Patient Support: Product Assistance Program | Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei]

Product Assistance Program

Qualifying patients can apply for the Product Assistance Program by downloading and completing the form, or calling 1-844-668-6732 for more information.^a

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^aThe Novo Nordisk Patient Assistance Program (PAP) is administered by NovoSecure™. To qualify for the PAP, patients must demonstrate financial need and must have attempted to find alternative reimbursement. Several factors are considered in evaluating financial need, including cost of living, size of household, and burden of total medical expenses. If the applicant qualifies under the PAP guidelines, a limited supply of the requested medication(s) will be shipped to the patient. Patients who qualify for PAP may be eligible to receive the prescribed Novo Nordisk product, for up to 1 year from the approval date. Product limits vary.

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Prescribing Information

Selected Important Safety Information

Contraindications

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

Warnings and Precautions

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

Indications and Usage

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

Important Safety Information

Contraindications

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

Warnings and Precautions

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

Adverse Reactions

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

Esperoct®

[antihemophilic factor (recombinant), glycopegylated-exei]