Marstacimab-hncq

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Marstacimab-hncq
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh, MBBS[2]

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Overview

Marstacimab-hncq is a tissue factor pathway inhibitor (TFPI) antagonist that is FDA approved for the prophylaxis of prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with:

  • hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, or

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

HYMPAVZI 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 (congenital factor VIII deficiency) without factor VIII inhibitors, or

hemophilia B (congenital factor IX deficiency) without factor IX inhibitors. 

====The recommended dosage of HYMPAVZI is:====
  • Loading dose: 300 mg (two 150 mg injections) by subcutaneous injection
  • Maintenance dose: One week after the loading dose, initiate maintenance dosing of 150 mg every week by subcutaneous injection on the same day each week, at any time of day.
  • Dose adjustment to 300 mg subcutaneous injection weekly can be considered.
  • Factor VIII and factor IX products can be administered for the treatment of breakthrough bleeds in patients receiving HYMPAVZI. Do not use additional doses of HYMPAVZI to treat breakthrough bleeds.
  • Temporarily discontinue HYMPAVZI before major surgery.
  • Injection: 150 mg/mL in a single-dose prefilled syringe.
  • Injection: 150 mg/mL in a single-dose prefilled pen.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Marstacimab-hncq in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Marstacimab-hncq in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Marstacimab-hncq FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Marstacimab-hncq in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Marstacimab-hncq in pediatric patients.

Contraindications

None.

Warnings

  • Thromboembolic Events: Thromboembolic events may occur. Interrupt HYMPAVZI prophylaxis if symptoms occur.
  • Hypersensitivity: Hypersensitivity reactions may occur. In the event of a severe allergic reaction, discontinue HYMPAVZI.
  • Embryofetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.

Adverse Reactions

Clinical Trials Experience

  • Thromboembolic Events.
  • Hypersensitivity.

Clinical Trials Experience

  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • The safety of HYMPAVZI was evaluated in adolescent and adult patients with severe hemophilia A or B without inhibitors (coagulation factor activity <1%) enrolled in the BASIS study.
  • Patients (N = 116) received HYMPAVZI prophylaxis 300 mg loading dose followed by 150 mg every week starting at Day 8 administered subcutaneously. Among patients receiving HYMPAVZI, 97% were exposed for 6 months or longer and 75% were exposed for at least 1 year.

A serious adverse reaction of peripheral swelling occurred in one patient. Table 1 summarizes the adverse reactions reported in ≥3% of patients who received HYMPAVZI prophylaxis.

Adverse Reactions Reported in ≥3% of Patients Treated with HYMPAVZI

During BASIS trial 12-month active treatment phase.

Postmarketing Experience

There is limited information regarding Marstacimab-hncq Postmarketing Experience in the drug label.

Drug Interactions

Partial Thromboplastin Time (aPTT) and Prothrombin Time (PT)

No clinically significant differences in standard measures of coagulation including activated partial thromboplastin time (aPTT) and prothrombin time (PT) were observed following marstacimab‑hncq therapy.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

Risk Summary

  • Based on its mechanism of action, HYMPAVZI may cause fetal harm when administered to a pregnant woman. There are no available data on HYMPAVZI use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Female animal reproduction studies have not been conducted with HYMPAVZI. Although there are no data on marstacimab‑hncq, monoclonal antibodies can be actively transported across the placenta, and marstacimab‑hncq may cause fetal harm.
  • The background risk of major birth defects and miscarriage for the indicated populations 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 defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.


Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Marstacimab-hncq in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Marstacimab-hncq during labor and delivery.

Nursing Mothers

Risk Summary

  • There are no data on the presence of marstacimab‑hncq in either human or animal milk, the effects on the breastfed child, or the effects on milk production.
  • Endogenous maternal IgG and monoclonal antibodies are known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to marstacimab‑hncq are unknown.
  • The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for HYMPAVZI and any potential adverse effects on the breastfed infant from HYMPAVZI or from the underlying maternal condition.

Pediatric Use

  • The safety and effectiveness of HYMPAVZI to prevent or reduce the frequency of bleeding episodes in hemophilia A or B without inhibitors have been established in pediatric patients aged 12 years and older. Use of HYMPAVZI for this indication is supported by evidence from an open‑label, multi‑center phase 3 study in 19 adolescents and 97 adults with hemophilia without inhibitors.
  • The safety and effectiveness of HYMPAVZI have not been established in pediatric patients younger than 12 years old.

Geriatic Use

  • One patient 65 years of age and older was enrolled in the clinical studies for hemophilia A or B without inhibitors. Clinical studies of HYMPAVZI did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.

Gender

There is no FDA guidance on the use of Marstacimab-hncq with respect to specific gender populations.

Race

There is no FDA guidance on the use of Marstacimab-hncq with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Marstacimab-hncq in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Marstacimab-hncq in patients with hepatic impairment.

Females of Reproductive Potential and Males

HYMPAVZI may cause fetal harm when administered to a pregnant woman.

Pregnancy Testing

  • Verify the pregnancy status of females of reproductive potential prior to initiating HYMPAVZI treatment.

Contraception

  • Females

Advise female patients of reproductive potential to use effective contraception during treatment with HYMPAVZI and for 2 months after the last dose.

Immunocompromised Patients

There is no FDA guidance one the use of Marstacimab-hncq in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Marstacimab-hncq Administration in the drug label.

Monitoring

There is limited information regarding Marstacimab-hncq Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Marstacimab-hncq and IV administrations.

Overdosage

There is limited information regarding Marstacimab-hncq overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Marstacimab-hncq Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Marstacimab-hncq Mechanism of Action in the drug label.

Structure

There is limited information regarding Marstacimab-hncq Structure in the drug label.

Pharmacodynamics

There is limited information regarding Marstacimab-hncq Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Marstacimab-hncq Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Marstacimab-hncq Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Marstacimab-hncq Clinical Studies in the drug label.

How Supplied

There is limited information regarding Marstacimab-hncq How Supplied in the drug label.

Storage

There is limited information regarding Marstacimab-hncq Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Marstacimab-hncq Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Marstacimab-hncq interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Marstacimab-hncq Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Marstacimab-hncq Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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