Routine prophylaxis treatment in a prefilled, subcutaneous pen to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older who have hemophilia B and A with or without inhibitors
No dose adjustment is required
for minor surgeries
No dose adjustment is required for minor surgeries
Management of Alhemo® in major surgeries
As there is limited experience in the perioperative setting:
BEFORE SURGERY
4 daysa
prior to major surgery
AFTER SURGERY
10-14 days
after surgery with same maintenance dose (no loading dose) while considering the overall clinical picture of the patient
Reaches steady state within 4 days and washes out quickly, also within 4 days.a
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).
Actor Portrayal.
Surgeries performed in patients with HB during explorer8 clinical trial2
Alhemo® is not indicated for perioperative management.1
Minor surgeries included:
- Dental extraction/procedures (n=7)
- Arthrocentesis, left elbow (n=1)
- Arthrodesis, left elbow (n=1)
- Hyaluronic acid infiltration, ankle (n=1)
- Hemophilic arthropathy, left and right elbow (n=1)
- Urethral augmentation (n=2)
Major surgeries included:
- Ankle arthropathy (n=1)
- Diagnostic laparoscopy with removal of blood, abdominal cavity (n=1)
- Liver transplant (n=1)
Information provided includes descriptive results from the 56-week cutoff for the explorer8 trial. The 56-week cutoff was defined as when all patients in arms 2, 3, and 4 completed the 56-week visit during the ongoing extension part of the trial (or permanently discontinued treatment).
HAwI=hemophilia A with inhibitors; HBwI=hemophilia B with inhibitors; SAE=serious adverse event.
Surgeries performed in patients with inhibitors during explorer7 clinical trial2
Alhemo® is not indicated for perioperative management.1
Minor surgeries included:
- Dental procedure (n=7, HAwI) (n=2, HBwI)
- Port removal (n=1, HBwl)
- Embolization of the right femoral artery for an SAE (recorded as retroperitoneal hematoma with active lumbar arterial spread after traumatic injury) (n=1, HAwl)
- Tongue mucous membrane injury (n=1, HBwl)
- Circumcision (phimosis) (n=1, HAwl)
- Venesection to perform infusion therapy in right foot (n=1, HAwl)
Major surgeries included:
- Hip arthroplasty (left hip hemophilic arthropathy) (n=1, HAwI)
- Total hip arthroplasty (right femoral neck fracture) (n=1, HBwI)
- Hematoma drainage (intracerebral hemorrhage) (n=1 HBwI)
- Bilateral total hip prosthesis (osteoarthritis) (n=1 HBwI)
Information provided includes descriptive results from the 56-week cutoff for the explorer7 trial. The 56- week cutoff was defined as when all patients in arms 2, 3, and 4 completed the 56-week visit during the ongoing extension part of the trial (or permanently discontinued treatment).
Alhemo® is not indicated for perioperative management.1
HAwI=hemophilia A with inhibitors; HBwI=hemophilia B with inhibitors; SAE=serious adverse event.
Watch Alhemo®’ in action
Alhemo® is the 1st and only TFPI antagonist for hemophilia with and without inhibitors5
Individualized dosing
Alhemo® offers individualized dosing for hemophilia patients with and without inhibitors.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 1.9% 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.
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.
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 1.9% 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.
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.
Reference:
- Alhemo [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
- Data on file. Novo Nordisk Inc; Plainsboro, NJ.