"The U.S. Food and Drug Administration today approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, k"...
Inform patients of the early signs of allergic or hypersensitivity reactions to RiaSTAP (fibrinogen concentrate (human) for intravenous use) , including hives, chest tightness, wheezing, hypotension, and anaphylaxis (see WARNINGS AND PRECAUTIONS). Advise them to notify their physician immediately if they experience any of these symptoms.
Inform patients that thrombosis with or without embolization may be due to the underlying fibrinogen deficiency and has been reported with the use of RiaSTAP (fibrinogen concentrate (human) for intravenous use) . Any symptoms of thrombotic events such as unexplained pleuritic, chest and/or leg pain or edema, hemoptysis, dyspnea, tachypnea or unexplained neurologic symptoms should be reported to their physician immediately (see WARNINGS AND PRECAUTIONS).
Transmissible Infectious Agents
Inform patients that RiaSTAP (fibrinogen concentrate (human) for intravenous use) is made from human plasma (part of the blood) and may contain infectious agents that can cause disease (e.g., viruses and, theoretically, the CJD agent). Explain the risk that RiaSTAP (fibrinogen concentrate (human) for intravenous use) may transmit an infectious agent has been reduced by screening the plasma donors, by testing the donated plasma for certain virus infections, and by a process demonstrated to inactivate and/or remove certain viruses during manufacturing (see WARNINGS AND PRECAUTIONS). Symptoms of a possible virus infection include headache, fever, nausea, vomiting, weakness, malaise, diarrhea, or, in the case of hepatitis, jaundice.
Last reviewed on RxList: 10/5/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional RiaSTAP Information
Report Problems to the Food and Drug Administration
Find out what women really need.