About ADVATE® [Antihemophilic Factor (Recombinant)]

For U.S. healthcare professionals only

Detailed Important Risk Information Prescribing Information Patient & caregiver site

In the hemophilia A
community, no two patients are the same

When finding a treatment for hemophilia A, your patients' individual needs as well as their lives outside the clinic should be taken into account.¹

There are many characteristics that make each patient different^1,2:

Physical activity and lifestyle
Bleeding phenotype
Pharmacokinetic (PK) profile
Infusion dose and frequency

Adherence and prophylaxis
Annualized bleed rate (ABR) and ABR for joint bleeds
Personal goals
Baseline characteristics
(eg, age, weight)

Living with hemophilia A will always be an undeniable part of their reality—both the welcome and unwelcome moments. Your patients need treatment options that can help them navigate the many complexities of real life with hemophilia A.

Hear from a peer about the ADVATE active patient type

Watch Jonathan C. Roberts, MD, discuss ADVATE as a personalized treatment option that can help protect against bleeds for his patient living with hemophilia A who has an active lifestyle. Learn more about the active patient type with a helpful brochure available here.

Hear from a peer about the ADVATE high-risk bleed patient type

Watch Mark Reding, MD, discuss ADVATE as a prophylactic treatment option for his Hemophilia A patient who is at a high risk for bleeds. Learn more about high-risk bleed patients in a helpful brochure available here.

ADVATE has 20+ years of experience treating hemophilia A in the real world³

ADVATE is a third-generation, full-length molecule, similar to the factor VIII that occurs naturally in the body.^3,4

Established formulation

with a later generation plasma/
albumin-free recombinant factor VIII.^3,4

Proven

clinical record.^5-7

ADVATE is a global leader in Factor VIII therapy, with over 43 billion International Units distributed globally*⁸
*As of July 2022

Extensively studied

with evidence spanning over 15 years with 15 prospective studies.^3,4,8

Committed to advancing hemophilia A care

In 2003, ADVATE became the first recombinant factor VIII treatment free of blood-based additives. Since then, TAKEDA has made advancements with flexible dosing options and reconstitution with BAXJECT^® system.^3,8

2003

ADVATE [Antihemophilic Factor (Recombinant)]: first recombinant factor VIII (rFVIII) made without added human or animal proteins.^3,8

2007

First rFVIII 3000-IU single-vial dose.⁸

2011

First and only rFVIII with physical health-related quality-of-life results in the Prescribing Information.³

2014

ADVATE with BAXJECT III^® reconstitution system.⁸

2006

BAXJECT II needleless transfer device.⁸

2010

First and only rFVIII 1700-IU single-vial dose.⁸

2012

First and only rFVIII 4000-IU single-vial dose and 2-mL diluent option (250 IU, 375 IU, 500 IU, 750 IU, 1000 IU, 1500 IU, and 1700 IU).^3,8

ADVATE has an established safety profile

See the data

See ADVATE prophylaxis study results

Learn more

IMPORTANT RISK INFORMATION

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CONTRAINDICATIONS: Patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product.

ADVATE [Antihemophilic Factor (Recombinant)] Important Information

Indications

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.

DETAILED IMPORTANT RISK INFORMATION

CONTRAINDICATIONS

Patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product.

WARNINGS & PRECAUTIONS

Hypersensitivity Reactions

Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with ADVATE. Symptoms include dizziness, paresthesia, rash, flushing, facial swelling, urticaria, dyspnea, pruritus, and vomiting. Discontinue ADVATE if hypersensitivity symptoms occur and administer appropriate emergency treatment.

Neutralizing Antibodies

Neutralizing antibodies (inhibitors) have been reported following administration of ADVATE predominantly in previously untreated patients (PUPs) and previously minimally treated patients (MTPs). Monitor all patients for the development of factor VIII inhibitors by appropriate clinical observation and laboratory testing. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration.

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.

Click to read Full Prescribing Information.

References References

Valentino LA. Considerations in individualizing prophylaxis in patients with haemophilia A. Haemophilia. 2014;20(5):6.
Petrini P, Valentino LA, Gringeri A, Re WM, Ewenstein B. Individualizing prophylaxis in hemophilia: a review. Expert Rev Hematol. 2015;8(2):237-246. doi:10.1586/17474086.2015.1002465
Advate. Prescribing information. Baxalta US Inc; 2018.
Grillberger L, Kreil TR, Nasr S, Reiter M. Emerging trends in plasma-free manufacturing of recombinant protein therapeutics expressed in mammalian cells. Biotechnol J. 2009;4(2):186-201. doi:10.1002/biot.200800241
Auerswald G, Thompson AA, Recht M, et al. Experience of Advate rAHF-PFM in previously untreated patients and minimally treated patients with haemophilia A. Thromb Haemost. 2012;107(6):1072-1082. doi:10.1160/TH11-09-0642
Khair K, Mazzucconi MG, Parra R, et al. Pattern of bleeding in a large prospective cohort of haemophilia A patients: a three-year follow-up of the AHEAD (Advate in HaEmophilia A outcome Database) study. Haemophilia. 2018;24(1):85-96. doi:10.1111/hae.13361
Valentino LA, Mamonov V, Hellmann A, et al. A randomized comparison of two prophylaxis regimens and a paired comparison of on-demand and prophylaxis treatments in hemophilia A management. J Thromb Haemost. 2012;10(3):359-367. Published correction appears in J Thromb Haemost. 2012;10(6):1204.
Takeda data on file.