whoa. whoa. whoa.

You're being directed to the ELOCTATE Healthcare Professional website. If you're okay with that, we're okay with that.

Come back soon!

SELECTED SAFETY DATA

ELOCTATE Safety Data from the clinical trials.

379 treated patients

treated
patients

ELOCTATE has been evaluated for safety in 276 previously treated patients who received at least one dose in clinical studies (207 adults and adolescents and 69 children). 107 subjects were treated for at least 208 weeks.

ELOCTATE has also been evaluated for safety in 103 previously untreated patients who received at least one dose in clinical studies. Subjects were treated for a median of 64 weeks.

Zero inhibitors were detected in clinical trials of previously treated patients (PTPs).

1 previously treated adult from the studies had a transient, positive neutralizing antibody that was not confirmed upon repeat testing.

In a clinical trial of previously untreated patients (PUPs), inhibitors were detected in:

-27% of patients (n=28/103)

-14% of patients (n=14/103) developed a high-titer inhibitor

MOST COMMON ADVERSE REACTIONS

4% (11 people)

of previously treated patients(11 people)

Adverse reactions (ARs) were reported for 11 of 276 (4.0%) subjects treated with routine prophylaxis or episodic (on-demand) therapy. The most common adverse reactions (incidence >0.5% of people) reported in previously treated patients (PTPs) clinical trials were joint pain, general discomfort, muscle pain, headache and rash.

Two subjects with cardiovascular risk factors each experienced a serious adverse reaction of heart attack during the study.

28% (29 people)

of previously untreated patients(29 Person)

Adverse drug reactions (ADRs) were reported in 29 of 103 (28.2%) subjects treated with ELOCTATE. The most common adverse reactions (incidence ≥1.0% of people) reported in previously untreated patients (PUPs) clinical trials were Factor VIII inhibition, device-related blood clots, and rash.

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.

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

IMPORTANT SAFETY INFORMATION AND INDICATIONS

+

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.

INDICATIONS

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 INFORMATION

MANUFACTURED BY

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

CLICK HERE TO LEARN MORE ABOUT SANOFI'S COMMITMENT TO FIGHTING COUNTERFEIT DRUGS.