References for FEIBA [Anti-Inhibitor Coagulant Complex]

References

  1. FEIBA Prescribing Information.
  2. What is an inhibitor? National Hemophilia Foundation website. http://www.hemophilia.org/Bleeding-Disorders/Inhibitors-Other-Complications/Inhibitors-for-Consumers/What-is-an-Inhibitor. Accessed August 3, 2015.
  3. An introduction to hemophilia. In: All About Hemophilia: A Guide for Families. Montreal, Quebec, Canada: Canadian Hemophilia Society; 2010. http://www.hemophilia.ca/files/Chapter%2001.pdf. Accessed August 3, 2015.
  4. DiMichele D. Inhibitors: resolving diagnostic and therapeutic dilemmas. Haemophilia. 2002;8:280-287.
  5. The challenges of inhibitors. National Hemophilia Foundation website. http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=239&contentid=418&rptname=inhibitors. Accessed August 3, 2015.
  6. Who is at risk for developing inhibitors? National Hemophilia Foundation website. http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=232&contentid=411&rptname=inhibitors. Accessed August 3, 2015.
  7. Aledort LM, DiMichele DM. Inhibitors occur more frequently in African-American and Latino haemophiliacs. Haemophilia. 1998;4:68.
  8. Kempton CL. Inhibitors in previously treated patients: a review of the literature. Haemophilia. 2010;16(102):61-65.
  9. Kasper CK. Diagnosis and Management of Inhibitors for Factors VIII and IX: An Introductory Discussion for Physicians. Montreal, QC: World Federation of Hemophilia; 2004.
  10. Leissinger CA. Prevention of bleeds in hemophilia patients with inhibitors: emerging data and clinical direction. Am J Hematol. 2004;77:187-193.
  11. Peerlinck K, Jacquemin M. Characteristics of inhibitors in mild/moderate haemophilia A. Haemophilia. 2006;12(suppl 6):43-47.
  12. Soucie JM, Symons J 4th, Evatt B, et al. Home-based factor infusion therapy and hospitalization for bleeding complications among males with haemophilia. Haemophilia. 2001;7:198-206.
  13. Tjønnfjord GE, Holme PA. Factor eight inhibitor bypass activity (FEIBA) in the management of bleeds in hemophilia patients with high-titer inhibitors. Vasc Health Risk Manag. 2007;3:527-531.
  14. Data on file.
  15. Gomperts ED. FEIBA safety and tolerability profile. Haemophilia. 2006;12(suppl 5):14-19.
  16. Data on file.
  17. MASAC recommendation regarding the use of bypassing agents in patients with hemophilia A or B and inhibitors. MASAC Recommendation #167. National Hemophilia Foundation website. http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=57&contentid=579. Accessed August 3, 2015.
  18. Turecek PL, Váradi K, Gritsch H, Schwarz HP. FEIBA: mode of action. Haemophilia. 2004;10(suppl 2):3-9.
  19. Management of bleeds. In: All About hemophilia: A Guide for Families. Montreal, QC: Canadian Hemophilia Society; 2010. http://www.hemophilia.ca/files/Chapter%2004.pdf. Accessed August 3, 2015.
  20. MASAC recommendation regarding prophylaxis with bypassing agents in patients with hemophilia and high titer inhibitors. MASAC Recommendation #220. National Hemophilia Foundation website. https://www.hemophilia.org/Researchers-Healthcare-Providers/Medical-and-Scientific-Advisory-Council-MASAC/MASAC-Recommendations/MASAC-Recommendation-Regarding-Prophylaxis-with-Bypassing-Agents-in-Patients-with-Hemophilia-and-High-Titer-Inhibitors. Accessed August 3, 2015.
  21. Medical and Scientific Advisory Council (MASAC). National Hemophilia Foundation website. http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=156&contentid=335. Accessed August 3, 2015.
  22. Antunes SV, Tangada S, Stasyshyn O, et al. Randomized comparison of prophylaxis and on-demand regimens with FEIBA NF in the treatment of haemophilia A and B with inhibitors. Haemophilia. 2014;20(1):65-72.
  23. Do the 5! National Hemophilia Foundation Steps for Living website. http://stepsforliving.hemophilia.org/next-step/maintaining-a-healthy-body/do-the-5. Accessed August 3, 2015.
  24. Blood clots. Medical dictionary website. http://medical-dictionary.thefreedictionary.com/Blood+Clots. Accessed August 3, 2015.
  25. Glossary. National Hemophilia Foundation website. http://www.hemophilia.org/Community-Resources/Glossary. Accessed August 3, 2015.

FEIBA [Anti-Inhibitor Coagulant Complex] Indications

What is FEIBA used for?
FEIBA (Anti-Inhibitor Coagulant Complex) is used for people with Hemophilia A or B with Inhibitors to control and prevent bleeding episodes, before surgery, or routinely to prevent or reduce the number of bleeding episodes. It is NOT used to treat bleeding conditions without inhibitors to Factor VIII or Factor IX.

Detailed Important Risk Information

When should I not take FEIBA?
You should not take FEIBA if you have had hypersensitivity or an allergic reaction to FEIBA or any of its components, including factors of the kinin generating system, if you have a condition called Disseminated Intravascular Coagulation, which is small blood clots in various organs throughout the body, or currently have blood clots or are having a heart attack. Make sure to talk to your healthcare provider about your medical history.

What Warnings should I know about FEIBA?
FEIBA can cause blood clots, including clots in the lungs, heart attack, or stroke, particularly after high doses of FEIBA or in people with a high risk of blood clots. Patients that have a risk of developing blood clots should discuss the risks and benefits of FEIBA with their healthcare provider since FEIBA may cause blood clots. FEIBA can cause hypersensitivity or allergic reactions and infusions site reactions, and these reactions can be serious. Because FEIBA is made from human plasma, it may carry the risk of transmitting infectious agents, for example, viruses, including Creutzfeldt-Jakob disease (CJD) agent, and the variant CJD agent. Although steps have been taken to minimize the risk of virus transmission, there is still a potential risk of virus transmission.

What should I tell my healthcare provider?
Make sure to discuss all health conditions and medications with your healthcare provider. If you are pregnant or are planning to become pregnant, or are a nursing mother, make sure to talk with your healthcare provider for advice on using FEIBA.

What are the side effects of FEIBA?
The most frequent side effects of FEIBA are: low red blood cell count, diarrhea, joint pain, hepatitis B surface antibody positivity, nausea, and vomiting. The most serious side effects of FEIBA include: hypersensitivity reactions, including anaphylaxis, stroke, blood clots in the lungs, and blood clots in the veins. Always immediately talk with your healthcare provider if you think you are experiencing a side effect.

What other medications might interact with FEIBA?
The use of other clotting agents with FEIBA is not recommended, for example, tranexamic acid and aminocaproic acid. Be sure to talk with your healthcare provider and pharmacist about all medications and supplements you are taking.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

The risk information provided here is not comprehensive. To learn more, talk about FEIBA with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at http://www.feiba.com/us/forms/feiba_pi.pdf or by calling 1-800-423-2090 and selecting option 5.