Demonstration Kit

Do not use in patients who have known hypersensitivity to Esperoct^® or its components, including hamster proteins

Hypersensitivity reactions, including anaphylaxis, may occur. Should hypersensitivity reactions occur, discontinue Esperoct^® and administer appropriate treatment

Esperoct^® [antihemophilic factor (recombinant), glycopegylated-exei] is indicated for use in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.

Esperoct^® is not indicated for the treatment of von Willebrand disease

Do not use in patients who have known hypersensitivity to Esperoct^® or its components, including hamster proteins

Hypersensitivity reactions, including anaphylaxis, may occur. Should hypersensitivity reactions occur, discontinue Esperoct^® and administer appropriate treatment
Development of neutralizing antibodies (inhibitors) has occurred. Perform an assay that measures Factor VIII inhibitor concentration if bleeding is not controlled with the recommended dose of Esperoct^® or if the expected plasma Factor VIII activity levels are not attained

The most frequently reported adverse reactions in clinical trials (≥1%) were rash, redness, itching (pruritus), and injection site reactions

Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight^® or its components, including hamster proteins

Anaphylaxis and severe hypersensitivity reactions are possible. Patients may develop hypersensitivity to hamster proteins, which are present in trace amounts in the product. Should symptoms occur, discontinue Novoeight^® and administer appropriate treatment

Novoeight^® (antihemophilic factor, recombinant) is indicated for use in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management, and routine prophylaxis to reduce the frequency of bleeding episodes.

Novoeight^® is not indicated for the treatment of von Willebrand disease

Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight^® or its components, including hamster proteins

Anaphylaxis and severe hypersensitivity reactions are possible. Patients may develop hypersensitivity to hamster proteins, which are present in trace amounts in the product. Should symptoms occur, discontinue Novoeight^® and administer appropriate treatment
Development of activity-neutralizing antibodies (inhibitors) may occur. Previously untreated patients (PUPs) are at greatest risk for inhibitor development with all factor VIII products. Inhibitors have been reported following administration of Novoeight in PUPs. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform testing for factor VIII inhibitors

The most frequently reported adverse reactions (≥1%) were inhibitors in Previously Untreated Patients (PUPs), injection site reactions, and pyrexia.

Novoeight®

[Antihemophilic Factor (Recombinant)]

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Important Safety Information

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Adverse Reactions

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