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| 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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Discover the Alhemo® approach1 |
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Alhemo® is the only TFPI antagonist that offers an FDA-authorized test (Concizumab ELISA) to measure plasma drug levels for individualized dose optimization. |
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This blood test measures concizumab-mtci plasma levels to assess whether levels are in the therapeutic range.a Along with weight-based dosing, this FDA-authorized test allows for treatment individualization to optimize dosing. |
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| Recommended Dosing Regimen: |
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| One-time loading dose is 1 mg/kg |
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| Once-daily dose is 0.2 mg/kg (until optimized dose determined) |
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| Administer Concizumab ELISA (4 weeks after initiation of Alhemo®) |
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Advise patients to administer Alhemo® after ELISA blood draw on day of the test |
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Results reported within 10 working days |
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| Personalized dose adjustment, if needed, will be confirmed no later than 8 weeks after treatment initiation. |
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| When should patients be tested? |
| Tests should be taken at routine clinical follow-ups, provided the patient has been on the same maintenance dose for 8 weeks of treatment to ensure steady-state plasma concentration.b |
| Adherence to daily dosing of Alhemo® is important to maintain protection against bleeding. This is especially important during the initial 4 weeks of treatment to ensure a correct maintenance dose is established. |
| ELISA=Enzyme-Linked Immunosorbent Assay; TFPI=tissue factor pathway inhibitor. |
| aOnce the concizumab-mtci concentration result is available, individualize the maintenance dose of Alhemo® no later than 8 weeks after initiation of treatment, based on the following concizumab-mtci plasma concentrations: |
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Less than 200 ng/mL: adjust to a once daily dose of 0.25 mg/kg |
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200 to 4,000 ng/mL: continue once daily dose of 0.2 mg/kg |
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Greater than 4,000 ng/mL: adjust to a once daily dose of 0.15 mg/kg |
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| bIf concizumab-mtci plasma concentration remains below 200 ng/mL at two consecutive measurements, evaluate the benefits of continued Alhemo® treatment versus the potential risk of bleeding events, and consider alternative therapies, if available. |
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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 ingredients |
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| Warnings and Precautions |
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| 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 |
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| Please click here or scroll below for additional Important Safety Information. |
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| Have questions? Novo Nordisk is here to help. |
| Connect with a Novo Nordisk Rare Blood Therapy Manager in your area. They can help you with: |
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Clinical product information |
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Rare bleeding education for patients |
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Resources for starting treatment |
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General questions & inquiries |
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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) |
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| 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 |
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| 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 |
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| Adverse Reactions |
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The most frequently reported adverse reactions (≥5%) were injection site reactions, headache, and urticaria |
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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 |
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| Drug Interactions |
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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 |
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| Please click here for Prescribing Information. |
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Alhemo [package insert]. Plainsboro, NJ: Novo Nordisk Inc. |
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