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Nonacog Gamma

Rixubis · ATC code B02BD04

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

Key facts
Active substance
Nonacog Gamma
ATC code
B02BD04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
RIXUBIS 250 IU powder and solvent for solution for injection / RIXUBIS 500 IU powder and solvent for solution for injection / RIXUBIS 1000 IU powder and solvent for solution for injection
Marketing authorisation holder
Baxalta Innovations GmbH
Information as of
2026-10-28

Key facts

Nonacog gamma (Rixubis) is a recombinant coagulation factor IX given by intravenous injection. It is 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), in all age groups.

Dosing

  • Dose and duration depend on the severity of factor IX deficiency, location and extent of bleeding, clinical condition, age and pharmacokinetics; factor IX levels should be measured to guide dosing.
  • On-demand treatment, 12 years and older: 1 International Unit of factor IX per kg body weight raises plasma factor IX activity by about 0.9 IU/dL; required units = body weight (kg) × desired rise × reciprocal of observed recovery.
  • Precise coagulation monitoring is indispensable for major surgery.
  • Prophylaxis and paediatric regimens: see the full text.

Contraindications

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

Important warnings

  • Allergic hypersensitivity reactions up to anaphylaxis are possible (traces of hamster protein); stop immediately if symptoms occur.
  • Neutralising antibodies (inhibitors) may develop; monitor patients, especially after allergic reactions.
  • Thromboembolic risk, e.g. in liver disease, post-operatively, in newborns or with risk of DIC.
  • In patients with cardiovascular risk factors, factor IX substitution may increase cardiovascular risk.

Side effects

  • Common: dysgeusia and pain in extremity.
  • Hypersensitivity reactions observed rarely, in some cases progressing to severe anaphylaxis, sometimes with factor IX inhibitors.
  • Nephrotic syndrome after immune tolerance induction in patients with inhibitors and a history of allergic reactions.

Interactions

  • No interactions with other medicines have been reported.

Pregnancy and breastfeeding

  • Use during pregnancy and breast-feeding only if clearly indicated.

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)

  • RixubisBaxalta Innovations GmbH · EMEA/H/C/003771

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
Rixubis
Liechtenstein
Rixubis
Norway
Rixubis

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