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nusinersen

Spinraza · ATC code M09AX07

Key facts
Active substance
nusinersen
ATC code
M09AX07
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Spinraza 12 mg solution for injection / Spinraza 28 mg solution for injection / Spinraza 50 mg solution for injection
Marketing authorisation holder
Biogen Netherlands B.V.
Information as of
2026-10-27

Key facts

Nusinersen is an antisense oligonucleotide given intrathecally by lumbar puncture. It is indicated for the treatment of 5q spinal muscular atrophy (SMA).

What it is used for

  • 5q spinal muscular atrophy (SMA)
  • Treatment should start as early as possible after diagnosis, by physicians experienced in SMA

Dosing

  • Low dose regimen: 12 mg on Day 0, 14, 28 and 63, then 12 mg once every 4 months.
  • High dose regimen: 50 mg on Day 0 and Day 14, then 28 mg once every 4 months.
  • Switching from 12 mg to 50/28 mg: one 50 mg loading dose at least 4 months after the last 12 mg dose, then 28 mg every 4 months.
  • Delayed or missed doses follow the tables in the full text.
  • Review the need for continued therapy regularly and individually.

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Risks of the lumbar puncture procedure (e.g. arachnoiditis, headache, back pain, vomiting); harder in very young patients and scoliosis
  • Thrombocytopenia and coagulation abnormalities seen with other antisense oligonucleotides; consider testing beforehand
  • Renal toxicity seen with other antisense oligonucleotides; consider urine protein testing
  • Communicating hydrocephalus reported post-marketing

Side effects

  • Very common: headache, vomiting, back pain (related to lumbar puncture)
  • Frequency not known: meningitis, aseptic meningitis, arachnoiditis, hypersensitivity

Interactions

  • No interaction studies; in vitro not an inducer or inhibitor of CYP450 metabolism
  • Low likelihood of interactions via plasma protein binding or transporters

Pregnancy and breastfeeding

  • As a precaution, preferably avoided during pregnancy.
  • Breast-feeding: weigh benefits for child and mother; a risk to infants cannot be excluded.

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

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)

  • SpinrazaBiogen Netherlands B.V. · EMEA/H/C/004312

Source: European Medicines Agency (EMA), product information

Turkey

  • SpinrazaBİOGEN TURKEY İLAÇ TİC. LTD. ŞTİ. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

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

EMA – Article 57 product data (EU/EEA), 2026-10-28

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

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Spinraza – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/spinraza-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · 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.