Alhemo® delivers a predictable response and hemostatic balance1-3
Alhemo® achieves normal thrombin generation2,5
Study Design: explorer7 was a phase 3, open-label study evaluating Alhemo® for routine PPx in adult and adolescent patients with HAwI (n=80) or HBwI (n=53). The trial assessed the number of bleeding episodes between patients using on-demand and those using Alhemo® PPx for a minimum of 24 and 32 weeks, respectively, to evaluate efficacy and safety outcomes. Pharmacokinetic and pharmacodynamic assessments were also performed.5
Adherence to daily dosing of Alhemo® is important to maintain protection against bleeding. The ELISA should be administered 4 weeks after starting Alhemo® to determine concizumab-mtci plasma concentrations and optimize the dose.5
Additional measurements should be taken at routine clinical follow-ups provided the patient has been on the same maintenance dose for 8 weeks.5
Graph shows a logarithmic scale.
ELISA=Enzyme-Linked Immunosorbent Assay; HAwI=hemophila A with inhibitors; HBwI=hemophilia B with inhibitors; PPx=prophylaxis; TFRI=tissue factor pathway inhibitor.
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The first TFPI antagonist for HBwI and HAwI5
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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.
Reference:
- 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
- Matsushita T, Shapiro A, Abraham A, et al. Phase 3 trial of concizumab in hemophilia with inhibitors. N Eng J Med. 2023;389(9):783-794
- Srivastava A, Santagostino E, Dougall A, et al. WFH guidelines for the management of hemophilia. Haemophilia. 2020;26(suppl 6):1-158.
- Data on file. Novo Nordisk Inc; Plainsboro, NJ.
- Alhemo [package insert]. Plainsboro, NJ; Novo Nordisk Inc.