Alhemo Pen (concizumab-mtci)
Antihemophilic Products Subcutaneous Pen Injector (ML)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Concizumab-mtci, a humanized immune globulin G type 4 (IgG4) monoclonal antibody, is a tissue factor pathway inhibitor (TFPI) antagonist.
Concizumab-mtci is a monoclonal antibody that inhibits endogenous tissue factor pathway inhibitor (TFPI), enhancing factor Xa production during the initiation phase of coagulation. This promotes thrombin formation and clot development to achieve hemostasis in patients with hemophilia A or B regardless of inhibitor status. The activity of concizumab is not affected by factor VIII or factor IX inhibitors, and the drug does not induce or increase the development of these inhibitors due to lack of structural or sequence similarity.
Following a single subcutaneous loading dose of 1 mg/kg, steady-state concentrations of concizumab-mtci were reached by day 4 and remained stable with once daily maintenance dosing. Exposure increased in a greater-than-dose-proportional manner following subcutaneous administration. Time to maximum plasma concentration ranged from 8-99 hours following a single dose of 0.05-3 mg/kg.
Concizumab-mtci is eliminated through both linear and non-linear mechanisms due to target-mediated drug disposition (TMDD), shifting to linear catabolism once TFPI is saturated. About 90% of the drug is eliminated within 4 days of the last dose, with a half-life of approximately 1 day. Concizumab-mtci is metabolized into small peptides via catabolic pathways.
Pharmacokinetics were not significantly affected by age (12-79 years), race, or hemophilia type (A or B with or without inhibitors). Although no studies have evaluated renal or hepatic impairment, altered exposure is not expected because concizumab-mtci is a monoclonal antibody. Drug exposure increases with body weight, as observed across a range of weights from 27-130.7 kg.
Higher doses of concizumab-mtci led to lower levels of free TFPI and prolonged suppression. In patients with inhibitors receiving concizumab-mtci prophylaxis, pre-dose free TFPI dropped from 88.3 ng/mL at baseline to 10.7 ng/mL at week 24, compared to 76 ng/mL in those treated on-demand. In patients without inhibitors receiving concizumab-mtci prophylaxis, pre-dose free TFPI dropped from 84.2 ng/mL at baseline to 11.1 ng/mL at week 24, compared to 80.6 ng/mL in those treated on-demand.
Thrombin peak levels indicated restored thrombin generation with concizumab-mtci.
USES: This medication is used by people with a certain inherited bleeding problem (hemophilia A or B) to help prevent or lessen how often you have bleeding problems. Concizumab belongs to a class of medications known as monoclonal antibodies. It works by helping your blood to clot normally, which helps prevent bleeding due to hemophilia.
Generic name: concizumab-mtci
Pronunciation: (kon-SIZ-ue-mab)
Drug class: Antihemophilic Products
Therapeutic class: Hematological Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Alhemo Pen
Indications
The following indications are listed for Alhemo Pen:
- Bleeding Prevention In Hereditary Factor Ix Deficiency
- Bleeding Prevention In Hereditary Factor Viii Deficiency
Also known as: Bleeding Prevention In Classic Hemophilia, Bleeding Prevention In Congenital Factor Viii Deficiency, Bleeding Prevention In Hemophilia A, Bleeding Prophylaxis In Hemophilia A, Hemorrhage Prophylaxis In Hemophilia A, Prevention Of Bleeding Episode In Hemophilia A.
Dosing
Concizumab-mtci is dosed by body weight (kg); recalculate the dose if the patient's body weight changes.
Administer concizumab-mtci by subcutaneous injection only. Concizumab-mtci is available as a 60 mg/1.5 mL, 150 mg/1.5 mL, and 300 mg/3 mL single-patient-use prefilled pen. The pen contains multiple doses of concizumab-mtci.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Alhemo 150 Mg/1.5 Ml Pen | Maintenance | Inject 0.2 mg/kg by subcutaneous route once daily. |
| Alhemo 300 Mg/3 Ml Pen | Maintenance | Inject 0.2 mg/kg by subcutaneous route once daily. |
| Alhemo 60 Mg/1.5 Ml Pen | Maintenance | Inject 0.2 mg/kg by subcutaneous route once daily. |
No dosing information is available for this tab.
Drug interactions
No formal drug interaction studies have been conducted to date.
There are no contraindication interactions for this drug.
Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
Igg Antibodies And Derivatives/Efgartigimod-Alfa
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3)
DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3)
Igg Antibodies And Derivatives/Nipocalimab-Aahu
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3)
DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3)
Moderate Interaction: Assess the risk to the patient and take action as needed.
Igg Antibodies And Derivatives/Rozanolixizumab-Noli
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3)
DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3)
Contraindications
*Patients with a known history of serious hypersensitivity to the drug or any of its components.
There are no contraindication contraindications for this drug.
- Pregnancy
- Thromboembolic disorder
Adverse reactions
Adverse reactions reported in >=5% of concizumab-mtci-treated patients in clinical studies were injection site reactions, headache, and urticaria.
Less Frequent
- Hypersensitivity drug reaction
- Renal infarction
- Thromboembolic disorder
More Frequent
- Arthralgia
- Injection site sequelae
- Urticaria
Less Frequent
- Fever
- Headache disorder
- Injection site erythema
- Upper respiratory infection
Rare or Very Rare
- Pruritus of skin
Precautions
No enhanced messaging available.
Concizumab-mtci is approved for hemophilia A and B with and without inhibitors in pediatric patients >=12 years of age, based on data from well-controlled studies. Safety and effectiveness have not been established in children <12 years of age.
Concizumab-mtci may cause fetal harm based on its mechanism of action. No human or animal studies have evaluated the effects of concizumab-mtci during pregnancy. Like other monoclonal antibodies, concizumab-mtci may cross the placenta. Use during pregnancy should be limited to situations where the potential benefit outweighs the risk.
It is unknown whether concizumab-mtci is present in human or animal milk, or if the drug has any effects on milk production or the breastfed infant. Human immune globulins pass into breast milk primarily in the first few days after birth; thus, a risk to the infant during this period cannot be excluded. After this time, concizumab-mtci may be used during breastfeeding if clinically necessary.
The manufacturer makes no specific dosage recommendations for geriatric patients.
Clinical studies of concizumab-mtci included too few patients >=65 years of age to assess differences in response compared to younger adults.
ICD codes
| Code | Type | Description |
|---|---|---|
| Bleeding prevention in hereditary factor IX deficiency | ||
| D67 | ICD10CM | Hereditary factor IX deficiency |
| Bleeding prevention in hereditary factor VIII deficiency | ||
| D66 | ICD10CM | Hereditary factor VIII deficiency |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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