Albutrepenonacog Alfa
Idelvion · ATC code B02BD04
Also known as: Albutrepenonakog alfa · Brand names: Idelvion, Aımafıx, Alprolix, Benefix, Haemonine, Immunine, Nonafact, Octanine F, Reblenine VF, Refixia, Rixubis
- Key facts
- Active substance
- Albutrepenonacog Alfa
- ATC code
- B02BD04
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- IDELVION 250 IU powder and solvent for solution for injection / IDELVION 500 IU powder and solvent for solution for injection / IDELVION 1000 IU powder and solvent for solution for injection
- Marketing authorisation holder
- CSL Behring GmbH
- Information as of
- 2026-10-28
Key facts
Albutrepenonacog alfa (Idelvion) is a recombinant coagulation factor IX fused to albumin, used to treat and prevent bleeding in patients with 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
- Given as an intravenous injection under the supervision of a physician experienced in treating haemophilia B; dose and duration depend on the severity of the deficiency, the site and extent of bleeding and the clinical condition.
- On-demand dosing is calculated from body weight and the desired factor IX rise: 1 IU/kg raises factor IX activity by an average of 1.3 IU/dl in patients ≥ 12 years and 1.0 IU/dl in patients < 12 years.
- Surgery: for major surgery 60 - 100 IU/dl factor IX target (pre- and postoperative), repeated every 24 – 72 hours in the first week; see the full text for bleeding-specific targets.
- Long-term prophylaxis in severe haemophilia B: usually 35 to 50 IU/kg once weekly; well-controlled patients may receive up to 75 IU/kg every 10 or 14 days.
- Children: prophylaxis 35 to 50 IU/kg once weekly; younger patients may need shorter intervals or higher doses.
- Factor IX levels should be monitored; some aPTT reagents (kaolin-based, Actin FS) can underestimate activity.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Known allergic reaction to hamster protein.
Important warnings
- Allergic hypersensitivity reactions, including anaphylaxis, are possible; the product contains traces of hamster proteins. Treatment should be stopped immediately if symptoms occur.
- Neutralising antibodies (inhibitors) to factor IX may develop; patients should be monitored, and those with allergic reactions evaluated for an inhibitor.
- Patients with factor IX inhibitors may be at increased risk of anaphylaxis on re-exposure.
- Nephrotic syndrome has been reported after attempted immune tolerance induction in patients with inhibitors and a history of allergic reaction.
- There is a potential risk of thromboembolic events with factor IX products.
Side effects
- Common: hypersensitivity, headache, dizziness, rash, injection site reactions.
- Uncommon: eczema.
- Not known: factor IX inhibitor development.
- Severe allergic reactions progressing to anaphylaxis have been observed rarely.
Interactions
- No interactions of recombinant factor IX products with other medicinal products have been reported.
Pregnancy and breastfeeding
- No experience in pregnancy and breast-feeding; factor IX should be used 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.
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)
- IdelvionCSL Behring GmbH · EMEA/H/C/003955
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
- Idelvion
- Liechtenstein
- Idelvion
- Norway
- Idelvion
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
- European Medicines Agency. Idelvion – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/idelvion-epar-product-information_en.pdf
- 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.