About FEIBA [Anti-Inhibitor Coagulant Complex]

About FEIBA

Inhibitors are tricky. We can help.

Timmy, Actual FEIBA Patient

FEIBA is made to help you manage inhibitors to factors VIII and IX to help you prevent bleeds. It's also made with your safety in mind.1

40

YEARS

We have a history of helping people with inhibitors. FEIBA has been approved for on-demand treatment for over 40 years.14

73

COUNTRIES

FEIBA is approved in more than 60 countries worldwide.14

40

COUNTRIES

FEIBA has been indicated for prophylaxis in more than 40 countries since 2013.14

Developed with HIGH standards.

You need to know that what you put into your body is as safe as possible. The purification process for FEIBA was created with your safety in mind.1

FEIBA is made with care at every step, from the plasma sourced and screened to the purification and testing.15

Made with care every step of the way.15

1

All plasma donors pass rigorous screenings for qualification

2

Each plasma donation is tested for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV)

3

Plasma from qualified donors is held for 60 days

4

Next up: viral serologic testing for HBV surface antigen, HCV antigen and antibody, HIV-1 and HIV-2 antibodies, and HIV p24 antigen is performed on all plasma donations

5

And more: nucleic acid amplification tests (NAT) for HIV, HCV, HBV, hepatitis A virus (HAV), and parvovirus B19 (PV B19)

FEIBA [Anti-Inhibitor Coagulant Complex] Purification Process15

As with all plasma-derived products, the risk of transmission of infectious agents cannot be totally eliminated. As of November 10, 2014 (from self-reported databases), there have been no confirmed reports of transmission of hepatitis A, B, or C or human immunodeficiency virus (HIV) associated with the use of FEIBA since the introduction of vapor heat treatment (ongoing surveillance indicates this remains valid).16

Selected Important Risk Information for FEIBA [Anti-Inhibitor Coagulant Complex]

WARNING: EVENTS INVOLVING CLOTS THAT BLOCK BLOOD VESSELS

  • Blood clots that block blood vessels and their effects have been reported during post-marketing surveillance following infusion of FEIBA, particularly following the administration of high doses and/or in patients with a risk of forming blood clots.
  • If you experience any of these side effects, call your doctor right away.

At first sign or symptom of a sudden blood vessel clot or blocked blood vessel (e.g., chest pain or pressure, shortness of breath, altered consciousness, vision, or speech, limb or abdomen swelling and/or pain), stop FEIBA administration promptly and seek emergency medical treatment.

Allergic-type hypersensitivity reactions, including severe, sometimes fatal allergic reactions that can involve the whole body, can occur following the infusion of FEIBA. If you experience any of these signs or symptoms, stop FEIBA administration immediately and seek emergency medical treatment.

Because FEIBA is made from human plasma it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Here's how FEIBA works.

Bypassing agents—like FEIBA—are important treatments for people with inhibitors. Because factor VIII or IX treatment will no longer be effective, FEIBA gets around the need for these factors and helps your blood form clots to stop bleeding.1,17,18

FEIBA acts at multiple sites in the clotting cascade.18

In vitro analysis

FEIBA contains several different clotting factors—factors II, IX, and X, mainly non-activated; and factor VII, mainly in the activated form.1

FEIBA acts at multiple sites in the clotting cascade and helps restore thrombin generation in people who have hemophilia with inhibitors. Thrombin helps with the formation of the fibrin clot, which helps stop bleeding.1,18

Bypassing inhibitors: the play-by-play.

  • For hemophilia A and B patients with inhibitors, clotting doesn't occur naturally during bleeding due to missing factor VIII or factor IX.3
  • As shown above, FEIBA bypasses (or "gets around") the need for these factors and helps your blood form clots to stop bleeding.1,18
  • FEIBA provides several different clotting factors—factors II, IX and X, mainly non-activated; and factor VII, mainly in the activated form—and works at different sites in the clotting system.1,18
  • This restores thrombin generation and helps with the formation of the fibrin clot, which stops bleeding.1,18

Find out if feiba is right for you.

You may be eligible for 15 free trial doses of FEIBA.

All you need to do is complete some information with help from your healthcare provider.

  • Download the form and fill it out with your healthcare provider.
  • If eligible, you will receive your free trial doses of FEIBA.
Download the form

Want to learn more? Check out our How It Helps page.

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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.