Prophylaxis should be considered standard of care therapy for individuals with severe hemophilia A or B (factor VIII or factor IX <1%), including those with inhibitors.[69]National Hemophilia Foundation Medical and Scientific Advisory Council (MASAC). MASAC document 267 - MASAC recommendation concerning prophylaxis for hemophilia A and B with and without inhibitors. Apr 2022 [internet publication].
https://www.hemophilia.org/healthcare-professionals/guidelines-on-care/masac-documents/masac-document-267-masac-recommendation-concerning-prophylaxis-for-hemophilia-a-and-b-with-and-without-inhibitors
It is defined as the regular administration of a hemostatic agent/agents with the goal of preventing bleeding in people with hemophilia while allowing them to lead active lives and achieve quality of life comparable to non-hemophilia individuals.[38]Srivastava A, Santagostino E, Dougall A, et al. WFH guidelines for the management of hemophilia, 3rd edition. Haemophilia. 2020 Aug;26 Suppl 6:1-158.
https://www.doi.org/10.1111/hae.14046
http://www.ncbi.nlm.nih.gov/pubmed/32744769?tool=bestpractice.com
There are different types of prophylaxis:[1]Blanchette VS, Key NS, Ljung LR, et al. Definitions in hemophilia: communication from the SSC of the ISTH. J Thromb Haemost. 2014 Nov;12(11):1935-9.
https://onlinelibrary.wiley.com/doi/full/10.1111/jth.12672
http://www.ncbi.nlm.nih.gov/pubmed/25059285?tool=bestpractice.com
[83]Rayment R, Chalmers E, Forsyth K, et al. Guidelines on the use of prophylactic factor replacement for children and adults with haemophilia A and B. Br J Haematol. 2020 Sep;190(5):684-95.
https://www.doi.org/10.1111/bjh.16704
http://www.ncbi.nlm.nih.gov/pubmed/32390158?tool=bestpractice.com
Primary prophylaxis refers to therapy initiated in young patients with hemophilia, prior to the second evident large joint bleed and before the age of 3 (preventive therapy)
Secondary prophylaxis refers to therapy initiated after 2 or more bleeds into large joints, and before the onset of established joint disease
Tertiary prophylaxis refers to therapy started after the onset of joint disease.
Prospective open-label and observational studies suggest that prophylaxis is superior to episodic treatment in delaying or preventing joint arthropathy, even in patients with severe hemophilia.[85]Gringeri A, Lundin B, von Mackensen S, et al. A randomized clinical trial of prophylaxis in children with hemophilia A (the ESPRIT Study). J Thromb Haemost. 2011 Apr;9(4):700-10.
https://onlinelibrary.wiley.com/doi/full/10.1111/j.1538-7836.2011.04214.x
http://www.ncbi.nlm.nih.gov/pubmed/21255253?tool=bestpractice.com
[87]Manco-Johnson MJ, Abshire TC, Shapiro AD, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007 Aug 9;357(6):535-44.
https://www.nejm.org/doi/10.1056/NEJMoa067659
http://www.ncbi.nlm.nih.gov/pubmed/17687129?tool=bestpractice.com
[155]Tagliaferri A, Feola G, Molinari AC, et al. Benefits of prophylaxis versus on-demand treatment in adolescents and adults with severe haemophilia A: the POTTER study. Thromb Haemost. 2015 Jul;114(1):35-45.
http://www.ncbi.nlm.nih.gov/pubmed/25855376?tool=bestpractice.com
For hemophilia A, the typical infusion schedule is 2 to 3 times weekly with standard recombinant or plasma-derived factor VIII, or once every 5 to 7 days for extended half-life (long-acting) factor VIII.[156]Gomber S, Singhal G, Dewan P, et al. Twice weekly vs. thrice weekly low-dose prophylactic factor VIII therapy in children with hemophilia A: an open label randomized trial. J Trop Pediatr. 2022 Apr 5;68(3):fmac039.
http://www.ncbi.nlm.nih.gov/pubmed/35595254?tool=bestpractice.com
Standard recombinant or plasma-derived factor IX is usually administered twice weekly for hemophilia B; however, extended half-life (long-acting) factor IX molecules are generally administered once every 7 to 14 days to maintain trough levels of 3% to 5% or higher.[38]Srivastava A, Santagostino E, Dougall A, et al. WFH guidelines for the management of hemophilia, 3rd edition. Haemophilia. 2020 Aug;26 Suppl 6:1-158.
https://www.doi.org/10.1111/hae.14046
http://www.ncbi.nlm.nih.gov/pubmed/32744769?tool=bestpractice.com
Prophylaxis is recommended following the initial treatment of intracranial bleeding.[83]Rayment R, Chalmers E, Forsyth K, et al. Guidelines on the use of prophylactic factor replacement for children and adults with haemophilia A and B. Br J Haematol. 2020 Sep;190(5):684-95.
https://www.doi.org/10.1111/bjh.16704
http://www.ncbi.nlm.nih.gov/pubmed/32390158?tool=bestpractice.com
In this scenario, different treatment regimens have been suggested, ranging from every-other-day infusions to weekly infusions.
Emicizumab prophylaxis in patients with hemophilia A
Emicizumab, a humanized monoclonal antibody that mimics the function of factor VIII without being affected by factor VIII inhibitors, is approved by the Food and Drug Administration and the European Medicines Agency for prophylaxis in hemophilia A patients with and without inhibitors.[70]National Hemophilia Foundation Medical and Scientific Advisory Council (MASAC). MASAC Document 280 - MASAC recommendations concerning products licensed for the treatment of hemophilia and selected disorders of the coagulation system. Aug 2023 [internet publication].
https://www.hemophilia.org/healthcare-professionals/guidelines-on-care/masac-documents/masac-document-280-masac-recommendations-concerning-products-licensed-for-the-treatment-of-hemophilia-and-selected-disorders-of-the-coagulation-system
[92]Mahlangu J, Oldenburg J, Paz-Priel I, et al. Emicizumab prophylaxis in patients who have hemophilia A without inhibitors. N Engl J Med. 2018 Aug 30;379(9):811-22.
https://www.nejm.org/doi/10.1056/NEJMoa1803550
http://www.ncbi.nlm.nih.gov/pubmed/30157389?tool=bestpractice.com
[93]Oldenburg J, Mahlangu JN, Kim B, et al. Emicizumab prophylaxis in hemophilia A with inhibitors. N Engl J Med. 2017 Aug 31;377(9):809-18.
https://www.nejm.org/doi/10.1056/NEJMoa1703068
http://www.ncbi.nlm.nih.gov/pubmed/28691557?tool=bestpractice.com
Emicizumab is administered subcutaneously and can be given in weekly, biweekly, or at 4-week intervals. Emicizumab has a long half-life and its plasma level remains constant (without peaks and troughs as in clotting factor prophylaxis) once a steady-state is reached after loading doses over the initial 4 weeks.
In patients with hemophilia A with or without inhibitors, emicizumab is associated with substantial and meaningful improvements in health-related outcomes.[94]Oldenburg J, Mahlangu JN, Bujan W, et al. The effect of emicizumab prophylaxis on health-related outcomes in persons with haemophilia A with inhibitors: HAVEN 1 Study. Haemophilia. 2019 Jan;25(1):33-44.
http://www.ncbi.nlm.nih.gov/pubmed/30427582?tool=bestpractice.com
Emicizumab cannot be used to treat acute bleeds or to cover surgical procedures, and cannot be used for hemophilia B prophylaxis.
Emicizumab will interfere with the activated partial thromboplastin time assay, one-stage based assay for clotting factor activity, and factor VIII inhibitor titer. When using emicizumab, a chromogenic assay using bovine reagents should be used for quantitation of endogenous or infused factor VIII levels, and a chromogenic Bethesda assay using bovine reagents should be used for quantitation of factor VIII inhibitor.[61]National Hemophilia Foundation Medical and Scientific Advisory Council (MASAC). MASAC document 268 - recommendation on the use and management of emicizumab-kxwh (Hemlibra®) for hemophilia A with and without inhibitors. Apr 2022 [internet publication].
https://www.hemophilia.org/healthcare-professionals/guidelines-on-care/masac-documents/masac-document-268-recommendation-on-the-use-and-management-of-emicizumab-kxwh-hemlibrar-for-hemophilia-a-with-and-without-inhibitors
[95]Nogami K, Shima M. New therapies using nonfactor products for patients with hemophilia and inhibitors. Blood. 2019 Jan 31;133(5):399-406.
http://www.ncbi.nlm.nih.gov/pubmed/30559263?tool=bestpractice.com
Anti-inhibitor coagulant complex (an activated prothrombin complex concentrate [aPCC]) should be avoided when patients are taking emicizumab to prevent the occurrence of thrombotic microangiopathy and thrombosis.[61]National Hemophilia Foundation Medical and Scientific Advisory Council (MASAC). MASAC document 268 - recommendation on the use and management of emicizumab-kxwh (Hemlibra®) for hemophilia A with and without inhibitors. Apr 2022 [internet publication].
https://www.hemophilia.org/healthcare-professionals/guidelines-on-care/masac-documents/masac-document-268-recommendation-on-the-use-and-management-of-emicizumab-kxwh-hemlibrar-for-hemophilia-a-with-and-without-inhibitors
[95]Nogami K, Shima M. New therapies using nonfactor products for patients with hemophilia and inhibitors. Blood. 2019 Jan 31;133(5):399-406.
http://www.ncbi.nlm.nih.gov/pubmed/30559263?tool=bestpractice.com
Bleeding prevention for surgery and trauma
Measures include:
Desmopressin for people (with a demonstrated positive response to desmopressin) with mild hemophilia A (factor levels >5%) having minor surgery or minor dental procedures.[70]National Hemophilia Foundation Medical and Scientific Advisory Council (MASAC). MASAC Document 280 - MASAC recommendations concerning products licensed for the treatment of hemophilia and selected disorders of the coagulation system. Aug 2023 [internet publication].
https://www.hemophilia.org/healthcare-professionals/guidelines-on-care/masac-documents/masac-document-280-masac-recommendations-concerning-products-licensed-for-the-treatment-of-hemophilia-and-selected-disorders-of-the-coagulation-system
Factor VIII or factor IX infusion, recommended for people with moderate and severe hemophilia A or B, respectively, undergoing minor surgery or minor dental procedures, or for patients having major surgery. Repeat doses may or may not be required depending on the extent of the procedure and risk of bleeding.
Patients with inhibitors undergoing major surgery should receive bypassing agents first-line.
For procedures associated with risk of mucosal bleeding, such as oral, dental, nasal, or gastrointestinal surgery, an antifibrinolytic agent is recommended orally every 6 hours for 7 to 10 days, beginning the night before the procedure. Aminocaproic acid can be given intravenously following oral or ear, nose and throat surgery.[70]National Hemophilia Foundation Medical and Scientific Advisory Council (MASAC). MASAC Document 280 - MASAC recommendations concerning products licensed for the treatment of hemophilia and selected disorders of the coagulation system. Aug 2023 [internet publication].
https://www.hemophilia.org/healthcare-professionals/guidelines-on-care/masac-documents/masac-document-280-masac-recommendations-concerning-products-licensed-for-the-treatment-of-hemophilia-and-selected-disorders-of-the-coagulation-system
Antifibrinolytics should be avoided if the patient has hematuria.
Preventive measures also include patient and family education, including the need to avoid contact sports and trauma (if possible). For immunizations, subcutaneous administration may be considered in preference to intramuscular injection. However, it is not clear if the benefit of reducing the risk of intramuscular hematoma outweighs the potential risk of reduced efficacy for some vaccines. Pneumococcal polysaccharide, inactivated polio, hepatitis A and hepatitis B have been shown to maintain efficacy when administered subcutaneously.[50]National Hemophilia Foundation Medical and Scientific Advisory Council (MASAC). MASAC Document 278 - MASAC recommendations on administration of vaccines to individuals with bleeding disorders. May 2023 [internet publication].
https://www.hemophilia.org/healthcare-professionals/guidelines-on-care/masac-documents/masac-document-278-masac-recommendations-on-administration-of-vaccines-to-individuals-with-bleeding-disorders
[151]Santagostino E, Riva A, Cesaro S, et al. Consensus statements on vaccination in patients with haemophilia-Results from the Italian haemophilia and vaccinations (HEVA) project. Haemophilia. 2019 Jul;25(4):656-67.
https://onlinelibrary.wiley.com/doi/10.1111/hae.13756
http://www.ncbi.nlm.nih.gov/pubmed/30990961?tool=bestpractice.com
Hepatitis A and B immunizations are recommended alongside all routine immunizations.[152]Steele M, Cochrane A, Wakefield C, et al. Hepatitis A and B immunization for individuals with inherited bleeding disorders. Haemophilia. 2009 Mar;15(2):437-47.
http://www.ncbi.nlm.nih.gov/pubmed/19335752?tool=bestpractice.com
A fine-gauge needle (23 gauge or smaller) may be used and firm pressure applied to the site for at least 2 minutes before injection. Treatment may also be considered before immunization to reduce the risk of hematoma, depending on the patient's factor level. For patients receiving prophylaxis, vaccination may be coordinated with prophylaxis administration to reduce the risk of hematoma.[50]National Hemophilia Foundation Medical and Scientific Advisory Council (MASAC). MASAC Document 278 - MASAC recommendations on administration of vaccines to individuals with bleeding disorders. May 2023 [internet publication].
https://www.hemophilia.org/healthcare-professionals/guidelines-on-care/masac-documents/masac-document-278-masac-recommendations-on-administration-of-vaccines-to-individuals-with-bleeding-disorders
Patients should be encouraged to practice regular exercise appropriate to joint status, especially swimming, to improve their quality of life.[153]Gomis M, Querol F, Gallach JE, et al. Exercise and sport in the treatment of haemophilic patients: a systematic review. Haemophilia. 2009 Jan;15(1):43-54.
http://www.ncbi.nlm.nih.gov/pubmed/18721151?tool=bestpractice.com
[154]Broderick CR, Herbert RD, Latimer J, et al. Association between physical activity and risk of bleeding in children with hemophilia. JAMA. 2012 Oct 10;308(14):1452-9.
http://www.ncbi.nlm.nih.gov/pubmed/23047359?tool=bestpractice.com
Annual assessment with a physical therapist is recommended, with ongoing education and support, including advice on physical activity and healthy living.[78]National Hemophilia Foundation Medical and Scientific Advisory Council (MASAC). MASAC Document 275 - MASAC Recommendations regarding physical therapy management for the care of persons with bleeding disorders. May 2023 [internet publication].
https://www.hemophilia.org/healthcare-professionals/guidelines-on-care/masac-documents/masac-document-275-masac-recommendations-regarding-physical-therapy-management-for-the-care-of-persons-with-bleeding-disorders