Alhemo® should be administered once daily.
For dose optimization, measure concizumab-mtci plasma concentration by Concizumab Enzyme-Linked Immunosorbent Assay (ELISA). An FDA-authorized test for the measurement of concizumab-mtci concentration in plasma is not currently available. An interim laboratory developed test is being offered only until an FDA-authorized test is available.
Recommended dosing regimen:
Loading dose of 1 mg/kg
Until individualization of maintenance dose is determined
Once-daily dose of 0.2 mg/kg
28 days after initiation of treatment: Concizumab ELISAa
Results reported within 10 working days
- Dose adjustment, if needed
Individualize the maintenance dose no later than 8 weeks after initiation of treatment
aShould be performed prior to administration of next scheduled dose.
FDA=US Food and Drug Administration; HCP=healthcare professional.
Following lab testing, adjust the dose:
Based on the following concizumab-mtci plasma concentrations:
In explorer7, a total of 108 patients received their individualized dose: 1 patient on 0.15 mg/kg, 79 patients on 0.2 mg/kg, and 28 patients on 0.25 mg/kg.
Adherence to daily dosing of Alhemo® is important to maintain protection against bleeding, especially during the initial 4 weeks, to ensure correct maintenance dose. Patients who miss a dose during this period should inform their HCP and resume dosing at 0.2 mg/kg.
Please see full dosing guidance in Prescribing Information.
For additional measurements of concizumab-mtci plasma concentration:
- Tests should be taken at routine clinical follow-ups, provided the patient has been on the same maintenance dose for 8 weeks
- Maintenance of concizumab-mtci plasma concentration above 200 ng/mL is important to decrease risk of bleeding
- If concentration remains below 200 ng/mL at 2 consecutive measurements, benefits of continued treatment should be evaluated vs potential bleeding risk and alternative therapies should be considered
Key points of administration1
Ensure that both patient and caregiver receive appropriate training before use. Treatment is intended for use under the guidance of a healthcare provider. Treatment should be initiated in a nonbleeding state. Alhemo® 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.
- Check Alhemo® pen
- Attach new needle
- Prime before dose
Dial 1 marking and test the flow before each dose - Select dose
- Prepare injection site
- Inject Alhemo®b
- Remove needle
- Recap pen
Needles sold separately and may require a prescription in some states.
bAdminister by subcutaneous injection to the abdomen or thigh with rotation of injection site every day. Subcutaneous injections should not be given in areas where the skin is tender, bruised, red, or hard,
or areas where there are moles, scars, or stretch marks. Each Alhemo® prefilled pen is for use by a single patient.
cStore 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.
dAfter 28 days, discard pen in an FDA-cleared sharps disposal container.
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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 components or the inactive ingredients
Warnings and Precautions
- 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
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 (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 cont'd
- 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
- 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)
Adverse Reactions
- The most frequently reported adverse reactions (incidence ≥5%) were injection site reactions and urticaria
Drug Interactions
- 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
Please click here for Alhemo® Prescribing Information.
Reference:
- Alhemo [package insert]. Plainsboro, NJ: Novo Nordisk Inc.