Tofersen Dosage

Medically reviewed by Drugs.com. Last updated on Oct 31, 2023.

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).

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For intrathecal use only; consult manufacturer product information prior to product administration.
• This drug should be administered by, or under the direction of, a healthcare professional experienced in performing lumbar punctures.
• Consider sedation as indicated by the clinical condition of the patient.
• Consider imaging techniques to guide intrathecal administration.
• Prior to administration, remove 10 mL of cerebrospinal fluid (CSF), and then give this drug as an intrathecal bolus injection over 1 to 3 minutes using a lumbar puncture needle.

Storage requirements:

• Refrigerate between 2C to 8C (36F to 46F); do not freeze.
• Store in original carton to protect from light.
• If refrigeration unavailable, may store in original carton at 30C (86F) or below for up to 14 days.
• If removed from original carton, unopened vials may be removed from and then returned to the refrigerator, if necessary, but not more than 6 hours per day at 30C (86F) or below for a maximum of 6 days (36 hours).

Reconstitution/preparation techniques:

• Consult the manufacturer product information prior to product preparation.
• Allow vial to warm to room temperature prior to administration; do not use external heat sources.
• Do not shake the vial.
• Inspect the vial solution and do not administer if visible particulates are observed or if the liquid in the vial is discolored.
• Do not remove plastic cap until confirming patient readiness; an unopened vial can be returned to refrigerator.
• Withdraw 100 mg (15 mL) from the single-dose vial and discard unused contents of vial.
• Do not dilute solution. The use of external filters are not required.
• Administer solution immediately (or within 4 hours of removal from the vial) at room temperature; otherwise, it must be discarded.

Monitoring:

• Monitor patients for serious adverse reactions of the nervous system.

Patient advice:

• Advise patients that this drug may cause serious adverse reactions of the nervous system including myelitis, radiculitis, elevated intracranial pressure, papilledema, and aseptic meningitis.

Further information

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

Medical Disclaimer