MedeliX
Start asking

Rurioctocog Alfa Pegol

Adynovi · ATC code B02BD02

Also known as: Rurioktokog alfa pegol · Brand names: Adynovi, Advate, Adynovate, Beriate, Elocta, Emoclot, Esperoct, Factor Viii, Faktor Viii, Fanhdi, Haemoctin SDH, Hemofil-M, Koate-Dvi, Novoeight, Octanate …

Key facts
Active substance
Rurioctocog Alfa Pegol
ATC code
B02BD02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
ADYNOVI 250 IU / 5 ml powder and solvent for solution for injection / ADYNOVI 500 IU / 5 ml powder and solvent for solution for injection / ADYNOVI 1 000 IU / 5 ml powder and solvent for solution for injection · ADYNOVI 250 IU / 2 ml powder and solvent for solution for injection / ADYNOVI 500 IU / 2 ml powder and solvent for solution for injection / ADYNOVI 1 000 IU / 2 ml powder and solvent for solution for injection
Marketing authorisation holder
Baxalta Innovations GmbH
Information as of
2026-10-28

Key facts

Rurioctocog alfa pegol is a pegylated recombinant coagulation factor VIII. It is used to treat and prevent bleeding in haemophilia A from 12 years of age.

What it is used for

  • Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency) (Adynovi).

Dosing

  • Intravenous use under the supervision of a physician experienced in haemophilia; determine factor VIII levels to guide dose and frequency, especially for major surgery.
  • On demand: 1 IU factor VIII per kg body weight raises factor VIII activity by 2 IU/dl; required units = body weight (kg) x desired rise (%) x 0.5. See the full text for target levels by bleed type.
  • Long-term prophylaxis: 40 to 50 IU per kg body weight twice weekly at 3 to 4 day intervals; adjust by factor VIII levels and bleeding tendency.
  • Adolescents 12 to 18 years as for adults; for children below 12 years see the full text.

Contraindications

  • Hypersensitivity to the active substance, to the parent molecule octocog alfa or to any of the excipients.
  • Known allergic reaction to mouse or hamster protein.

Important warnings

  • Allergic hypersensitivity reactions including anaphylaxis; contains traces of mouse and hamster proteins. Stop immediately if symptoms occur.
  • Formation of neutralising antibodies (inhibitors) to factor VIII, with the highest risk within the first 50 exposure days; monitor for inhibitors.
  • The name and batch number should be recorded. See the full text for further warnings.

Side effects

  • Common: headache, dizziness; uncommon: including hypersensitivity, ocular hyperaemia, flushing.
  • Factor VIII inhibition: uncommon in previously treated, very common in previously untreated patients.
  • Rarely, hypersensitivity or allergic reactions that may progress to severe anaphylaxis (including shock).

Interactions

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

Pregnancy and breastfeeding

  • No experience in pregnancy and breast-feeding; factor VIII 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.

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)

  • AdynoviBaxalta Innovations GmbH · EMEA/H/C/004195

Source: European Medicines Agency (EMA), product information

Turkey

  • AdvateTAKEDA İLAÇ SAĞLIK SAN. TİC. LTD. ŞTİ. · 6 register entries
  • AdynovateTAKEDA İLAÇ SAĞLIK SAN. TİC. LTD. ŞTİ. · 5 register entries
  • BeriateCSL BEHRİNG BİYOTERAPİ İLAÇ DIŞ TİC. A.Ş. · 2 register entries
  • EloctaPROCEUTİCA İLAÇ PAZARLAMA VE DANIŞMANLIK A.Ş. · 6 register entries
  • EmoclotKEDRİON BETAPHAR BİYOFARMASÖTİK İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • EsperoctNOVO NORDİSK SAĞLIK ÜRÜNLERİ TİC LTD. ŞTİ. · 5 register entries
  • Factor ViiiVİTALİS SAĞLIK ÜRÜNLERİ DANIŞMANLIK VE TİC. A.Ş. · 1 register entry
  • Faktor ViiiVİTALİS SAĞLIK ÜRÜNLERİ DANIŞMANLIK VE TİC. A.Ş. · 1 register entry
  • FanhdiDEM İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • Haemoctin SDHMAXICELLS İLAÇ SAN. A.Ş. · 2 register entries
  • Hemofil-MTAKEDA İLAÇ SAĞLIK SAN. TİC. LTD. ŞTİ. · 2 register entries
  • Koate-DviDEM İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
Show all 16 brand names
  • NovoeightNOVO NORDİSK SAĞLIK ÜRÜNLERİ TİC LTD. ŞTİ. · 6 register entries
  • OctanateBERK İLAÇ İTHALAT VE PAZARLAMA A.Ş · 2 register entries
  • OptivateVİTALİS SAĞLIK ÜRÜNLERİ DANIŞMANLIK VE TİC. A.Ş. · 1 register entry
  • Refacto AFPFİZER PFE İLAÇLARI A.Ş. · 5 register entries

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

Brand names in 3 more European countries
Iceland
Adynovi
Liechtenstein
Adynovi
Norway
Adynovi

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