Categories without clinically meaningful changes?

PHYSICAL HEALTH: The physical health-related subcategories of General Health and Physical Functioning. MENTAL HEALTH: The mental health-related component score and subcategories of Mental Health, Role Emotional, Social Functioning, and Vitality

ADVATE® [Antihemophilic Factor (Recombinant)] Bleed Control for Surgical Procedures.

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

Proven bleed protection when you need it most

It’s important to have a treatment plan should you need to have a surgical procedure. ADVATE is indicated for surgical use and can be used before, during, and after a procedure.¹

study design^1,2

A study of 58 children and adults with moderate to severe hemophilia A was conducted to evaluate the efficacy and safety of ADVATE for surgical use. Patients in the study had a total of 65 surgical procedures. ADVATE was given before, during, and after surgery. The dose and amount of time the dose was given depended on the patient age and the type of procedure performed. Bleed control was rated on a scale from excellent to poor.

A total of 65 procedures were performed in 58 subjects: one enrolled subject cancelled his surgery, and six subjects underwent more than one procedure. Of the 65 procedures, 22 were major (21 orthopedic); 35 were minor (19 orthopedic); and eight were dental procedures.

Surgical Data

In a study of 58 patients, ADVATE was rated positively for surgical use¹

During the procedure

94%

of surgeries (61 of 65)
rated bleed control as
excellent or good¹

For the remaining 4 procedures, either the rating was not done or is unknown.¹

After the procedure

95%

of surgeries (62 of 65)
rated bleed control as
excellent or good¹

For the remaining 3 procedures, either the rating was not done or is unknown.¹

In surgical procedures, what is an excellent or good rating?

An excellent rating means the blood loss during surgery was less than expected for the type of procedure performed. A good rating means the blood loss during surgery was as expected for the type of procedure performed.¹

study design^1,2

A study of 58 children and adults with moderate to severe hemophilia A was conducted to evaluate the efficacy and safety of ADVATE for surgical use. Patients in the study had a total of 65 surgical procedures. ADVATE was given before, during, and after surgery. The dose and amount of time the dose was given depended on the patient age and the type of procedure performed. Bleed control was rated on a scale from excellent to poor.

A total of 65 procedures were performed in 58 subjects: one enrolled subject cancelled his surgery, and six subjects underwent more than one procedure. Of the 65 procedures, 22 were major (21 orthopedic); 35 were minor (19 orthopedic); and eight were dental procedures.

Selected Important Risk Information

What are possible side effects of ADVATE?

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, and 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.

Please see Detailed Important Risk Information below.