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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

The first TFPI antagonist for HBwI and HAwI1

HBwI=hemophilia B with inhibitors;
HAwI=hemophilia A with inhibitors

As Alhemo® concentration increases, free TFPI decreases1

Antibody antagonist of endogenous TFPI that enhances Factor Xa production during coagulation initiation

By blocking TFPI, Alhemo® enhances thrombin production to support hemostasis

Efficacy of Alhemo® is not influenced by the presence of inhibitory antibodies to FVIII or FIX

Does not induce or enhance development of inhibitors to FVIII or FIX

Targets TFPI upstream in initiation phase of coagulation and does not directly affect downstream activity of activated protein C or antithrombin2

Reaches steady state and washes out quickly, within 4 daysa

aFollowing a single Alhemo® loading dose of 1 mg/kg, the steady state concentrations were reached around Day 4 and remained within a stable exposure range with daily maintenance doses. Based on population pharmacokinetic analysis, 90% of concizumab-mtci is expected to be eliminated by the end of approximately 4 days after the last dose (time for 50% of drug to be eliminated is approximately 1 day).
FIX=Factor IX; FIXa=Activated Factor IX; FVIIa=Activated Factor VII; FVIII=Factor VIII; FVIIIa=Activated Factor VIII; FX=Factor X; FXa=Activated Factor X; HAwI=hemophilia A with inhibitors; HBwI=hemophilia B with inhibitors; TF=tissue factor; TFPI=tissue factor pathway inhibitor.

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Individualized dosing for HBwI and HAwI

For your hemophilia patients with inhibitors, Alhemo® offers individualized dosing.1

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Curious about managing BTBs or surgeries?

Alhemo® requires no dose adjustment for breakthrough bleeds or minor surgeries.1

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. Mast AE, Ruf W. Regulation of coagulation by tissue factor pathway inhibitor: implications for hemophilia therapy. J Thromb Haemost. 2022;20(6):1290-1300.