Eftrenonacog Alfa
Alprolix · ATC code B02BD04
Also known as: Eftrenonakog alfa · Brand names: Alprolix, Aımafıx, Benefix, Haemonine, Immunine, Nonafact, Octanine F, Reblenine VF, Refixia, Rixubis
- Key facts
- Active substance
- Eftrenonacog Alfa
- ATC code
- B02BD04
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- ALPROLIX 250 IU powder and solvent for solution for injection / ALPROLIX 500 IU powder and solvent for solution for injection / ALPROLIX 1000 IU powder and solvent for solution for injection
- Marketing authorisation holder
- Swedish Orphan Biovitrum AB (publ)
- Information as of
- 2026-10-28
Key facts
Eftrenonacog alfa is a recombinant coagulation factor IX fused to an Fc fragment. It is used to treat and prevent 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); can be used in all age groups (Alprolix).
Dosing
- Alprolix is injected intravenously over several minutes (no more than 10 mL/min); treatment under the supervision of a physician experienced in haemophilia.
- On-demand treatment: dose based on body weight, desired factor IX rise and observed recovery; 1 IU/kg raises factor IX activity by about 1% of normal. See the full text for target levels by type of bleed or surgery.
- Prophylaxis, adults and adolescents 12 years and older: 50 IU/kg once weekly or 100 IU/kg once every 10 days, adjusted to individual response; highest recommended prophylactic dose 100 IU/kg.
- Children below 12 years: higher or more frequent doses may be needed; recommended starting dose 50-60 IU/kg every 7 days.
- Factor IX levels should be determined during treatment, especially for major surgery; some aPTT reagents (kaolin-based) may underestimate activity.
Contraindications
- Hypersensitivity to the active substance or any of the excipients.
Important warnings
- Allergic hypersensitivity reactions up to anaphylaxis are possible; stop immediately if symptoms occur.
- Monitor for neutralising antibodies (inhibitors); inhibitors may be associated with allergic reactions and an increased risk of anaphylaxis.
- Thromboembolic complications are possible, especially in liver disease, after surgery, in neonates or with a risk of DIC.
- Existing cardiovascular risk factors: cardiovascular risk may increase; consider catheter-related complications with a central venous access device.
Side effects
- Common: headache, factor IX inhibition, hypersensitivity; uncommon: including decreased appetite, dizziness, dysgeusia.
- Rare: hypersensitivity or allergic reactions, which may progress to severe anaphylaxis (including shock).
- Nephrotic syndrome has been reported after attempted immune tolerance induction in patients with inhibitors.
Interactions
- No interactions have been reported; no interaction studies have been performed.
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)
- AlprolixSwedish Orphan Biovitrum AB (publ) · EMEA/H/C/004142
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
- Alprolix
- Liechtenstein
- Alprolix
- Norway
- Alprolix
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. Alprolix – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/alprolix-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.