Product Dossier
REFIXIA
Product Dossier for REFIXIA (nonacog beta pegol, Novo Nordisk Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Novo Nordisk Pharmaceuticals
- Active ingredient: nonacog beta pegol
- Therapeutic area: Haematology
- Same area: REVOLADE
- Same area: NOVICRIT
What it is
REFIXIA is a nonacog beta pegol powder and solvent for solution for injection supplied in four strengths: 500 IU, 1000 IU, 2000 IU, and 3000 IU. Nonacog beta pegol has an improved pharmacokinetic profile with a longer half-life due to its PEG moiety, enabling once-weekly dosing for haemophilia B patients.
Approved indications
— Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia B (congenital factor IX deficiency).
Key safety warnings
The TGA's evaluation supported the product's efficacy and safety for its proposed use. No specific safety warnings are detailed in the available regulatory documentation.
Regulatory history
REFIXIA was approved on 2019-09-02 for treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia B (congenital factor IX deficiency). ARTG registrations for the 500 IU, 1000 IU, and 2000 IU strengths were first listed on 2019-09-04. A 3000 IU strength was added to the ARTG on 2024-11-12.