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.

See also:

Further information

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

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