Tofersen
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From MedlinePlus, U.S. National Library of Medicine
Antisense Oligonucleotide
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Your numbers for tofersen. Take vial strength, diluent, and limits from the label below.
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Inspect the solution in the QALSODY vial prior to administration. Do not administer if particles are observed or the liquid in the vial is not clear and colorless to slightly yellow. Do not shake the QALSODY vial. Procedural preparation instructions If indicated by the clinical condition of the patient, consider sedation.
Do not dilute QALSODY. External filters are not required. Administer QALSODY using a lumbar puncture needle as an intrathecal bolus injection over 1 to 3 minutes. QALSODY contains no preservatives. Once drawn into the syringe, the solution should be administered immediately (within 4 hours of removal from the vial) at room temperature; otherwise, it must be discarded.
Drug interactions
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- Tofersen
Contraindications
None. None ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ELikelihood score E: Unlikely cause of clinically apparent liver injury.
Tofersen is an antisense oligonucleoside directed against mutated forms of SOD1 used in the treatment of adults with amyotrophic lateral sclerosis with mutations in the SOD1 gene. Tofersen has been associated with minor liver test abnormalities during therapy but has not been linked instances of clinically apparent liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1. Pregnancy Risk Summary There are no adequate data on developmental risks associated with the use of QALSODY in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.
Data Animal Data Subcutaneous administration of tofersen (0, 3, 10, 30 mg/kg) every other day to pregnant mice during the period of organogenesis resulted in no adverse effects on embryofetal development. Plasma exposure at the highest dose tested (30 mg/kg) was approximately 4 times that in humans at the recommended human dose (RHD) of 100 mg. Subcutaneous administration of tofersen (0, 3, 10, 30 mg/kg) every other day to pregnant rabbits during the period of organogenesis resulted in no adverse effects on embryofetal development. Plasma exposure at the highest dose tested (30 mg/kg) was approximately 20 times that in humans at the RHD.
Subcutaneous administration of tofersen (0, 3, 10, or 30 mg/kg) every other day to male and female mice prior to and during mating and continuing in females throughout organogenesis resulted in no adverse effects on pre- or postnatal development. Plasma exposures at the highest dose tested (30 mg/kg) were approximately 4 times that in humans at the RHD.
Breastfeeding (LactMed)
No information is available on the clinical use of tofersen during breastfeeding. Because small doses of tofersen are given intrathecally, amounts in the breastmilk are likely to be low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. If tofersen is required by the mother, it is not a reason to discontinue breastfeeding.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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