For US healthcare professionals only.
For US healthcare professionals only.

Important Safety Information:

CONTRAINDICATIONS: ELOCTATE is contraindicated in patients who have had life-threatening hypersensitivity reactions to ELOCTATE or its excipients.

WARNINGS AND PRECAUTIONS: Hypersensitivity reactions have been reported with ELOCTATE. Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with Factor VIII replacement products.

Full Important Safety Information

ELOCTATE® has a demonstrated safety profile1

In clinical trials, zero inhibitors were detected in previously treated patients1

  • Formation of neutralizing antibodies (inhibitors) to factor VIII has been reported following administration of ELOCTATE, including in previously untreated patients
  • Monitor all patients for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests

The most frequently occurring adverse reactions (0.5%–<1% of patients) in clinical trials were arthralgia, malaise, myalgia, headache, and rash1

  • Two subjects with cardiovascular risk factors each experienced a serious adverse reaction of myocardial infarction during the study
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INDICATIONS: ELOCTATE® [Antihemophilic factor (recombinant), Fc fusion protein] is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.

Limitation of Use

ELOCTATE is not indicated for the treatment of von Willebrand disease.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: ELOCTATE is contraindicated in patients who have had life-threatening hypersensitivity reactions to ELOCTATE or its excipients.

WARNINGS AND PRECAUTIONS:

  • Hypersensitivity reactions have been reported with ELOCTATE. Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with Factor VIII replacement products. Immediately discontinue ELOCTATE and initiate appropriate treatment if hypersensitivity reactions occur.
  • Formation of neutralizing antibodies (inhibitors) to Factor VIII has been reported following administration of ELOCTATE, including in previously untreated patients. Patients using ELOCTATE should be monitored for the development of Factor VIII inhibitors.
  • Clotting assays (e.g., one-stage) may be used to confirm that adequate Factor VIII levels have been achieved and maintained.

ADVERSE REACTIONS: The most frequently occurring adverse reactions (>0.5% of subjects) in clinical trials were arthralgia, malaise, myalgia, headache, and rash.

Please see Full Prescribing Information.

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Reference: 1. ELOCTATE [package insert]. Waltham, MA: Bioverativ; 2019.

References: 1. Srivastava A et al. Haemophilia. 2013;19(1):e1-e47. 2. Mazepa MA et al. Blood. 2016;127(24):3073-3081.

References: 1. ELOCTATE [package insert]. Waltham, MA: Bioverativ; 2019. 2. Mahlangu JN et al. Thromb Haemost. 2016;116:1-8. 3. Shapiro A. Expert Opin Biol Ther. 2013;13(9):1287-1297. 4. Kaneko Y et al. Science. 2006(5787);313:670-673. 5. Kis Toth K et al. Blood Adv. 2018;2(21):2904-2916.

References: 1. ELOCTATE [package insert]. Waltham, MA: Bioverativ; 2019. 2. Data on file. Waltham, MA; Bioverativ Therapeutics Inc. 3. Mahlangu JN et al. Thromb Haemost. 2016;116:1-8. 4. Oldenburg J et al. Haemophilia. 2018;24(1):77-84. 5. Young G et al. J Thromb Haemost. 2015;13:1-11. 6. Nolan B et al. Haemophilia. 2016;22:72-80.

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