Tofersen

Generic name: tofersen [ toe-FER-sen ]
Brand name: Qalsody
Dosage form: intrathecal solution (100 mg/15 mL)
Drug class: Miscellaneous central nervous system agents

Medically reviewed by Drugs.com on Oct 31, 2023. Written by Cerner Multum.

What is tofersen?

Tofersen is used in adults to treat certain types of amyotrophic lateral sclerosis (ALS).

Your doctor will make sure you have the correct type to be treated with tofersen.

Tofersen may also be used for purposes not listed in this medication guide.

Tofersen side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Tofersen may cause serious side effects. Call your doctor at once if you have:

• severe muscle pain, cramps;

• signs of nerve pain--numbness, weakness, tingling, burning pain;

• signs of meningitis--fever, headache, neck stiffness, increased sensitivity to light, nausea, vomiting, confusion, drowsiness;

• signs of an eye condition called papilledema--blurry vision, swelling, vision changes ; or

• increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Your treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of tofersen may include:

• muscle or joint pain, muscle stiffness;

• feeling very tired;

• nerve or back pain;

• pain in your hands or feet; or

• increased white blood cells and protein in fluid around spine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

Tell your doctor about all your medical conditions or allergies before receiving tofersen.

It is not known if tofersen will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while receiving tofersen.

How is tofersen given?

Your doctor will perform tests to make sure tofersen is the right treatment for you.

Tofersen is injected into the fluid that surrounds the spinal cord. A healthcare provider will give you this injection.

Tofersen is given initially as 3 injections every 14 days, followed by maintenance injections every 28 days.

You may be given a sedative to help you relax during the injection.

After receiving an injection, you will be watched closely to make sure you do not have serious side effects.

You will need frequent medical tests.

Tofersen dosing information

Usual Adult Dose for Amyotrophic Lateral Sclerosis:

Loading dose: 100 mg intrathecally every 14 days for 3 doses
Maintenance dose: 100 mg intrathecally every 28 days

Comments:
-Consider utilizing patient sedation and/or imaging techniques to facilitate administration of this drug.
-Prior to administration, remove 10 mL from cerebrospinal fluid and administer as an intrathecal bolus injection over 1 to 3 minutes using a lumbar puncture needle.
-If the second loading dose is missed, administer it 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 it as soon as possible, and administer the next dose 28 days later.

Use: For the treatment of amyotrophic lateral sclerosis in adults who have a mutation in the superoxide dismutase 1 gene. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Related/similar drugs

riluzole, Radicava, edaravone, Rilutek, Radicava ORS, sodium phenylbutyrate / taurursodiol

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your tofersen injection.

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid while receiving tofersen?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect tofersen?

Other drugs may affect tofersen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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