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 and Detailed Important Risk Information for Patients

Indications for 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.

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. The safety and efficacy of FEIBA for breakthrough bleeding in patients receiving emicizumab has not been established. If you take, or anticipate taking, FEIBA with emicizumab, tell your doctor, since they will need to closely monitor you.

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.

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.