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


Changes in joint health were evaluated1

In a post hoc study of patients ≥ 12 years of age treated with ELOCTATE prophylaxis

Study Design

Study Design1

  • This post hoc study assessed change in joint health among 47 adult and adolescent males (≥12 years of age) with severe hemophilia A who were treated with ELOCTATE prophylaxis
  • Subjects completed the A-LONG pivotal trial, enrolled in the ASPIRE extension study (data cutoff of December 8, 2014), and had available mHJHS data
  • Forty-seven subjects had mHJHS data at all 4 time points (A-LONG baseline, ASPIRE baseline, Year 1, and Year 2)
  • Joint health assessments included the change in mHJHS from A-LONG baseline to follow-up visits and comparisons of individual mHJHS domains. In addition, factors such as target joints, weight-bearing and non–weight-bearing joints, and prestudy dosing regimen were assessed for impact on mHJHS. Negative values indicate improvement

Study Limitations1

  • Data are reported from a post hoc analysis that was not powered to show statistical significance. There was a small sample size, no control group, and potential for interobserver variability
  • The mHJHS is not a validated tool
  • Further studies are needed to confirm these findings as well as the effect of improvements in joint health on overall quality of life
Improvement in Total mHJHS Was Observed Over Time
From A‐LONG Baseline to ASPIRE Year 2, patients treated with factor prior to switching to ELOCTATE experienced improvements in total mHJHS score.

mHJHS=modified Hemophilia Joint Health Score; SHL=standard half-life.

Published in Haemophilia

See the research:

Improved joint health in subjects with severe haemophilia A treated prophylactically with recombinant factor VIII Fc fusion protein

Oldenburg J, Kulkarni R, Srivastava A, et al. Haemophilia. 2018;24(1):77-84.

TAKE ME TO THE ARTICLE

See the research:

Improved joint health in subjects with severe haemophilia A treated prophylactically with recombinant factor VIII Fc fusion protein

Oldenburg J, Kulkarni R, Srivastava A, et al. Haemophilia. 2018;24(1):77-84.

TAKE ME TO THE ARTICLE

Swelling, range of motion, and strength components
contributed most to changes in joint health scores1

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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., one-stage) 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 J 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.

Reference: 1. Oldenburg J, et al. Haemophilia. 2018:24(1):77-84.

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