Home - Rare Diseases - Hympavzi® | Marstacimab | Hemophilia A and B | DengYueRX
Description
Indication & Scope
Hympavzi® (Marstacimab) is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older weighing at least 35 kg with hemophilia A (without factor VIII inhibitors) or hemophilia B (without factor IX inhibitors).
- Mechanism: Marstacimab is a human IgG1 monoclonal antibody that binds to the Kunitz-2 domain of tissue factor pathway inhibitor (TFPI), enhancing thrombin generation and restoring hemostatic balance independently of factor VIII or factor IX.
- Drug Class: Tissue factor pathway inhibitor (TFPI) inhibitor.
- Clinical Use: Routine prophylaxis for patients with hemophilia A or B without inhibitors.
| Generic Name | Marstacimab Injection |
| Brand Name | Hympavzi® |
| Ingredient | Marstacimab |
| Dosage Form | Injection |
| Package | 150 mg/1 mL prefilled syringe, 1 syringe/box |
| Conditions Treated | Hemophilia A and Hemophilia B |
| Taboos | Hypersensitivity to Marstacimab or any excipient, including polysorbate 80. |
| Place of origin | United States |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Store refrigerated at 2–8°C. Protect from light. Do not freeze or shake. |
| Manufacturer | Pfizer Inc. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | SJ20250026 |
| Date of Revision | 2025 |
| Shelf Life | Refer to the approved package labeling. |
How to use ?
Recommended Dose: An initial loading dose of 300 mg (two 150 mg injections) is administered subcutaneously on Day 1, followed by a maintenance dose of 150 mg once weekly. For patients weighing 50 kg or more who continue to experience breakthrough bleeding, the maintenance dose may be increased to 300 mg once weekly according to the approved prescribing information.
Time: Administer by subcutaneous injection once weekly on the same day each week. Treatment should be initiated when the patient is not experiencing an active bleeding episode.
Instructions for use: Inject subcutaneously into the abdomen, thigh, or upper arm using the prefilled syringe. Injection sites should be rotated. After appropriate training, patients or caregivers may administer the injections. No dose adjustment is required in patients with mild or moderate hepatic or renal impairment; caution is advised in severe impairment.
Interaction: Marstacimab is not metabolized through the CYP450 enzyme system and has a low potential for drug-drug interactions. Caution is recommended when coagulation factor concentrates are administered concurrently, as thrombotic risk may increase.
Side effects: Common adverse reactions include injection-site reactions, headache, fatigue, upper respiratory tract infection, and arthralgia. Transient elevations in liver enzymes and D-dimer levels have also been reported. The most important safety concern is thromboembolic events, particularly in patients receiving higher maintenance doses.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What is Hympavzi® (Marstacimab)?
Hympavzi® is a monoclonal antibody that targets TFPI and is used for routine prophylaxis in hemophilia A and B patients without inhibitors.
What is Hympavzi® used for?
It is used to reduce the frequency of bleeding episodes in patients aged 12 years and older with hemophilia A or B who do not have factor inhibitors.
How does Marstacimab work?
Marstacimab inhibits TFPI, increasing thrombin generation and restoring coagulation independently of factor VIII or factor IX.
How should Hympavzi® be administered?
It is administered by subcutaneous injection once weekly following an initial loading dose.
Hympavzi® | Marstacimab | Hemophilia A and B | DengYueRX
INN: Marstacimab
Indications: Hemophilia A and Hemophilia B
Dosage Form: Injection
Strength: 150 mg(1 mL)/Syringe