Marstacimab-Hncq Application Scope

HYMPAVZI is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients aged 12 years and older with:

Hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors
Hemophilia B (congenital factor IX deficiency) without factor IX inhibitors

It is the first once-weekly subcutaneous prophylactic treatment for eligible individuals with hemophilia B and the first to be administered via a pre-filled pen or syringe for eligible individuals with hemophilia A or B in the U.S.

Marstacimab-Hncq Characteristics

Ingredients: Each 1 mL contains 150 mg of marstacimab-hncq and inactive ingredients including edetate disodium, histidine, L-histidine monohydrochloride, polysorbate 80, sucrose, in Water for Injection, USP.
Properties: Marstacimab-hncq is a human monoclonal IgG1 antibody that binds to the Kunitz domain 2 (K2) of tissue factor pathway inhibitor (TFPI), neutralizing its activity and enhancing coagulation.
Packaging Specification: Available as a sterile, preservative-free solution in a single-dose prefilled syringe or pen for subcutaneous administration.
Storage: Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light.
Expiry Date: Refer to the expiration date printed on the syringe or pen label. Do not use if the expiration date has passed.
Executive Standard: Approved by the U.S. Food and Drug Administration (FDA)
Approval Number: Biologics License Application (BLA) 761369
Date of Revision: October 11, 2024
Manufacturer: Pfizer Inc.

Guidelines for the Use of Marstacimab-Hncq

Dosage and Administration:
For patients aged 12 years and older:

Loading Dose: 300 mg subcutaneously (two 150 mg injections)
Maintenance Dose: 150 mg subcutaneously once weekly, starting one week after the loading dose, on the same day each week at any time of day.

Adverse Reactions:
Common adverse reactions (≥3%) include:

Injection site reactions (pain, itching, swelling, bruising, hardening, or redness)
Headache
Pruritus (itching)

Serious adverse reactions are rare but may include hypersensitivity reactions such as urticaria and pruritus.

Contraindications:
Known hypersensitivity to marstacimab-hncq or any of its components.

Precautions:

Monitor for signs of hypersensitivity reactions; discontinue use if severe reactions occur.
Not recommended for use in patients with inhibitors to factor VIII or IX.
The safety and efficacy in patients under 12 years of age have not been established.

Marstacimab-Hncq Interactions

Drug Interactions:
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.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.