Marstacimab-hncq
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
- hemophilia B (congenital factor IX deficiency) without factor IX inhibitors.. Common adverse reactions include injection site reaction, headache andpruritus..
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
There is limited information regarding Marstacimab-hncq Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Marstacimab-hncq Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Marstacimab-hncq Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Marstacimab-hncq in women who are pregnant.
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
There is no FDA guidance on the use of Marstacimab-hncq in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Marstacimab-hncq in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Marstacimab-hncq in geriatric settings.
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
There is no FDA guidance on the use of Marstacimab-hncq in women of reproductive potentials and males.
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.