RIXUBIS [Coagulation Factor IX (Recombinant)] Risk

RIXUBIS® is manufactured using a validated 2-step process to remove and inactivate viruses1

RIXUBIS [Coagulation Factor IX (Recombinant)] two step manufacturing process

Please see RIXUBIS Indications and Detailed Important Risk Information.

  • RIXUBIS is a third-generation recombinant factor IX, produced by DNA technology1,8
  • No human or animal proteins are added during any stage of manufacturing or formulation of RIXUBIS1,8

RIXUBIS safety with you in mind1-3

During clinical development, in a combined study, 99 male previously treated patients received a total of 14,018 infusions of RIXUBIS and were treated with RIXUBIS for a median of 156 exposure days (range: 8 to 316 days), with a median number of 163 infusions (range: 8 to 327 infusions).

As of September 2014, none of the study patients had developed inhibitors. Low-titer, non-neutralizing antibodies against factor IX were observed in 21 (21.2%) subjects at one or more time points. Three of these 21 subjects were found to have these antibodies at screening, prior to receiving RIXUBIS. Six of the 21 subjects were pediatric (2 subjects in <6 years of age cohort, 4 subjects in 6 to <12 years of age cohort). No clinical adverse findings were observed in any of these 21 subjects.1

Selected Important Risk Information for RIXUBIS [Coagulation Factor IX (Recombinant)]

Allergic reactions have been reported with RIXUBIS. Call your healthcare provider or get emergency treatment right away if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea, or fainting.

Your body may form inhibitors to factor IX. An inhibitor is part of the body's defense system. If you form inhibitors, it may stop RIXUBIS from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for development of inhibitors to factor IX.

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