Concizumab
Other Systemic Hemostatics
Sold as ALHEMO
- Drug class
- Other Systemic Hemostatics
- Availability
- Prescription only
- Routes
- Subcutaneous
- Markets covered
- 4
- Products on record
- 10
- FDA reports (12 mo)
- 19
Overview
Plain-language summary, compiled from the cited regulatory records
Concizumab is a medication belonging to the drug class of other systemic hemostatics [1]. It is approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older who have hemophilia A or hemophilia B [1]. This includes patients with or without factor VIII (FVIII) or factor IX (FIX) inhibitors, respectively [1].
Concizumab is available under the brand name Alhemo [1]. In the past 12 months, there have been 19 adverse event reports associated with this active ingredient [2]. Common adverse events reported include haemarthrosis, injection site pain, and haematoma muscle [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 4 | May 15, 2026 |
| CA Canada | Health Canada | 4 | March 22, 2025 |
| US United States | FDA | 1 | July 1, 2025 |
| EU European Union | EMA | 1 | September 25, 2025 |
GBUnited Kingdom· MHRA
4 products
Uses
Alhemo is indicated for routine prophylaxis of bleeding in patients with: • haemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and of 12 years of age or more. • haemophilia B (congenital factor IX deficiency) with FIX inhibitors and of 12 years of age or more.
How to take
CACanada· Health Canada
4 products
Uses
TBD TABLE OF CONTENTS TABLE OF CONTENTS ........................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ...............................................................
4 1 INDICATIONS ............................................................................................................... 1 Pediatrics................................................................................................................
2 Geriatrics ................................................................................................................ 4 2 CONTRAINDICATIONS ................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS .............................................................. 4 4 DOSAGE AND ADMINISTRATION .............................................................................. 1 Dosing Considerations............................................................................................
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE Alhemo is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with: • hemophilia A (congenital factor VIII deficiency) with or without FVIII inhibitors • hemophilia B (congenital factor IX deficiency) with or without FIX inhibitors Alhemo is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with: • hemophilia A (congenital factor VIII deficiency) with or without FVIII inhibitors • hemophilia B (congenital factor IX deficiency) with or without FIX inhibitors ( 1 )
How to take
EUEuropean Union· EMA
1 product
Uses
Alhemo is indicated for routine prophylaxis of bleeding in patients 12 years of age or more with: • haemophilia A (congenital factor VIII deficiency) with FVIII inhibitors. • severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%) without FVIII inhibitors.
• haemophilia B (congenital factor IX deficiency) with FIX inhibitors. • moderate/severe haemophilia B (congenital factor IX deficiency, FIX ≤ 2%) without FIX inhibitors.
How to take
Sources & citations
- [1]MHRA (UK) · PL046680456 · revised May 15, 2026
- [2]Health Canada (DPD) · 02536080 · revised March 22, 2025
- [3]FDA DailyMed · 156f6404-1f6f-41… · revised July 1, 2025 [PDF]
- [4]European Medicines Agency · EMEA/H/C/005938 · revised September 25, 2025
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.