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Lonoctocog Alfa

Afstyla · ATC code B02BD02

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

Key facts
Active substance
Lonoctocog Alfa
ATC code
B02BD02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
AFSTYLA 250 IU powder and solvent for solution for injection / AFSTYLA 500 IU powder and solvent for solution for injection / AFSTYLA 1000 IU powder and solvent for solution for injection
Marketing authorisation holder
CSL Behring GmbH
Information as of
2026-10-28

Key facts

Lonoctocog alfa (Afstyla) is a recombinant single-chain coagulation factor VIII used to treat and prevent bleeding in patients with haemophilia A.

What it is used for

  • Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency), in all age groups.

Dosing

  • Intravenous injection under the supervision of a physician experienced in haemophilia; dose and duration depend on the severity of the deficiency, the site and extent of bleeding and the clinical condition.
  • On demand: 1 IU factor VIII per kg raises plasma factor VIII activity by 2 IU/dl; dose (IU) = body weight (kg) x desired rise (IU/dl) x 0.5. See the full text for bleeding- and surgery-specific targets.
  • Prophylaxis: starting regimen 20 to 50 IU/kg 2 to 3 times weekly, adjusted to response.
  • Children 0 to <12 years: 30 to 50 IU per kg 2 to 3 times weekly; more frequent or higher doses may be needed.
  • Injected slowly at a maximum rate of 10 ml/min. The chromogenic assay is preferred for monitoring; one-stage clotting assay results should be multiplied by a conversion factor of 2.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients.
  • Known allergic reaction to hamster proteins.

Important warnings

  • Allergic hypersensitivity reactions are possible (the product contains traces of hamster proteins); use should be stopped immediately if symptoms occur.
  • Neutralising antibodies (inhibitors) to factor VIII may develop, with the highest risk within the first 50 exposure days; patients should be monitored.
  • In case of shock, standard medical treatment for shock should be implemented.

Side effects

  • Common: hypersensitivity, dizziness, paraesthesia, rash, pyrexia.
  • Uncommon: erythema, pruritus, injection site pain, chills, feeling hot.
  • Factor VIII inhibition: uncommon in previously treated patients, very common in previously untreated patients.

Interactions

  • No interactions of human coagulation factor VIII products with other medicinal products 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 →

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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)

  • AfstylaCSL Behring GmbH · EMEA/H/C/004075

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
Afstyla
Liechtenstein
Afstyla
Norway
Afstyla

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.

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Sources

  1. European Medicines Agency. Afstyla – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/afstyla-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.