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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

Challenges persist in managing hemophilia with inhibitors1-6

Red blood cells

Patients with HBwI are clinically underserved with a dire need for additional prophylaxis treatments1,2

A real-world observational study that included 31 patients who have HBwI3

High rate of bleeds persists with current treatment options2,3

Median ABR of

18

Patients using on-demand treatment (n=16)3,a

Median ABR of

10

Patients using
prophylaxis (n=15)3,a

aStudy using historical data to describe real-world unmet needs in males aged ≥12 years with severe HA, moderate/severe HB, or HAwI/HBwI of any severity (N=31 patients with HBwI). BPAs were used on demand (n=16) for 111 months (mean) and as prophylaxis (n=15) for 85 months (mean).3

ABR=annualized bleeding rate; BPA=bypassing agent; HA=hemophilia A; HB=hemophilia B.

Significant treatment burdens remain for patients managing HAwI2,4-6

Current treatment administration requires time and multiple steps2,4,5

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Up to 15 minutes or more to prepare and administer 
FVIII mimetic4

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Large needles

can be up to 23G4,5

Syringe and vial icon

Multiple steps to prepare and administer vials and syringes4,5

There can be uncertainty surrounding individual response to treatment and limited ability to measure6

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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.

References:

  1. Hermans C, Giangrande PLF, O’Mahony B, et al. European principles of inhibitor management in patients with haemophilia: implications of new treatment options. Orphanet J Rare Dis. 2020;15(1):219.
  2. Srivastava A, Santagostino E, Dougall A, et al. WFH guidelines for the management of hemophilia. Haemophilia. 2020;26(suppl 6):1-158.
  3. Windyga J, Apte S, Frei-Jones M, et al. Disease and treatment burden of patients with haemophilia entering the explorer6 non-interventional study. J Haematol. 2024;113(5):631-640.
  4. HEMLIBRA®. Instructions for Use. Genentech, Inc.
  5. World Federation of Hemophilia. Protocols for the treatment of hemophilia and von Willebrand disease. WFH. April 2008. Accessed December 13, 2024. https://www1.wfh.org/publication/files/pdf-1137.pdf
  6. Nardi MA. Hemophilia A: emicizumab monitoring and impact on coagulation testing. Adv Clin Chem. 2023;113:273-315.