ELOCTATE^® Has an Established Safety Profile¹

ELOCTATE is contraindicated in patients who have had a life-threatening hypersensitivity reaction to ELOCTATE or its excipients.

Hypersensitivity reactions, including anaphylaxis, have been reported with ELOCTATE.

Clinical Trial Subjects Were Monitored for Neutralizing Antibodies to FVIII

• Zero inhibitors were detected in clinical trials of PTPs
• Formation of neutralizing antibodies (inhibitors) to factor VIII has been reported following administration of ELOCTATE

Additional Warnings and Precautions

• Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as nonhemophilic patients when clotting has been normalized by treatment with factor VIII

• If a CVAD is required, risk of CVAD-related complications including local infections, bacteremia, and catheter-site thrombosis should be considered

Adverse Reactions

PTPs: The most frequently occurring adverse reactions (>0.5% of patients) in clinical trials were arthralgia, malaise, myalgia, headache, and rash.

• Two subjects with cardiovascular risk factors each experienced a serious adverse reaction of myocardial infarction during the study

The safety of ELOCTATE was studied in PUPs

Among clinical trial subjects younger than 6 years (median 0.58 year; range: 0.02–4 years), the development of neutralizing antibodies to FVIII was monitored:

Adverse Reactions in PUPs

• The most frequently occurring adverse reactions (incidence ≥1% of patients) in clinical trials were factor VIII inhibition (27.2%), device-related thrombosis (1.9%), and rash papular (1.0%)
• The use of ELOCTATE for ITI was investigated in 15 PUPs who developed inhibitors (12 with high-titer inhibitors and 3 with low-titer inhibitors)
• Two subjects who experienced events of factor VIII inhibition also experienced events of deep vein thrombosis in 1 subject and rash papular in another subject

CVAD=central venous access device; FVIII=factor VIII; ITI=immune tolerance induction; PTPs=previously treated patients; PUPs=previously untreated patients.