Data from FDA (Food and Drug Administration, USA) - Curated by Toby Galbraith - Last updated 19 April 2017

Indication(s)

RIXUBIS (Coagulation Factor IX [Recombinant]) is an antihemophilic factor indicated in adults and children with hemophilia B for:
• Control and prevention of bleeding episodes, perioperative management, and routine prophylaxis. (1)

RIXUBIS is not indicated for induction of immune tolerance in patients with Hemophilia B.

Full Prescribing information

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Advisory information

contraindications
Do not use in patients with:
• Known hypersensitivity to RIXUBIS or its excipients including hamster protein. (4)
• Disseminated intravascular coagulation (DIC). (4)
• Signs of fibrinolysis. (4)
Special warnings and precautions

• Hypersensitivity reactions, including anaphylaxis, may occur. Should symptoms occur, discontinue RIXUBIS and administer appropriate treatment. Patients may also develop hypersensitivity to hamster (CHO) protein, which is present in trace amounts in the product. (5.1)
• Development of neutralizing antibodies (inhibitors) to RIXUBIS may occur. If expected factor IX activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures factor IX inhibitor concentration. (5.2)
• Nephrotic syndrome has been reported following immune tolerance induction with factor IX products in hemophilia B patients with factor IX inhibitors. (5.3)
• The use of factor IX containing products has been associated with the development of thromboembolic complications. (5.4)

Adverse reactions

Common adverse reactions observed in >1% of subjects in clinical trials were: dysgeusia, pain in extremity, and positive test for furin antibody. (6.1)

Usage information

Dosing and administration
For intravenous use after reconstitution only. (2)

Control and prevention of bleeding episodes and perioperative management:
• One international unit of RIXUBIS per kg of body weight increases the circulating activity of factor IX by 0.7 international units/dL for patients <12 years of age and 0.9 international units/dL for patients ≥12 years of age. (2.1)

Initial Dose:
• Required international units = body weight (kg) x desired factor IX increase (% of normal or IU/dL) x reciprocal of observed recovery (IU/kg per IU/dL). (2.1)
• The maintenance dose depends on the type of bleed or surgery, the intensity of the hemostatic challenge, and number of days until adequate wound healing is achieved. (2.2)

Routine prophylaxis:
• Patients <12 years of age: 60 to 80 international units per kg twice weekly
• Patients ≥ 12 years of age: 40 to 60 international units per kg twice weekly. (2.1)
Use in special populations
Pregnancy: No human or animal data. Use only if clearly needed. (8.1)
Pediatric Use: A 22% lower recovery has been observed in pediatric patients (<12 years, n=23). Clearance (based on per kg body weight) was 30% (6-12 years) and 59% (<6 years) higher in children than adults. Dose adjustment is needed. (2.1, 8.4)

More information

Category Value
Authorisation number BLA125446
Orphan designation No
Product NDC 0944-3026; 0944-3028; 0944-3030; 0944-3032; 0944-3034
Date First Approved 26-06-2013
Marketing authorisation holder Baxter Healthcare Corporation