Median AsjBR With ELOCTATE® Individualized Prophylaxis
0.0 median overall ABR for subjects <6 years of age. 1.5 median overall ABR for subjects 6–11 years of age.
Nearly 60% of pediatric patients taking individualized prophylaxis experienced 0 bleeds during ASPIRE2
ABR=annualized bleed rate; AsjBR=annualized spontaneous joint bleed rate.
of target joints were resolved* in patients on ELOCTATE® prophylaxis3†
†Data are from the third interim cut of ASPIRE taken on January 11, 2016. In patients on ELOCTATE prophylaxis for at least 12 months who had target joints at baseline, 9 out of 9 target joints were resolved. Seven subjects had no target joint bleeding episodes.3
ABR=annualized bleed rate.
Over 2 years, nearly all bleeds were controlled with 2 infusions of ELOCTATE®
*The total number of bleeding episodes was 51 for ASPIRE.2
In Kids A-LONG, 86 bleeding episodes in 69 patients were treated with ELOCTATE, and 93.0% required 1 or 2 infusions to treat a bleeding episode.1
In Kids A-LONG, 9 out of 10 patients felt pain relief with the first infusion of ELOCTATE1†
†Per the FDA-approved Prescribing Information, 92.6% of patients rated the response to the first infusion of ELOCTATE as “excellent” or “good.” “Excellent” was defined as abrupt pain relief and/or improvement in bleeding; “good” was defined as definite pain relief and/or improvement in signs of bleeding, but possibly requiring more than 1 infusion. Response was evaluated approximately 8 to 12 hours after treatment.
ELOCTATE® demonstrated efficacy across a wide range of surgeries
10 total surgeries* in patients 11 years of age5
Major surgeries: 10 total in 10 patients
- The median number of infusions on the day of surgery was 2 (range, 1–3)
- In 100% of all surgeries assessed, hemostatic response was rated “excellent” or “good”
Minor surgeries: No major surgeries were performed after the first dose of ELOCTATE in the Kids A-LONG study
Major surgeries: 24 total in 22 patients
*From Kids A-LONG and ASPIRE.
|Type of Surgery5||Number of Procedures (Number of Patients)||Hemostatic Response†|
|Major surgery||23* (22)||19||3|
|Ankle fusion||2 (2)||2||–|
|Laparoscopic hernia surgery||2 (2)||1||1|
|Discopathy repair||1 (1)||1||–|
|Decompression of spine stenosis||1 (1)||1||–|
|Knee arthroplasty converted to amputation||1 (1)||–||1|
*Across A-LONG and ASPIRE, 22 patients underwent 24 major surgeries. One surgery was not evaluable because the patient received a nonstudy drug.
†Results based on a 4-point scale of excellent, good, fair, and poor/none. The median dose per infusion was 58.3 IU/kg (range, 45–102 IU/kg). The total dose on the day of surgery ranged from 50.8 to 126.6 IU/kg.
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.
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.
Please see Full Prescribing Information.
References: 1. ELOCTATE® [package insert]. Waltham, MA: Bioverativ®; 2017. 2. Nolan B, et al. Haemophilia. 2016;22:72-80. 3. Data on file, Bioverativ®, a Sanofi Company. 4. Blanchette VS, et al. J Thromb Haemost. 2014;12(11):1935-1939. 5. Mahlangu JN, et al. Thromb Haemost. 2016;116:1-8. 6. Nolan B, et al. Haemophilia. 2016;22(1)(suppl):1-10. 7. Mahlangu J, et al. Blood. 2014;123(3):317-325. 8. Clinicaltrials.gov. NCT01454739. https://clinicaltrials.gov/ct2/show/NCT01454739. Accessed April 25, 2018. 9. Young G, et al. J Thromb Haemost. 2015;13:1-11. 10. Clinicaltrials.gov. NCT02234323. https://clinicaltrials.gov/ct2/show/NCT02234323. Accessed April 25, 2018. 11. Shapiro A. Expert Opin Biol Ther. 2013;13(9):1287-1297. 12. Kaneko Y, et al. Science. 2006;313:670-673. 13. ADVATE® [package insert]. Westlake Village, CA: Baxalta US Inc.; 2016. 14. ADYNOVATE® [package insert]. Westlake Village, CA: Baxalta US Inc.; 2016. 15. AFSTYLA® [package insert]. Kankakee, IL: CSL Behring LLC; 2017. 16. ALPHANATE® [package insert]. Los Angeles, CA: Grifols Biologicals Inc.; 2015. 17. HEMOFIL M® [package insert]. Westlake Village, CA: Baxalta US Inc.; 2016. 18. HUMATE-P® [package insert]. Kankakee, IL: CSL Behring LLC; 2014. 19. KOATE®-DVI [package insert]. Research Triangle Park, NC: Grifols Therapeutics Inc.; 2012. 20. KOGENATE FS® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2016. 21. KOVALTRY® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2016. 22. MONOCLATE-P® [package insert]. Kankakee, IL: CSL Behring LLC; 2014. 23. NOVOEIGHT® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; 2016. 24. NUWIQ® [package insert]. Hoboken, NJ: Octapharma USA, Inc.; 2015. 25. RECOMBINATE® [package insert]. Westlake Village, CA: Baxalta US Inc.; 2017. 26. REFACTO® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc.; 2007. 27. XYNTHA® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc.; 2014. 28. Lara M, Duncan N, Andres R. Effect of hemophilia treatment center digital monitoring on bleeding rates: 12 month study. Am J Hematol. 2016;91(9):E408.