Indication: ADVATE is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: Control and prevention of bleeding episodes. Perioperative management; Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. ADVATE is not indicated for the treatment of von Willebrand disease.
Proven bleed protection* for real life1
Prophylaxis with ADVATE has generated consistently low bleed rates and joint bleed rates across clinical and real-world studies.1,2
A multicenter, open-label, prospective, randomized, 2-arm, controlled postmarketing clinical study of the relative efficacy of ADVATE use in 2 prophylactic treatment regimens compared to that of on-demand treatment; 53 previously treated patients (PTPs) with severe to moderately severe hemophilia A (FVIII level <2 IU/dL) were analyzed in the per-protocol group. Patients were initially treated for 6 months of on-demand therapy and then randomized to 12 months of either a standard prophylaxis regimen (20 - 40 IU/kg every 48 hours) or a pharmacokinetic-driven prophylaxis regimen (20 - 80 IU/kg every 72 hours).
ABR=annualized bleed rate; AJBR=annualized joint bleed rate; IQR=interquartile range.
Selected Important Risk Information
Adverse Reactions
- Serious adverse reactions seen with ADVATE are hypersensitivity reactions, including anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.
- The most common adverse reactions observed in clinical trials (<5% of subjects) were pyrexia, headache, cough, nasopharyngitis, arthralgia, vomiting, upper respiratory tract infection, limb injury, nasal congestion, and diarrhea.
Please see additional detailed important risk information below.
ADVATE clinical studies demonstrated a reduction in bleeds and joint bleeds after switching from on-demand to either standard or PK-guided prophylaxis1
Low median ABR and
AJBR of 11
98% reduction in bleeds
from 44 (IQR, 20.8) to 1 (IQR, 4.1) median ABR1
97% reduction in joint bleeds
from 38.7 (IQR, 24.8) to 1 (IQR, 4.1) median AJBR1
After switching from on-
demand to prophylaxis, 42% of
patients experienced ZERO
bleeding episodes
ABR=annualized bleed rate; AJBR=annualized joint bleed rate; IQR=interquartile range.
A noninterventional, prospective, long-term cohort study has been conducted in severe and moderate hemophilia A patients treated with ADVATE. This 3-year interim data report included 522 patients: 57% of patients had severe hemophilia A (FVIII <1%), 406 patients (78%) on prophylaxis, and 109 patients (21%) were on-demand. The primary study objective is to describe joint health in patients receiving ADVATE in a routine clinical practice setting using any treatment regimen. Secondary objectives include assessing long-term outcome data, annualized (joint) bleeding rates, and safety.
The limitations of this noninterventional study include: lack of a standardized treatment protocol and a control arm, with most safety and effectiveness parameters based on participants’ recall or self-reported information.
- This is a preliminary analysis after a 3-year period rather than a final study analysis after complete follow-up. Data on adherence/concordance with the prescribed regimen, which may have an impact on treatment outcomes, were not collected in this study.
- Since these data are from a prospective, noninterventional study, they have less evidentiary value than prospective, controlled studies. Further confirmatory studies are required to draw any conclusions from these data.
ABR=annualized bleed rate; AJBR=annualized joint bleed rate; IQR=interquartile range.
SELECTED IMPORTANT RISK INFORMATION
CONTRAINDICATIONS: Patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product.
Please see additional detailed important risk information below.
In the AHEAD prospective, noninterventional real-world study, ADVATE showed2:
![Bar chart showing the median ABR in the AHEAD real-world study treating patients with ADVATE® [Antihemophilic Factor (Recombinant)] on-demand vs prophylaxis.](/dist/images/graphs/prophylaxis-graph-median-abr.svg)
![Bar chart showing the median AJBR in the AHEAD real-world study treating patients with ADVATE® [Antihemophilic Factor (Recombinant)] on-demand vs prophylaxis.](/dist/images/graphs/prophylaxis-graph-median-ajbr.svg)
ABR=annualized bleed rate; AJBR=annualized joint bleed rate; IQR=interquartile range.
IMPORTANT RISK INFORMATION
