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. View more


ELOCTATE® has an established safety profile1


ELOCTATE is contraindicated in patients who have had a life-threatening hypersensitivity reaction to ELOCTATE or its excipients.

Hypersensitivity reactions, including anaphylaxis, have been reported with ELOCTATE.


Clinical trial subjects were monitored for neutralizing antibodies to FVIII

  • Zero inhibitors were detected in clinical trials of PTPs
  • Formation of neutralizing antibodies (inhibitors) to factor VIII has been reported following administration of ELOCTATE

Additional warnings and precautions

  • Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as nonhemophilic patients when clotting has been normalized by treatment with factor VIII
  • If a CVAD is required, risk of CVAD-related complications including local infections, bacteremia, and catheter-site thrombosis should be considered

Adverse reactions

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

  • Two subjects with cardiovascular risk factors each experienced a serious adverse reaction of myocardial infarction during the study

The safety of ELOCTATE was studied in PUPs

Clinical trial subjects were monitored for neutralizing antibodies to factor VIII

27% (n=28/103) | 27% of PUPs developed inhibitors | 14%(n=14/103) developed a high-titer inhibitor

<6 years of age (median 0.58 year; range: 0.02–4 years)

Adverse reactions in PUPs

  • The most frequently occurring adverse reactions (incidence ≥1% of patients) in clinical trials were factor VIII inhibition (27.2%), device-related thrombosis (1.9%), and rash papular (1.0%)
  • The use of ELOCTATE for ITI was investigated in 15 PUPs who developed inhibitors (12 with high-titer inhibitors and 3 with low-titer inhibitors)
  • Two subjects who experienced events of factor VIII inhibition also experienced events of deep vein thrombosis in 1 subject and rash papular in another subject

CVAD=central venous access device; ITI=immune tolerance induction; PTPs=previously treated patients; PUPs=previously untreated patients.

CVAD=central venous access device; ITI=immune tolerance induction;
PTPs=previously treated patients; PUPs=previously untreated patients.

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INDICATION
ELOCTATE 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. Patients using ELOCTATE should be monitored for the development of Factor VIII inhibitors. Clotting assays (e.g., onestage) may be used to confirm that adequate Factor VIII levels have been achieved and maintained.
  • Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-hemophilic patients when clotting has been normalized by treatment with Factor VIII.
  • If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteremia, and catheter-site thrombosis should be considered.

ADVERSE REACTIONS
The most frequently occurring adverse reactions (incidence >0.5% of subjects) reported in previously treated patients (PTPs) clinical trials were arthralgia, malaise, myalgia, headache, and rash. The most frequently occurring adverse reactions (incidence ≥1.0% of subjects) reported in previously untreated patients (PUPs) clinical trials were Factor VIII inhibition, device-related thrombosis, and rash papular.


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Reference: 1. ELOCTATE [package insert]. Waltham, MA: Bioverativ Therapeutics Inc.

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 Therapeutics Inc. 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 Therapeutics Inc. 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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