4 mins read

Overview: Qalsody is used to treat amyotrophic lateral sclerosis (ALS) in certain people. Tiredness is a common side effect. Tell your health care provider right away if you have any unusual pain or numbness, stiff neck, confusion, nausea, severe headache, or vision changes. Qalsody will be given to you as an injection into or near your spine by your health care provider.

Uses

What is Qalsody used for?

Qalsody (tofersen) is commonly used to treat amyotrophic lateral sclerosis (ALS) in certain people.

Qalsody may also be used for other conditions as determined by your health care provider.

How does Qalsody work (mechanism of action)?

Some people with amyotrophic lateral sclerosis have a protein called superoxide dismutase 1 (SOD1) that is abnormal because of a gene change. This abnormal protein causes nerve damage. Qalsody works by lowering the amount of the abnormal protein. 

How is Qalsody supplied (dosage forms)?

Qalsody is available in an injectable form that is given by a health care provider.

How should I store Qalsody?

Qalsody is usually given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Qalsody?

The most common side effects of Qalsody are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Tiredness
  • Back, leg, arm, joint, or muscle pain

There may be other side effects of Qalsody that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Qalsody?

While less common, the most serious side effects of Qalsody are described below, along with what to do if they happen.

Severe Allergic Reactions. Qalsody may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Nerve or Spinal Cord Problems. Qalsody may cause inflammation in your spinal cord (myelitis) or to the nerves near your spinal cord (radiculitis). Tell your health care provider right away if you have any of the following symptoms.

  • Muscle weakness
  • Numbness or tingling in arms or legs
  • Sharp shooting pain in the back, neck, arms, or legs
  • Trouble walking or balancing
  • Loss of bladder (peeing) or bowel (pooping) control 

Increased Pressure Around the Brain. Qalsody can increase the pressure around the brain, a serious condition called increased intracranial pressure. It can also cause swelling of your optic nerve (papilledema). Call your health care provider right away if you have any of the following symptoms.

  • Dizziness
  • Nausea and vomiting
  • Severe headache
  • Vision changes

Meningitis. Qalsody may cause a condition called meningitis. People with meningitis have inflammation of the membranes that surround the brain and spinal cord. Sometimes medicines like Qalsody can cause meningitis. Call your health care provider right away if you have any of the following symptoms.

  • Stiff neck so that you can not lower your chin to your chest
  • Confusion
  • Fever
  • Severe headache with nausea and vomiting
  • Numbness in your face
  • Sensitivity to light 

Warnings & Precautions

Who should not use Qalsody?

Allergies to Ingredients. People who are allergic to any of the following should not use Qalsody.

  • Qalsody 
  • Tofersen
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Qalsody.

What should I know about Qalsody before using it?

Qalsody is injected into or near the spine (intrathecally) by a health care professional. 

What should I tell my health care provider before using Qalsody?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Qalsody is right for you.

In particular, make sure that you discuss any of the following.

Pregnancy. It is not known if or how Qalsody could affect pregnancy or harm an unborn baby. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Qalsody passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Qalsody?

For more information about Qalsody, you can visit the drugmaker’s website at www.qalsody.com or call them at 877-725-7639.

Interactions

Does Qalsody interact with foods or drinks?

There are no known interactions between Qalsody and foods or drinks.

It is unknown if drinking alcohol will affect Qalsody.

Does Qalsody interact with other medicines (drug interactions)?

There are no known interactions between Qalsody and other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Qalsody?

If you or someone else has used too much Qalsody, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Qalsody?

If you miss an appointment to get your Qalsody dose, call to make another appointment as soon as possible.