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


Bleed and joint bleed protection with ELOCTATE®1*

Adult and Adolescent


*ELOCTATE has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.1

With ELOCTATE individualized prophylaxis, adult and adolescent patients experienced a decrease in overall ABR over 5 years of clinical data1-4†

Over 5 years, the overall ABR for ELOCTATE was 1.6 and below while joint AsBR was 0 Over 5 years, the overall ABR for ELOCTATE was 1.6 and below while joint AsBR was 0

In the individualized prophylaxis arm, additional annualized bleed rates were1,2,4:

  • AsBR: 0.0 (0.0-2.0) in A-LONG, 0.1 (0.0-1.1) in ASPIRE
  • Traumatic ABR: 0.0 (0.0-1.8) in A-LONG, 0.2 (0.0-1.1) in ASPIRE
  • Joint ABR: 0.0 (0.0-3.1) in A-LONG, 0.5 (0.0-1.7) in ASPIRE

In the A-LONG study, of 117 patients enrolled in the individualized prophylaxis arm, 112 were treated for ≥6 months. Dosing intervals were evaluated during the last 3 months of the study. Number of infusions may vary per individual. Individualized prophylaxis regimen: 25 IU/kg and 50 IU/kg of ELOCTATE on the first and fourth days of the week, respectively. Dose adjustments (25 to 65 IU/kg) and interval adjustments (every 3 to 5 days) were allowed based on a subject’s PK data and observed bleeding pattern.1

In the ASPIRE study, the individualized prophylaxis regimen was 25 to 65 IU/kg every 3 to 5 days or twice weekly (20 to 65 IU/kg on Day 1, 40 to 65 IU/kg on Day 4).5

Nearly 100% of target joints‡ were resolved with ELOCTATE prophylaxis6§

  • In 111 adult and adolescent patients taking ELOCTATE prophylaxis, 234 out of 235 target joints were resolved6

†The median cumulative treatment duration from the beginning of A-LONG to the end of ASPIRE was 4.5 years (range: 0.7 to 5.9 years).5

‡ A target joint is defined as a major joint with ≥3 bleeding episodes in a consecutive 6-month period. Target joint resolution is defined as ≤2 spontaneous bleeds in a 12-month period.6

§ Data are from the third interim cut of ASPIRE taken on January 11, 2016. 48 adult and adolescent patients and 7 pediatric patients had no target joint bleeding episodes.

ABR=annualized bleed rate; AsBR=annualized spontaneous bleed rate; PK=pharmacokinetic.


*ELOCTATE has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.1

With ELOCTATE prophylaxis, adult and adolescent patients experienced a decrease in ABR over 5 years of clinical data1-3

Over 5 years of clinical data, the median overall ABR was 1.6 (0.0-4.7) in A-LONG (n=117) and 0.74 (0.0-2.68) in ASPIRE (n=110). The median joint ABR was 0.0 (0.0-1.7) in A-LONG and 0.0 (0.0-0.71) in ASPIRE. Over 5 years of clinical data, the median overall ABR was 1.6 (0.0-4.7) in A-LONG (n=117) and 0.74 (0.0-2.68) in ASPIRE (n=110). The median joint ABR was 0.0 (0.0-1.7) in A-LONG and 0.0 (0.0-0.71) in ASPIRE.

In the A-LONG study, of 117 patients enrolled in the individualized prophylaxis arm, 112 were treated for ≥6 months. Dosing intervals were evaluated during the last 3 months of the study. Number of infusions may vary per individual. Individualized prophylaxis regimen: 25 IU/kg and 50 IU/kg of ELOCTATE on the first and fourth days of the week, respectively. Dose adjustments (25 to 65 IU/kg) and interval adjustments (every 3 to 5 days) were allowed based on a subject’s PK data and observed bleeding pattern.1

In the ASPIRE study, the individualized prophylaxis regimen was 25 to 65 IU/kg every 3 to 5 days or twice weekly (20 to 65 IU/kg on Day 1, 40 to 65 IU/kg on Day 4).2

Nearly 100% of target joints‡ were resolved with ELOCTATE prophylaxis6§

  • In 111 adult and adolescent patients taking ELOCTATE prophylaxis, 234 out of 235 target joints were resolved
  • In 13 pediatric patients taking ELOCTATE prophylaxis, 9 out of 9 target joints were resolved

‡A target joint is defined as a major joint with ≥3 bleeding episodes in a consecutive 6-month period. Target joint resolution is defined as ≤2 spontaneous bleeds in a 12-month period.6

§Data are from the third interim cut of ASPIRE taken on January 11, 2016. Forty-eight adult and adolescent patients and seven pediatric patients had no target joint bleeding episodes.


*ELOCTATE has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.1

With ELOCTATE individualized prophylaxis, children <12 experienced a decrease in overall ABR over 4 years of clinical data1,2,7

Over 4 years of clinical data, the median overall ABR was 2.0 (0.0-4.0) in Kids A-LONG (n=69). In ASPIRE (n=59), the median overall ABR was 1.18 (0.60-2.37) for patients aged <6 years (n=29) and 1.59 (0.55-3.55) in patients aged 6 to <12 years (n=30). The median joint ABR was 0.0 (0.0-0.0) in Kids A-LONG. In ASPIRE, the median joint AsBR was 0.0 (0.0-0.55) in patients aged <6 years and 0.0 (0.0-0.55) in patients aged 6 to <12 years. Over 4 years of clinical data, the median overall ABR was 2.0 (0.0-4.0) in Kids A-LONG (n=69). In ASPIRE (n=59), the median overall ABR was 1.18 (0.60-2.37) for patients aged <6 years (n=29) and 1.59 (0.55-3.55) in patients aged 6 to <12 years (n=30). The median joint ABR was 0.0 (0.0-0.0) in Kids A-LONG. In ASPIRE, the median joint AsBR was 0.0 (0.0-0.55) in patients aged <6 years and 0.0 (0.0-0.55) in patients aged 6 to <12 years.

In the Kids A-LONG study, individualized prophylaxis regimen: 25 IU/kg and 50 IU/kg of ELOCTATE on the first and fourth days of the week, respectively. Adjustments in dose (25 to 80 IU/kg) and interval (every 2 days or longer) were allowed based on a subject’s available PK data and observed bleeding pattern.1

In the ASPIRE study, the individualized prophylaxis regimen was 25 to 65 IU/kg every 3 to 5 days, or twice weekly (20 to 65 IU/kg on Day 1, 40 to 65 IU/kg on Day 4). In subjects <12 years of age, dose adjustments were made up to a maximum of 80 IU/kg up to every 2 days, if necessary.7

Nearly 100% of target joints‡ were resolved with ELOCTATE prophylaxis6§

  • In 111 adult and adolescent patients taking ELOCTATE prophylaxis, 234 out of 235 target joints were resolved
  • In 13 pediatric patients taking ELOCTATE prophylaxis, 9 out of 9 target joints were resolved

‡A target joint is defined as a major joint with ≥3 bleeding episodes in a consecutive 6-month period. Target joint resolution is defined as ≤2 spontaneous bleeds in a 12-month period.6

§Data are from the third interim cut of ASPIRE taken on January 11, 2016. Forty-eight adult and adolescent patients and seven pediatric patients had no target joint bleeding episodes.

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ELOCTATE clinical trial experience demonstrated safety and efficacy in previously treated patients1

ELOCTATE was studied in A‐LONG, Kids A‐LONG, and extension trial ASPIRE

A-LONG Pivotal Trial1,7

  • Multicenter, prospective, open-label, phase 3 study that evaluated the safety, efficacy, and PK of ELOCTATE for prophylaxis, treatment of acute bleeding, and perioperative hemostatic control
  • Enrolled a total of 165 previously treated males aged 12 to 65 years with severe hemophilia A
  • Included 113 patients with ≥1 target joint at baseline
  • 6.0 prestudy median ABR among patients treated with prophylaxis

Kids A-LONG Pivotal Trial1,4

  • Multicenter, open-label, phase 3 study that evaluated the safety and efficacy of ELOCTATE for prophylaxis, treatment of acute bleeding, and perioperative hemostatic control
  • The primary endpoint was the development of inhibitors; key secondary endpoints included the PK profile of ELOCTATE, ABR, dose administered for treatment of a bleeding episode, and patients’ rating of response to ELOCTATE for the treatment of bleeding
  • Enrolled a total of 71 previously treated males aged <12 years with severe hemophilia A; 69 patients (1–5 years of age, n=35; 6–11 years of age, n=34) were evaluable for safety and efficacy; 61 patients (88.4%) had >50 ELOCTATE EDs on study
  • Included 13 patients with target joints

ASPIRE Extension Trial5

  • Multicenter, open-label, nonrandomized evaluation of ELOCTATE in 150 previously treated males ≥12 years of age and 61 previously treated males <12 years of age with severe hemophilia A who completed the A-LONG or Kids A-LONG pivotal trials
  • The primary endpoint was development of inhibitors (neutralizing antibodies). Key secondary endpoints included ABR, EDs, and subject’s assessment of response to treatment of a bleeding episode
  • The median treatment duration from the beginning of A-LONG to the end of ASPIRE was 4.5 years (range: 0.7 to 5.9 years)
  • The median treatment duration from the beginning of Kids A-LONG to the end of ASPIRE was 3.5 years (range: 0 to 4.4 years)

Across A-LONG and ASPIRE, 22 patients underwent 24 major surgeries. One surgery was not evaluable because the patient received a nonstudy drug.

Additional ABR Cohorts

Median ABRs among adult and adolescent patients over 5 years of clinical data1-3

A-LONG Individualized prophylaxis (n=117) ASPIRE Individualized prophylaxis (n=110) A-LONG
On-demand (n=23)		 ASPIRE
On-demand (n=13)
Overall ABR 1.6 (0.0–4.7) 0.74 (0.00–2.68) 33.6 (21.1–48.7) 19.10 (15.12–30.46)
Spontaneous ABR 0.0 (0.0–2.0) 0.10 (0.00–1.06) 20.2 (12.2–36.8) 14.61 (10.88–16.37)
Joint ABR 0.0 (0.0–3.1) 0.49 (0.00–1.70) 22.8 (15.1–39.0) 13.05 (7.35–26.97)
A-LONG Individualized prophylaxis (n=117) ASPIRE Individualized prophylaxis (n=110)
Overall ABR 1.6 (0.0–4.7) 0.74 (0.00–2.68)
Spontaneous ABR 0.0 (0.0–2.0) 0.10 (0.00–1.06)
Joint ABR 0.0 (0.0–3.1) 0.49 (0.00–1.70)
A-LONG On-demand (n=23) ASPIRE On-demand (n=13)
Overall ABR 33.6 (21.1–48.7) 19.10 (15.12–30.46)
Spontaneous ABR 20.2 (12.2–36.8) 14.61 (10.88–16.37)
Joint ABR 22.8 (15.1–39.0) 13.05 (7.35–26.97)

Median ABRs among pediatric patients over 4 years of clinical data1-3

Kids A-LONG (n=69) ASPIRE (n=59)
<12 years <6 years 6 to <12 years
Overall ABR 2.0
(0.0–4.0)		 1.2
(0.6–2.4)		 1.6
(0.6–3.6)
Spontaneous ABR 0.0
(0.0–0.0)		 0.6
(0.0–0.9)		 0.3
(0.0–0.9)
Joint ABR 0.0
(0.0–2.0)		 0.6
(0.0–1.3)		 0.7
(0.0–1.7)

Bleed control

Nearly all bleeds were controlled with ≤2 infusions of ELOCTATE1,5

93% of patients or more treated on‐demand bleeds with 2 infusions or less

Perioperative management

In 100% of assessed surgeries, hemostatic response with ELOCTATE was rated as “excellent” or “good”1||

  • For 41 major surgeries in 29 patients from A-LONG or ASPIRE, hemostatic response was assessed and rated as excellent in 38 (93%) surgeries and good in 3 (7%) surgeries
  • In 72 minor surgical procedures in 59 patients from all 3 studies, all (100%) had excellent response (61 of 72; 84.7%) or good response (11 of 72; 15.3%)

Major surgeries from A-LONG1,8

Number of Procedures Hemostatic Responseb
Type of Surgery (Number of Patients) Excellent Good
Major surgery 23a (22) 19 3
Arthrodesis 1 (1) 1 –
Ankle fusion 2 (2) 2 –
Appendectomy 1 (1) 1 –
Arthroscopy 2 (2) 2 –
Ventriculostomy 1 (1) 1 –
Laparoscopic hernia surgery 2 (2) 1 1
Discopathy repair 1 (1) 1 –
Decompression of spine stenosis 1 (1) 1 –
Arthroplastyc 11 (10) 9 1
Knee arthroplasty converted to amputation 1 (1) – 1

aAcross A-LONG and ASPIRE, 22 patients underwent 24 major surgeries. One surgery was not evaluable because the patient received a nonstudy drug.

bResults 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.

cOne surgical rating was not available.

|| Major Surgeries: Hemostasis was assessed in 45 surgeries in 32 subjects from the A-LONG and ASPIRE studies. There were no major surgeries in the Kids A-LONG study. Of the 45 major surgeries, 36 surgeries (80.0%) required a single perioperative dose to maintain hemostasis. Of the 42 major surgeries treated with at least one dose, the median average dose per injection to maintain hemostasis during surgery was 59.1 IU/kg (range: 35–111). On the day of surgery, most subjects received a second injection. The total dose on the day of surgery ranged from 37.6–157.9 IU/kg. 1


Minor Surgeries: A hemostatic assessment of 72 minor surgical procedures in 59 subjects from all 3 studies was conducted. “Excellent” was defined as intraoperative and postoperative blood loss similar to (or less than) the nonhemophilic patient. No extra doses of ELOCTATE needed, and blood component transfusions required are similar to nonhemophilic patient. “Good” was defined as intraoperative and/or postoperative bleeding slightly increased over expectations for the nonhemophilic patient, but the difference was not clinically significant. Intraoperative blood loss no more than 250 mL greater than expected for a nonhemophilic patient, no extra doses of ELOCTATE needed, and blood component transfusions required are similar to nonhemophilic patient.1

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.

References: 1. ELOCTATE [package insert]. Waltham, MA: Bioverativ Therapeutics Inc. 2. Data on file. Waltham, MA; Bioverativ Therapeutics Inc. 3. Nolan B et al. Haemophilia. 2020;26(suppl 3):494-502. 4. Mahlangu J et al. Blood. 2014;123(3):317-325. 5. Nolan B et al. Haemophilia. 2020;26(3):494-502. 6. Oldenburg J, et al. Poster presented at: 12th Annual Congress of the European Association for Haemophilia and Allied Disorders; February 6-8, 2019; Prague, Czech Republic Poster P158. 7. Young G et al. J Thromb Haemost. 2015;13:1-11. 8. Mahlangu J et al. J Thromb Haemost. 2016;116(1):1-8.

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