Assessing breakthrough bleeding
When and how would you decide to treat a potential breakthrough bleed?
Assessing the patient
Actor portrayal
Meet the patient
- The patient is a 19-year-old man (160 lbs, 73 kg) with congenital hemophilia A with inhibitors. He called his healthcare provider (HCP) to share that he had recently fallen while playing soccer
- His medical history includes prophylactic emicizumab 219 mg subcutaneously every 2 weeks, dosed at 3 mg/kg
Patient conversation
- He wanted to learn whether the fall needed treatment right away or if he should wait – a “watch and wait” approach
- The patient described the fall as typical, not serious, and with mild symptoms, such as swelling, but did not provide much more detail
Based on the patient’s description of events, when and how would you treat the patient for a potential breakthrough bleed?
Facts to keep in mind
Real-world data show that untreated bleeds persist, despite therapy with emicizumab1
Study design: An observational study was conducted that analyzed breakthrough bleeding patterns in patients with severe hemophilia A who were prophylactically treated with emicizumab. The study included 70 patients (42 with hemophilia A and 28 with hemophilia A with inhibitors) who completed at least 18 months of follow-up.1
40% of bleeds in people
with FVIII inhibitors were
untreated2
(n=815)
63% of untreated bleeds
in patients with FVIII
inhibitors were
spontaneous bleeds2
Which approach would you take?
Watch and wait approach
After considering the patient’s assessment of the severity of the bleed and his prophylactic treatment, the HCP determined the bleed/symptoms should be monitored before treating.
- The patient was told to call if his symptoms worsened
- The next day, the patient reported some swelling in his right knee and was advised to get the bleed treated immediately at the emergency department (ED)
- In the ED, the patient was administered a dose of NovoSeven® RT, Coagulation Factor VIIa (Recombinant), followed by 2 additional doses at 2-hour intervals
Outcome
- The bleed resolved with 3 total infusions of NovoSeven® RT.
- Post-discharge, pain and swelling did not fully resolve for 3 days.
Treat urgently approach
The HCP decided to treat the bleed proactively, rather than waiting to see if the bleed worsened.
- The patient was told to call if symptoms did not resolve
- The patient self-administered a dose of NovoSeven® RT at home within 2 hours of the bleed
Outcome
- Bleeding and symptoms resolved with 1 dose of NovoSeven® RT on the same day.
Hypothetical scenario for illustrative purposes. Individual results may vary.
Ready to discover more?
Find out more about NovoSeven® RT as a treatment option for patients with breakthrough bleeds.
MASAC and WFH provide guidelines for treating breakthrough bleeds.
Selected Important Safety Information for NovoSeven® RT
WARNING: THROMBOSIS
- Serious arterial and venous thrombotic events following administration of NovoSeven® RT have been reported
- Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven® RT
- Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis
Warnings and Precautions
- Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance
- Patients with congenital hemophilia receiving concomitant treatment with aPCCs (activated prothrombin complex concentrates), older patients particularly with acquired hemophilia and receiving other hemostatic agents, and patients with a history of cardiac and vascular disease may have an increased risk of developing thrombotic events
Indications and Usage
NovoSeven® RT (coagulation Factor VIIa, recombinant) is a coagulation factor indicated for:
- Treatment of bleeding episodes and perioperative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets
- Treatment of bleeding episodes and perioperative management in adults with acquired hemophilia
Important Safety Information
WARNING: THROMBOSIS
- Serious arterial and venous thrombotic events following administration of NovoSeven® RT have been reported
- Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven® RT
- Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis
Warnings and Precautions
- Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance
- Patients with congenital hemophilia receiving concomitant treatment with aPCCs (activated prothrombin complex concentrates), older patients particularly with acquired hemophilia and receiving other hemostatic agents, and patients with a history of cardiac and vascular disease may have an increased risk of developing thrombotic events
- Hypersensitivity reactions, including anaphylaxis, can occur with NovoSeven® RT. Patients with a known hypersensitivity to mouse, hamster, or bovine proteins may be at a higher risk of hypersensitivity reactions. Discontinue infusion and administer appropriate treatment when hypersensitivity reactions occur
- Factor VII deficient patients should be monitored for prothrombin time (PT) and factor VII coagulant activity (FVII:C). If FVII:C fails to reach the expected level, or PT is not corrected, or bleeding is not controlled after treatment with the recommended doses, antibody formation may be suspected and analysis for antibodies should be performed
- Laboratory coagulation parameters (PT/INR, aPTT, FVII:C) have shown no direct correlation to achieving hemostasis
Adverse Reactions
- The most common and serious adverse reactions in clinical trials are thrombotic events. Thrombotic adverse reactions following the administration of NovoSeven® RT in clinical trials occurred in 4% of patients with acquired hemophilia and 0.2% of bleeding episodes in patients with congenital hemophilia
Drug Interactions
- Thrombosis may occur if NovoSeven® RT is administered concomitantly with Coagulation Factor XIII
Please click here for NovoSeven® RT Prescribing Information, including Boxed Warning.
References:
- Levy-Mendelovich S, Brutman-Barazani T, Budnik I, et al. Real-world data on bleeding patterns of hemophilia A patients treated with emicizumab. J Clin Med. 2021;10(19):4303.
- Callaghan MU, Asikanius E, Lehle M, et al. Untreated bleeds in people with hemophilia A in a noninterventional study and intrapatient comparison after initiating emicizumab in HAVEN 1-3. Res Pract Thromb Haemost. 2022;6(6):e12782.