jump into the details

jump into the details

there's more to learn about eloctate

safety data

See additional safety information.

get more info

clinical study
design details

We dig into the data for you on how ELOCTATE clinical trials were set up.

see the data

once-weekly dosing
regimen

see the results

high-quality
manufacturing

Our manufacturing process is state of the art.

see how eloctate is made

vial availability

ELOCTATE is available in the most vial strength options of any FACTOR VIII replacement therapy.

check out your options

ELOCTATE 101:
Get the basics

learn more

ELOCTATE
Patient Stories

watch their stories

safety
data

All the ELOCTATE Safety Data from the clinical trials. All in one place.

233

previously
treated
patients

ELOCTATE has been evaluated for safety in 233 previously treated patients who received at least one dose in A-LONG (n=164) and Kids A-LONG (n=69). 136 subjects were treated for at least 104 weeks.

Zero inhibitors were detected in the adult and adolescent clinical study.*

0

*Inhibitors to FACTOR VIII can occur following administration of ELOCTATE. Your healthcare provider may give you blood tests to check for inhibitors.

Formation of inhibitors to FACTOR VIII has been reported following administration of ELOCTATE, including in previously untreated patients.

In the adult study one person had a transient, positive neutralizing antibody that was not confirmed upon repeat testing.

In the adult study one person had a transient, positive neutralizing antibody that was not confirmed upon repeat testing.

adverse reactions in the clinical studies

0.9

%

(2 people)

Most frequently occurring adverse reactions in the clinical studies were headache, rash, joint pain, muscle pain and general discomfort; each occurred in 0.9% (or 2 people).

0.4

%

(1 person)

Abdominal pain (lower), back pain, altered sense of taste, chest pain, cough, dizziness, feeling cold, feeling hot, headache, high blood pressure, joint swelling, muscle pain, procedural low blood pressure, rash, slow heart rate, and vascular pain after injection of drug; each occurred in 0.4% (or 1 person).

2 people withdrew from the study due to adverse reactions one individual for a rash, and one for joint pain.

2 people withdrew from the study due to adverse reactions one individual for a rash, and one for joint pain.

Get informed. Stay informed.

Let's stay in touch. We'll occasionally send you important information on Hemophilia A and ELOCTATE. If you're new to ELOCTATE, we'll send you a Bluetooth® speaker so you can listen to patient stories, or if you're already on ELOCTATE, a cooler bag for your product.


Bluetooth is a registered trademark of Bluetooth SIG, Inc. All rights reserved.

Bluetooth is a registered trademark of Bluetooth SIG, Inc. All rights reserved.

clinical
study
design

A little more detail on ELOCTATE clinical trial study design:

The efficacy and safety of ELOCTATE has been studied longer than any FACTOR VIII with an extended half-life. Evaluated in previously treated patients with severe Hemophilia A in two completed studies (A-LONG and Kids A-LONG), and one ongoing extension study (n=233).

Ellipse

Pharmacokinetics

The pharmacokinetics of ELOCTATE were evaluated following a single dose of 50 IU/kg in the Phase 3 study of 28 adult and 11 adolescent (ages 12-17), previously treated patients and in an open-label, multicenter study of 54 pediatric patients (ages 1-11). The adult subgroup included two adolescent subjects (a 15- and 16-year old).

164

people

(age 12-65)

164

people
(age 12-65)

In the A-LONG study
received ELOCTATE in
1 of 3 treatment arms:

  • Every 3 to every 5 days (dose or interval could be adjusted to maintain appropriate FVIII levels)
  • Weekly prophylaxis
  • On-demand

69

people

(age 1-11)

69

people
(age 1-11)

In the Kids A-LONG study
received ELOCTATE in
1 of 2 treatment arms:

In the Kids A-LONG study
received ELOCTATE in 1 of 2
treatment arms:

  • Twice-weekly (dose or interval could be adjusted to maintain appropriate FVIII levels)
  • On-demand

211

people

(age 2-66)

211

people
(age 2-66)

In the ongoing extension
study includes people
who completed A-LONG
or Kids A-LONG

Get informed. Stay informed.

Let's stay in touch. We'll occasionally send you important information on Hemophilia A and ELOCTATE. If you're new to ELOCTATE, we'll send you a Bluetooth® speaker so you can listen to patient stories, or if you're already on ELOCTATE, a cooler bag for your product.


Bluetooth is a registered trademark of Bluetooth SIG, Inc. All rights reserved.

Bluetooth is a registered trademark of Bluetooth SIG, Inc. All rights reserved.

once-weekly dosing
regimen was studied

On Demand Study
76

Here are the study design and results:

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.

Get informed. Stay informed.

Let's stay in touch. We'll occasionally send you important information on Hemophilia A and ELOCTATE. If you're new to ELOCTATE, we'll send you a Bluetooth® speaker so you can listen to patient stories, or if you're already on ELOCTATE, a cooler bag for your product.


Bluetooth is a registered trademark of Bluetooth SIG, Inc. All rights reserved.

Bluetooth is a registered trademark of Bluetooth SIG, Inc. All rights reserved.

high-quality manufacturing

Making DNA work for you

Making DNA work
for you

We make ELOCTATE by producing FACTOR VIII Fc Fusion using recombinant DNA technology. And we like to set the bar high.

We make ELOCTATE by
producing FACTOR VIII Fc Fusion
using recombinant DNA
technology. And we like to set
the bar high.

Our manufacturing process is state of the art. Purification and viral standards are our main goal. We test ELOCTATE at every stage of the manufacturing process to ensure it meets strict quality standards.

watch how
eloctate is made

watch how
eloctate is made

Get informed. Stay informed.

Let's stay in touch. We'll occasionally send you important information on Hemophilia A and ELOCTATE. If you're new to ELOCTATE, we'll send you a Bluetooth® speaker so you can listen to patient stories, or if you're already on ELOCTATE, a cooler bag for your product.


Bluetooth is a registered trademark of Bluetooth SIG, Inc. All rights reserved.

Bluetooth is a registered trademark of Bluetooth SIG, Inc. All rights reserved.

vial availability

the most vial strength options of any FACTOR VIII replacement therapy1-14.

ELOCTATE is the only extended half-life therapy with 4000-IU, 5000-IU and 6000-IU dosage strengths. Having all these options means patients may be able to achieve their recommended dose with a single vial*.

Talk to your doctor to see what option may be best for you. When infusing, refer to the Reconstitution video below.

Talk to your doctor to see what option may be best for you.
When infusing, refer to the Reconstitution video below.

*Dosing and frequency may vary based on individual patient response.

Vials Vials 2

Image not representative of actual drug product vials.

For more information about safe sharps disposal, go to the FDA's website at:

  • 1. ADVATE® [package insert]. Westlake Village, CA: Baxalta US Inc; 2016.

  • 2. AFSTYLA® [package insert]. Kankakee, IL: CSL Behring LLC; 2017.

  • 3. ALPHANATE® [package insert]. Los Angeles, CA: Grifols Biologicals Inc; 2015.

  • 4. HEMOFIL M® [package insert]. Westlake Village, CA: Baxalta US Inc; 2016.

  • 5. HUMATE-P® [package insert]. Kankakee, IL: CSL Behring LLC; 2017.

  • 6. KOATE®-DVI [package insert]. Research Triangle Park, NC: Grifols Therapeutics Inc; 2012.

  • 7. KOGENATE FS® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2016.

  • 8. KOVALTRY® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2016.

  • 9. MONOCLATE-P® [package insert]. Kankakee, IL: CSL Behring LLC; 2014.

  • 10. NOVOEIGHT® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2016.

  • 11. NUWIQ® [package insert]. Hoboken, NJ: Octapharma USA, Inc; 2015.

  • 12. RECOMBINATE® [package insert]. Westlake Village, CA: Baxalta US Inc; 2017.

  • 13. REFACTO® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc; 2007.

  • 14. XYNTHA® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc; 2014.

when infusing eloctate, refer to this reconstitution video

when infusing eloctate, refer to this reconstitution video

Get informed. Stay informed.

Let's stay in touch. We'll occasionally send you important information on Hemophilia A and ELOCTATE. If you're new to ELOCTATE, we'll send you a Bluetooth® speaker so you can listen to patient stories, or if you're already on ELOCTATE, a cooler bag for your product.


Bluetooth is a registered trademark of Bluetooth SIG, Inc. All rights reserved.

Bluetooth is a registered trademark of Bluetooth SIG, Inc. All rights reserved.

indications and important facts about eloctate 

what is the most important information I should know about ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein]? You should not use ELOCTATE if you are allergic to ELOCTATE or any of its other ingredients. Tell your healthcare provider if you have had an allergic reaction to any Factor VIII product prior to using ELOCTATE.
Allergic reactions may occur. Call your healthcare provider or emergency department 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. This can stop ELOCTATE from working properly. Your healthcare provider may give you blood tests to check for inhibitors.


THE MOST COMMON SIDE EFFECTS OF ELOCTATE INCLUDE: headache, rash, joint pain, muscle pain and general discomfort. These are not all the possible side effects of ELOCTATE. Talk to your healthcare provider for more information and about any side effect that bothers you or does not go away.


WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE STARTING ELOCTATE?

Tell your healthcare provider about all your health conditions, including if you:

  • Have or have had any medical problems.
  • Are taking any prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal medicines.
  • Are pregnant or planning to become pregnant. It is not known if ELOCTATE may harm your unborn baby.
  • Are breastfeeding. It is not known if ELOCTATE passes into breast milk or if it can harm your baby.

AFTER STARTING ELOCTATE:

If your bleeding is not controlled and you experience a lack of clinical response to Factor VIII therapy, call your healthcare provider right away.

Medicines are sometimes prescribed for purposes other than those listed here. Do not use ELOCTATE for a condition for which it was not prescribed. Do not share ELOCTATE with other people, even if they have the same symptoms that you have.


ELOCTATE INDICATIONS

ELOCTATE 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.


HOW SHOULD I RECEIVE ELOCTATE?

ELOCTATE should be administered as ordered by your healthcare provider. You should be trained on how to do infusions by your healthcare provider. Many people with hemophilia A learn to infuse ELOCTATE by themselves or with the help of a family member. See the booklet called "Instructions for Use" packaged in your ELOCTATE for directions on infusing. If you are unsure of the procedure, please ask your healthcare provider.


IMPORTANT FACTS ABOUT ELOCTATE

Please read this information carefully before using ELOCTATE and each time you get a refill, as there may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.


QUESTIONS?

The risk information provided here is not comprehensive. To learn more, talk about ELOCTATE with your healthcare provider or pharmacist.
The FDA-approved product labeling can be found at www.eloctate.com or 1-855-MyELOCTATE (693-5628). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.


MANUFACTURED BY

Bioverativ Therapeutics Inc.
Waltham, MA 02451 USA
U.S. License #2078


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


Please see Full Prescribing Information

Questions?

1-855-MYELOCTATE (1-855-693-5628)

Monday-Friday, 8am-8pm, EST

BIVV logo

©2017 Bioverativ. All rights reserved.

ELO logo

ELO-US-1631

Questions?

1-855-MYELOCTATE (1-855-693-5628)

Monday-Friday, 8am-8pm, EST