Powerful bleed protection for patients with inhibitors1,2
Explorer7 was a phase 3, open-label study evaluating Alhemo® for routine PPx in adult and adolescent patients with HBwI and HAwI.
Royal lives with hemophilia B with inhibitors,
uses Alhemo®, and is an employee of Novo Nordisk.
Royal lives with hemophilia B with inhibitors,
uses Alhemo®, and is an employee of Novo Nordisk.
Treated spontaneous and traumatic bleeds1,2
Primary Endpoint: The estimated mean ABR ratio was 0.14 (P<0.001)1
Study design: explorer7 was a multinational, multicenter, open-label, phase 3 trial that investigated the safety and efficacy of Alhemo® for routine prophylaxis in 91 adult males (58 HAwI and 33 HBwI) and 42 adolescent males (22 HAwI and 20 HBwI) who had been prescribed or are in need of treatment with BPAs. Efficacy was evaluated when all patients in arms 1 and 2 had completed at least 24 or at least 32 weeks, respectively, by comparing the number of treated bleeding episodes between Alhemo® prophylaxis (arm 2, n=33) and no prophylaxis treatment (on demand with BPAs; arm 1, n=19). Using a negative binomial model, a ratio of the ABR was estimated to 0.14 (P<0.001).
ABR=annualized bleeding rate; BPA=bypassing agents; HAwI=hemophilia A with inhibitors; HBwI=hemophilia B with inhibitors; IQR=interquartile range; PPx=prophylaxis.
Discover lower target joint bleed rate and more bleed-free patients
88% lower target joint bleed rate
Supportive secondary end point was an estimated mean target joint ABR of 0.1 (95% CI: 0.0-0.9) with Alhemo® (n=33) vs 1.1 (95% CI: 0.3-5.2) with no PPx (n=19), corresponding to estimated mean target joint ABR ratio of 0.122,3,a
Not alpha controlled
64% bleed-free for 24 weeks
for patients on Alhemo® (n=21) vs 10.5% on no prophylaxis (n=2)2,3,b
Additional assessment that is not alpha controlled
aTreated target joint bleeds.
bPatients with zero treated bleeds within first 24 weeks.
ABR=annualized bleeding rate; BPA=bypassing agent; HAwI=hemophilia A with inhibitors; HB=hemophilia B; HBwI=hemophilia B with inhibitors, PPx=prophylaxis.
Individualized dosing for HBwI and HAwI
For your hemophilia patients with inhibitors, Alhemo® offers individualized dosing.1
Curious about managing BTBs or surgeries?
Alhemo® requires no dose adjustment for breakthrough bleeds or minor surgeries.1
Important Safety Information for Alhemo®
Contraindications
- Alhemo® is contraindicated in patients with a history of known serious hypersensitivity to Alhemo® or its ingredients
Warnings and Precautions
- Thromboembolic Events (TEs): Venous and arterial TEs were reported in 1.3% of patients (4/320) who also had multiple risk factors, including the use of high doses or prolonged treatment with factor products or bypassing agents (2 of 4 events). Risk factors for TEs may also include conditions in which tissue factor is overexpressed (eg, atherosclerotic disease, crush injury, cancer, disseminated intravascular coagulation, thrombotic microangiopathy, or septicemia).
Inform patients about and monitor them for signs and symptoms of TEs. In case of suspicion of TEs, discontinue Alhemo® and initiate further investigations and management strategies
Indications and Usage
Alhemo® (concizumab-mtci) injection 60 mg, 150 mg, or 300 mg is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A with FVIII inhibitors and hemophilia B with FIX inhibitors.
Important Safety Information cont'd
Warnings and Precautions cont'd
- Hypersensitivity Reactions: Alhemo® is contraindicated in patients with a history of known serious hypersensitivity to Alhemo® or its ingredients. Hypersensitivity reactions, including erythema, rash, pruritus, and abdominal pain, have occurred in patients treated with Alhemo®. One patient (<1%) experienced anaphylaxis, which resolved after treatment with antihistamines and corticosteroids. Instruct patients of the signs of acute hypersensitivity reactions and to contact their healthcare provider for mild reactions and to seek urgent medical attention for moderate to severe reactions. Discontinue Alhemo® if severe hypersensitivity symptoms occur, and initiate medical management
- Increased Laboratory Values of Fibrin D-dimer and Prothrombin Fragment 1.2: Increased levels of fibrin D-dimer and prothrombin fragment 1.2 were seen in 29 (9.1%) and 18 (5.6%) patients, respectively, which is positively correlated with the plasma concentration of concizumab-mtci, indicating a hemostatic effect. For patients taking Alhemo®, these coagulation biomarkers may not be reliable predictive markers for clinical decision-making with suspicion of thrombosis, such as deep vein thrombosis and pulmonary embolism
Adverse Reactions
- The most frequently reported adverse reactions (≥5%) were injection site reactions and urticaria
- Serious adverse reactions were reported in 6.1% of patients who received Alhemo®. Permanent discontinuation of Alhemo® occurred in 1 patient due to a renal infarct and dosage interruptions of Alhemo® occurred in 1 patient (3%) and was a hypersensitivity reaction
Drug Interactions
- Bypassing Agents (BPAs): Take appropriate precautions when treating breakthrough bleeding events in hemophilia patients receiving Alhemo® prophylaxis and a BPA (eg, rFVIIa or aPCC). For mild and moderate bleeds, the lowest approved dose in the approved BPA product labeling is recommended. For aPCC, a maximum dose of 100 units/kg within 24 hours is recommended. For severe bleeds, follow the dosing instructions in the approved labeling based on clinical judgment
Please click here for Alhemo® Prescribing Information.
References:
- Alhemo [package insert]. Plainsboro, NJ; Novo Nordisk Inc.
- Matsushita T, Shapiro A, Abraham A, et al. Phase 3 trial of concizumab in hemophilia with inhibitors. N Engl J Med. 2023;389(9):783-794.
- Matsushita T, Shapiro A, Abraham A, et al. Phase 3 trial of concizumab in hemophilia with inhibitors. Supplementary Appendix. N Engl Med. 2022;389:783-794. Accessed October 2, 2024. https://www.nejm.org/doi/full/10.1056/NEJMoa2216455