Tofersen (toe-FER-sen)

Treats amyotrophic lateral sclerosis (ALS).

Brand Name(s):

Qalsody

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• A doctor or other trained health professional will give you this medicine in a hospital. It is given through a needle placed into your spinal cord.
• Missed dose: Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding.
• This medicine may cause the following problems:
  • Myelitis (swelling of the spinal cord) and radiculitis (nerve problem)
  • Papilledema (eye problem) and increased pressure in the head
  • Aseptic meningitis (swelling of the brain)
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred or change in vision, confusion, headache, nausea, vomiting
• Difficulty moving, joint or muscle pain
• Fever, stiff neck, back numbness, pain, tingling, or weakness
• Unusual tiredness or weakness

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088