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

74

COUNTRIES

FEIBA is approved in more than 70 countries worldwide.15

40

COUNTRIES

FEIBA has been indicated for prophylaxis in more than 40 countries since 2013.15

Microscope icon: Learn about the FEIBA purification process

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.1

Made with care every step of the way1,16

1

All plasma donors pass rigorous screenings for qualification

2

Plasma from qualified donors is held for 60 days

3

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

4

Next up: viral serologic testing for HBV surface antigen, HCV 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 Process1,16

FEIBA purification process: 1) Plasma; 2) Fractionation; 3) Purification; 4) Viral Inactivation; 5) FEIBA FEIBA purification process: 1) Plasma; 2) Fractionation; 3) Purification; 4) Viral Inactivation; 5) FEIBA

As with all plasma-derived products, the risk of transmission of infectious agents cannot be totally eliminated. As of October 12, 2017 (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).17

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 administration of high doses (above 200 units per kg per day) and/or in patients at risk for forming blood clots.
  • If you experience any of these side effects, call your doctor right away.

Who should not use FEIBA?

You should not use FEIBA if:

  • You had a previous severe allergic reaction to the product
  • You have Disseminated Intravascular Coagulation (DIC), or signs of small blood vessel clots throughout the body
  • You have sudden blood vessel clots or blocked blood vessels, (such as, heart attack or stroke)

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.1,18,19

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.19

Flowchart depicting the blood clotting cascade

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.1,19

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.1,19
  • FEIBA provides several different clotting factors—mainly unactivated factors II, IX, and X; and mainly activated factor VII—and works at different sites in the clotting system.1,19
  • This restores thrombin generation and helps with the formation of the fibrin clot, which stops bleeding.1,19
Vial icon: Learn about the free trial program for FEIBA

Find out if feiba is right for you

Find out if you’re eligible for 15 free trial doses of FEIBA by completing the form with your healthcare provider.

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What is FEIBA?

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

  • Control and prevention of bleeding episodes

Detailed Important Risk Information

What is FEIBA?

FEIBA is an Anti-Inhibitor Coagulant Complex approved 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

Detailed Important Risk Information

  • 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 (above 200 units per kg per day) and/or in patients at risk for forming blood clots.
  • If you experience any of these side effects, call your doctor right away.

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

What is FEIBA?

FEIBA is an Anti-Inhibitor Coagulant Complex approved 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 for use in the treatment of bleeding episodes resulting from coagulation factor deficiencies without inhibitors to factor VIII or factor IX.

Detailed Important Risk Information for FEIBA

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 (above 200 units per kg per day) and/or in patients at risk for forming blood clots.
  • If you experience any of these side effects, call your doctor right away.

Who should not use FEIBA?

You should not use FEIBA if:

  • You had a previous severe allergic reaction to the product
  • You have Disseminated Intravascular Coagulation (DIC), or signs of small blood vessel clots throughout the body
  • You have sudden blood vessel clots or blocked blood vessels, (such as, heart attack or stroke)

What other important information should I know about FEIBA?

Events involving blood clots blocking blood vessels (such as blood clot in vein, blood clot in the lung, heart attack, and stroke) can occur with FEIBA, particularly after receiving high doses (above 200 units per kg per day) and/or in patients with risk factors for clotting.

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

Infusion of FEIBA should not exceed a single dose of 100 units per kg body weight 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.

The safety and efficacy of FEIBA for breakthrough bleeding in patients receiving emicizumab has not been established. Events of thrombotic microangiopathy (TMA), a condition where blood clots and damage occur in small blood vessels, were reported in an emicizumab (Hemlibra®) clinical trial where patients received FEIBA with emicizumab as part of a treatment plan for breakthrough bleeding. If you are on emicizumab and are taking or anticipate taking FEIBA for a breakthrough bleeding episode, tell your doctor immediately because there are specific safety considerations and you must be closely monitored by your hemophilia treater or treatment center.

Allergic reactions, including severe, sometimes fatal allergic reactions that can involve the whole body, can occur following the infusion of FEIBA. Stop using FEIBA promptly and 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, such as viruses, variant Creutzfeldt-Jakob disease (vCJD) and, theoretically, the Creutzfeldt-Jakob disease (CJD).

What are the possible side effects of FEIBA?

The most common side effects observed during the prophylaxis clinical study were low number of red blood cells, diarrhea, bleeding into a joint, positive test for 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.

What other medications might interact with FEIBA?

Talk with your doctor about the possibility of formation of blood clots when taking drugs that may prevent clot breakdown such as tranexamic acid, and aminocaproic acid. There have not been adequate studies of the use of FEIBA and rFVIIa (NovoSeven®), or emicizumab together, or one after the other. Use of drugs that may prevent clot breakdown within approximately 6 to 12 hours after the administration of FEIBA is not recommended.

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.

Please see FEIBA full Prescribing Information, including BOXED WARNING on blood clots, and discuss with your doctor.