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Intended for US HCPs Only

Inhibitor InSights, a Shire educational program, was developed in collaboration with leading hematologists with expertise in the treatment of hemophilia patients with inhibitors.

This educational program is designed to provide meaningful clinical information, and is based on real-world patient cases.

Inhibitor InSights focuses on the distinct needs of and treatment considerations for patients with inhibitors and may help you with determining a path for your most challenging cases.




Disease State Overview


In this video, Dr. Michael Tarantino highlights the differences between Congenital Hemophilia A and B with inhibitors and Acquired Hemophilia A.


For Hematology Professionals


Prophylaxis:

Jaden is an energetic toddler who has severe congenital hemophilia A. In this video, watch Dr. Tami Singleton present Jaden’s journey from his diagnosis with congenital hemophilia A with inhibitors to managing Jaden’s condition with prophylactic treatment1

For Short-Term Treater Professionals


Bleed Control:

Jaden is an energetic toddler who has severe congenital hemophilia A. In this video, watch Dr. Tami Singleton present Jaden’s journey from his diagnosis with congenital hemophilia A with inhibitors to managing Jaden’s condition with on demand treatment1


 

Prophylaxis and Surgery:

Newly married, Roberto has severe congenital hemophilia A with inhibitors and manages his condition with FEIBA Prophylaxis. In this video, watch Dr. Tami Singleton present Roberto’s journey as he chooses elective surgery and how treatment with FEIBA was recommended by a hematologist consult for this surgical procedure1

 

Surgery:

Roberto and his wife want to start a family—but not until they address concerns about his hemophilia A with inhibitor and future health. In this video, watch Dr. Tami Singleton present Roberto’s journey as he is treated with FEIBA prophylactically and for perioperative surgical use1

Disease State Overview


In this video, Dr. Michael Tarantino highlights the differences between Congenital Hemophilia A and B with inhibitors and Acquired Hemophilia A.


For Hematology Professionals


Prophylaxis:

Jaden is an energetic toddler who has severe congenital hemophilia A. In this video, watch Dr. Tami Singleton present Jaden’s journey from his diagnosis with congenital hemophilia A with inhibitors to managing Jaden’s condition with prophylactic treatment1

 

Prophylaxis and Surgery:

Newly married, Roberto has severe congenital hemophilia A with inhibitors and manages his condition with FEIBA Prophylaxis. In this video, watch Dr. Tami Singleton present Roberto’s journey as he chooses elective surgery and how treatment with FEIBA was recommended by a hematologist consult for this surgical procedure1



For Short-Term Treater Professionals


Bleed Control:

Jaden is an energetic toddler who has severe congenital hemophilia A. In this video, watch Dr. Tami Singleton present Jaden’s journey from his diagnosis with congenital hemophilia A with inhibitors to managing Jaden’s condition with on demand treatment1

 

Surgery:

Roberto and his wife want to start a family—but not until they address concerns about his hemophilia A with inhibitor and future health. In this video, watch Dr. Tami Singleton present Roberto’s journey as he is treated with FEIBA prophylactically and for perioperative surgical use1




Please see full detailed Important Risk Information for FEIBA and OBIZUR below.

Please note that Inhibitor InSights is not a CE or CME program.

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

Indications for FEIBA

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
  • Perioperative management
  • 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 coagulation factor IX.

Detailed Important Risk Information for FEIBA

WARNING: THROMBOEMBOLIC EVENTS

  • Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA, particularly following the administration of high doses (above 200 units per kg per day) and/or in patients with thrombotic risk factors.
  • Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events.

CONTRAINDICATIONS

The use of FEIBA is contraindicated in patients with:

  • History of anaphylactic or severe hypersensitivity reactions to FEIBA or any of its components, including factors of the kinin generating system
  • Disseminated intravascular coagulation (DIC)
  • Acute thrombosis or embolism (including myocardial infarction)

WARNINGS AND PRECAUTIONS

Thromboembolic events (including venous thrombosis, pulmonary embolism, myocardial infarction, and stroke) can occur with FEIBA, particularly following the administration of high doses (above 200 units per kg per day) and/or in patients with thrombotic risk factors. Thrombotic microangiopathy (TMA) has not been reported in FEIBA clinical studies. Cases of TMAs were reported in an emicizumab clinical trial where subjects received FEIBA as part of a treatment regimen for breakthrough bleeding. The safety and efficacy of FEIBA for breakthrough bleeding in patients receiving emicizumab has not been established. If treatment with FEIBA is considered required for patients receiving emicizumab, patients must be closely monitored by their physicians.

Patients with DIC, advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with recombinant factor VIIa have an increased risk of developing thrombotic events due to circulating tissue factor or predisposing coagulopathy. Potential benefit of treatment with FEIBA should be weighed against the potential risk of these thromboembolic events.

Infusion of FEIBA should not exceed a single dose of 100 units per kg body weight and daily doses of 200 units per kg body weight. Maximum injection or infusion rate must not exceed 2 units per kg of body weight per minute. Monitor patients receiving more than 100 units per kg of body weight of FEIBA for the development of DIC, acute coronary ischemia and signs and symptoms of other thromboembolic events. If clinical signs or symptoms occur, such as chest pain or pressure, shortness of breath, altered consciousness, vision, or speech, limb or abdomen swelling and/or pain, discontinue the infusion and initiate appropriate diagnostic and therapeutic measures.

Hypersensitivity and allergic reactions, including severe anaphylactoid reactions, can occur following the infusion of FEIBA. The symptoms include urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotension. These reactions can be severe and systemic (e.g., anaphylaxis with urticaria and angioedema, bronchospasm, and circulatory shock). Other infusion reactions, such as chills, pyrexia, and hypertension have also been reported. If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of FEIBA and provide appropriate supportive care.

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 contains blood group isohemagglutinins (anti-A and anti-B). Passive transmission of antibodies to erythrocyte antigens, e.g., A, B, D, may interfere with some serological tests for red cell antibodies, such as antiglobulin test (Coombs test).

ADVERSE REACTIONS

The most frequently reported adverse reactions observed in >5% of subjects in the prophylaxis trial were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting.

The serious adverse reactions seen with FEIBA are hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

DRUG INTERACTIONS

Consider the possibility of thrombotic events when systemic antifibrinolytics such as tranexamic acid and aminocaproic acid are used during treatment with FEIBA. No adequate and well-controlled studies of the combined or sequential use of FEIBA and recombinant factor VIIa, antifibrinolytics or emicizumab, have been conducted. Use of antifibrinolytics within approximately 6 to 12 hours after the administration of FEIBA is not recommended.

Clinical experience from an emicizumab clinical trial suggests that a potential drug interaction may exist with emicizumab.

Please see FEIBA full Prescribing Information, including BOXED WARNING on Thromboembolic Events.

OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence] Important Information

Indication

OBIZUR, Antihemophilic Factor (Recombinant), Porcine Sequence, is a recombinant DNA derived, antihemophilic factor indicated for the treatment of bleeding episodes in adults with acquired hemophilia A.

Limitations of Use:

  • Safety and efficacy of OBIZUR has not been established in patients with baseline anti-porcine factor VIII inhibitor titer greater than 20 BU
  • OBIZUR is not indicated for the treatment of congenital hemophilia A or von Willebrand disease

Detailed Important Risk Information

CONTRAINDICATIONS

OBIZUR is contraindicated in patients who have had life-threatening hypersensitivity reactions to OBIZUR or its components (including traces of hamster proteins).

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions can occur with OBIZUR. OBIZUR contains trace amounts of hamster proteins. Early signs of allergic reactions, which can progress to anaphylaxis, include angioedema, chest-tightness, dyspnea, hypotension, wheezing, urticaria, and pruritus. Immediately discontinue administration and initiate appropriate treatment if allergic or anaphylactic-type reactions occur.

Inhibitory Antibodies

Inhibitory antibodies to OBIZUR have occurred. Monitor patients for the development of antibodies to OBIZUR by appropriate assays. If the plasma factor VIII level fails to increase as expected, or if bleeding is not controlled after OBIZUR administration, suspect the presence of an anti-porcine factor VIII antibody. If such inhibitory antibodies to anti-porcine factor VIII are suspected and there is a lack of clinical response, consider other therapeutic options.

Monitoring Laboratory Tests

  • Perform one-stage clotting assay to confirm that adequate factor VIII levels have been achieved and maintained
    • Monitor factor VIII activity 30 minutes and 3 hours after initial dose
    • Monitor factor VIII activity 30 minutes after subsequent doses
  • Monitor the development of inhibitory antibodies to OBIZUR. Perform a Nijmegen Bethesda inhibitor assay if expected plasma factor VIII activity levels are not attained or if bleeding is not controlled with the expected dose of OBIZUR. Use Bethesda Units (BU) to report inhibitor levels

ADVERSE REACTIONS

Common adverse reactions observed in greater than 5% of subjects in the clinical trial were development of inhibitors to porcine factor VIII.

Please see OBIZUR full Prescribing Information.

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