How It Helps

Here to help you manage   inhibitors.

Timmy, Actual FEIBA Patient

There are two ways you can take FEIBA. Depending on the treatment you and your doctor decide on, it can help prevent bleeds or help stop them.19

Prophylaxis treatment

Routine treatment, also known as prophylaxis, means you take FEIBA regularly, before a bleed occurs.

On-demand treatment

This means you take FEIBA as soon as possible after a bleed starts.

The Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation recently recommended the consideration of prophylaxis treatment in patients with inhibitors.20,21

If you're living with inhibitors, you can have more freedom to reduce bleeds with FEIBA routine prophylaxis.

FEIBA Prophylactic use. See how this option stacks up.

In a clinical study, people on FEIBA routine prophylaxis experienced a significant reduction in Annual Bleed Rate (ABR), as compared to on-demand treatment.1*

-0%1%2%3%4%5%6%7%8%9%10%11%12%13%14%15%16%17%18%19%20%21%22%23%24%25%26%27%28%29%30%31%32%33%34%35%36%37%38%39%40%41%42%43%44%45%46%47%48%49%50%51%52%53%54%55%56%57%58%59%60%61%62%63%64%65%66%67%68%69%70%71%72%73%74%75%76%77%78%79%80%81%82%83%84%85%86%87%88%89%90%91%92%93%94%95%96%97%98%99%100%
Fewer bleeds1,22

28.7 median ABR with
on-demand treatment1,22
(629 bleeding episodes)

vs

7.9 median ABR with
prophylaxis treatment1,22
(196 bleeding episodes)

-0%1%2%3%4%5%6%7%8%9%10%11%12%13%14%15%16%17%18%19%20%21%22%23%24%25%26%27%28%29%30%31%32%33%34%35%36%37%38%39%40%41%42%43%44%45%46%47%48%49%50%51%52%53%54%55%56%57%58%59%60%61%62%63%64%65%66%67%68%69%70%71%72%73%74%75%76%77%78%79%80%81%82%83%84%85%86%87%88%89%90%91%92%93%94%95%96%97%98%99%100%
Fewer joint bleeds22

ABR for joint bleeds was reduced from 22.9 in the on-demand arm to 6.0 in the prophylaxis arm

-0%1%2%3%4%5%6%7%8%9%10%11%12%13%14%15%16%17%18%19%20%21%22%23%24%25%26%27%28%29%30%31%32%33%34%35%36%37%38%39%40%41%42%43%44%45%46%47%48%49%50%51%52%53%54%55%56%57%58%59%60%61%62%63%64%65%66%67%68%69%70%71%72%73%74%75%76%77%78%79%80%81%82%83%84%85%86%87%88%89%90%91%92%93%94%95%96%97%98%99%100%
Decrease in new target joints22,ns

7 new target joints in 5 people with prophylaxis treatment vs 23 new target joints in 11 people with on-demand treatment

ns=not significant

*Based on results from the FEIBA PROOF clinical study of 36 hemophilia A and B patients with inhibitors receiving FEIBA for prophylaxis or on-demand treatment for 12 months.22

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.

Annual bleed rate data.

When the Annual Bleed Rate (ABR) results from the same study were grouped by bleeding cause and/or type, FEIBA prophylaxis treatment showed significant differences vs on-demand treatment.22*

On-demand treatment
Prophylaxis treatment
Annual Bleed Rate (ABR)
35
30
25
20
15
10
5
0
Spontaneous
Traumatic
Joint
Non-Joint
Spontaneous Joint
Spontaneous non-joint
Traumatic joint
Bleeding Etiology and/or Type
71% reduction in
spontaneous
bleeds22
18.9
5.6
47%
4.7
2.5
74%
22.9
6.0
83%
2.9
0.5
73%
16.6
4.5
100%
1.0
0.0
75%
4.0
1.0

FEIBA prophylaxis significantly reduced ABR for all bleeds, compared with on-demand treatment.22

*Based on results from the FEIBA PROOF clinical study of 36 hemophilia A and B patients with inhibitors receiving FEIBA for prophylaxis or on-demand treatment for 12 months.22

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.

FEIBA on demand: another treatment option.

Bleeds can happen. If you don't infuse regularly with FEIBA, you can take FEIBA on demand to help stop bleeding episodes when they occur.

FEIBA is effective at treating various types of bleeding episodes, including spontaneous and traumatic bleeds.

In a separate clinical study, FEIBA was used to treat 165 bleeding episodes and showed the following results1:

Up to 12 hours between doses minimizes need for more frequent redosing1*
*Depends on bleed type. Some bleeds may require dosing at 6-hour intervals. Please consult with your doctor.

-0%1%2%3%4%5%6%7%8%9%10%11%12%13%14%15%16%17%18%19%20%21%22%23%24%25%26%27%28%29%30%31%32%33%34%35%36%37%38%39%40%41%42%43%44%45%46%47%48%49%50%51%52%53%54%55%56%57%58%59%60%61%62%63%64%65%66%67%68%69%70%71%72%73%74%75%76%77%78%79%80%81%82%83%84%85%86%87%88%89%90%91%92%93%94%95%96%97%98%99%100%

of bleeding episodes (153 of 165) were controlled with on-demand treatment1

-0%1%2%3%4%5%6%7%8%9%10%11%12%13%14%15%16%17%18%19%20%21%22%23%24%25%26%27%28%29%30%31%32%33%34%35%36%37%38%39%40%41%42%43%44%45%46%47%48%49%50%51%52%53%54%55%56%57%58%59%60%61%62%63%64%65%66%67%68%69%70%71%72%73%74%75%76%77%78%79%80%81%82%83%84%85%86%87%88%89%90%91%92%93%94%95%96%97%98%99%100%

of those bleeding episodes (130 of 165) were stopped with 1 or more infusions of FEIBA within 36 hours1

-0%1%2%3%4%5%6%7%8%9%10%11%12%13%14%15%16%17%18%19%20%21%22%23%24%25%26%27%28%29%30%31%32%33%34%35%36%37%38%39%40%41%42%43%44%45%46%47%48%49%50%51%52%53%54%55%56%57%58%59%60%61%62%63%64%65%66%67%68%69%70%71%72%73%74%75%76%77%78%79%80%81%82%83%84%85%86%87%88%89%90%91%92%93%94%95%96%97%98%99%100%

of those bleeding episodes (47 of 130) were stopped with 1 infusion of FEIBA within 12 hours1

FEIBA was previously licensed in the United States as FEIBA VH and FEIBA NF, and is now available as FEIBA. FEIBA and FEIBA NF are identical in formulation to FEIBA VH. Biochemical and preclinical studies have confirmed the comparability of FEIBA NF and FEIBA VH.

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.

Want to learn more? Check out our About FEIBA 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.