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emicizumab

Hemlibra · ATC code B02BX06

Also known as: Emisizumab

Key facts
Active substance
emicizumab
ATC code
B02BX06
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Hemlibra 30 mg/mL solution for injection / Hemlibra 150 mg/mL solution for injection
Marketing authorisation holder
Roche Registration Limited
Information as of
2026-10-28

Key facts

Emicizumab (Hemlibra) is a bispecific monoclonal antibody that takes over the function of missing activated factor VIII and is used for routine bleeding prophylaxis in haemophilia A.

What it is used for

  • Routine prophylaxis of bleeding episodes in haemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.
  • Without inhibitors in severe disease (FVIII < 1%) or moderate disease (FVIII ≥ 1% and ≤ 5%) with a severe bleeding phenotype.
  • Can be used in all age groups.

Dosing

  • Loading: 3 mg/kg once weekly for the first 4 weeks, subcutaneously.
  • Maintenance from week 5, by preference: 1.5 mg/kg once weekly, 3 mg/kg every two weeks or 6 mg/kg every four weeks.
  • Stop bypassing agents (aPCC, rFVIIa) the day before starting; FVIII prophylaxis may continue for the first 7 days.
  • No more than 2 mL per injection; do not combine the 30 mg/mL and 150 mg/mL concentrations in one syringe. For dose and volume calculation see the full text.

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Thrombotic microangiopathy and thrombotic events occurred when on average a cumulative amount of >100 U/kg/24 hours of aPCC was given for 24 hours or more.
  • Possible hypercoagulability with rFVIIa or FVIII; lower doses may achieve haemostasis. Follow bypassing agent dosing guidance for at least 6 months after stopping emicizumab.
  • Intrinsic pathway coagulation tests (e.g. aPTT, ACT) give overly shortened clotting times with emicizumab and should not be used to monitor its activity.
  • Neutralising antibodies with loss of efficacy (increased breakthrough bleeding) have been uncommonly observed.

Side effects

  • Most common (≥ 10%): injection site reactions (19.4%), arthralgia (14.2%) and headache (14.0%).
  • Most serious: thrombotic microangiopathy and thrombotic events, including cavernous sinus thrombosis and superficial vein thrombosis with skin necrosis.

Interactions

  • Interaction with aPCC (risk of TMA and thrombosis).
  • Possible hypercoagulability with rFVIIa or FVIII; consider discontinuation in case of thrombosis.

Pregnancy and breastfeeding

  • Women of childbearing potential should use effective contraception during and for at least 6 months after stopping treatment.

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)

  • HemlibraRoche Registration Limited · EMEA/H/C/004406

Source: European Medicines Agency (EMA), product information

Turkey

  • HemlibraROCHE MÜSTAHZARLARI SAN.A.Ş. · 4 register entries

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

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

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