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Drug overview for ALHEMO PEN (concizumab-mtci):
Generic name: CONCIZUMAB-MTCI (kon-SIZ-ue-mab)
Drug class: Antihemophilic Products
Therapeutic class: Hematological Agents
Concizumab-mtci is a tissue factor pathway inhibitor (TFPI) antagonist.
No enhanced Uses information available for this drug.
Generic name: CONCIZUMAB-MTCI (kon-SIZ-ue-mab)
Drug class: Antihemophilic Products
Therapeutic class: Hematological Agents
Concizumab-mtci is a tissue factor pathway inhibitor (TFPI) antagonist.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for ALHEMO PEN (concizumab-mtci) have been approved by the FDA:
Indications:
Bleeding prevention in hereditary factor IX deficiency
Bleeding prevention in hereditary factor VIII deficiency
Professional Synonyms:
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
Indications:
Bleeding prevention in hereditary factor IX deficiency
Bleeding prevention in hereditary factor VIII deficiency
Professional Synonyms:
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
The following dosing information is available for ALHEMO PEN (concizumab-mtci):
No enhanced Dosing information available for this drug.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ALHEMO 150 MG/1.5 ML PEN | Maintenance | Adults inject 0.2 mg/kg by subcutaneous route once daily |
| ALHEMO 300 MG/3 ML PEN | Maintenance | Adults inject 0.2 mg/kg by subcutaneous route once daily |
| ALHEMO 60 MG/1.5 ML PEN | Maintenance | Adults inject 0.2 mg/kg by subcutaneous route once daily |
No generic dosing information available.
The following drug interaction information is available for ALHEMO PEN (concizumab-mtci):
There are 0 contraindications.
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| 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) |
VYVGART, VYVGART HYTRULO |
| 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) |
IMAAVY |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| 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) |
RYSTIGGO |
The following contraindication information is available for ALHEMO PEN (concizumab-mtci):
Drug contraindication overview.
Concizumab-mtci is contraindicated in patients with a history of known serious hypersensitivity to concizumab-mtci or its components or the inactive ingredients.
Concizumab-mtci is contraindicated in patients with a history of known serious hypersensitivity to concizumab-mtci or its components or the inactive ingredients.
There are 0 contraindications.
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Pregnancy |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Thromboembolic disorder |
The following adverse reaction information is available for ALHEMO PEN (concizumab-mtci):
Adverse reaction overview.
The most frequently reported adverse reactions (incidence >=5%) were injection site reactions and urticaria.
The most frequently reported adverse reactions (incidence >=5%) were injection site reactions and urticaria.
There are 3 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Hypersensitivity drug reaction Renal infarction Thromboembolic disorder |
| Rare/Very Rare |
|---|
| None. |
There are 2 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Injection site sequelae Urticaria |
None. |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for ALHEMO PEN (concizumab-mtci):
The safety and effectiveness of concizumab-mtci for hemophilia A and B with inhibitors have been established in pediatric patients 12 years of age and older. Use of concizumab-mtci for this indication is supported by evidence from adequate and well-controlled studies in adult and pediatric patients 12 years of age and older. The safety and effectiveness of concizumab-mtci for hemophilia A and B with inhibitors have not been established in pediatric patients younger than 12 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Based on its mechanism of action, concizumab may cause fetal harm when administered to a pregnant woman. There are no available data on concizumab-mtci use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with concizumab-mtci.
Although there are no data on concizumab-mtci, monoclonal antibodies can be actively transported across the placenta, and concizumab may cause fetal harm. It is unknown whether concizumab can affect reproductive capacity. Concizumab-mtci should only be used during pregnancy if the potential benefit for the mother outweighs the potential risk to the fetus.
The estimated background risk of birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Although there are no data on concizumab-mtci, monoclonal antibodies can be actively transported across the placenta, and concizumab may cause fetal harm. It is unknown whether concizumab can affect reproductive capacity. Concizumab-mtci should only be used during pregnancy if the potential benefit for the mother outweighs the potential risk to the fetus.
The estimated background risk of birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
There is no information regarding the presence of concizumab in either human or animal milk, the effect on the breastfed child, or the effects on milk production. Human IgGs are known to be excreted in breast milk during the first few days after birth, decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. Afterwards, concizumab could be used during breast-feeding if clinically needed.
Clinical studies of concizumab-mtci did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
The following prioritized warning is available for ALHEMO PEN (concizumab-mtci):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ALHEMO PEN (concizumab-mtci)'s list of indications:
| Bleeding prevention in hereditary factor IX deficiency | |
| D67 | Hereditary factor IX deficiency |
| Bleeding prevention in hereditary factor VIII deficiency | |
| D66 | Hereditary factor VIII deficiency |
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