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SAFETY AND
SIDE EFFECTS

It is important to talk with your doctor about the potential benefits and risks of any medication

QALSODY can cause serious side effects, including:

  • Inflammation of the spinal cord (myelitis) and/or irritation of the nerve roots (radiculitis), including serious cases, have been reported in patients treated with QALSODY
  • Six patients treated with QALSODY experienced inflammation of the spinal cord or irritation of the nerve roots in the clinical studies
  • Two patients stopped treatment with QALSODY and their symptoms resolved with treatment. In the remaining 4 patients, symptoms resolved without stopping QALSODY
  • If you experience common symptoms such as abnormal sensations (pins and needles), numbness, or weakness, please contact your healthcare provider
  • Your healthcare provider can help you determine how to address symptoms, and may recommend that you stop taking QALSODY
  • Swelling of the optic nerve (papilledema) and increased pressure inside the skull (elevated intracranial pressure), including serious cases, have been reported in patients treated with QALSODY
  • The optic nerve connects the eyes with the brain and is responsible for vision
  • Four patients developed increased pressure inside the skull and/or swelling of the optic nerve
  • All patients received treatment from their healthcare provider that resolved these symptoms, and no events led to stopping QALSODY
  • If you experience common symptoms of swelling of the optic nerve such as blurred vision, double vision, or vision loss, please contact your healthcare provider
  • If you experience symptoms of increased pressure inside the skull, such as headache, vomiting, or numbness or weakness, please contact your healthcare provider
  • Inflammation of the brain linings (aseptic meningitis, also called chemical meningitis or drug-induced aseptic meningitis), including serious cases, have been reported in patients treated with QALSODY
  • One patient experienced a serious side effect of inflammation of the brain linings, which led to the patient stopping QALSODY
  • One patient experienced a serious side effect of inflammation of the brain linings, which did not lead to the patient stopping QALSODY
  • In addition, nonserious side effects that can be signs of inflammation or infection have also been reported with QALSODY, including increased white blood cells and increased protein in the cerebrospinal fluid (the fluid around the spinal cord and the brain)
  • If you experience symptoms such as headache, fever, vomiting, neck stiffness, nausea or vomiting, please contact your healthcare provider

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FOR MORE INFORMATION
ABOUT QALSODY

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What is QALSODY?

QALSODY® (tofersen) is a prescription medicine used to treat adults with amyotrophic lateral sclerosis (ALS) who have a mutation, or change, in the superoxide dismutase 1 (SOD1) gene. QALSODY is approved under accelerated approval based on reduction in neurofilament light chain (NfL) in the blood observed in patients treated with QALSODY. Continued approval of QALSODY may require verification of clinical benefit in a confirmatory study.

IMPORTANT SAFETY INFORMATION

What is the most important information that I should know about QALSODY?

QALSODY can cause serious side effects, including:

  • Inflammation of the spinal cord (myelitis) and/or irritation of the nerve roots (radiculitis), including serious cases, have been reported in patients treated with QALSODY. Six patients treated with QALSODY experienced inflammation of the spinal cord or irritation of the nerve roots in the clinical studies. Two patients stopped treatment with QALSODY and their symptoms resolved with treatment. In the remaining 4 patients, symptoms resolved without stopping QALSODY. If you experience common symptoms such as abnormal sensations (pins and needles), numbness, or weakness, please contact your healthcare provider. Your healthcare provider can help you determine how to address symptoms, and may recommend that you stop taking QALSODY.
  • Swelling of the optic nerve (papilledema) and increased pressure inside the skull (elevated intracranial pressure), including serious cases, have been reported in patients treated with QALSODY. The optic nerve connects the eyes with the brain and is responsible for vision. Four patients developed increased pressure inside the skull and/or swelling of the optic nerve. All patients received treatment from their healthcare provider that resolved these symptoms, and no events led to stopping QALSODY. If you experience common symptoms of swelling of the optic nerve such as blurred vision, double vision, or vision loss, please contact your healthcare provider. If you experience symptoms of increased pressure inside the skull, such as headache, vomiting, or numbness or weakness, please contact your healthcare provider.
  • Inflammation of the brain linings (aseptic meningitis, also called chemical meningitis or drug-induced aseptic meningitis), including serious cases, have been reported in patients treated with QALSODY. One patient experienced a serious side effect of inflammation of the brain linings, which led to the patient stopping QALSODY. One patient experienced a serious side effect of inflammation of the brain linings, which did not lead to the patient stopping QALSODY. In addition, nonserious side effects that can be signs of inflammation or infection have also been reported with QALSODY, including increased white blood cells and increased protein in the cerebrospinal fluid (the fluid around the spinal cord and the brain). If you experience symptoms such as headache, fever, vomiting, neck stiffness, nausea or vomiting, please contact your healthcare provider.
What should I tell my healthcare provider before I start using QALSODY?

Before taking QALSODY, tell your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding or plan to breastfeed.

What are the possible side effects of QALSODY?

QALSODY can cause serious side effects. See "What is the most important information I should know about QALSODY?" above.

The most common side effects reported in patients treated with QALSODY were pain (back pain, pain in arms or legs), feeling tired, joint pain, increased white blood cell count in the cerebrospinal fluid (CSF), and muscle pain.

These are not all the possible side effects of QALSODY. Please talk to your healthcare provider if you experience any of these symptoms, or other new symptoms that concern you.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-10881-800-FDA-1088.

This information is not intended to replace discussions with your healthcare provider.

Please see full Prescribing Information.

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