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Nonacog Beta Pegol

Refixia · ATC code B02BD04

Also known as: Nonakog beta pegol · Brand names: Refixia, Aımafıx, Alprolix, Benefix, Haemonine, Immunine, Nonafact, Octanine F, Reblenine VF, Rixubis

Key facts
Active substance
Nonacog Beta Pegol
ATC code
B02BD04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Refixia 500 IU powder and solvent for solution for injection / Refixia 1 000 IU powder and solvent for solution for injection / Refixia 2 000 IU powder and solvent for solution for injection
Marketing authorisation holder
Novo Nordisk A/S
Information as of
2026-10-28

Key facts

Nonacog beta pegol (Refixia) is a pegylated, long-acting recombinant coagulation factor IX for treatment and prophylaxis of bleeding in haemophilia B in all age groups.

What it is used for

  • Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency), all age groups.

Dosing

  • Prophylaxis: 40 IU/kg body weight once weekly; doses and intervals may be adjusted based on achieved factor IX levels and individual bleeding tendency. Take a forgotten dose on discovery, avoid a double dose.
  • On-demand treatment: dose and duration depend on location and severity of bleeding; for severe or life-threatening haemorrhages additional doses of 40 IU/kg can be given – details see the full text.
  • Surgery: dose depends on the procedure and local practice, see the full text.
  • Routine factor IX activity monitoring for dose adjustment is not necessary; when needed use a chromogenic assay and avoid silica-based aPTT reagents.
  • Treatment under supervision of a physician experienced in haemophilia.

Contraindications

  • Hypersensitivity to the active substance or any excipient.
  • Known allergic reaction to hamster protein.

Important warnings

  • Allergic hypersensitivity reactions up to anaphylaxis may occur; discontinue immediately if symptoms appear.
  • Neutralising antibodies (inhibitors) to factor IX may develop; monitor, and test for inhibitors after allergic reactions.
  • Potential risk of thromboembolic episodes after factor IX products.
  • Nephrotic syndrome reported after immune tolerance induction in patients with inhibitors and a history of allergic reaction.

Side effects

  • Common: hypersensitivity, nausea, pruritus, rash, fatigue, injection site reactions; in previously untreated patients factor IX inhibition and anaphylactic reaction were common.
  • Uncommon: palpitations, hot flush.

Interactions

  • No interactions of recombinant factor IX products with other medicines have been reported.

Pregnancy and breastfeeding

  • Use during pregnancy and lactation only if clearly indicated; no experience is available.

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)

  • RefixiaNovo Nordisk A/S · EMEA/H/C/004178

Source: European Medicines Agency (EMA), product information

Turkey

  • AımafıxKEDRİON BETAPHAR BİYOFARMASÖTİK İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • AlprolixPROCEUTİCA İLAÇ PAZARLAMA VE DANIŞMANLIK A.Ş. · 5 register entries
  • BenefixPFİZER PFE İLAÇLARI A.Ş. · 4 register entries
  • HaemonineMAXICELLS İLAÇ SAN. A.Ş. · 2 register entries
  • ImmunineTAKEDA İLAÇ SAĞLIK SAN. TİC. LTD. ŞTİ. · 2 register entries
  • NonafactCENTURION PHARMA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry
  • Octanine FBERK İLAÇ İTHALAT VE PAZARLAMA A.Ş · 2 register entries
  • Reblenine VFVİTALİS SAĞLIK ÜRÜNLERİ DANIŞMANLIK VE TİC. A.Ş. · 1 register entry
  • RefixiaNOVO NORDİSK SAĞLIK ÜRÜNLERİ TİC LTD. ŞTİ. · 3 register entries
  • RixubisTAKEDA İLAÇ SAĞLIK SAN. TİC. LTD. ŞTİ. · 5 register entries

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

Brand names in 2 more European countries
Iceland
Refixia
Norway
Refixia

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. Refixia – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/refixia-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 2026-10-28 · 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.