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ONCE-WEEKLY DOSING REGIMEN
WAS STUDIED
The recommended starting regimen is 50 IU/kg of ELOCTATE administered every 4 days. Adjust the regimen based on patient response with dosing in the range of 25-65 IU/kg at 3-5 day intervals.
For children <6 years of age, the recommended starting regimen is 50 IU/kg of ELOCTATE administered twice weekly. Adjust the regimen based on patient response with dosing in the range of 25-65 IU/kg at 3-5 day intervals. More frequent or higher doses up to 80 IU/kg may be required.
Study Design
A-LONG, a multicenter, prospective, open-label, Phase 3 study (n=165) that evaluated the safety and efficacy of ELOCTATE in previously treated male patients aged 12-65 years with severe Hemophilia A (<1% endogenous FVIII activity or a genetic mutation consistent with severe Hemophilia A), compared the efficacy of each of 2 prophylactic treatment regimens (individualized interval and fixed weekly) to episodic (on-demand) treatment. Hemostatic efficacy was determined during treatment of bleeding episodes and during perioperative management in subjects undergoing major surgical procedures. 164 and 163 subjects were evaluable for safety and efficacy, respectively.
RESULTS
In the A-LONG clinical trial, 46 patients who had been treating with FACTOR VIII on-demand were enrolled and randomly assigned to receive ELOCTATE 65 IU/kg once-weekly prophylaxis (n=23) or to receive ELOCTATE on-demand (n=23). At study end, subjects in the once-weekly arm of the study experienced a statistically significant reduction of 76% (P <0.001) in mean overall annualized bleed rate (ABR) compared to that of the on-demand arm.
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LET'S GET STARTEDELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] is an injectable medicine that is used to help control and prevent bleeding in people with Hemophilia A (congenital Factor VIII deficiency). Your healthcare provider may give you ELOCTATE when you have surgery.
IMPORTANT SAFETY INFORMATION AND INDICATION
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IMPORTANT SAFETY INFORMATION
Do not use ELOCTATE if you have had an allergic reaction to it in the past.
Tell your healthcare provider if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines, have any allergies, are breastfeeding, are pregnant or planning to become pregnant, or have been told you have inhibitors (antibodies) to Factor VIII.
Allergic reactions may occur with ELOCTATE. Call your healthcare provider or get emergency treatment right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash, or hives.
Your body can also make antibodies called "inhibitors" against ELOCTATE, which may stop ELOCTATE from working properly.
Additional common side effects of ELOCTATE are headache, rash, joint pain, muscle pain and general discomfort.
If you have risk factors for developing abnormal blood clots in your body, such as an indwelling venous catheter, treatment with Factor VIII may increase this risk.
These are not all the possible side effects of ELOCTATE. Talk to your healthcare provider right away about any side effect that bothers you or that does not go away, or if bleeding is not controlled after using ELOCTATE.
INDICATION
ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] is an injectable medicine that is used to help control and prevent bleeding in people with Hemophilia A (congenital Factor VIII deficiency). Your healthcare provider may give you ELOCTATE when you have surgery.
PLEASE SEE FULL PRESCRIBING INFORMATIONMANUFACTURED BY
Bioverativ Therapeutics Inc.
Waltham, MA 02451 USA
U.S. License #2078
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INDICATION
ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] is an injectable medicine that is used to help control and prevent bleeding in people with Hemophilia A (congenital Factor VIII deficiency). Your healthcare provider may give you ELOCTATE when you have surgery.
MAT-US-2021871-v5.0-01/2023 Last Updated: January 2023