Tofersen

Tofersen is a prescription medication used to treat amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. 

• Tofersen is available under the following different brand names: Qaslody.

Common side effects of Tofersen include:

• Fatigue, arthralgia (joint pain), 
• Increased cerebrospinal (brain and spinal cord) fluid white blood cells, 
• Myalgia (muscle pain).

Serious side effects of Tofersen include:

• Inflammation of the spinal cord (myelitis) 
• Irritation of the nerve roots (radiculitis),
• Inflammation of the brain linings (aseptic meningitis),
• Swelling of the optic nerve (papilledema) 
• Increased pressure inside the skull (elevated intracranial pressure),

Rare side effects of Tofersen include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, solution

• 100 mg/15 mL (6.7 mg/mL) single-dose vial

Amyotrophic Lateral Sclerosis

Adult dosage

• 100 mg per administration intrathecally using a lumbar puncture by, or under the direction of, healthcare professionals experienced in performing lumbar punctures
• Loading doses: 1 dose every 14 days for 3 doses
• Maintenance doses: Administer every 28 days.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Tofersen has no noted severe interactions with any other drugs.
• Tofersen has no noted serious interactions with any other drugs.
• Tofersen has no noted moderate interactions with any other drugs.
• Tofersen has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice or health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tofersen?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tofersen?”

Cautions

• Myelitis and radiculitis reported; initiate workup and treatment according to the standard of care if symptoms consistent with myelitis or radiculitis occur; management may require dosage interruption or discontinuation.
• Papilledema and elevated intracranial pressure reported; if symptoms develop, initiate diagnostic workup and treatment according to a standard of care.
• Aseptic meningitis (ie, chemical meningitis, drug-induced aseptic meningitis) reported; additionally, nonserious adverse drug reactions of increased CSF white blood cells and CSF protein have also been reported; if symptoms consistent with aseptic meningitis develop, initiate diagnostic workup and treatment according to a standard of care

Pregnancy and Lactation

• There are no adequate data on developmental risks associated with use in pregnant females to evaluate for drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
• Lactation
  • Data are not available on the presence of Tofersen or its metabolites in human milk, effects on breastfed infants, or effects on milk production.
  • Detected in the milk of lactating mice following subcutaneous administration.