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Medical Information | Non-US Health Care Professionals
Important Safety Information | Patient Site
Prescribing Information
Alhemo® (concizumab-mtci) injection 60 mg, 150 mg, 300 mg pens logo

Alhemo® is a tissue factor pathway inhibitor (TFPI)-antagonist 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 or hemophilia B with FIX inhibitors.

Prescribing Information
Important Safety Information | Patient Site

Administration made easy with the Alhemo® pen1

Treatment is intended for use under the guidance of an HCP and may be self-administered or administered by a caregiver after appropriate training and reading the IFU if a healthcare provider determines that is appropriate.

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aAfter the dose counter is at “0,” count slowly to 6 while the needle is still in skin.

Study design: In a device-handling study of the Alhemo® pen in 44 adults and 21 adolescents with hemophilia A or B, with or without inhibitors, and 15 caregivers, participants received training and performed a single simulated pen injection into a pad or manikin before completing a questionnaire. Time for training, preparation, injections, and number of complete injections were assessed. 98% (n=78) of participants rated Alhemo® pen easy or very easy to use. Average time to complete an injection was 1 min 21s. May not completely reflect experience of at-home use.

Alhemo® is administered once daily

Patients and caregivers should receive training from an HCP before use and initiate in a nonbleeding state.
Read the Instructions for Use or view the video below.

Step 1: Check Alhemo® pen and attach needle
  1. Check Alhemo® pen
  2. Attach new needle
Step 2: Prime before dose and select dose
  1. Prime before dose
    Dial 1 marking and test the flow before each dose
  2. Select dose
Step 3: Prepare injection site and inject
  1. Prepare injection site
  2. Inject Alhemo®a,b,c
Step 4: remove needle and recap pen
  1. Remove needle
  2. Recap pen

Needles sold separately and may require a prescription in some states.
aAfter the dose counter is at “0,” count slowly to 6 while the needle is still in skin.
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.
FDA=USA Food and Drug Administration; IFU=Instructions for Use; HCP=healthcare provider.

Alhemo offers innovative administration1,3

Not intended to be a comparison of efficacy or safety

Administration chart Administration chart

eFor a patient weighing 70 kg, the volume of emicizumab to inject ranges from 0.7 mL to 2.8 mL depending on dosing frequency. For the same patient on Alhemo® 0.2 mg/kg, the volume to inject ranges from 0.14 mL to 0.35 mL, depending on pen size. For a patient weighing 70 kg, a single infused dose of NovoSeven® RT for a joint bleed (90 mcg/kg) is 6.3 mL. For a patient weighing 70 kg, a single infused dose of Sevenfact® for a joint bleed (75 mcg/kg) is 5.25 mL. For a patient weighing 70 kg, a single infused dose of FEIBA® for a joint bleed (75 U/kg) is 105 mL. Qfitlia® volume to inject is 0.5 mL for a 50 mg dose, 0.2 mL for a 20 mg dose, and 0.1mL for a 10 mg dose.
fTreatment is intended under the guidance of an HCP, and may be self-administered or administered by a caregiver after appropriate training and reading the IFU, if HCP determines it appropriate.
gNovoSeven® RT and FEIBA® can be stored at 36 °F to 77 °F. Sevenfact® can be stored at 36 °F to 86 °F.
BPA=bypassing agent; FVIII=Factor VIII; IFU=Instructions for Use.; RNA=ribonucleic acid; siRNA=small interfering RNA.

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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 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:

  1. Alhemo [package insert]. Plainsboro, NJ; 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.
  3. Matsushita T, Shapiro A, Abraham A, et al. Phase 3 trial of concizumab in hemophilia with inhibitors. N Engl J Med. 2023;389(9):783-794
  4. HEMLIBRA® [package insert]. Genentech, Inc; 2024.
  5. Qfitlia®[package insert]. Genzyme Corporation; 2025.
  6. FEIBA® [package insert]. Takeda Pharmaceuticals USA, Inc; 2024.
  7. NovoSeven® RT [package insert]. Novo Nordisk Inc.
  8. Sevenfact® [package insert]. Prescribing Information. HEMA Biologics.
  9. World Federation of Hemophilia. Protocols for the treatment of hemophilia and von Willebrand disease. WFH. April 2008. Accessed May 30, 2025. https://www1.wfh.org/publication/files/pdf-1137.pdf