What is ADVATE?
ADVATE is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called “classic” hemophilia). ADVATE is used to prevent and control bleeding in adults and children (0-16 years) with hemophilia A. Your healthcare provider (HCP) may give you ADVATE when you have surgery. ADVATE can reduce the number of bleeding episodes in adults and children (0-16 years) when used regularly (prophylaxis). ADVATE is not used to treat von Willebrand disease.1
ADVATE has an established safety profile2
study Description2
The safety of ADVATE was evaluated in 8 studies in 276 previously treated patients (PTPs) with moderately severe to severe hemophilia A. PTPs were defined as having ≥50 or ≥150 exposure days (EDs) to FVIII products, depending on the study. In this analysis, PTPs were defined as patients with ≥50 EDs. For PTP inhibitor incidence, all PTPs with ≥10 consecutive EDs (N=276) during the course of individual studies were included in the analysis. EDs were defined as calendar days on which rAHF-PFM (recombinant Antihemophilic Factor – Manufacture Protein Free) was administered.
Inhibitor data for PTPs
Low risk of factor VIII inhibitor development was seen across studies2
in PTPs (1/276)2
(95% CI: 0.009%-2.002%)
1 PTP developed a nonpersistent, low-titer inhibitor.
There was 1 additional case of a possible low-titer factor VIII inhibitor, which was unconfirmed, unaccompanied by symptoms of inhibitor presence, and disappeared at the subject's subsequent test.2
What are PTPs?
In these ADVATE clinical studies, previously treated patients (PTPs) represent patients who have had either ≥50 or ≥150 exposure days (EDs) to factor VIII products depending on the study. In this specific analysis, PTPs represent patients with ≥50 EDs.2
study Description2
The safety of ADVATE was evaluated in 8 studies in 276 previously treated patients (PTPs) with moderately severe to severe hemophilia A. PTPs were defined as having ≥50 or ≥150 exposure days (EDs) to FVIII products, depending on the study. In this analysis, PTPs were defined as patients with ≥50 EDs. For PTP inhibitor incidence, all PTPs with ≥10 consecutive EDs (N=276) during the course of individual studies were included in the analysis. EDs were defined as calendar days on which rAHF-PFM (recombinant Antihemophilic Factor – Manufacture Protein Free) was administered.
Selected Important Risk Information
What else should I know about ADVATE and Hemophilia A?
Your body may form inhibitors to factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop ADVATE from working properly. Talk with your HCP to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.
Please see Detailed Important Risk Information below.
study Description1,3
The safety of ADVATE was evaluated in a multicenter, open-label clinical study of 55 previously untreated patients (PUPs) and minimally treated patients (MTPs) <6 years of age with severe (FVIII level <1%) or moderately severe (FVIII level 1%–2%) hemophilia A determined at baseline. PUPs and MTPs were defined as having had up to 3 exposures to a factor VIII product at time of enrollment. Patients were followed for 75 exposure days or 3 years, whichever occurred first. The primary safety endpoint was the percentage of subjects who developed an inhibitor to FVIII.
Inhibitor data for PUPs and MTPs
An Established Safety Profile in PUPs and MTPs1,3,4
inhibitors (16/55)1,3
(95% CI: 17.1%-41.1%)
What are PUPs and MTPs?
In these ADVATE clinical studies, previously untreated patients (PUPs) and minimally treated patients (MTPs) represent patients who have had up to 3 exposures to a factor VIII product at the time they were enrolled in the study.1
study Description1,3
The safety of ADVATE was evaluated in a multicenter, open-label clinical study of 55 previously untreated patients (PUPs) and minimally treated patients (MTPs) <6 years of age with severe (FVIII level <1%) or moderately severe (FVIII level 1%–2%) hemophilia A determined at baseline. PUPs and MTPs were defined as having had up to 3 exposures to a factor VIII product at time of enrollment. Patients were followed for 75 exposure days or 3 years, whichever occurred first. The primary safety endpoint was the percentage of subjects who developed an inhibitor to FVIII.
Important information to know about ADVATE1
Allergic reactions have been reported with ADVATE. Call your HCP right away and stop treatment if you experience any of the following symptoms:
- Rash or hives
- Itching
- Tightness of the throat
- Chest pain or tightness
- Difficulty breathing
- Lightheadedness
- Dizziness
- Nausea or fainting
Possible side effects of ADVATE1
Side effects that have been reported with ADVATE include:
- cough
- headache
- joint swelling/aching
- sore throat
- fever
- itching
- unusual taste
- dizziness
- hematoma
- abdominal pain
- hot flashes
- swelling of legs
- diarrhea
- chills
- runny nose/congestion
- nausea/vomiting
- sweating
- rash
Tell your HCP about any side effects that bother you or do not go away or if your bleeding does not stop after taking ADVATE.
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