Long-acting recombinant coagulation factor IX

Albutrepenonacog alfa (ألبوتريبينوناكوج ألفا)

Albutrepenonacog alfa is a long-acting recombinant factor IX replacement for people with haemophilia B. It prevents and treats bleeding and supports surgery under the supervision of a specialist haemophilia centre.

This medicine is used under close medical supervision, usually by a specialist. Never start, stop or change it without your doctor.

What it is used for

  • Routine prevention of bleeding in people with haemophilia B
  • Treatment of bleeding episodes when they occur
  • Prevention and control of bleeding before, during and after surgery

How it is used

  • The haemophilia centre sets the plan and dose from the clinical situation and test results
  • The powder is mixed with its supplied solvent and injected into a vein after training; a patient or caregiver may give it if the team approves
  • Use only the pack equipment, inspect the solution and do not use it if cloudy or particulate
  • Record the product name and batch number with every injection and report every bleed to the centre
  • Do not mix it with other medicines in the syringe or intravenous line

Possible side effects

  • Headache or dizziness
  • Injection-site reaction
  • Rash or itching
  • Development of antibodies that reduce factor IX effectiveness
  • Rare severe hypersensitivity or thrombosis

Who should not use it

  • Allergy to albutrepenonacog alfa or any product ingredient
  • Known allergy to hamster proteins

Before and while using it

  • Stop the injection and seek urgent help for breathing difficulty, facial swelling, hives or severe dizziness
  • If bleeding does not respond as usual, factor IX antibodies may have developed; contact the centre immediately
  • Thrombosis risk can rise in selected patients, especially with liver disease, after surgery, in newborns or with other risk factors
  • An intravenous access device requires monitoring for infection and clots
  • Do not change factor IX product or the prevention plan without the haemophilia team
  • Keep a record of the product name and batch number for traceability

Medicine interactions

  • No important medicine interactions are known, but tell the haemophilia centre about all medicines and supplements
  • Anticoagulants and antiplatelet medicines can increase bleeding and require specialist supervision
  • Do not mix it with another product in the same syringe or infusion line

Pregnancy and breastfeeding

  • Haemophilia B is rare in women and pregnancy data are limited; use only when a specialist identifies a clear need
  • Tell the team if you are breastfeeding so treatment benefit can be weighed against limited information on transfer into milk

How to store it

  • Keep in the original pack protected from light under the labelled refrigeration or temperature conditions; do not freeze, and use the prepared solution as the leaflet directs

Get medical help straight away if

  • Your face, lips or tongue swell, or you find it hard to breathe.
  • You get a severe rash, blistering or peeling skin.
  • A side effect worries you or doesn’t go away: contact your doctor or pharmacist.

Questions about this medicine?

Talk to a doctor by video, or send your question by text.

Source: Standard international medicine references

This guide is general information and doesn’t replace advice from your doctor or pharmacist. Don’t start, stop or change a medicine without asking them, and always read the leaflet in the pack.