HYMPAVZI 150 mg/mL
marstacimab-hncq · INJECTION, SOLUTION · Pfizer Laboratories Div Pfizer Inc
HYMPAVZI is a injection, solution containing marstacimab-hncq at 150 mg/mL, taken subcutaneous. Manufactured by Pfizer Laboratories Div Pfizer Inc.
Key Facts
- Brand Name
- HYMPAVZI
- Generic Name
- marstacimab-hncq
- NDC Code (Product)
0069-2151- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Strength
- 150 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761369
- Marketing Start
- 11/05/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE HYMPAVZI is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with: • hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or • hemophilia B (congenital factor IX deficiency) with or without factor IX inhibitors. HYMPAVZI is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with: • hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or • hemophilia B (congenital factor IX deficiency) with or without factor IX inhibitors. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • See Full Prescribing Information for important dosing and administration instructions. ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 ) • Recommended Dosage in Adults and Pediatric Patients 12 Years of Age and Older: o Loading dose: 300 mg (two 150 mg injections) by subcutaneous injection. ( 2.1 ) o 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. ( 2.1 ) o Dose adjustment to 300 mg subcutaneous injection weekly can be considered. ( 2.1 ) • Recommended Dosage in Pediatric Patients 6 to less than 12 Years of Age: o Loading dose: 150 mg (one 150 mg injection or two 75 mg injections) by subcutaneous injection. ( 2.2 ) o Maintenance dose: One week after the loading dose, initiate maintenance dosing of 75 mg every week by subcutaneous injection on the same day each week, at any time of day. ( 2.2 ) o Dose adjustment to 150 mg subcutaneous injection (one 150 mg injection or two 75 mg injections) weekly can be considered. ( 2.2 ) • Factor VIII and factor IX products or bypassing agents (e.g., rFVIIa or aPCC) can be administered for the …
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 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.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Thromboembolic Events [see Warnings and Precautions (5.1) ] • Hypersensitivity [see Warnings and Precautions (5.2) ] Adverse reactions reported in ≥2% of HYMPAVZI-treated patients were injection site reaction, headache, pyrexia, arthralgia, diarrhea, pruritus, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 adults and pediatric patients 6 years of age and older with severe hemophilia A (FVIII <1%) or moderately severe to severe hemophilia B (FIX ≤2%) with and without inhibitors enrolled in the BASIS and BASIS KIDS studies. A total of 259 patients received the recommended HYMPAVZI prophylaxis loading dose followed by a weekly maintenance dose …
Frequently Asked Questions
What is HYMPAVZI used for?
HYMPAVZI contains marstacimab-hncq. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is HYMPAVZI a controlled substance?
HYMPAVZI is not classified as a controlled substance by the DEA.
What is the generic name for HYMPAVZI?
The generic name for HYMPAVZI is marstacimab-hncq. There are no other listed brand versions of marstacimab-hncq.
What is the NDC code for HYMPAVZI 150 mg/mL?
The NDC (National Drug Code) for HYMPAVZI 150 mg/mL is 0069-2151, listed by Pfizer Laboratories Div Pfizer Inc.
Other HYMPAVZI Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)