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Important Safety Information | | | Prescribing Information
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 or B with or without Factor VIII or IX inhibitors.
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More than a pen—
A springboard to
everyday bleed protection1
Adherence to daily dosing of Alhemo® is important to maintain protection against bleeding.
Routine prophylaxis treatment in a prefilled, subcutaneous pen for patients 12 and older with hemophilia B and A with or without inhibitors.
Get to know Alhemo®
Actor portrayal. Needles sold separately and may require a prescription in some states.
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Important Safety Information
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 1.9% of patients (6/320) who also had multiple risk factors, including the use of high doses or prolonged treatment with factor product or bypassing agent (2 of 6 patients). 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
Please click here or scroll below for additional Important Safety Information.
“Because it is prefilled and doesn’t need mixing, the Alhemo® pen is ready when I need it. I find the administration easy, so I can have daily bleed protection.”
—Royal lives with hemophilia B with inhibitors, uses Alhemo®, and is an employee of Novo Nordisk
Adherence to daily dosing of Alhemo® is important to maintain protection against bleeding.
90 seconds to prepare and administer.
~6 seconds to inject.1,2,a
The Alhemo® prefilled pen was rated as both easy to use (98%, n=78) and easy to learn to use (97%, n=78).1,2,b
Read IFU for full administration instructions.
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aAfter the dose counter is at “0,” count slowly to 6 while the needle is still in skin.
bAlhemo® is intended for use under the guidance of 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.
Study design: A device handling study of the Alhemo® pen that included 80 participants: 65 patients (44 adults, 21 adolescents) with hemophilia A or B, with or without inhibitors, using factor replacement or FVIII mimetic therapy (51% on factor, 49% on FVIII mimetic), and 15 caregivers. The main objectives were to determine whether the concizumab pen-injector is easy to learn how to use and easy to use using the Hemophilia Device Handling and Preference Assessment questionnaire. After training, participants independently prepared and performed a single pen injection, administering into an injection pad or manikin. An injection was complete if participant could attach needle, remove outer and inner caps, and set and inject intended dose. Time for training, preparation, injections, and number of complete injections were assessed. Average time to complete an injection was 1 min, 21 sec. Survey rating scale included: Very Difficult, Difficult, Neither difficult nor easy, Easy, and Very easy. Limitations: simulated use models may not completely reflect experience of at-home use. In addition, it may be difficult for a participant to evaluate the pen-injector based on a single simulated injection.
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Indications and Usage for Alhemo®
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 or B with or without Factor VIII or IX 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 26 (8.1%) 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, headache, and urticaria
• |  | Serious adverse reactions were reported in 6.1% of patients with inhibitors 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
• |  | Breakthrough Bleeding Treatment: Take appropriate precautions when treating breakthrough bleeding events in patients receiving Alhemo® prophylaxis and FVIII or FIX or a bypassing agent (eg, rFVIIa or aPCC). For mild and moderate bleeds, the lowest approved dose in the approved 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 Prescribing Information.
References:
1. | Alhemo [Prescribing Information]. Novo Nordisk Inc.
2. | 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.
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