THE SHIRE HAEMOPHILIA PORTFOLIO

Shire plc develops, manufactures, and markets products that save and sustain the lives of people with haemophilia. As a global, diversified healthcare company, Shire applies a unique combination of expertise in medical devices, pharmaceuticals, and biotechnology to create products that advance patient care worldwide. Click on the different products below to get more information on the products in the Shire global haemophilia portfolio.

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Shire—A Global Haemophilia Portfolio Like No Other

HAEMOPHILIA A

Advate
ADVATE [Octocog alfa (Recombinant coagulation factor VIII)]

Powder and solvent for solution for injection for treatment and prophylaxis of bleeding in patients with haemophilia A.

Click here for the Prescribing Information for ADVATE octocog alfa.

This Prescribing Information is based on the Summary of Product Characteristics (SPC) for ADVATE as approved in the European Union by Centralised Procedure. Please always read your local prescribing information/SPC prior to using the product.

RECOMBINATE
RECOMBINATE [Octocog alfa (Recombinant coagulation factor VIII)]

Powder and solvent for solution for injection for the treatment and prophylaxis of bleeding in patients with haemophilia A.

Click here for the Prescribing Information for RECOMBINATE.

This Prescribing Information is based on the Summary of Product Characteristics (SPC) for RECOMBINATE as approved in the European Union by Mutual Recognition Procedure in certain member states of EU. Please always read your local prescribing information/SPC prior to using the product.

HEMOFIL M
HEMOFIL M [Antihemophilic Factor (Human) Method M, Monoclonal Purified]

Click here for Prescribing Information for HEMOFIL M.

This Prescribing Information is based on the currently approved US Hemofil M prescribing information. Please always read your local prescribing information prior to using the product.

IMMUNATE
IMMUNATE (Human Plasma-Derived Coagulation Factor VIII Concentrate)

Powder and solvent for solution for injection for the treatment and prophylaxis of bleeding in patients with congenital (haemophilia A) or acquired factor VIII deficiency, and for the treatment of bleeding in patients with von Willebrand disease with factor VIII deficiency if no specific preparation effective against von Willebrand disease is available, and when desmopressin (DDAVP) treatment alone is ineffective or contraindicated.

Click here for the Prescribing Information for IMMUNATE.

This Prescribing Information is based on the Summary of Product Characteristics (SPC) for IMMUNATE as approved in the European Union by Mutual Recognition Procedure in certain member states of EU. Please always read your local prescribing information prior to using the product.

HAEMOPHILIA WITH INHIBITORS

FEIBA
FEIBA [Factor VIII Inhibitor Bypassing Activity]*

Powder and solvent for solution for injection for therapy and prophylaxis of bleeding in haemophilia A patients with inhibitors to factor VIII; therapy and prophylaxis of bleeding in haemophilia B patients with inhibitors to factor IX; therapy and prophylaxis of bleeding in non-haemophiliacs with acquired inhibitors to factors VIII, IX and XI.

Click here for the Prescribing Information for FEIBA.

This Prescribing Information is based on the Summary of Product Characteristics (SPC) for FEIBA as approved in certain member states of the European Union by National Procedure. Please always read your local prescribing information prior to using the product.

* In some markets, FEIBA is also approved for acquired haemophilia A.

ACQUIRED HAEMOPHILIA A

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

Powder and solvent for solution for injection for the treatment of bleeding in adult patients with acquired haemophilia A.

Click here for US Prescribing Information for OBIZUR.

Indicated for use only in the United States.

HAEMOPHILIA B

RIXUBIS
RIXUBIS [Coagulation Factor IX (Recombinant)]

Powder and solvent for solution for injection for treatment and prophylaxis of bleeding in patients for hemophilia B (congenital factor IX deficiency) in patients of all age groups.

Click here for the Prescribing Information for RIXUBIS.

This prescribing information is based on the Summary of Product Characteristics (SPC) for RIXUBIS as approved in the EU by Centralised Procedure. Please always read your local prescribing information prior to using the product.

IMMUNINE
IMMUNINE (Human Plasma-Derived Coagulation Factor IX Concentrate)

Powder and solvent for solution for injection or infusion for the treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).

IMMUNINE is indicated for all age groups from children elder than 6 years to adults. There are insufficient data to recommend the use of IMMUNINE in children less than 6 years of age.

Click here for the Prescribing Information for IMMUNINE.

This Prescribing Information is based on the Summary of Product Characteristics (SPC) for IMMUNINE as approved in the European Union by Mutual Recognition Procedure in certain member states of EU. Please always read your local prescribing information prior to using the product.

Delivery of Care

BAXJECT II device
BAXJECT II Needleless Transfer Device

This device was designed to make the reconstitution and mixing of haemophilia factor therapies easier and faster. The BAXJECT II device is used with ADVATE, RIXUBIS and RECOMBINATE.

As compared to original BAXJECT and needle.

BAXJECT III device
BAXJECT III Reconstitution System

Shire's commitment to innovation continues with the BAXJECT III reconstitution device. No assembly is required; ADVATE and the solvent are already connected in one system.

myPKFiT personalized treatment with ADVATE
ADVATE with myPKFiT

myPKFiT is an advancement from Shire that aims to support personalisation of prophylaxis for patients taking ADVATE. The myPKFiT Web-based device enables you to estimate your patients' pharmacokinetics (PK) profiles so you can tailor treatment regimens based on their individual needs.

Research and development and scientific productivity continue to be key strategic priorities for Shire to drive innovation in the area of bleeding conditions.

This is an international site and may therefore contain information on products that are not licensed/not licensed for the exact same indications in the country where you are practicing. Before using any product, please make sure to have read your local prescribing information carefully, and use the product in accordance with the local prescribing information.

Not all products are licensed and marketed in all countries.

Please visit your local Shire Web site for specific local product information.

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