Qalsody: Uses, Side Effects and Dosage

What QALSODY is used for:

What is a Notice of Compliance with Conditions (NOC/c)?

A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada.

Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious or life-threatening illness. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in Canada, or be much safer than existing treatments.

Drug makers must agree in writing to clearly state on the label that the drug was given an NOC/c, to complete more testing to make sure the drug works the way it should, to actively monitor the drug’s performance after it has been sold, and to report their findings to Health Canada.

How QALSODY works:

ALS associated with an altered SOD1 gene causes a build-up of toxic SOD1 protein in the body. This causes loss of nerve cells in the brain and spine, leading to weakness in muscles, including those used for movement, breathing, and swallowing.

QALSODY contains the active substance tofersen. It belongs to a group of medicines known as antisense oligonucleotides. QALSODY works by reducing the amount of SOD1 protein produced. This may reduce the loss of nerve cells and slow down the loss of muscle strength and function.

The ingredients in QALSODY are:

Medicinal ingredient(s): tofersen

Non-medicinal ingredients: calcium chloride dihydrate, magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic dihydrate, and water for injection

QALSODY comes in the following dosage form(s):

Solution for intrathecal injection: 100 mg / 15 mL (6.7 mg / mL).

Do not use QALSODY if:

• You are allergic to tofersen or to any of the other ingredients in QALSODY.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you are given QALSODY. Talk about any health conditions or problems you may have, including if you:

• have inflamed skin or an infection at or near the proposed site of injection for QALSODY.
• have symptoms of increased pressure around the brain such as a headache that may become severe, accompanied with nausea, vomiting and/or vision problems.
• have a disease or condition affecting your blood’s ability to coagulate.
• have a traumatic spinal cord injury.
• are pregnant, think you are pregnant, planning to become pregnant or could become pregnant and are not using an effective birth control method.
• are breastfeeding or planning to breastfeed.

Other warnings you should know about:

QALSODY may cause serious side effects associated with inflammation of the nervous system. These include:

• Myelitis (inflammation of the spinal cord)
• Radiculitis (inflamed nerve root)
• Aseptic or chemical meningitis (inflammation of the protective lining of the brain and spinal cord)
• Increased intracranial pressure (increased pressure around the brain). This can also lead to papilledema (swelling of the nerve that connects the eye to the brain).

See the Serious side effects and what to do about them table for more information on these and other serious side effects.

Pregnancy and breastfeeding:

• It is not known if QALSODY can harm an unborn baby. Therefore, QALSODY is not recommended during pregnancy and in patients able to get pregnant who are not using an effective birth control method.
• It is not known if QALSODY can pass into breast milk and harm a breastfed baby. Therefore. breastfeeding is not recommended during your treatment.

Driving and using machines: It is not known if QALSODY can affect your ability to drive or use machines. If you develop vision problems while taking QALSODY, you should not drive or use machinery.

Testing and check-ups: Your healthcare professional may do laboratory tests before starting and/or regularly during your treatment with QALSODY. They may perform:

• Blood tests to:

  • check the level of platelets in your blood; and
  • measure your blood’s ability to clot and how long it takes.
• Urine tests to check the health of your kidneys.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with QALSODY:

No drug interaction studies have been performed.

How QALSODY is given:

• QALSODY is given by injection in the lower back. This injection:

  • is called a lumbar puncture and is done by inserting a needle in the space around the spinal cord (intrathecal). It should not be injected anywhere else or taken any other way.
  • will be given by a healthcare professional experienced in doing lumbar punctures and will be done in a healthcare setting.
• You may also be given a medicine to make you relax or sleep during the injection. Your healthcare professional may use imaging techniques to help with the administration of QALSODY if required.
• Your healthcare professional will tell you how long you need to keep receiving QALSODY. Don’t stop treatment with QALSODY unless your healthcare professional tells you to.
• Ask your healthcare professional if you have any questions about how QALSODY is given.

Usual dose:

The recommended dose of QALSODY is 100 mg (15 mL). You will receive QALSODY based on the schedule below:

• The first 3 doses of QALSODY will be administered 14 days apart: on Day 0, Day 14 and Day 28 of your treatment.
• And once every 28 days thereafter: on Day 56, Day 84, etc.

Overdose:

Missed Dose:

If you miss an appointment, contact your healthcare professional right away to let them know you missed your injection. Your healthcare professional will advise you when to come next for your scheduled appointment.

Possible side effects from using QALSODY:

These are not all the possible side effects you may have when taking QALSODY. If you experience any side effects not listed here, tell your healthcare professional.

Side effects with QALSODY may include:

• pain, including back pain and pain in your extremities
• muscle pain or stiffness
• joint pain
• nerve pain (including burning, stabbing and “pins and needles” sensations)
• lack of energy (fatigue)
• fever

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

QALSODY will be stored by your healthcare professional as follows:

• Refrigerated between 2^oC to 8^oC in the original carton to protect from light. Do not freeze.
• The vial in its original carton can be stored for up to 14 days at room temperature (not to exceed 30^oC).
• If removed from the original carton, the unopened vial can be removed from and returned to the refrigerator, if necessary, for not more than 6 hours per day at room temperature (not to exceed 30°C) for a maximum of 6 days (36 hours).
• If not administered right away, the solution may be stored in a syringe with a polypropylene barrel at room temperature (15 - 30°C) for up to 4 hours. Otherwise, it must be discarded.

Keep out of reach and sight of children.

If you want more information about QALSODY:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://health-products.canada.ca/dpd-bdpp/); the manufacturer’s (Biogen Canada Inc.) website www.biogen.ca/products/QALSODY_PM_EN, or by calling at 1-833-883-2676.

Date of Authorization: 2026-09-28