Octocog Alfa
Advate, Kovaltry · ATC code B02BD02
Also known as: Oktokog alfa · Brand names: Advate, Kovaltry, Recombinate, Adynovate, Beriate, Elocta, Emoclot, Esperoct, Factor Viii, Faktor Viii, Fanhdi, Haemoctin SDH, Hemofil-M, Koate-Dvi, Novoeight …
- Key facts
- Active substance
- Octocog Alfa
- ATC code
- B02BD02
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- ADVATE 250 IU/5 ml powder and solvent for solution for injection / ADVATE 500 IU/5 ml powder and solvent for solution for injection / ADVATE 1 000 IU/5 ml powder and solvent for solution for injection · ADVATE 250 IU/2 ml powder and solvent for solution for injection / ADVATE 500 IU/2 ml powder and solvent for solution for injection / ADVATE 1 000 IU/2 ml powder and solvent for solution for injection · Kovaltry 250 IU powder and solvent for solution for injection / Kovaltry 500 IU powder and solvent for solution for injection / Kovaltry 1000 IU powder and solvent for solution for injection
- Marketing authorisation holder
- Takeda Manufacturing Austria AG, Bayer AG
- Information as of
- 2026-10-28
Key facts
Octocog alfa (Advate, Kovaltry) is a recombinant coagulation factor VIII for treatment and prophylaxis of bleeding in haemophilia A in all age groups.
What it is used for
- Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency), all age groups (Advate and Kovaltry).
Dosing
- On-demand treatment (both products): required units = body weight (kg) x desired factor VIII rise (%) x 0.5; target factor VIII levels depend on the bleed, e.g. 20 – 40 % for early haemarthrosis, muscle or oral bleeding, repeated every 12 to 24 hours.
- Advate, long-term prophylaxis in severe haemophilia A: usually 20 to 40 IU/kg body weight at intervals of 2 to 3 days; younger patients may need shorter intervals or higher doses.
- Kovaltry, long-term prophylaxis: adolescents ≥ 12 years and adults 20 to 40 IU/kg two to three times per week; children 0 - 12 years 20-50 IU/kg twice weekly, three times weekly or every other day.
- Measure factor VIII levels to guide dosing, especially in major surgery; surgical dosing see the full text.
- Intravenous use under supervision of a physician experienced in haemophilia.
Contraindications
- Hypersensitivity to the active substance or any excipient.
- Known allergic reaction to mouse or hamster protein.
Important warnings
- Allergic hypersensitivity reactions including anaphylaxis; discontinue immediately if symptoms occur.
- Neutralising antibodies (inhibitors) to factor VIII, risk highest within the first 50 exposure days; monitor regularly.
- In patients with existing cardiovascular risk factors, substitution therapy may increase cardiovascular risk.
- Catheter-related complications are possible with central venous access.
Side effects
- Advate: most frequent were factor VIII inhibitor development, headache and fever.
- Kovaltry: most frequent were pyrexia, headache and rash; in previously untreated patients the most frequent was FVIII inhibitor.
- Rarely hypersensitivity reactions up to severe anaphylaxis; antibodies to mouse and hamster protein may develop.
Interactions
- No interactions of recombinant factor VIII products with other medicines have been reported.
Pregnancy and breastfeeding
- Use during pregnancy and breast-feeding only if clearly indicated; 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.
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)
Source: European Medicines Agency (EMA), product information
Germany
- RecombinateTakeda Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
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 6 more European countries
- Iceland
- Advate, Kovaltry
- Italy
- Recombinate
- Liechtenstein
- Advate, Kovaltry
- Lithuania
- Recombinate
- Netherlands
- Recombinate
- Norway
- Advate, Kovaltry
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. Advate – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/advate-epar-product-information_en.pdf
- European Medicines Agency. Kovaltry – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/kovaltry-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- 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.