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Nonacog Alfa

BeneFIX · ATC code B02BD04

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

Key facts
Active substance
Nonacog Alfa
ATC code
B02BD04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
BeneFIX 250 IU powder and solvent for solution for injection / BeneFIX 500 IU powder and solvent for solution for injection / BeneFIX 1000 IU powder and solvent for solution for injection
Marketing authorisation holder
Pfizer Europe MA EEIG
Information as of
2026-10-28

Key facts

Nonacog alfa (BeneFIX) is a recombinant coagulation factor IX used to treat and prevent bleeding in haemophilia B.

What it is used for

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

Dosing

  • Dose and duration depend on the severity of factor IX deficiency, the location and extent of bleeding and the clinical condition; doses are expressed in International Units (IU).
  • On-demand treatment: body weight (kg) × desired factor IX increase (% or IU/dL) × reciprocal of observed recovery; one IU per kg raises factor IX by an average of 0.8 IU/dL (range 0.4 to 1.4 IU/dL) in patients ≥ 12 years.
  • Factor IX levels should be monitored during treatment, especially in major surgery; dosing may need adjustment in underweight or overweight patients.
  • For prophylaxis regimens and paediatric details, see the full text.
  • Under supervision of a physician experienced in haemophilia; initial administrations may be given under medical observation.

Contraindications

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

Important warnings

  • Allergic hypersensitivity reactions up to anaphylaxis are possible (contains traces of hamster proteins); stop immediately and contact a physician if symptoms occur.
  • Factor IX inhibitor development: patients should be monitored carefully; allergic reactions may be associated with inhibitors.
  • Risk of thrombosis and disseminated intravascular coagulation, particularly with fibrinolysis or DIC.
  • Nephrotic syndrome has been reported after immune tolerance induction in patients with inhibitors.

Side effects

  • Hypersensitivity reactions (including angioedema, infusion-site burning, chills, flushing, urticaria, headache, hypotension, nausea, tachycardia) that may progress to severe anaphylaxis.
  • Others: headache, dizziness, dysgeusia, cough, pyrexia, infusion-site reactions, factor IX inhibition, thrombosis.
  • Allergic reactions might be experienced more frequently in children.

Interactions

  • No interactions with other medicines have been reported.

Pregnancy and breastfeeding

  • Use in pregnancy and breast-feeding only if clearly indicated, as 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 →

Common questions – ask Medelix

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)

  • BeneFIXPfizer Europe MA EEIG · EMEA/H/C/000139

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 3 more European countries
Iceland
Benefix
Liechtenstein
Benefix
Norway
Benefix

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

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