| Learn about the first and only once-daily, prefilled pen injection for patients with inhibitors. |
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| Introducing the 1st and only prophylaxis treatment in a prefilled, subcutaneous pen for HBwI and HAwI1 |
| Alhemo® 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 (congenital factor VIII deficiency) with FVIII inhibitors and hemophilia B (congenital factor IX deficiency) with FIX inhibitors. |
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| Needles sold separately and may require a prescription in some states. New needle is required for each injection. |
| HAwI=hemophilia A with inhibitors; HBwI=hemophilia B with inhibitors |
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| Keep scrolling to learn more about Alhemo® |
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| Important Safety Information |
| Contraindications |
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Alhemo® is contraindicated in patients with a history of known serious hypersensitivity to Alhemo® or its components or the inactive ingredients |
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| Warnings and Precautions |
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| Thromboembolic Events: Venous and arterial thromboembolic events were reported in 1.3% of patients (4/320) in Alhemo® clinical trials. These cases occurred in patients with multiple risk factors for thromboembolism, including the use of high doses or prolonged treatment with factor products or bypassing agents (2 of 4 events). |
| Risk factors for thromboembolism may include the use of high and/or frequent doses of breakthrough bleed treatments (factor products or bypassing agents) or conditions in which tissue factor is overexpressed (eg, atherosclerotic disease, crush injury, cancer, disseminated intravascular coagulation, thrombotic microangiopathy, or septicemia). |
| Inform patients treated with Alhemo® of signs and symptoms of thromboembolic events. Monitor patients for thromboembolic events. In case of suspicion of thromboembolic events, discontinue Alhemo® and initiate further investigations and management strategies |
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| Please click here or scroll below for additional Important Safety Information. |
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| Could a once-daily, subcutaneous pen option make a difference for your patients? |
| Meet Alhemo®: A new treatment option available in three pens, each containing multiple doses. It is portable and ready to use in a prefilled pen with no mixing required.1,a |
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| aStore in refrigerator before first use. After first use, Alhemo® can be stored at room temperature below 86 °F (30 °C) or in a refrigerator at 36 °F to 46 °F (2 °C to 8 °C) for up to 4 weeks. Please see Prescribing Information for full storage information. |
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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 (congenital factor VIII deficiency) with FVIII inhibitors and hemophilia B (congenital factor IX deficiency) with FIX inhibitors. |
| Important Safety Information (cont’d) |
| Warnings and Precautions |
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| Hypersensitivity Reactions: Alhemo® is contraindicated in patients with a history of known serious hypersensitivity to Alhemo® or its components or the inactive ingredients. Hypersensitivity reactions, including erythema, rash, pruritus, and abdominal pain, have occurred in patients treated with Alhemo®. One patient (less than 1% of patients treated in the clinical studies) experienced anaphylaxis, which resolved after treatment with antihistamines and corticosteroids. Instruct patients of the signs of acute hypersensitivity reactions. Instruct patients 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 |
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| Increased Laboratory Values of Fibrin D-dimer and Prothrombin Fragment 1.2: Increased levels of fibrin D-dimer and increased levels of prothrombin fragment 1.2 were seen in 29 (9.1%) and 18 (5.6%) of patients, respectively. The plasma concentration of concizumab-mtci is positively correlated with fibrin D-dimer and prothrombin fragments 1.2, indicating a hemostatic effect of concizumab-mtci. 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 (DVT) and pulmonary embolism (PE) |
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| Adverse Reactions |
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The most frequently reported adverse reactions (incidence ≥5%) were injection site reactions and urticaria |
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| Drug Interactions |
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Bypassing Agents: Take appropriate precautions when treating breakthrough bleeding events in hemophilia patients receiving Alhemo® prophylaxis and a bypassing agent. For mild and moderate bleeds that require additional treatment with bypassing agents (eg, rFVIIa or aPCC), the lowest approved dose in the approved product labeling is recommended. For aPCC, a maximum dose of 100 units/kg body weight within 24 hours is recommended. For severe bleeds, follow the dosing instructions provided in the approved labeling for the specific product based on clinical judgment. An additive and sometimes synergistic increase in thrombin peak, as quantified in the thrombin generation assay, has been observed in plasma from hemophilia patients who were on prophylactic treatment with concizumab-mtci with concomitant presence of rFVIII, rFIX or bypassing agents including rFVIIa and aPCC |
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| Please click here for Prescribing Information. |
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Alhemo [Prescribing Information]. Novo Nordisk Inc. |
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