Simoctocog Alfa
Nuwiq, Vihuma · ATC code B02BD02
Also known as: Simoktokog alfa · Brand names: Nuwiq, Vihuma, Advate, Adynovate, Beriate, Elocta, Emoclot, Esperoct, Factor Viii, Faktor Viii, Fanhdi, Haemoctin SDH, Hemofil-M, Koate-Dvi, Novoeight …
- Key facts
- Active substance
- Simoctocog Alfa
- ATC code
- B02BD02
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Nuwiq 250 IU powder and solvent for solution for injection / Nuwiq 500 IU powder and solvent for solution for injection / Nuwiq 1000 IU powder and solvent for solution for injection · Vihuma 250 IU powder and solvent for solution for injection / Vihuma 500 IU powder and solvent for solution for injection / Vihuma 1000 IU powder and solvent for solution for injection
- Marketing authorisation holder
- Octapharma AB
- Information as of
- 2026-10-28
Key facts
Simoctocog alfa is a recombinant coagulation factor VIII used to treat and prevent bleeding in haemophilia A in all age groups (Nuwiq, Vihuma).
What it is used for
- Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency); can be used for all age groups.
Dosing
- Nuwiq and Vihuma: dose and duration depend on the severity of factor VIII deficiency, location and extent of bleeding and clinical condition; monitoring of factor VIII levels is advised.
- On-demand treatment: 1 IU factor VIII per kg body weight raises factor VIII activity by approximately 2% or 2 IU/dL; required units = body weight (kg) x desired rise (%) x 0.5.
- Required factor VIII levels, e.g. 20–40% for early joint, muscle or oral bleeding, 60–100% for life-threatening haemorrhages and 80–100% for major surgery; details: see the full text.
- Long-term prophylaxis in severe haemophilia A: usually 20 to 40 IU per kg body weight every 2 to 3 days; younger patients may need shorter intervals or higher doses.
- Intravenous use, not more than 4 mL per minute.
Contraindications
- Hypersensitivity to the active substance or any excipient.
Important warnings
- Allergic hypersensitivity reactions including anaphylaxis are possible; contains traces of human host cell proteins. Stop use immediately if symptoms occur.
- Formation of neutralising antibodies (inhibitors) to factor VIII, risk highest in the first 50 exposure days; monitor carefully, especially after a product switch.
- In patients with cardiovascular risk factors, substitution therapy may increase cardiovascular risk.
- Consider catheter-related complications (infections, bacteraemia, thrombosis) with central venous access devices.
Side effects
- Factor VIII inhibition: uncommon in previously treated patients, very common in previously untreated patients.
- Common: hypersensitivity, pyrexia.
- Uncommon: anaemia, dizziness, headache, paraesthesia, vertigo, dyspnoea, dry mouth, back pain, injection site pain or inflammation.
Interactions
- No interaction studies have been performed.
Pregnancy and breastfeeding
- No experience in pregnancy or breast-feeding; use 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)
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
- Nuwiq
- Liechtenstein
- Nuwiq
- Norway
- Nuwiq
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. Nuwiq – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/nuwiq-epar-product-information_en.pdf
- European Medicines Agency. Vihuma – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/vihuma-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.