overseal and withdraw the required dose of 15 mL (equivalent to 100 mg) from the vial.

• Do not dilute QALSODY.
• External filters are not required.

Administer QALSODY using a lumbar puncture needle as an intrathecal bolus injection over 1 to 3 minutes.

• QALSODY contains no preservatives. Once drawn into the syringe, the solution should be administered immediately (within 4 hours of removal from the vial) at room temperature; otherwise, it must be discarded.

Any unused contents of the single-dose vial should be discarded.

Store refrigerated between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze.

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.

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).