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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

Safety demonstrated
in patients with inhibitors in the explorer7 study1

Alhemo® offers safety backed by strong clinical evidence, including explorer7, a trial that investigated the safety and efficacy of Alhemo® for patients with HBwI and HAwI.

0 TEs

in explorer7,
after trial restart2,a

NO

routine liver
monitoring required1

NO

boxed warning1

1.3% (4/320) of patients in Alhemo® clinical trials reported venous and arterial thromboembolic events. Cases occurred in patients with multiple risk factors for thromboembolism, including high doses or prolonged treatment with factor products or BPAs (2 of 4 events).

1.3% (4/320) of patients in Alhemo® clinical trials reported venous and arterial thromboembolic events. Cases occurred in patients with multiple risk factors for thromboembolism, including high doses or prolonged treatment with factor products or BPAs (2 of 4 events).

Safety established
in clinical trial program with studies including all hemophilia types1

Patient's weight in the study ranged from 31.2 kg (68.6 lb) to 127.1 kg (279.6 lb).3

475

patient-years of exposure

320

patients, including 133 males with inhibitors, received at least one dose of Alhemo® as routine prophylaxis

Adverse reaction data reflects exposure of 52 patients with HAwI and HBwI who were previously treated with on-demand therapy and who were randomized in explorer7 to arm 1 to receive on-demand treatment with BPAs (n=19) or arm 2 to receive Alhemo® PPx (n=33) at the recommended dosing regimen. The median duration of treatment was 31.1 weeks (range 3.9, 72.9 weeks) in arm 1 (on-demand arm) and 40.1 weeks (range 3.1, 56.3 weeks) in arm 2 (Alhemo® PPx).

Man injecting pen

The most frequently reported adverse reactions (incidence ≥5%) were injection site reactions (18%) and urticaria (6%).1,b

Majority of injection site reactions were mild.2

Dosage interruptions of Alhemo® due to an adverse reaction occurred in 1 patient (3%) and was a hypersensitivity reaction.1

aThe explorer7 and explorer8 clinical trials were temporarily paused because 3 patients experienced 5 nonfatal TEs. In response, a plan was put in place that included deploying a laboratory-developed test to measure concizumab-mtci levels in order to individualize dosing, as well as guidance around how to treat breakthrough bleeds.1,2
bInjection site reactions included: injection site bruising, injection site erythema, injection site hematoma, injection site hemorrhage, injection site reaction, and injection site urticaria.
Urticaria included: urticaria and injection site urticaria.
BPA=bypassing agent; HAwI=hemophilia A with inhibitors; HBwI=hemophilia B with inhibitors; PPx=prophylaxis; TE=thromboembolic event.

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Individualized dosing for HBwI and HAwI

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

Scissors and scalpel icon

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. 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.
  3. Data on file. Novo Nordisk Inc: Plainsboro, NJ.