Alhemo® Administration

Funded and developed by Novo Nordisk.

Important Safety Information

Prescribing Information

Third Edition – April 2026

For formulary decision-makers only.

Important Safety Information

Prescribing Information

For formulary decision-makers only.

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 or B with or without Factor VIII or IX inhibitors.

Highlights from the ​previous newsletter:

For patients aged 12 years and older with hemophilia A or B with or without inhibitors1

Alhemo® is a tissue factor pathway inhibitor antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes1

Alhemo® provides effective bleed protection, with efficacy and safety evaluated in the explorer7 and explorer8 clinical trials1

In this issue:

  • Dosing graphic

    Daily subcutaneous dosing1 >

  • Dosing and Administration graphic

    Dosing and administration >

  • Injection volume graphic

    Injection volume and small needle size (32G)1,a >

  • Administration graphic

    Administration in less than 90 seconds2 and ~6 seconds to inject1,b >

    aNeedles sold separately and may require a prescription in some states. New needle is required for each injection.1

    bInstruct patients that after the dose counter is at “0,” they should count slowly to 6 while the needle is still in their skin.1

aNeedles sold separately and may require a prescription in some states. New needle is required for each injection.1

bInstruct patients that after the dose counter is at “0,” they should count slowly to 6 while the needle is still in their skin.1

Video: The Alhemo® pen

Watch video

Alhemo® offers transformative administration with a prefilled, subcutaneous pen

The Alhemo® prefilled pen offers fast administration in less than 90 seconds,1 does not require venous access,1 which patients may find easy to use.2

Alhemo Pen Alhemo Pen

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 the 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.2

Injection volume and small needle size (32 g)

Injection volume graphic

Alhemo® uses NovoFine or NovoFine Plus needles (32-gauge, 4-mm),1 which are designed for increased injection comfort and less pain.3,4,c In addition to the small needle size, Alhemo® prefilled pens have a low injection volume (0.14-0.35 mL).1,d The Alhemo® prefilled pen builds on Novo Nordisk’s legacy of innovation since launching the first insulin pen in 1985.5

c32-gauge needles are associated with less pain compared with thicker needles.3 Thicker needles include 27-gauge, 28-gauge, 30-gauge, and 31-gauge.3

dFor a person weighing 70 kg on Alhemo® 0.2 mg/kg, the volume to inject ranges from 0.14 to 0.35 mL, depending on pen size.1

Subcutaneous injection

Dosing graphic

Alhemo® is administered as a once-daily subcutaneous injection to the abdomen or thigh, with rotation of the injection site every day.1,e As Alhemo is given subcutaneously,1 it can be prepared and administered in under 90 seconds.2 In a device-handling study of Alhemo® in 80 patients2:

• 98% of participants reported that the Alhemo® prefilled
pen was “easy” or “very easy” to use

Study design: The device-handling study of the Alhemo® pen included 80 participants (65 patients with HA/HB/HwI and 15 caregivers) with 51% on factor replacement and 49% on FVIII mimetic therapy. The main objective was to determine whether the concizumab pen injector is easy to learn how to use and easy to use via training and a simulated injection (administered into an injection pad or manikin) using the Hemophilia Device Handling and Preference Assessment Questionnaire. Injection was complete if participant could attach the needle, remove outer and inner caps, set and inject intended dose. Training time, preparation, and injection completion were assessed. Average time to complete an injection was 1 min 21s. Survey rating scale included: Very difficult, difficult, neither difficult nor easy, easy, and very easy. Limitations include simulated use models and may not fully reflect at-home experience and evaluations based on 1 injection only.2

eAlhemo® is intended for use under the guidance of a 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.

Prefilled pen design

Administration graphic

Alhemo® is available as a single-patient-use prefilled pen containing a clear to slightly opalescent solution.1 As part of the Alhemo® pen design, the dose selector can dial up to 80 dose increments and can be turned in either direction to adjust dose.

A device-handling study of Alhemo® in 80 participants found that2:

  • Alhemo® can be prepared and administered in less than 90 seconds2
    and takes ~6 seconds to inject1,f
  • 97% of participants reported the Alhemo® prefilled pen was “easy”
    or “very easy” to learn to use2

Study design: The device-handling study of the Alhemo® pen included 80 participants (65 patients with HA/HB/HwI and 15 caregivers) with 51% on factor replacement and 49% on FVIII mimetic therapy. The main objective was to determine whether the concizumab pen injector is easy to learn how to use and easy to use via training and a simulated injection (administered into an injection pad or manikin) using the Hemophilia Device Handling and Preference Assessment Questionnaire. Injection was complete if participant could attach the needle, remove outer and inner caps, set and inject intended dose. Training time, preparation, and injection completion were assessed. Average time to complete an injection was 1 min 21s. Survey rating scale included: Very difficult, difficult, neither difficult nor easy, easy, and very easy. Limitations include simulated use models and may not fully reflect at-home experience and evaluations based on 1 injection only.2

fInstruct patients that after the dose counter is at “0,” they should count slowly to 6 while the needle is still in their skin.1

Dosing & administration

Dosing and Administration graphic

Alhemo® uses weight-based dosing, starting with a 1-mg/kg loading dose on Day 1, then
transitioning to a dose of 0.2 mg/kg from Day 2 on until optimized dose is determined.1

For dose optimization, 4 weeks after initiation of treatment, measure concizumab-mtci plasma concentration by Concizumab Enzyme-Linked Immunosorbent Assay (ELISA) prior to administration of next scheduled dose using an FDA-authorized test.1

  • Dose adjustment, if needed, should be no later than 8 weeks after treatment initiation
  • Tests should be conducted 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

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. Maintenance of concizumab plasma concentration above 200 ng/mL is important to decrease the risk of bleeding episodes.1,g

gIf concizumab-mtci plasma concentration remains below 200 ng/mL at 2 consecutive measurements, the benefits of continued Alhemo® treatment should be evaluated vs the potential risk of bleeding events and alternative therapies, if available, should be considered.1

Please see Prescribing Information for full Dosing and Administration information

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Alhemo® prefilled pens are designed for subcutaneous use in patients aged 12 years and older with hemophilia A or B, with or without inhibitors1

Alhemo® prefilled pens aim to place the patient at the center of the process of hemophilia management.h With once-daily subcutaneous dosing, ultra-thin needle size (32G x 4 mm), low injection volume,1,i and easy-to-learn-to-use design,2 the Alhemo® pen demonstrates the commitment of Novo Nordisk to supporting the patient experience in hemophilia care.

hAlhemo® is intended for use under the guidance of a 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.

iFor a person weighing 70 kg on Alhemo® 0.2 mg/kg, the volume to inject ranges from 0.14 to 0.35 mL, depending on pen size.1

Study design: The device-handling study of the Alhemo® pen included 80 participants (65 patients with HA/HB/HwI and 15 caregivers) with 51% on factor replacement and 49% on FVIII mimetic therapy. The main objective was to determine whether the concizumab pen injector is easy to learn how to use and easy to use via training and a simulated injection (administered into an injection pad or manikin) using the Hemophilia Device Handling and Preference Assessment Questionnaire. Injection was complete if participant could attach the needle, remove outer and inner caps, set and inject intended dose. Training time, preparation, and injection completion were assessed. Average time to complete an injection was 1 min 21s. Survey rating scale included: Very difficult, difficult, neither difficult nor easy, easy, and very easy. Limitations include simulated use models and may not fully reflect at-home experience and evaluations based on 1 injection only.2

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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 or B with or without Factor VIII or IX inhibitors.

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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
  • 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 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. doi:10.2147/PPA.S470091 3. Arendt-Nielsen L, Egekvist H, Bjerring P. Pain following controlled cutaneous insertion of needles with different diameters. Somatosens Mot Res. 2006;23(1-2):37-43. doi:10.1080/08990220600700925 4. NovoFine® Plus 32G packaging label. 5. Selam JL. Evolution of diabetes insulin delivery devices. J Diabetes Sci Technol. 2010;4(3):505-513. doi:10.1177/193229681000400302