"The U.S. Food and Drug Administration yesterday approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older. Rixubis is indicated for the control and prevention of bleeding episodes"...
Autoplex® T (anti-inhibitor coagulant complex, heat treated)
Anti-Inhibitor Coagulant Complex Heat Treated
- Patient Information:
Details with Side Effects
Caution: This product is to be used only in patients with inhibitors to Factor VIII.
Warning: This is a potent drug with potential hazards. For maximal safety and efficacy, carefully read and follow directions below.
Autoplex® T*, Anti-Inhibitor Coagulant Complex, Heat Treated, is a sterile product prepared from pooled human plasma with subsequent alcohol fractionation to Cohn Fraction IV1. It contains, in concentrated form, variable amounts of activated and precursor vitamin K-dependent clotting factors. Factors of the kinin generating system are also present. The product is standardized by its ability to correct the clotting time of Factor VIII deficient plasma or Factor VIII deficient plasma which contains inhibitors to Factor VIII.
When reconstituted, this product contains a maximum of 2 units per mL of heparin and a residual amount of polyethylene glycol (2 mg per mL, maximum). It also contains 0.02 M sodium citrate and the sodium content is 177 ± 15 milliequivalents per liter.
Laboratory testing of several lots of Autoplex® T, Anti-Inhibitor Coagulant Complex, Heat Treated, has shown the presence of Factor VIII coagulant antigen (VIII:CAg). Although anamnestic response to this antigen following administration of the product was not observed during the clinical trials, the possibility of such a response does exist.
Each lot of Autoplex® T, Anti-Inhibitor Coagulant Complex, Heat Treated, is assayed and labeled for units of Hyland Factor VIII correctional activity. Factor VIII correctional activity may not be exclusively related to the efficacious component(s). (See CLINICAL PHARMACOLOGY.)
During the manufacturing process, this product was heated for 6 days at 60°C. This heating step is designed to reduce the risk of transmission of hepatitis and other viral diseases. However, no procedure has been shown to be totally effective in removing hepatitis infectivity from Anti-Inhibitor Coagulant Complex.
Autoplex® T, Anti-Inhibitor Coagulant Complex, Heat Treated, must be administered intravenously.
*This product and/or its manufacture covered by U.S. Patent Nos. 4,286,056, 4,287,180, 4,357,321, 4,382,083, 4,459,288, and 4,495,278. The “T” indicates that the product is heat treated.
Last reviewed on RxList: 1/13/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Autoplex-T Information
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