Product Dossier
Rixubis
Product Dossier for Rixubis (nonacog gamma, water for injections, Takeda Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by…
- Sponsor: Takeda Pharmaceuticals
- Active ingredient: nonacog gamma, water for injections
- Therapeutic area: Haematology
- Same area: REVOLADE
- Same area: NOVICRIT
What it is
RIXUBIS is a recombinant coagulation factor IX (rFIX), nonacog gamma (rch). It is presented as a white lyophilised powder and diluent for solution, for intravenous administration. The product is available in strengths of 250 IU, 500 IU, 1000 IU, 2000 IU, and 3000 IU.
Approved indications
— Routine prophylaxis of bleeding episodes in patients with haemophilia B — Treatment and prevention of bleeding episodes in patients with haemophilia B (congenital factor IX deficiency) — Peri-operative management in patients with haemophilia B
Dosing overview
The dosage and duration of substitution therapy depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and pharmacokinetic parameters of factor IX, such as incremental recovery and half-life. For patients over 12 years of age, 1 IU of RIXUBIS per kg body weight is expected to increase the circulating level of factor IX by 0.9 IU/dL of plasma (0.9% of normal). For patients under 12 years of age, 1 IU of RIXUBIS per kg body weight is expected to increase the circulating level of factor IX by 0.7 IU/dL of plasma (0.7% of normal). Doses administered should be titrated to the patient's clinical response and individual pharmacokinetics, in particular incremental recovery and half-life.
Key safety warnings
Patients using RIXUBIS should be monitored for the development of factor IX inhibitors by appropriate clinical observations and laboratory tests. If expected plasma factor IX activity levels are not attained, or if bleeding is not controlled with an expected dose, an assay that measures factor IX inhibitor concentration should be performed. Careful monitoring using an appropriate factor IX activity assay is advised and, if necessary, appropriate adjustments to the dose and the frequency of repeated infusions should be performed.
Regulatory history
RIXUBIS nonacog gamma (rch) in five strengths (250 IU, 500 IU, 1000 IU, 2000 IU, and 3000 IU) were first listed on the ARTG on 5 February 2014. The AusPAR approval date was 30 January 2014.