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tofersen

Qalsody · ATC code N07XX22

Key facts
Active substance
tofersen
ATC code
N07XX22
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Qalsody 100 mg solution for injection
Marketing authorisation holder
Biogen Netherlands B.V.
Information as of
2026-10-28

Key facts

Tofersen (Qalsody) is an antisense oligonucleotide that reduces production of the SOD1 protein and is used in adults with SOD1-associated amyotrophic lateral sclerosis (ALS).

What it is used for

  • Treatment of adults with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene.

Dosing

  • 100 mg tofersen per treatment as an intrathecal bolus injection by lumbar puncture over 1 to 3 minutes; about 10 ml of CSF is removed beforehand.
  • Start with 3 loading doses at 14-day intervals, then a maintenance dose once every 28 days.
  • Give missed doses as soon as possible; subsequent intervals run from that dose (see the full text).
  • Not studied in renal or hepatic impairment; no special dose considerations by age. Review the need to continue regularly on an individual basis.

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Risks of the lumbar puncture procedure (headache, back pain, post lumbar puncture syndrome, infection).
  • Serious cases of myelitis and radiculitis.
  • Serious cases of increased intracranial pressure and/or papilloedema.
  • Thrombocytopenia and coagulation abnormalities seen with other antisense oligonucleotides; platelet and coagulation tests before dosing if clinically indicated.
  • Renal toxicity may occur (see the full text).

Side effects

  • Most common: pain (68.7%), arthralgia (36.7%), fatigue (30.6%), CSF white blood cell increased (27.9%), CSF protein increased (26.5%), myalgia (22.4%) and pyrexia (20.4%).
  • Serious: myelitis (4.1%), increased intracranial pressure and/or papilloedema (2.7%), radiculitis (1.4%) and aseptic meningitis (1.4%).

Interactions

  • No interaction studies; co-administration of other intrathecal medicines not evaluated. No effect on CYP450 metabolism expected.

Pregnancy and breastfeeding

  • Not recommended during pregnancy or in women of childbearing potential not using contraception.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • QalsodyBiogen Netherlands B.V. · EMEA/H/C/005493

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Qalsody
Liechtenstein
Qalsody
Norway
Qalsody

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Sources

  1. European Medicines Agency. Qalsody – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/qalsody-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.