More than a pen
A springboard to everyday bleed protection1
Alhemo® is the first routine prophylaxis treatment in a prefilled, subcutaneous pen to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older who have HBwI or HAwI.
Adherence to daily dosing of Alhemo® is important to maintain protection against bleeding.
Adherence to daily dosing of Alhemo® is important to maintain protection against bleeding.
Needles sold separately and may require a prescription in some states.
HAwI=hemophilia A with inhibitors; HBwI=hemophilia B with inhibitors.
Are your patients ready to dive into proven, effective bleed protection?1,3
Proven, effective bleed protection:
1.7 mean ABR and 0 median ABR1,3
Safety demonstrated in patients with inhibitors in explorer73
Portable and ready to use: Prefilled, no mixing required1,a
Proactive treatment individualization1
Most common adverse reactions with Alhemo®—injection site reaction (18%) and urticaria (6%)1,b
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 male adolescents (22 HAwI and 20 HBwI) who had been prescribed or were 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). The estimated mean ABR was 1.7 [95% CI: 1.01; 2.87] for patients on Alhemo® prophylaxis and 11.8 [95% CI: 7.03; 19.86] for patients on no prophylaxis. The median ABR was 0 (IQR: 0.0-3.3) for patients on Alhemo® and 9.8 (IQR: 6.5-20.2) for patients on no prophylaxis. Using a negative binomial model, a ratio of the ABR was estimated to 0.14 (P<0.001).1,3
aStore in refrigerator before first use. After first use, Alhemo® can be stored at room temperature below 86 ℉ (30 ℃) or in a refrigerator at 36 ℉ to 46 ℉ (2 ℃ to 8 ℃) for up to 4 weeks.
bInjection site reactions included: injection-site bruising, erythema, hematoma, hemorrhage, hypersensitivity reaction, and urticaria. Urticaria included: urticaria and injection-site urticaria.
Patients with hemophilia with inhibitors who previously used BPAs on demand can take the plunge into transformative administration with a prefilled, subcutaneous pen1,c,d
Prefilled and portable, the Alhemo® pen is ready to use. It uses ultra-thin needles that are designed for injection comfort; it requires no mixing or vials. And each pen is stable at room-temperature for up to 4 weeks.1,4,c,d,e
cAlhemo® is intended for use under the guidance of a healthcare provider, and may be self-administered or administered by a caregiver after appropriate training and reading the Instructions for Use, if a healthcare provider determines that is appropriate.
dNeedles sold separately and may require a prescription in some states. New needle is required for each injection.
eStore in refrigerator before first use. After first use, Alhemo® can be stored at room temperature below 86 ℉ (30 ℃) or in a refrigerator at 36 ℉ to 46 ℉ (2 ℃ to 8 ℃) for up to 4 weeks.
Please see Prescribing Information for full storage information.
Calculate your patient’s dose of Alhemo®
Want to determine your patient’s dose of Alhemo®? This tool makes it easy.
Calculate your patient’s dose of Alhemo®
Want to determine your patient’s dose of Alhemo®? This tool makes it easy.
Have questions? We’re here to help
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.
- Hedner U. History of rFVIIa therapy. Thromb Res. 2010;125(suppl 1):S4-S6.
- 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.
- Rasmussen NK, Berg B, Christiansen ASL, et al. The concizumab pen-injector is easy to use and preferred by hemophilia patients and caregivers: a usability study assessing pen-injector handling and preference. Patient Prefer Adherence. 2024:18 1713-1727.