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 factor VIII
- Zero inhibitors were detected in clinical trials of previously treated patients (PTPs)
- 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
- 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 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
Previously treated patients (PTPs): The most frequently occurring adverse reactions (>0.5% to <1% 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
Previously untreated patients (PUPs): The most frequently occurring adverse reactions (incidence ≥1% of patients) in clinical trials were factor VIII inhibition, device-related thrombosis, and rash papular
Calculate an ELOCTATE dose for different clinical needs
- The use of ELOCTATE for immune tolerance induction (ITI) was also investigated in 15 PUPs who had 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