Hympavzi Pen (marstacimab-hncq)
Antihemophilic Products Subcutaneous Pen Injector (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Marstacimab-hncq, a humanized monoclonal immunoglobulin G Type 1 (IgG1), is a tissue factor pathway inhibitor (TFPI) antagonist.
Marstacimab-hncq is a human monoclonal IgG1 antibody that binds to the Kunitz domain 2 (K2) of tissue factor pathway inhibitor (TFPI), blocking its function and promoting coagulation. TFPI regulates the extrinsic coagulation pathway by inhibiting thrombin generation through its interaction with factor Xa and the factor Xa/factor VIIa/tissue factor complex. Marstacimab-hncq neutralizes TFPI activity at the K2 domain, thereby reducing factor Xa inhibition, leading to increased thrombin formation and enhanced hemostasis.
Marstacimab exhibits dose-dependent pharmacokinetics characterized by both linear and non-linear pathways due to target-mediated drug disposition (TMDD). TMDD occurs when the pharmacokinetics of the drug are significantly influenced by the drug's interaction with a specific target, such as TFPI in this case. At lower doses, marstacimab-hncq binds to TFPI to form a drug-target complex, which accelerates clearance.
As doses increase and TFPI binding sites become saturated, clearance slows and elimination shifts to non-target pathways such as catabolism, leading to linear pharmacokinetics.
After subcutaneous administration, marstacimab achieves steady-state concentrations after 8-9 weekly doses, at (approximately day 60) and has a half-life of 7-10 days. The bioavailability of the drug following subcutaneous administration is approximately 71%. Marstacimab is eliminated through catabolism, with 90% of the drug expected to be cleared within a month after the last dose.
Pharmacokinetics are influenced by body weight but do not require dose adjustment. Clearance of marstacimab is 29% lower in adolescents 12-18 years of age compared to adults. No significant differences in pharmacokinetics were observed based on race, hemophilia type, or mild renal or hepatic impairment, though data on severe impairment and geriatric patients are limited.
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. Marstacimab 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: marstacimab-hncq
Pronunciation: (mar-STAK-i-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 Hympavzi Pen
Indications
The following indications are listed for Hympavzi Pen:
- Hemophilia A
- Hemophilia B
Also known as: Christmas Disease, Congenital Factor Viii Deficiency Disease, Factor Ix Deficiency, Factor Ix Dysfunction, Plasma Thromboplastin Component Deficiency, Ptc Deficiency.
Dosing
No dosing information is available for this tab.
Administer marstacimab-hncq by subcutaneous injection only. Marstacimab-hncq is available as a 150 mg/mL single-dose prefilled syringe or a 150 mg/mL single-dose prefilled pen with needle guard.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Hympavzi 150 Mg/Ml Pen | Maintenance | Inject 150 mg by subcutaneous route once weekly. |
No dosing information is available for this tab.
Drug interactions
Marstacimab-hncq therapy does not cause clinically significant changes in activated partial thromboplastin time (aPTT) or prothrombin time (PT).
Effects on the pharmacokinetics of other drugs have not been established.
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
*None.
There are no contraindication contraindications for this drug.
- Infection
- Invasive surgical procedure
- Major traumatic injury
- Pregnancy
- Thromboembolic disorder
There are no moderate contraindications for this drug.
Adverse reactions
Adverse reactions reported in >=3% of marstacimab-hncq-treated patients were injection site reaction, headache, and pruritus.
Rare or Very Rare
- Acute arterial thromboembolism
More Frequent
- Fever
- Headache disorder
- Injection site sequelae
- Pruritus of skin
Less Frequent
- Arthralgia
- Diarrhea
- Hypersensitivity drug reaction
- Urticaria
Rare or Very Rare
- Skin rash
Precautions
No enhanced messaging available.
The safety and efficacy of marstacimab-hncq to prevent or reduce bleeding episodes in hemophilia A or B without inhibitors are established for patients >=12 years of age, supported by a phase 3 study in 19 adolescents and 97 adults. Safety and efficacy in patients <=12 years of age have not been established.
Marstacimab-hncq may cause fetal harm based on its mechanism of action. No data are available on the use of marstacimab-hncq in pregnant women to assess risks of birth defects, miscarriage, or other adverse maternal or fetal outcomes. While animal reproduction studies have not been conducted, monoclonal antibodies like marstacimab can cross the placenta and may pose risks to the fetus.
No data exist on the presence of marstacimab-hncq in human or animal milk, its effects on the breastfed child, or milk production. Maternal IgG and monoclonal antibodies are present in human milk, but the impact of marstacimab on GI or systemic exposure in infants is unknown. Weigh the benefits of breastfeeding against the mother's need for marstacimab-hncq and potential risks to the infant.
The manufacturer makes no specific dosage recommendations for geriatric patients.
Only one patient >=65 years of age was included in clinical studies of marstacimab-hncq for hemophilia A or B without inhibitors. The studies did not include enough older patients to determine if their response differs from younger patients.
ICD codes
| Code | Type | Description |
|---|---|---|
| Hemophilia A | ||
| D66 | ICD10CM | Hereditary factor VIII deficiency |
| Z14.02 | ICD10CM | Symptomatic hemophilia A carrier |
| Hemophilia B | ||
| D67 | ICD10CM | Hereditary factor IX 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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