MORE IS NOT BETTER - When it comes to the use of Bypassing Therapies for the treatment of bleeding episodes in both Hemophilia A and Hemophilia B patients with inhibitors. PLEASE BE AWARE OF THE RISKS ASSOCIATED WITH THESE PRODUCTS AND WHAT LAB TESTS SHOULD BE DONE TO MONITOR FOR THE DEVELOPMENT OF SERIOUS THROMBOLITIC COMPLICATIONS. (If this sounds like medical advice it is not. It is just communicating what we know about these products and the risks of DIC. Always be sure to discuss anything you read with your physician) Any patient who is being prescribed these products for an extended period of time or in combination with each other should be closely monitored for the development of a condition called DISSEMINATED INTRAVASCULAR COAGULATION or DIC. In fact the product information for both Novoseven RT and FEIBA discuss the risks of thrombotic events and the development of DIC and recommend monitoring for the possibility that DIC could be occurring. Attached are links to both the FEIBA and NovoNordisk product information, please read through this and look for the areas where thrombosis and DIC are mentioned. nhlbi.nih.gov/health/health-topics/topics/dic/ novosevenrt/pdfs/PI_novosevenrt.pdf fda.gov/downloads/biologicsbloodvaccines/bloodbloodproducts/approvedproducts/licensedproductsblas/fractionatedplasmaproducts/ucm221749.pdf The signs and symptoms of DIC are subtle and are not always immediately evident. It is possible by monitoring certain lab values to determine if the precursors to DIC are present. The following are key indicators that DIC may be developing. 1. Drop in fibrinogen levels (even if still within normal range - if fibrinogen levels are dropping, caution should be excised with treatment) 2. Increase in D Dimers (if D-Dimers are positive, and especially if the levels are increasing) 3. Decrease in platelets (even if still within normal range) 4. Increase in PT or significant shortening of PT (DIC is a complex condition involving both bleeding and clotting tendencies). Note: The PTT will already be prolonged due to the underlying hemophilia. In addition, there are some other clinical indications that DIC may be developing: 1. Clotting off of venous access lines. If a peripheral or internal venous access device becomes non functional due to clot formation, especially if TPA is required to try to clear the line, DIC should be monitored very closely. 2. Lack of bleeding control. If it seems like the more product you give, the more bleeding is occurring (if the same bleed doesnt resolve or other bleeds develop for no known reasons) DIC should be considered. So what can be done if there are indications of DIC: 1. Cut back on treatment and see if the persons own body will recover. If a person is showing any indication of DIC, giving more clotting agents is unlikely to improve the situation and may in fact make it even worse. 2. Decrease in Fibrinogen levels can be corrected by giving cryoprecipitate or other agents. There are very important things to consider before this type of treatment should be considered, but we just think people should be aware that this may be something to consider. 3. Other interventions may be necessary and should be thoroughly discussed with the physician. The important thing is to closely monitor during treatment.
Posted on: Tue, 19 Nov 2013 21:53:06 +0000
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