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

35

YEARS

We have a history of helping people with inhibitors. FEIBA has been approved for on-demand treatment for over 35 years.14

60

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

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 6 free 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.
  • Receive your free trial doses of FEIBA.
Download the form

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

Go

FEIBA [Anti-Inhibitor Coagulant Complex]
Indications and Detailed Important Risk Information for Patients

INDICATIONS FOR FEIBA [Anti-Inhibitor Coagulant Complex]

FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for:

  • Control and prevention of bleeding episodes
  • Use around the time of surgery
  • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulant factor IX.

DETAILED 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 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.

You should not use FEIBA if:

  • You had a previous severe allergic reaction to the product (reactions causing discomforts that are damaging and life threatening)
  • You have signs of development of small blood vessel clots throughout the body
  • You have sudden blood vessel clots or blocked blood vessels, (e.g., heart attack or stroke)

Events involving blood clots blocking blood vessels can occur with FEIBA, particularly after receiving high doses and/or in patients with risk factors for clotting.

Infusion of FEIBA should not exceed a dose of 100 units per kg body weight every 6 hours and daily doses of 200 units per kg of body weight. Maximum injection or infusion rate must not exceed 2 units per kg of body weight per minute.

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. Call your doctor or get emergency treatment right away if you get a rash, hives or welts, experience itching, tightness of the throat, vomiting, abdominal pain, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.

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.

The most frequent side effects observed during the prophylaxis trial were anemia, diarrhea, bleeding into a joint, signs of hepatitis B surface antibodies, nausea, and vomiting.

The serious side effects seen with FEIBA are allergic reactions and clotting events involving blockage of blood vessels, which include stroke, blockage of the main blood vessel to the lung, and deep vein blood clots.

Call your doctor right away about any side effects that bother you during or after you stop taking FEIBA.

Please see FEIBA full Prescribing Information.

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.