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Intended for US audiences only. Solo para personas de los Estados Unidos

A Pressing Need

Did you know it has been estimated that approximately 2 million or more women in the U.S. might be living with a bleeding disorder?1 It is challenging to be more precise because the actual number of women with factor deficiencies is likely underestimated. It has long been erroneously believed that hemophilia is rare in women. However, because women, unlike men, can inherit hemophilia from both their mothers and their fathers, logic dictates that there should be two females for every male carrying the gene for hemophilia.37 Because hemophilia often presents in women as heavy menstrual bleeding, its symptoms can be missed, or its cause misidentified.20 Women with von Willebrand disorder (VWD) have been estimated to range from 0.6 – 1.3% of American women and girls.2,3 However, even these estimates may be low. Looking at data from the UK, it is reported that there were 11,288 people treated for VWD in 2021-2022 in a population of 67 million — or 168 people per million.4 As a point of comparison, the U.S. has 15,349 patients registered for VWD (treated or not) in a population of 330 million — or 46 people per million.5 Due to inaccurate, sex-based beliefs rooted in an outdated understanding of genetics, females are likely over-represented in the VWD count, while under-represented in the hemophilia counts. And that the reverse is true for males. Accurate data on prevalence and distribution of bleeding disorders remains elusive; the hard truth is, more likely, that we have simply failed to capture a large portion of individuals affected by bleeding disorders in the U.S. as well as to diagnose their disorder type correctly. Sex bias affects the outcomes of these and so many other conditions, through misdiagnosis and missed diagnosis. It is critically important for system improvement to assist with finding the missing and diagnosing them correctly.

Despite women experiencing bleeding episodes throughout every stage of their life — infancy, childhood, adolescence, young adulthood, adulthood, and older age — many are never diagnosed.1 Some of this may be attributed to a general lack of awareness of bleeding disorders in women, and some to sex bias — even among professionals. For example, a 2009 CDC study showed that the prevalence of VWD and factor VIII deficiency in women with heavy menstrual bleeding was much higher than U.S. gynecologists perceived it to be.6 Systematic review of published studies indicated that an estimated 5-24% of women with heavy menstrual bleeding might have undiagnosed VWD.6 A 2017 study confirmed that misrecognition and misdiagnosis of women with VWD is an ongoing problem.

Serial Misrecognition of Women with VWD7

Serially misrecognized patients are defined as those who visited the same specialist type at least twice for an episodic bleed prior to VWD diagnosis. Twenty-five percent were misrecognized during their journey, with an average time from first bleed claim to VWD diagnostic claim of 669 (range 2-3,284) days.

They were:

  • Female (82%)
  • Aged 16-45 years (54%)
  • Under the care of
    • OBGYN (35%)
    • ER/Hospitalist (33%)
    • Primary Care Provider (33%).

A previous study, from 2004, Trends in Clinical Management of Women with Von Willebrand Disease, found that the average time from first symptom to clinician recognition was 16 years.34

Likewise, a 2020 study, Patterns of von Willebrand Disease Screening in Girls and Adolescents with Heavy Menstrual Bleeding,8 noted that despite recommendations by the American College of Obstetricians and Gynecologists (ACOG) for more than 15 years, fewer than 20% of the 23,888 post-pubertal adolescents with heavy menstrual bleeding included in the analysis underwent screening for VWD. And the problem has been shown to extend beyond adolescence. A 2012 survey6 of providers, implemented by ACOG, found that the majority of physicians surveyed reported they would be likely or very likely to consider a bleeding disorder as causing heavy menstrual bleeding in adolescent patients; however, less than 40% would consider bleeding disorders in adult women with the same menstrual characteristics.

Clearly, there is a need to increase awareness of the lifelong issues of concern for women with bleeding disorders and to better understand, diagnose, and appropriately treat women with these conditions.

Answering the Call; Advancing Understanding

The goals of recent research respond to the need to better understand the impact of bleeding disorders on women throughout their lifetime. Studies have been undertaken to understand how many women are affected by bleeding disorders, to develop and implement interventions to help prevent complications, to generate awareness fostering early diagnosis and informed treatment, and to refine testing to better identify women at risk for bleeding disorders.

Symptoms of Bleeding Disorders in Women and Girls9

  • Menstrual bleeding that lasts longer than 7 days
  • Flooding or gushing of menstrual blood
  • Passing blood clots larger than grapes during menstruation
  • Soaking a tampon or pad hourly or more frequently
  • Using more than one hygiene product at a time
  • Using heavy absorbency hygiene products for the majority of menstrual cycle duration
  • Anemia / iron deficiency
  • Abnormal or frequent bleeding, for example, nose bleeds that last longer than 10 minutes or require medical intervention
  • Abnormal bruising
  • Excessive bleeding after medical procedures, such as tooth extraction
  • Muscle and joint bleeding

Advances have been facilitated by data collection. Data collected by the CDC in two major longitudinal research initiatives, Universal Data Collection (UDC) and Community Counts, with collaboration from the American Thrombosis and Hemostasis Network (ATHN), has expanded our knowledge and made meaningful headway in increasing health equity for women and girls, especially those with bleeding disorders.

Universal Data Collection: Setting the Foundation

Using a specially designed data collection instrument for women, the UDC initiative at the CDC collected data from 2009–2010 on more than 4,000 women and girls treated at Hemophilia Treatment Centers (HTCs) in the U.S. The tasks of the study were fourfold10:

  • Characterize the women and girls receiving treatment at an HTC
  • Characterize the bleeding episodes associated only with females, including menstruation, pregnancy, and childbirth
  • Investigate what services were provided to these patients at HTCs
  • Study the care provided to females with bleeding disorders

The research helped to define the symptoms associated with women and bleeding disorders. Of the 4,000+ women and girls participating in the research11:

  • 78.3% reported heavy menstrual bleeding as their most common bleeding symptom
  • 49.2% reported experiencing more than 4 symptoms of a bleeding disorder
  • 76.6% reported pregnancy and childbirth complications, including miscarriage
  • 37.6% reported postpartum hemorrhage

Community Counts and ATHNdataset: Building on the Foundation

Following the initial UDC research, the CDC launched a new initiative in January 2012, Community Counts – Registry for Bleeding Disorders Surveillance. Led by the American Thrombosis & Hemostasis Network (ATHN) in partnership with the U.S. Hemophilia Treatment Center Network and the CDC, data collected through October 31, 2022 indicates that Community Counts is happening at 144 HTCs nationwide and includes 62,476 patients.5 Demographic data from HTC visits has been collected in a safe and secure national database – the ATHNdataset. The data collected tracks common health issues, medical complications, and causes of death that affect people with bleeding disorders who are cared for in U.S. HTCs.12

The impact of bleeding disorders on women and girls is tracked as a subset of the overall data. Data collection is ongoing and research findings are helping to improve our understanding of the prevalence and impact of bleeding disorders on women. The goal of tracking this information is to support continued research and to improve treatment.

A note about the ATHNdataset tracking females: although progress has been made, sex and gender bias still exist among the bleeding disorder community. This, along with the persistence of outdated knowledge regarding treatment approaches, contributes to misdiagnosis, delay in diagnosis, and underdiagnosis of bleeding disorders in women and girls. Females remain under-represented in hemophilia A (15.3% versus males at 84.7%) and over-represented in VWD (66.2% versus males at 33.8%).5 While the published numbers from HTC treatment data are reflective of diagnoses made, they are not consistent with current research estimates provided for these conditions, highlighting the increased need for identification even amongst centers of excellence in the United States.

Shaping Perceptions

As the saying goes, “perception is reality” — changing thinking can change the world. The CDC has undertaken several research initiatives to better understand what women and girls experience because of delayed diagnosis and treatment as a result of antiquated beliefs that no longer hold true. These studies are designed to pinpoint areas of understanding and misunderstanding that can be improved through better diagnostic and management information and used to support development of more effective tools and outreach communications.

Harris Interactive Study: Surveying What Women Think

In September 2010, in a collaborative effort between the CDC, the National Hemophilia Foundation (now the National Bleeding Disorders Foundation [NBDF] ), and Harris Interactive, a web-based survey was conducted to understand what women thought about menstruation and heavy menstrual bleeding, awareness of bleeding disorders and their signs and symptoms, and the types of messages that would best speak to young women and motivate them to seek care if appropriate. The study found that lack of information about bleeding disorders is a serious public health concern.1 This should come as no surprise given that outdated beliefs and misinformation has been propagated throughout the entire population — even by clinicians.

The study found that messages with a positive slant are most effective at influencing women with symptoms of a bleeding disorder to seek medical care. The most motivating messages were:

  • Treatment is available!
  • Care for the disorder can prevent pregnancy complications and miscarriages
  • Care could result in a work and school life that is not disrupted by heavy bleeding

Better You Know and Journey to Know: Translating Research into Action

The Better You Know campaign was developed by the NHF (now the NBDF) in partnership with the CDC. It is designed to raise awareness of bleeding disorders among women and girls who may experience symptoms but have not yet been diagnosed. The program includes a free online risk assessment tool, information about normal and abnormal menstrual bleeding, a downloadable menstrual tracking chart, and postcards to increase awareness about bleeding disorders in women. Find all the available materials at Better You Know

An additional initiative developed as part of the program is Journey to Know, an opportunity for participation in a 3-month program for women as well as people with the potential to menstruate who are more than 18 years of age and have bleeding symptom(s). Its purpose is to help people take the step to work with a health care provider and provides support on their journeys to find out the medical reason(s) for their bleeding symptoms. After enrolling in the program, participants will receive:

  • Automated check-ins from NHF (now the NBDF) via email or text to check on progress and encourage participants to continue to seek a diagnosis
  • Videos to help with next steps, including information about bleeding disorders, resources available through Better You Know, and how to advocate for themselves when speaking to a health care provider
  • Information about virtual opportunities to interact monthly with others on similar journeys and have questions answered by diagnosed women, as well as providers and experts in the field.

To sign up or learn more about the program, visit Journey to Know.

Refining Diagnostic and Treatment Management Guidelines

Significant research has been conducted to better characterize, diagnose, and manage bleeding disorders:

Diagnosis and Disease Burden of Von Willebrand Disease in a Large US Population Based-Dataset35

This 2024 analysis of the largest, single-source, US VWD administrative and laboratory dataset, incorporating treatment claims and laboratory values, provided an almost doubling of potential VWD patients identified compared with using International Classification of Diseases (ICD) diagnostic claims alone. Criteria used to identify VWD included two or more claims for VWD diagnosis, one or more claims for VWD treatment, and one or more laboratory values of VWF:Ag <50 IU/dl.

Health Issues in Women and Girls Affected by Hemophilia with a Focus on Nomenclature, Heavy Menstrual Bleeding, and Musculoskeletal Issues38

This 2022 literature review suggests that women and girls affected by hemophilia, including hemophilia carriers, are at risk of bleeding symptoms that may go unrecognized, including heavy menstrual and musculoskeletal bleeding. To better address the health impacts of hemophilia in women and girls, the authors recommend revised nomenclature in which women with factor levels less than 50% should be classified as having hemophilia, while carriers with normal levels should be characterized according to symptomatology.

2021 Guidelines on the Diagnosis of von Willebrand Disease19

These evidence-based clinical guidelines published in 2021 by a multidisciplinary panel from the American Society of Hematology (ASH), the International Society on Thrombosis and Haemostasis (ISTH), the National Hemophilia Foundation (NHF) – now the National Bleeding Disorders Foundation, and the World Federation of Hemophilia (WFH) are intended to support patients, clinicians, and other health care professionals in their decisions about VWD diagnosis. Key recommendations of these guidelines include the role of bleeding-assessment tools in the assessment of patients suspected of VWD, diagnostic tests and laboratory cutoffs for type 1 and type 2 VWD, how to approach a type 1 VWD patient with normalized levels over time, and the role of genetic testing vs. phenotypic testing for types 2B and 2N. Future critical research priorities were also identified.

ASH ISTH NHF WFH 2021 Guidelines on the Management of von Willebrand Disease33

These evidence-based guidelines from the American Society of Hematology (ASH), the International Society on Thrombosis and Haemostasis (ISTH), the National Hemophilia Foundation (NHF) – now the National Bleeding Disorders Foundation, and the World Federation of Hemophilia (WFH) are intended to support patients, clinicians, and health care professionals in their decisions about management of VWD. They include recommendations about use of prophylaxis for frequent recurrent bleeding, desmopressin trials to determine therapy, use of antiplatelet agents and anticoagulant therapy, target VWF and factor VIII activity levels for major surgery, strategies to reduce bleeding during minor surgery or invasive procedures, management options for heavy menstrual bleeding, management of VWD in the context of neuraxial anesthesia during labor and delivery, and management in the postpartum setting.

A New Hemophilia Carrier Nomenclature to Define Hemophilia in Women and Girls: Communication from the SSC of the ISTH20

This 2021 article by Karen P.M. van Galen et al proposes new parameters for the designation of hemophilia carrier status in women and girls. Hemophilia A and B predominantly attract clinical attention in males due to X-linked inheritance, introducing a bias toward female carriers to be designated asymptomatic. Finding that the term “hemophilia carrier” understates bleeding symptoms in women and girls, it recommends a new nomenclature defined by experts and patient advocacy groups and the establishment of five new categories (severe/moderate/mild hemophilia, symptomatic, and asymptomatic), with the belief that clear, precise nomenclature will enhance diagnosis, management, and research on hemophilia carriers.

Von Willebrand Disease: Proposing Definitions for Future Research18

This 2021 article recommends establishing consistent definitions for classifications associated with abnormal bleeding symptoms, with an eye to improving evidence-based guidelines for VWD. The recommendations provide proposed definitions for what constitutes major bleeding, a prophylaxis regimen, desmopression responsiveness, heavy menstrual bleeding, and postpartum hemorrhage.

Characterizing Females Patients with Hemophilia A: Administrative Claims Analysis and Medical Chart Review16

Women and girls can have factor VIII (FVIII) deficiency with bleeding events requiring treatment. This 2020 study aimed to identify and characterize female patients with HA by a review of medical claims processed between January 1, 2012 – July 31, 2016. Among 353 patients meeting initial inclusion criteria, 86 charts were procured, with 8 patients identified as having HA. The study concluded that identifying females with HA is challenging using healthcare claims, because diagnostic nomenclature is unclear for female patients treated for bleeding events; very few female patients were identified with HA. Nevertheless, even in the small sample, a sizeable burden in comorbidity (presence of other diseases) and healthcare use was observed. It suggested that improved nomenclature and coding for HA diagnoses for women and girls is key to improving research and treatment.

Depression and Anxiety in Persons with Von Willebrand Disease22

This 2022 study assessed sociodemographic and clinical characteristics associated with depression and anxiety in individuals with Von Willebrand disease (VWD) aged ≥12 years. The analyses included 77 participants. The rates of depression and anxiety were 63.6% and 58.3%, respectively. The study revealed concerning levels of depression and anxiety in the studied VWD sample. Lack of social support was determined an important factor associated with depression and anxiety in the sample. The study concluded that mental health screening is critical in VWD clinical evaluation and care.

MASAC VWD Working Group

The Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation (NHF) – now the National Bleeding Disorders Foundation – formed a VWD Working Group in 2016 to improve diagnostic testing and laboratory standards, assess existing standards of care and clinical practice guidelines, develop educational programing for HTCs, providers, and patients, research and develop effective treatments for VWD, and collaborate with partner organizations to identify and achieve common goals. In 2021 they published their latest recommendations addressing21:

  • Diagnostic evaluation and management of girls and women presenting with symptoms of a bleeding disorder, including appropriate lab testing and additional considerations such as family history, and access to the full complement of multidisciplinary services available at HTCs, including appropriate therapies, clinical management, genetic testing, and counseling.
  • Diagnosis and management of women with bleeding disorders during pregnancy, labor, and delivery, including the critical postpartum period with specific recommendations designed to both mitigate the risk of bleeding-related complications in women and early identification of affected infants.
  • Current therapies available for treatment of VWD and detailed considerations for the prescription of VWD therapies and for assessing patient responses to treatment, with an eye to ensuring efficacy and avoiding complications.

Recent Research Focused on Gynecological and Obstetric Treatment

Much recent research has focused on improving awareness and expanding options for treatment related to menstruation, pregnancy, and childbirth:

Pregnancy and Delivery in Women with von Willebrand Disease13

This 2019 article underscores the challenges for pregnancy and delivery for women with VWD and recommends a careful evaluation of VWD type, subtype, and treatment response in pregnant women to plan the most appropriate treatment at the time of delivery. It additionally addresses problems with amniocentesis, vaginal bleeding associated with detachment of the placenta, and sudden abortion, recommending various interventions in line with the type and severity of VWD diagnosed.

Significant Gynecological Bleeding in Women with Low von Willebrand Factor Levels14

This study from 2019 found that gynecological bleeding is frequently reported in women with von Willebrand disease (VWD). Low von Willebrand factor (VWF) may be associated with significant bleeding despite only mild plasma VWF reductions. In a study of 120 women, 89% reported heavy menstrual bleeding — bleeding that was not detected using a clinical bleeding assessment tool, resulting in 40% of the women not seeking medical care for the condition. For those who did report their heavy menstrual bleeding to physicians, the low VWF diagnosis was not expedited. Despite pregnancy-related increases in plasma VWF levels, 63.5% of women studied who had given birth self-reported postpartum hemorrhage, requiring transfusion, critical care, radiological, or surgical interventions. Better tools for the detection of heavy menstrual bleeding and better pregnancy management protocols are indicated for women with low VWF.

Patterns of von Willebrand Disease Screening in Girls and Adolescents with Heavy Menstrual Bleeding15

In this retrospective 2018 study, researchers identified 23,888 post-pubertal adolescents and adolescents with heavy menstrual bleeding (986 with severe heavy menstrual bleeding). Von Willebrand disease screening was performed in 8% of females with heavy menstrual bleeding and 16% with severe heavy menstrual bleeding. Younger age at diagnosis, commercial insurance, and living within a metropolitan statistical area were associated with higher screening rates. Patients who underwent testing for iron deficiency anemia had the highest likelihood of undergoing screening. Among patients living in a metropolitan statistical area, those 60 minutes or more from a hemophilia treatment center were less likely to undergo screening. Researchers concluded that despite recommendations by the American College of Obstetricians and Gynecologists for more than 15 years, fewer than 20% of post-pubertal adolescents and adolescents with heavy menstrual bleeding underwent screening for von Willebrand disease in the cohort studied. Increased clinician awareness and adherence to recommended screening protocols was recommended.

Women and Girls with Hemophilia and Bleeding Tendencies: Outcomes Related to Menstruation, Pregnancy, Surgery and Other Bleeding Episodes from a Retrospective Chart Review17

A 2021 retrospective, non-interventional review of 2012-2018 medical records from women and girls with hemophilia (WGH) among three hemophilia treatment centers (HTCs) was conducted in the United States. The study found that WGH represent a group of female symptomatic carriers who experience bleeding events more frequently than non-carriers. Bleeding events included spontaneous/traumatic bleeds and prolonged bleeding related to surgery, menstruation, and pregnancy. Challenges for the treatment of WGH include lack of screening, diagnosis, and treatment guidelines. The study concluded that bleeding events in WGH, such as excessive and prolonged bleeding during menstruation, demonstrate a unique burden and require specific medical intervention.

Study on Bleeding During Early Pregnancy10

Some reports have suggested that women with VWD or other bleeding disorders are more likely to bleed during pregnancy and experience miscarriage and postpartum hemorrhage. Ongoing CDC research studies women who experience bleeding in early pregnancy to see if an underlying bleeding disorder exists, and if so, what treatments can be given to stop bleeding and improve pregnancy outcomes.

Current Research Initiatives Sponsored by Octapharma

Several research initiatives sponsored by Octapharma have been completed or are underway to help health care providers better understand how to identify and treat women with bleeding disorders:

WIL-31 Study: Von Willebrand Factor/Factor VIII Concentrate (wilate®) Prophylaxis in Children and Adults with von Willebrand disease31

This prospective study examined the efficacy and safety of regular prophylaxis in patients with VWD. Importantly, the study included a diverse patient population, including children and adults, males and females, and all types of VWD. The findings from WIL-31 provide strong evidence to support the use of VWF prophylaxis and have led to the recent addition of wilate prophylaxis as a therapeutic indication for VWD in the US. This marks a milestone in improving long-term care for patients with severe von Willebrand disease.32

Efficacy of Regular Prophylaxis with a Plasma-derived Von Willebrand Factor/factor FVIII Concentrate with a 1:1 Activity Ratio in Reducing Heavy Menstrual Bleeding in Girls/women with Von Willebrand Disease36

As part of the WIL-31 study, researchers found that prophylaxis with pdVWF/FVIII was efficacious in reducing heavy menstrual bleeding in women and girls with VWD compared with on-demand treatment. Results showed that prophylaxis with pdVWF/FVIII reduced the mean annualized heavy menstrual bleeding rate by 75% compared with on-demand treatment (2.4 vs 9.7 in WIL-31 and WIL-29, respectively). None of the cases of heavy menstrual bleeding during prophylaxis was severe enough to require additional treatment.

WIL-33: Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease (VWD) Patients <6 Years of Age24

The WIL-33 study aims to determine the efficacy, pharmacokinetics, immunogenicity and safety of wilate as routine prophylaxis in up to 12 pediatric patients under the age of 6 years, with severe von Willebrand Disease, over a period of 12 months. The study was completed in December 2024, with publication of results pending, not yet FDA approved for this indication.

Von Willebrand Factor in Pregnancy (VIP) Study (VIP)25

In pregnant women with von Willebrand disease (VWD) who by the third trimester do not have von Willebrand factor (VWF) or factor VIII (FVIII) levels greater than 50-100%, specific guidance is lacking for delivery planning in terms of how high of a VWF level should be achieved to reduce bleeding. This is a prospective, open-label, cohort study in women with VWD using wilate replacement therapy to maintain trough or minimum VWF levels of 100-150% for delivery and the immediate postpartum period, followed by levels of 50-100% for 5-10 days after delivery, depending upon the route of delivery. The primary objective is to document the rate of primary postpartum hemorrhage (PPH). The secondary objective is to document further effectiveness outcomes and safety. The study is currently underway with an estimated completion date of December 2026.

Effectiveness and Tolerability of Eqwilate in Real-life Conditions26

This study is looking at modalities of use, effectiveness, and tolerability of Eqwilate®, a balanced combination of VWF and FVIII, in von Willebrand patients > 6 years old, in real-life conditions involving on-demand treatment for bleeds and perioperative prophylaxis. The study is currently recruiting participants in France.

The EMPOWER Study — Design of a Randomized Clinical Trial to Assess the Efficacy and Safety of a Plasma-Derived Von Willebrand Factor / Factor VIII Concentrate for Heavy Menstrual Bleeding in Women with Von Willebrand Disease27

The EMPOWER pilot trial will determine the feasibility of the trial design, aimed at evaluating the effect of prophylaxis with plasma-derived VWF/FVIII (1:1; pdVWF:FVIII) concentrate compared with placebo on heavy menstrual bleeding in women with VWD. If the pilot trial is deemed feasible, a definitive international randomized controlled trial will be conducted.

NUWIQ Dosing and Outcomes in the Management of Women/Girls with Hemophilia A Needing FVIII Treatment for Surgery – an International, Open-Label, Non-Controlled Study (NuDIMENSION)28

The goal of this study is to evaluate the efficacy and safety of the recombinant FVIII simoctocog alfa (NUWIQ®) in women/girls with hemophilia A undergoing major surgery. Results will contribute to the evidence needed to generate specific treatment guidelines for these situations.

Other Current Research Initiatives

ISTH New Registry on Hemophilia A/B Carriers29

The real worldwide burden of hemophilia in females, the incidence of symptomatic women, their treatment and their quality of life are still not completely known. As such, the SSC Subcommittee on Women's Health Issues in Thrombosis and Hemostasis has created the International Registry on the Symptomatic Hemophilia A/B Carriers. The aim of this registry is to determine how many women with Hemophilia A and B are actually followed in the different Hemophilia Treatment Centers around the world and how many of these are symptomatic. It also aims to define types of bleeding, most affected sites of bleeding, and clinical and psychological outcomes. The registry is free and open for participants. Learn more about participating here.

Related Resources

Interested in learning more about women and bleeding disorders? Check out these other Factor My Way resources.

  • Heavy Menstrual Bleeding—What’s a Woman to Do? (Educational Article)
    Many women, particularly those with an underlying bleeding disorder such as von Willebrand disease or hemophilia, experience troublesome, heavy menstrual bleeding. This informative article covers the fundamentals of puberty and menstruation, definition and symptoms of heavy menstrual bleeding, diagnosis, and treatment options.
  • Women Have Bleeding Disorders Too! (On-Demand Video)
    This on-demand video, presented by Dr. Claudio Sandoval, covers how women can inherit genetic bleeding disorders, how women’s bleeding symptoms are evaluated, what bleeding symptoms mean at various life stages, and what treatments are available.
  • Women Have Bleeding Disorders Too! (Educational Article)
    Bleeding disorders in women are often seen as normal, misdiagnosed, or not diagnosed at all, leading to reduced quality of life and development of problematic health conditions. This article discusses genetic inheritance of bleeding disorders, evaluation of women’s bleeding symptoms, their meaning at various life stages, and available treatments.
  • The Facts about Women and Bleeding Disorders (Infographic / Fact Sheet)
    Contrary to many common beliefs, bleeding disorders affect many women. Learn about the prevalence of bleeding disorders in women, their signs and symptoms, and the importance of early diagnosis.
  • Algorithm for the Diagnosis and Management of F8 Variants in People with the Potential to Menstruate (Infographic / Fact Sheet)
    This screening and diagnostic decision tree created in collaboration by Octapharma Senior Clinical Nurse Educator Amber Federizo, DNP, Dr. Danielle Nance of Banner MD Anderson Cancer Center, and Ashley Gregory and Kimberly Haugstad of the FAIR Time for Women Coalition, is designed to assess factor 8 (F8) deficiency and hemophilia A in those with the capacity to menstruate. A first of its kind, the algorithm guides clinical decision making in the diagnosis and management of the comprehensive care needs for those with F8 deficiency. It intended to provide education to all about the diagnosis and treatment pathways available to ensure long-term quality of life.
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References

1. Rhynders, P.A. et al., “Providing Young Women with Credible Health Information about Bleeding Disorders”, American Journal of Preventive Medicine. 2014;47(5):674-680.

2. Centers for Disease Control and Prevention, “Hemophilia Characteristics Among Women and Girls Receiving Care in Specialized Treatment Centers in the United States”, https://www.cdc.gov/ncbddd/hemophilia/features/hemophilia-characteristics-among-women.html, (accessed 1/27/2023).

3. The American College of Obstetricians and Gynecologists, “Von Willebrand Disease in Women”, Committee Opinion. 2013;580:1-6.

4. United Kingdom Haemophilia Centres Doctors’ Organisation, “UKHCDO Annual Report 2022 & Bleeding Disorder Statistics for the Financial Year 2021/22”, http://www.ukhcdo.org/wp-content/uploads/2022/12/UKHCDO-Annual-Report-2022-2021-22-Data.pdf, (accessed 1/27/2023).

5. American Thrombosis & Hemostasis Network, “ATHNdataset Report”. Winter 2022.

6. Byams, V.R. et al., “Evaluation of bleeding disorders in women with menorrhagia: a survey of obstetrician-gynecologists”, American journal of obstetrics and gynecology. 2012;207(4):269.e1-269.e2695.

7. Sidonio, R.F., Haley, K.M. and Fallaize, D., “Impact of diagnosis of von Willebrand disease on patient outcomes: Analysis of medical insurance claims data”, Haemophilia. 2017;23:743-749.

8. Jacobson, A.E. et al., “Patterns of von Willebrand Disease Screening in Girls and Adolescents With Heavy Menstrual Bleeding”, Obstet Gynecol. 2018;131(6):1121-1129.

9. Centers for Disease Control and Prevention, “Signs and Symptoms of Bleeding Disorders in Women”, https://www.cdc.gov/ncbddd/blooddisorders/women/symptoms.html, (accessed 12/14/2021).

10. Centers for Disease Control and Prevention, “Research on Bleeding Disorders in Women”, https://www.cdc.gov/ncbddd/blooddisorders/women/research.html, (accessed 11/11/2021).

11. Byams, V.R. et al., “Surveillance of female patients with inherited bleeding disorders in United States Haemophilia Treatment Centres”, Haemophilia. 2011;17:6-13.

12. Centers for Disease Control and Prevention, “About Community Counts”, https://www.cdc.gov/ncbddd/hemophilia/communitycounts/about.html, (accessed 1/19/2023).

13. Castaman, G. & James, P.D., “Pregnancy and delivery in women with von Willebrand disease”, Eur J Haematol. 2019;103(2):73-79.

14. Lavin, M. et al., “Significant gynecological bleeding in women with low von Willebrand factor levels”, Blood Adv. 2018; 2(14):1784-1791.

15. Jacobson, A.E. et al., “Patterns of von Willebrand Disease Screening in Girls and Adolescents with Heavy Menstrual Bleeding”, Obstetrics & Gynecology. 2018;131(6):1121-1129.

16. Farej, R. et al., “Characterizing female patients with haemophilia A: Administrative claims analysis and medical chart review”, Haemophilia. 2020;26:520-528.

17. Chaudhury, A. et al., “Women and girls with haemophilia and bleeding tendencies: Outcomes related to menstruation, pregnancy, surgery and other bleeding episodes from a retrospective chart review”, Haemophilia. 2021;27:293-304.

18. Connell, N.T. et al., “von Willebrand disease: proposing definitions for future research”, Blood Adv. 2021;5(2):565-569.

19. James, P.D. et al., “ASH ISTH NHF WFH 2021 guidelines on the diagnosis of von Willebrand disease”, Blood Adv. 2021;5(1):280-300.

20. van Galen, K.P.M., et al., “A new hemophilia carrier nomenclature to define hemophilia in women and girls: Communication from the SSC of the ISTH”, J Thromb Haemost. 2021;19:1883-1887.

21. National Hemophilia Foundation, “Newly Updated MASAC Documents Dedicated to Females Affected by Bleeding Disorders, Pregnancy, VWD”, https://www.hemophilia.org/news/updated-masac-documents-address-females-affected-by-bleeding-disorders-pregnancy-vwd, (accessed 1/11/2022).

22. Roberts, J.C. et al., “Depression and anxiety in persons with Von Willebrand disease”, Haemophilia. 2022;1-10.

23. Clinical Trials, “Clinical Study to Investigate the Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With VWD”, https://clinicaltrials.gov/ct2/show/NCT04052698?cond=Von+Willebrand+Diseases&draw=5&rank=34, (accessed 1/14/2022).

24. Clinical Trials, “Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease VWD) Patients <6 Years of Age”, https://clinicaltrials.gov/ct2/show/NCT04953884?spons=octapharma&draw=2&rank=2, (accessed 1/27/2023).

25. Clinical Trials, “Von Willebrand Factor in Pregnancy (VIP) Study (VIP)”, https://clinicaltrials.gov/ct2/show/NCT04146376?spons=octapharma&draw=2&rank=81, (accessed 1/27/2023).

26. Clinical Trials, “Effectiveness and Tolerability of Eqwilate in Real-life Conditions”, https://clinicaltrials.gov/ct2/show/NCT04106908?spons=octapharma&draw=2&rank=11, (accessed 1/17/2023).

27. Sholzberg, M. et al., “The EMPOWER Study - Design of a Randomized Clinical Trial to Assess the Efficacy and Safety of a Plasma-Derived Von Willebrand Factor / Factor VIII Concentrate for Heavy Menstrual Bleeding in Women with Von Willebrand Disease”, Blood. 2022;140(1):8483-8484.

28. Oldenburg, J. et al., “Nuwiq Dosing and Outcomes in the Management of Women/Girls with Haemophilia a Needing FVIII Treatment for Surgery - an International, Open-Label, Non-Controlled Study (NuDIMENSION)”, Blood. 2022;140(1):11323-11324.

29. International Society on Thrombosis and Haemostasis, “Participate in New Registry on Hemophilia A/B Carriers”, https://www.isth.org/news/549385/Participate-in-New-Registry-on-Hemophilia-AB-Carriers.htm, (accessed 1/12/2022).

30. Clinical Trials, “Minimize Menorrhagia in Women With von Willebrand Disease (VWDMin)”, https://clinicaltrials.gov/ct2/show/NCT02606045, (accessed 1/12/2022).

31. Robert F. Sidonio Jr., et al., Von Willebrand Factor/Factor VIII Concentrate (wilate®) Prophylaxis in Children and Adults with von Willebrand disease, Blood Advances, 3/14/2024.

32. Octapharma, Publication of Data from WIL-3 Study Marks a Milestone in Improving Long-Term Care for Patients with Severe von Willebrand Disease (VWD), 1/22/24

33. Connell, Nathan T, et al., ASH ISTH NHF WFH 2021 Guidelines on the Management of Von Willebrand Disease, Blood Advances, 2021 5 (1):301-325.

34. Kirtava A, Crudder S, Dilley A, et al. Trends in clinical management of women with von Willebrand disease: a survey of 75 women enrolled in haemophilia treatment centres in the United States. Haemophilia. 2004; 10: 158–161.

35. Michelle Sholzberg, Angela C Weyand, Jacob S Lai, Benjamin Kim, Gary Patou, Nicole M. Engel-Nitz, Qiana Amos, Robert F. Sidonio, Jr. Diagnosis and Disease Burden of Von Willebrand Disease in a Large US Population Based-Dataset. Blood (2024) 144 (Supplement 1)1:3980.

36. Csongor Kiss, Zoltan Boda, Claudia Djambas Khayat, Leonid Dubey, Robert F Sidonio, Jr. Efficacy of Regular Prophylaxis with a Plasma-Derived Von Willebrand Factor/Factor VIII Concentrate in Reducing Heavy Menstrual Bleeding in Females with Von Willebrand Disease. AJOG Glob Rep. 2025;5(2):1-8.

37. Centers for Disease Control and Prevention, “How Hemophilia Is Inherited”, https://www.cdc.gov/hemophilia/testing/how-hemophilia-is-inherited.html?CDC_AAref_Val=https://www.cdc.gov/ncbddd/hemophilia/inheritance-pattern.html, (accessed 9/8/2025).

38. Weyand A et al. Health Issues in Women and Girls Affected by Haemophilia with a Focus on Nomenclature, Heavy Menstrual Bleeding, and Musculoskeletal Issues. Haemophilia 2022;28:18-25

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This material represents individual patient and/or caregiver experience living with a bleeding disorder.
This page contains general information about health care insurance and coverage but should not be applied to any individual case. Please consult your insurance company for advice.
This content is not intended to be a substitute for professional medical advice, diagnosis or treatment. Please consult with your local Hemophilia Treatment Center physician or other health care provider if you have any questions related to management of bleeding disorders.

Este material representa la experiencia individual de un paciente o cuidador que vive con un trastorno hemorrágico.
Esta página contiene información general sobre los seguros y la cobertura de atención médica pero no se debe aplicar a ningún caso individual. Consulte a su compañía de seguro para obtener asesoramiento.
Este contenido no tiene como objetivo reemplazar el consejo, diagnóstico o tratamiento médico profesional. Consulte con el médico de su Centro de Tratamiento para la Hemofilia local u otro proveedor de atención médica si tiene preguntas relacionadas con el manejo de los trastornos hemorrágicos.

This content is not intended to be a substitute for professional medical or nursing advice, counseling, diagnosis or treatment. Please consult with your local Hemophilia Treatment Center physician or other health care provider if you have any questions related to management of bleeding disorders.

Este contenido no tiene como objetivo reemplazar el consejo, diagnóstico o tratamiento médico profesional. Consulte con el médico de su Centro de Tratamiento para la Hemofilia local u otro proveedor de atención médica si tiene preguntas relacionadas con el manejo de los trastornos hemorrágicos.

COAG-0994
Indications and Important Safety Information for NUWIQ® and wilate®.
Please see NUWIQ® full Prescribing Information and Instructions For Use, or wilate® full Prescribing Information
Indicaciones e Información de seguridad importante de NUWIQ® y wilate® .
Consulte la Información de prescripción completa de NUWIQ® y instrucciones de uso, o Información de prescripción completa de wilate®.
Indications and Important Safety Information for NUWIQ® [Antihemophilic Factor (Recombinant)]
Please see NUWIQ® full Prescribing Information and Instructions For Use
Indicaciones e Información de seguridad importante de NUWIQ® [factor antihemofílico (recombinante)].
Consulte la Información de prescripción completa de NUWIQ®. Instrucciones de uso
Indications and Important Safety Information for wilate® [von Willebrand Factor/Coagulation Factor VIII Complex (Human)].
Please see wilate® full Prescribing Information
Indicaciones e Información de seguridad importante de wilate® [complejo de factor de von Willebrand/factor VIII de la coagulación (humanos)].
Consulte la Información de prescripción completa de wilate®.

Indications and Important Safety Information for NUWIQ® [Antihemophilic Factor (Recombinant)].

Please see NUWIQ® full Prescribing Information. Instructions For Use

Indications and Usage

NUWIQ® is a recombinant antihemophilic factor [coagulation factor VIII (Factor VIII)] indicated in pediatric and adult patients with Hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. NUWIQ® is not indicated for the treatment of von Willebrand Disease.

Contraindications

NUWIQ® is contraindicated in patients who have manifested life-threatening hypersensitivity reactions, including anaphylaxis, to the product or its components.

Warnings and Precautions

Hypersensitivity reactions, including anaphylaxis, are possible with NUWIQ®. Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema, chest tightness, dyspnea, wheezing, urticaria, or pruritus. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.

The formation of neutralizing antibodies (inhibitors) to Factor VIII can occur following the administration of NUWIQ®. Monitor all patients for the development of Factor VIII inhibitors by appropriate clinical observations and laboratory tests. If the plasma Factor VIII level fails to increase as expected, or if bleeding is not controlled after NUWIQ® administration, suspect the presence of an inhibitor (neutralizing antibody).

Adverse Reactions

The most frequently occurring adverse reactions (>5%) in clinical trials were upper respiratory tract infection, headache, fever, cough, lower respiratory tract infection, rhinitis, chills, abdominal pain, arthralgia, anemia, and pharyngitis.

Please see NUWIQ®  full Prescribing Information. Instructions For Use

Indicaciones e Información de seguridad importante de NUWIQ® [factor antihemofílico (recombinante)].

Consulte la Información de prescripción completa de NUWIQ®. Instrucciones de uso

Indicaciones y uso

NUWIQ® es un factor antihemofílico recombinante [factor VIII para la coagulación (factor VIII)] indicado en pacientes pediátricos y adultos con hemofilia A para el tratamiento y el control a demanda de los episodios hemorrágicos, el control perioperativo de las hemorragias y profilaxis de rutina con el fin de reducir la frecuencia de los episodios hemorrágicos. NUWIQ® no está indicado para el tratamiento de la enfermedad de von Willebrand.

Contraindicaciones

NUWIQ® está contraindicado en pacientes que hayan manifestado reacciones de hipersensibilidad al producto o sus componentes, como anafilaxia, que ponen en riesgo la vida.

Advertencias y precauciones

Es posible que NUWIQ® cause reacciones de hipersensibilidad, como anafilaxia. Los primeros signos de reacciones de hipersensibilidad que pueden progresar y derivar en anafilaxia incluyen angioedema, opresión en el pecho, disnea, sibilancias, urticaria o prurito. Si se producen reacciones de hipersensibilidad, suspenda la administración de inmediato e inicie el tratamiento adecuado.

Se pueden formar anticuerpos neutralizantes (inhibidores) del factor VIII luego de administrar NUWIQ®. Controle a todos los pacientes para detectar el desarrollo de inhibidores del factor VIII mediante observaciones clínicas y análisis de laboratorio adecuados. Si el nivel del factor VIII en plasma no aumenta según lo esperado o si la hemorragia no se controla luego de la administración de NUWIQ®, se debe sospechar la presencia de un inhibidor (anticuerpo neutralizante).

Reacciones adversas

Las reacciones adversas más frecuentes (>5%) que tuvieron lugar en ensayos clínicos fueron infección del tracto respiratorio superior, dolor de cabeza, fiebre, tos, infección del tracto respiratorio inferior, rinitis, escalofríos, dolor abdominal, artralgia, anemia, y faringitis.

Consulte la Información de prescripción completa de NUWIQ®. Instrucciones de uso


Indications and Important Safety Information for wilate® [von Willebrand Factor/Coagulation Factor VIII Complex (Human)].

Please see wilate® full Prescribing Information.

Indications

wilate® is a von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated in children and adults with von Willebrand disease for on-demand treatment and control of bleeding episodes; for perioperative management of bleeding; and for routine prophylaxis to reduce the frequency of bleeding episodes in children 6 years of age and older and adults with VWD. wilate® is also indicated in adolescents and adults with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes; and for on-demand treatment and control of bleeding episodes.

Contraindications

wilate® is contraindicated in patients with known hypersensitivity reactions, including anaphylactic or severe systemic reactions, to human plasma-derived products, any ingredient in the formulation, or components of the container.

Warnings and Precautions

Hypersensitivity Reactions

Hypersensitivity reactions may occur with wilate®. Signs and symptoms include angioedema, burning and stinging at the infusion site, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, and wheezing that may progress to severe anaphylaxis (including shock) with or without fever. Closely monitor patients receiving wilate® and observe for any symptoms throughout the infusion period.

Because inhibitor antibodies may occur concomitantly with anaphylactic reactions, evaluate patients experiencing an anaphylactic reaction for the presence of inhibitors.

Thromboembolic Events

In VWD, continued treatment using a FVIII-containing VWF product may cause an excessive rise in FVIII activity, which may increase the risk of thromboembolic events. Monitor plasma levels of VWF:RCo and FVIII activities in patients receiving wilate® to avoid sustained excessive VWF and FVIII activity levels.

Neutralizing Antibodies

VWD

  • Neutralizing antibodies (inhibitors) to FVIII and VWF in patients with VWD, especially type 3 patients, may occur. If a patient develops inhibitor to VWF (or to FVIII), the condition will manifest itself as an inadequate clinical response. Thus, if expected VWF activity plasma levels are not attained, or if bleeding is not controlled with an adequate dose or repeated dosing, perform an appropriate assay to determine whether a VWF inhibitor is present.
  • In patients with antibodies against VWF, VWF is not effective and wilate® administration may lead to severe adverse events. Consider other therapeutic options for such patients.

Hemophilia A

  • Monitor plasma Factor VIII activity by performing a validated test (e.g., one stage clotting assay), to confirm that adequate Factor VIII levels have been achieved and maintained.
  • Monitor for the development of Factor VIII inhibitors. Perform a Bethesda inhibitor assay if expected Factor VIII plasma levels are not attained, or if bleeding is not controlled with the expected dose of Wilate®. Use Bethesda Units (BU) to report inhibitor levels.

Transmissible Infectious Agents

wilate® is made from human plasma. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent. There is also the possibility that unknown infectious agents may be present in the product. The risk that wilate® will transmit viruses has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and removing certain viruses during manufacture. Despite these measures, it may still potentially transmit disease.

Record the batch number of the product every time wilate® is administered to a patient, and consider appropriate vaccination (against hepatitis A and B virus) of patients in regular/repeated receipt of wilate®. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Octapharma USA, Inc., at 1-866-766-4860.

Monitoring and Laboratory Tests

  • Monitor plasma levels of VWF:RCo and FVIII activities in patients receiving wilate® to avoid sustained excessive VWF and FVIII activity levels, which may increase the risk of thromboembolism, particularly in patients with known clinical or laboratory risk factors.
  • Monitor for development of VWF and FVIII inhibitors. Perform assays to determine whether VWF and/or FVIII inhibitor(s) is present if bleeding is not controlled with the expected dose of wilate®.

Adverse Reactions

The most common adverse reactions to treatment with wilate® (≥ 1%) in patients with VWD were hypersensitivity reactions, urticaria, chest discomfort and dizziness. The most common adverse reactions to treatment with wilate® (≥ 1%) in previously treated patients with hemophilia A was pyrexia (fever).

Please see wilate®  full Prescribing Information.

Indicaciones e Información de seguridad importante de wilate® [complejo de factor de von Willebrand/factor VIII de la coagulación (humanos)].

Consulte la Información de prescripción completa de wilate®.

Indicaciones

wilate® es un complejo de factor de von Willebrand/factor VIII de la coagulación (humanos) indicado en niños y adultos con enfermedad de von Willebrand para el tratamiento y el control a demanda de los episodios hemorrágicos, para el control perioperativo de las hemorragias y para profilaxis de rutina con el fin de reducir la frecuencia de los episodios hemorrágicos en niños de 6 años de edad en adelante y adultos con EvW. wilate® también se indica en adolescentes y adultos con hemofilia A para profilaxis de rutina con el fin de reducir la frecuencia de los episodios hemorrágicos; y para el tratamiento y el control a demanda de los episodios hemorrágicos.

Contraindicaciones

wilate® está contraindicado en pacientes con reacciones de hipersensibilidad conocidas, incluidas las reacciones anafilácticas o las reacciones sistémicas graves a productos derivados de plasma humano, cualquier ingrediente de la formulación o los componentes del envase.

Advertencias y precauciones

Reacciones de hipersensibilidad

Pueden producirse reacciones de hipersensibilidad con el uso de wilate®. Los signos y síntomas incluyen angioedema, ardor y picazón en el lugar de la infusión, escalofríos, sofoco, urticaria generalizada, dolor de cabeza, ronchas, hipotensión, letargo, náuseas, inquietud, taquicardia, opresión en el pecho, hormigueo, vómitos y sibilancias que pueden progresar y derivar en anafilaxia grave (incluido shock) con o sin fiebre. Controle de cerca a los pacientes que reciban wilate® y preste atención a cualquier síntoma durante todo el período de infusión.

Debido a que los anticuerpos inhibidores pueden desarrollarse de forma concomitante con las reacciones anafilácticas, evalúe a los pacientes que experimenten una reacción anafiláctica para detectar la presencia de inhibidores.

Eventos tromboembólicos

En la enfermedad de von Willebrand, el tratamiento continuo con un producto de FvW que contiene FVIII puede provocar un incremento excesivo en la actividad del FVIII, y eso puede aumentar el riesgo de eventos tromboembólicos. Controle los niveles en plasma de las actividades del FvW:RCo y el FVIII en los pacientes que reciben wilate® para evitar niveles de actividad excesivos y sostenidos del FvW y el FVIII.

Anticuerpos neutralizantes

EvW

  • Pueden desarrollarse anticuerpos neutralizantes (inhibidores) del FVIII y del FvW en pacientes con enfermedad de von Willebrand, especialmente en los pacientes de tipo 3. Si un paciente desarrolla un inhibidor del FvW (o del FVIII), la afección se manifestará como una respuesta clínica inadecuada. Por lo tanto, si no se alcanzan los niveles en plasma esperados de la actividad del FvW o si la hemorragia no se controla con una dosis adecuada o repetida, realice la prueba correspondiente para determinar la presencia de un inhibidor del FvW.
  • En los pacientes con anticuerpos contra el FvW, este no es eficaz y la administración de wilate® puede provocar eventos adversos graves. Considere otras opciones de tratamiento para dichos pacientes.

Hemofilia A

  • Controle la actividad del factor VIII mediante un análisis validado (por ejemplo, una prueba de coagulación de una etapa), para confirmar que se hayan alcanzado y mantenido los niveles del factor VIII.
  • Controle el desarrollo de inhibidores contra el factor VIII. Realice una prueba del inhibidor Bethesda si no se alcanzan los niveles en plasma esperados del factor VIII o si la hemorragia no se controla con la dosis esperada de Wilate®. Utilice la unidad Bethesda (UB) para informar los niveles del inhibidor.

Agentes infecciosos transmisibles

wilate® está hecho a partir de plasma humano. Debido a que este producto está hecho de sangre humana, puede implicar un riesgo de transmisión de agentes infecciosos, como virus y, en teoría, el agente de la variante de la enfermedad de Creutzfeldt-Jakob (vCJD). También existe la posibilidad de que haya agentes infecciosos desconocidos en el producto. El riesgo de que wilate® transmita virus se ha reducido mediante la realización de pruebas de detección a los donantes de plasma para detectar la exposición previa a determinados virus, mediante análisis para detectar la presencia de ciertas infecciones virales actuales y mediante la desactivación y eliminación de determinados virus durante la fabricación. A pesar de estas medidas, aún existe la posibilidad de que transmita enfermedades.

Registre el número de lote del producto cada vez que wilate® se administre a un paciente y considere aplicar las vacunas adecuadas (contra los virus de la hepatitis A y B) a los pacientes que reciban wilate® de manera regular o repetida. TODAS las infecciones que un médico considere que se pueden haber transmitido a través de este producto deben ser informadas por el médico u otro proveedor de atención médica a Octapharma USA, Inc., al 1-866-766-4860.

Control y análisis de laboratorio

  • Controle los niveles en plasma de las actividades del FvW:RCo y el FVIII en los pacientes que reciban wilate® para evitar niveles de actividad excesivos del FvW y el FVIII, que pueden aumentar el riesgo de tromboembolia, especialmente en pacientes con factores de riesgo clínicos o de laboratorio conocidos.
  • Realice controles para detectar el desarrollo de inhibidores del FvW y el FVIII. Realice pruebas para determinar la presencia de inhibidores del FvW o el FVIII si la hemorragia no se controla con la dosis esperada de wilate®.

Reacciones adversas

Las reacciones adversas más comunes al tratamiento con wilate® (≥ 1%) en pacientes con enfermedad de von Willebrand fueron reacciones de hipersensibilidad, urticaria, malestar en el pecho y mareos. La reacción adversa más común al tratamiento con wilate® (≥ 1%) en pacientes con hemofilia A previamente tratados fue pirexia (fiebre).

Consulte la Información de prescripción completa de wilate®.





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