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


Calculate your patient’s ELOCTATE® starting dose for routine prophylaxis, bleed control, or surgery1 The ELOCTATE recommended starting regimen is 1

  • 50 IU/kg administered every 4 days
  • For children <6 years of age, 50 IU/kg is administered twice weekly

2x weekly
Adjust the regimen based on patient response with dosing in the range of 25 to 65 IU/kg at 3- to 5-day intervals. In children <6 years of age, more frequent or higher doses up to 80 IU/kg may be required.
Estimated increment of factor VIII (% of normal) 50%
Estimated increment of factor VIII (% of normal) 100%
Factor VIII level required (IU/dL or % of normal) 40 – 60
 
Factor VIII level required (IU/dL or % of normal) 80 – 100
Dose range (IU/kg) 20 – 30
Dose range (IU/kg) 40 – 50
Frequency of dosing (hours) Repeat every 24–48 hours (12–24 hours for patients <6 years of age)
Frequency of dosing (hours) Repeat every 12–24 hours (8–24 hours for patients <6 years of age)
Duration of therapy Until the bleeding episode is resolved
Duration of therapy Until the bleeding episode is resolved (approximately 7–10 days)
 
Estimated increment of factor VIII
(% of normal)
50%100%
Factor VIII level required
(IU/dL or % of normal)
40 – 6080 – 100
Dose range (IU/kg)
20 – 3040 – 50
Frequency of dosing (hours)
Repeat every 24–48 hours (12–24 hours for patients
<6 years of age)Repeat every 12–24 hours (8–24 hours for patients
<6 years of age)
Duration of therapy
Until the bleeding episode is resolvedUntil the bleeding episode is resolved
(approximately
7–10 days)
 
Factor VIII level required (IU/dL or % of normal) 50 – 80
 
Dose range (IU/kg) 25 – 40
 
Frequency of dosing (hours) Repeat every 24 hours (12–24 hours for patients <6 years of age)
 
Duration of therapy (days) At least 1 day, until healing is achieved
 
Factor VIII level required (IU/dL or % of normal) 80 – 120
 
Frequency of dosing (hours) Preoperative dose of 40–60 IU/kg followed by a repeat dose of 40–50 IU/kg after 8–24 hours (6–24 for patients <6 years of age) and then every 24 hours to maintain FVIII activity within the target range
 
Duration of therapy (days) Until adequate wound healing, then continue therapy for at least 7 days to maintain a factor VIII activity within the target range
 

Information in the above calculator is provided as a guide for dosing ELOCTATE for prophylaxis, the control of bleeding episodes, and perioperative management. Your independent medical consideration should be given to maintaining factor VIII activity at or above the target range.

*Minor and moderate bleed events: joint, superficial muscle/no neurovascular compromise (except iliopsoas), deep laceration and renal, superficial soft tissue, mucous membranes.1

†Major bleed events: life- or limb-threatening hemorrhage, iliopsoas and deep muscle with neurovascular injury, retroperitoneum, intracranial, or gastrointestinal.1

Fc Fusion helps ELOCTATE stay in circulation through a natural pathway and does not accumulate1,2

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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.


Please see full Prescribing Information.

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References: 1. ELOCTATE [package insert]. Waltham, MA: Bioverativ Therapeutics Inc. 2. Shapiro A. Expert Opin Biol Ther. 2012;13(9):1287-1297.

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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