HYMPAVZI marstacimab-hncq 150 mg/mL Injection, Solution, 1 syringe
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Other systemic hemostatics class.
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🏭 Manufacturer & labeler
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🩺 Clinical
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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0.05 mg / 1 mL
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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1.12 mg / 1 mL
UNII 4QD397987E
An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
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2.67 mg / 1 mL
UNII X573657P6P
Histidine monohydrochloride monohydrate is an amino acid salt used as a buffer in medicines. It helps maintain the proper acidity level of liquid formulations to keep the drug stable and effective.
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0.2 mg / 1 mL
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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85 mg / 1 mL
UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hympavzi 150 mg/mLthis 00069-1510-01 | Pfizer | 1 syringe | — | — | FDA listed | — |
| Hympavzi 150 mg/mL 00069-2151-01 | Pfizer | 1 syringe | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Oct 11, 2036 |
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🔬 Reported adverse events (FAERS)
Top reported reactions
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00069-1510-01 You're viewing this | 1 SYRINGE in 1 CARTON (0069-1510-01) / 1 mL in 1 SYRINGE | 2025-10-15 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and 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 and 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 treatment of breakthrough bleeds in patients receiving HYMPAVZI. Do not use additional doses of HYMPAVZI to treat breakthrough bleeds.
( 2.5 ) • Temporarily pause HYMPAVZI at least 7 days before major surgery. ( 2.6 )
2.1Recommended Dosage in Adults and Pediatric Patients 12 Years of Age and Older For subcutaneous use only. The recommended dosage of HYMPAVZI for adults and pediatric patients 12 years of age and older is as follows: Loading Dose 300 mg (two 150 mg subcutaneous injections) If more than one injection is required to deliver a complete dose, administer each injection at a different injection site. 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 During Treatment In patients weighing greater than or equal to 50 kg, consider a dose adjustment to 300 mg subcutaneous injection weekly when control of bleeding events is judged to be inadequate by the healthcare provider. Safety and efficacy of HYMPAVZI at doses above 300 mg weekly have not been established. If more than one injection is required to deliver a complete dose, administer each injection at a different injection site.
Missed Doses For patients on a maintenance dose of 150 mg: If a dose is missed, administer as soon as possible before the day of the next scheduled dose, and then resume usual 150 mg subcutaneous weekly dosing schedule (same schedule as prior to the missed dose or new schedule based on date of administration of missed dose). If more than 13 days have passed since the last dose was administered, administer a loading dose of 300 mg by subcutaneous injection followed by a resumption of 150 mg by subcutaneous injection once weekly thereafter.
For patients on a maintenance dose of 300 mg: If one or more doses are missed, administer a dose as soon as possible, and then resume 300 mg subcutaneous weekly dosing schedule (same schedule as prior to the missed dose or new schedule based on date of administration of missed dose).
2.2Recommended Dosage in Pediatric Patients 6 to less than 12 Years of Age For subcutaneous use only. The recommended dosage of HYMPAVZI for pediatric patients 6 to less than 12 years of age is as follows: Loading Dose 150 mg (one 150 mg subcutaneous injection or two 75 mg subcutaneous injections) If more than one injection is required to deliver a complete dose, administer each injection at a different injection site. 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.
Dose Adjustment During Treatment In patients weighing greater than or equal to 25 kg, consider a dose adjustment to 150 mg subcutaneo…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS HYMPAVZI (marstacimab‑hncq) is a clear and colorless to light yellow solution available as: Prefilled Syringe • Injection: 150 mg/mL in a single-dose prefilled syringe • Injection: 75 mg/0.5 mL in a single-dose prefilled syringe Prefilled Pen • Injection: 150 mg/mL in a single-dose prefilled pen • Injection: 75 mg/0.5 mL in a single-dose prefilled pen • Injection: 150 mg/mL and 75 mg/0.5 mL in a single-dose prefilled syringe ( 3 ) • Injection: 150 mg/mL and 75 mg/0.5 mL in a single-dose prefilled pen ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Thromboembolic Events: Thromboembolic events may occur. Interrupt HYMPAVZI prophylaxis if symptoms occur. ( 5.1 ) • Hypersensitivity: Hypersensitivity reactions may occur.
In the event of a severe allergic reaction, discontinue HYMPAVZI. ( 5.2 ) • Embryofetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.
( 5.3 , 8.1 , 8.3 ) • Increased Laboratory Values of Fibrin D-dimer and Prothrombin Fragment 1.2: HYMPAVZI can cause sporadic or transient increases in fibrin D-dimer and prothrombin fragment 1.2 above physiological values. ( 5.4 )
5.1Thromboembolic Events HYMPAVZI is a tissue factor pathway inhibitor (TFPI) antagonist, and may increase the risk of thromboembolic complications. Venous and arterial thromboembolic events were reported in 0.8% of patients (2/259) treated with HYMPAVZI in the open-label extension study [see Adverse Reactions (6.1) ] . Patients with independent risk factors for thromboembolic events may be at increased risk of thromboembolic events with use of HYMPAVZI.
HYMPAVZI has not been studied in patients with a history of previous thromboembolic events [see Clinical Studies (14.1) ] . Consider the benefit and risk of using HYMPAVZI in patients with known risk factors for thromboembolism. Interrupt HYMPAVZI prophylaxis if diagnostic findings consistent with thromboembolism occur and manage as clinically indicated.
If factor VIII or factor IX products or bypassing agents are indicated in a patient receiving HYMPAVZI prophylaxis, the minimum effective dose according to the product label is recommended [see Dosage and Administration (2.5) ] .
5.2Hypersensitivity HYMPAVZI may cause hypersensitivity reactions (including but not limited to urticaria and pruritus). If HYMPAVZI-treated patients develop a severe hypersensitivity reaction, advise patients to discontinue HYMPAVZI and seek immediate emergency treatment.
5.3Embryofetal Toxicity Based on its mechanism of action, HYMPAVZI may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with HYMPAVZI and for 2 months after the last dose [see Use in Specific Populations (8.1 , 8.3) ] .
5.4 Increased Laboratory Values of Fibrin D-dimer and Prothrombin Fragment
1.2Consistent with its mechanism of action and hemostatic effect, HYMPAVZI causes an increase in fibrin D‑dimer and prothrombin fragment 1.2 [see Clinical Pharmacology (12.1 , 12.2) ] . Sporadic or transient increases in levels of these biomarkers above physiological values were reported with no associated safety concerns [see Clinical Pharmacology (12.2) ] . Increased levels of fibrin D-dimer were seen in 10 (8.1%) pediatric patients age 6 to less than 18 years and 6 (4.4%) adults.
Increased levels of prothrombin fragment 1.2 were seen in 13 (10.5%) pediatric patients age 6 to less than 18 years and 6 (4.4%) adults. For patients taking HYMPAVZI, these coagulation biomarkers may not be reliable predictive markers for clinical decision-making with suspicion of thrombosis such as deep vein thrombosis (DVT) and pulmonary embolism (PE).
🤒 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.
6.1Clinical 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 starting at Day 8 administered subcutaneously [see Clinical Studies (14.1 , 14.2 , 14.3 )] . One-hundred-thirty-five (52%) were adults (18 years of age and older), 56 (22%) were adolescents (12 to less than 18 years of age), and 68 (26%) were children (6 to less than 12 years of age). Among patients receiving HYMPAVZI, 90% were exposed for 6 months or longer and 82% were exposed for at least 1 year.
The median duration of exposure across the studies was 364 days (min, max: 14, 406 days). Table 1 summarizes the adverse reactions reported in ≥2% of patients in all age groups who received HYMPAVZI prophylaxis. Table 1.
Adverse Reactions Reported in ≥2% of Patients Treated with HYMPAVZI During BASIS and BASIS KIDS studies 12-month active treatment phase By Age Group Adverse Reaction Number of Patients 6 to less than 18 Years n (%) (N = 124) Number of Patients 18 Years and Older n (%) (N = 135) Number of Patients (All Age Groups) n (%) (N = 259) Injection site reaction Injection site reaction is a grouped term which includes the following terms: injection site pruritus, injection site swelling, injection site erythema, injection site bruising, injection site induration, injection site pain, injection site edema, injection site hematoma, injection site hemorrhage, injection site warmth, and injection site urticaria.
19 (15) 11 (8) 30 (12) Headache Headache is a grouped term which includes migraine. 9 (7) 10 (7) 19 (7) Pyrexia 12 (10) 3 (2) 15 (6) Arthralgia 4 (3) 5 (4) 9 (3) Diarrhea 5 (4) 2 (2) 7 (3) Pruritus 1 (1) 5 (4) 6 (2) Rash 2 (2) 3 (2) 5 (2)
🔄 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Based on its mechanism of action, HYMPAVZI may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . 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.
8.2Lactation 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.
8.3Females and Males of Reproductive Potential HYMPAVZI may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1 )] . 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.
8.4Pediatric Use The safety and effectiveness of HYMPAVZI to prevent or reduce the frequency of bleeding episodes in hemophilia A or B with and without inhibitors have been established in pediatric patients 6 years of age and older [see Clinical Studies (14.1 , 14.2 , 14.3 )] . Use of HYMPAVZI in pediatric patients for this indication is supported by evidence from two open‑label, multi‑center studies (BASIS and BASIS KIDS). These two studies treated 56 adolescents (12 to less than 18 years of age).
BASIS KIDS treated 68 children (6 to less than 12 years of age). Efficacy and adverse reaction profile were comparable between pediatric patients and adults [see Adverse Reactions (6.1) and Clinical Studies (14.1 , 14.2 , 14.3) ] . Differences observed in steady‑state pharmacokinetic (PK) exposures between pediatric patients and adults were mostly accounted for by body weight [see Clinical Pharmacology (12.3) ] .
The safety and effectiveness of HYMPAVZI have not been established in pediatric patients younger than 6 years of age.
8.5Geriatric Use Two patients 65 years of age and older were enrolled in the clinical studies for hemophilia A or B with or without inhibitors [see Clinical Studies (14.1 , 14.2) ] . Clinical studies of HYMPAVZI did not include sufficient numbers of subjects 65 years of age and over to determine whether they respond differently from younger subjects.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on its mechanism of action, HYMPAVZI may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . 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.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of HYMPAVZI to prevent or reduce the frequency of bleeding episodes in hemophilia A or B with and without inhibitors have been established in pediatric patients 6 years of age and older [see Clinical Studies (14.1 , 14.2 , 14.3 )] . Use of HYMPAVZI in pediatric patients for this indication is supported by evidence from two open‑label, multi‑center studies (BASIS and BASIS KIDS). These two studies treated 56 adolescents (12 to less than 18 years of age).
BASIS KIDS treated 68 children (6 to less than 12 years of age). Efficacy and adverse reaction profile were comparable between pediatric patients and adults [see Adverse Reactions (6.1) and Clinical Studies (14.1 , 14.2 , 14.3) ] . Differences observed in steady‑state pharmacokinetic (PK) exposures between pediatric patients and adults were mostly accounted for by body weight [see Clinical Pharmacology (12.3) ] .
The safety and effectiveness of HYMPAVZI have not been established in pediatric patients younger than 6 years of age.
🧓 Geriatric Use ▾
8.5Geriatric Use Two patients 65 years of age and older were enrolled in the clinical studies for hemophilia A or B with or without inhibitors [see Clinical Studies (14.1 , 14.2) ] . Clinical studies of HYMPAVZI did not include sufficient numbers of subjects 65 years of age and over to determine whether they respond differently from younger subjects.
🆘 Overdosage ▾
10 OVERDOSAGE Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for overdose management recommendations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Marstacimab‑hncq is a human monoclonal IgG1 antibody directed against the Kunitz domain 2 (K2) of TFPI to neutralize TFPI activity and enhance coagulation. TFPI is the primary inhibitor of the extrinsic coagulation cascade and negatively regulates thrombin generation within the extrinsic pathway of coagulation by inactivating the protease functions of FXa/FVIIa/TF complex. TFPI binds to and inhibits the factor Xa active site via its second Kunitz inhibitor domain (K2).
12.2Pharmacodynamics For adults, adolescents and pediatric patients 6 to less than 12 years of age, marstacimab-hncq causes an increase in total TFPI (comprised of free TFPI and TFPI bound to marstacimab) and downstream biomarkers of thrombin generation such as prothrombin fragment 1+2, peak thrombin, and D‑dimer in patients with hemophilia with and without inhibitors. These changes were observed and persisted over a 7-day period following a single subcutaneous dose and were reversible after treatment discontinuation.
Sporadic or transient increases in D-dimer and prothrombin fragment 1+2 above physiological values were reported in the study with no associated safety concerns. There were no clinically relevant differences in pharmacodynamic effects between hemophilia participants with and without inhibitors or between age groups, following weekly subcutaneous administration of marstacimab‑hncq. Drug Interaction In Vitro Studies In vitro studies in plasma from patients with hemophilia A and B with inhibitors demonstrated that marstacimab‑hncq in combination with rFVIIa resulted in no additive effect on thrombin generation compared to marstacimab‑hncq treatment alone.
Thrombin generation increased when marstacimab‑hncq was used in combination with aPCC compared to marstacimab‑hncq treatment alone without exceeding peak thrombin levels achieved in non-hemophilic plasma treated with marstacimab‑hncq alone and in some cases were within the range reported for non-hemophilic normal plasma.
12.3Pharmacokinetics Estimated mean marstacimab-hncq C min,ss , C max,ss , and C avg,ss for adults and adolescents weighing at least 25 kg following marstacimab-hncq 150 mg subcutaneous once‑weekly administration (with a loading dose of 300 mg subcutaneous), and for pediatric patients 6 to less than 12 years of age weighing at least 19 kg following marstacimab‑hncq 75 mg subcutaneous once‑weekly administration (with a loading dose of 150 mg subcutaneous) are shown in Table 2. In adults and adolescents, the marstacimab‑hncq area under the plasma concentration-time curve (AUC) and the maximum plasma concentration (C max ) increase in a greater than dose-proportional manner over the dose range of 100 mg to 450 mg (0.67 to 3 times the approved recommended dosage).
In adult and adolescent patients, the mean steady-state accumulation ratio for marstacimab‑hncq is approximately 4 to 5. Marstacimab‑hncq steady‑state concentrations are achieved by approximately 60 days (8 th or 9 th subcutaneous dose) when administered once weekly. Similar results were observed in pediatric patients 6 to less than 12 years of age.
Table 2. Steady-State Marstacimab-hncq Plasma Concentrations Following Once-Weekly Subcutaneous Administration • Data are presented as arithmetic mean (%CV). N = number of participants • C min,ss = minimum plasma concentration at steady state; C max,ss = maximum plasma concentration at steady state; C avg,ss = average plasma concentration at steady state • Adults: 18 years and older, Adolescents: 12 to less than 18 years Parameter Adults without Inhibitors (150 mg SC QW) Adults with Inhibitors (150 mg SC QW) Adolescents without Inhibitors (150 mg SC QW) Adolescents with Inhibitors (150 mg SC QW) Pediatric Patients 6 to less than 12 Years without Inhibitors (75 mg SC QW) Pediatric Patients 6 to less than 12 Years with Inhibitors (75 mg SC QW) N 99 34 29 21 18 11 C min,ss (mcg/mL) 13.2 (95.5%) 16.1 (77.9%) 30.1 (74.5%) 35.5 (69.0%) 1…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Marstacimab‑hncq is a human monoclonal IgG1 antibody directed against the Kunitz domain 2 (K2) of TFPI to neutralize TFPI activity and enhance coagulation. TFPI is the primary inhibitor of the extrinsic coagulation cascade and negatively regulates thrombin generation within the extrinsic pathway of coagulation by inactivating the protease functions of FXa/FVIIa/TF complex. TFPI binds to and inhibits the factor Xa active site via its second Kunitz inhibitor domain (K2).
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied HYMPAVZI (marstacimab-hncq) injection is a sterile, preservative-free, clear and colorless to light yellow solution for subcutaneous administration available as a single-dose prefilled syringe or pen in the following presentations: Presentation Package Size NDC Number Single-dose prefilled syringe: 75 mg/0.5 mL Carton of 1 NDC 0069-1575-01 150 mg/mL Carton of 1 NDC 0069-1510-01 Single-dose prefilled pen: 75 mg/0.5 mL Carton of 1 NDC 0069-0775-01 150 mg/mL Carton of 1 NDC 0069-2151-01 Prefilled Syringe Each carton contains a single-dose prefilled syringe (Type I glass) with a plunger stopper (chlorobutyl elastomer) and a stainless steel 27 gauge, ½ inch staked needle with a rigid needle shield (thermoplastic elastomer).
Prefilled Pen Each carton contains a single-dose prefilled pen with needle guard. The syringe inside the pen is made from Type I glass with a plunger stopper (chlorobutyl elastomer) and a stainless steel 27 gauge, ½ inch staked needle with a rigid needle shield (thermoplastic elastomer). HYMPAVZI is not made with natural rubber latex.
16.2Recommended Storage and Handling • Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. • If needed, HYMPAVZI may be stored one time at room temperature [up to 86°F (30°C)] in its original carton to protect from light for up to 7 days. Once stored at room temperature, do not return to the refrigerator and discard after 7 days. • Do not freeze. • Do not shake.
16.1How Supplied HYMPAVZI (marstacimab-hncq) injection is a sterile, preservative-free, clear and colorless to light yellow solution for subcutaneous administration available as a single-dose prefilled syringe or pen in the following presentations: Presentation Package Size NDC Number Single-dose prefilled syringe: 75 mg/0.5 mL Carton of 1 NDC 0069-1575-01 150 mg/mL Carton of 1 NDC 0069-1510-01 Single-dose prefilled pen: 75 mg/0.5 mL Carton of 1 NDC 0069-0775-01 150 mg/mL Carton of 1 NDC 0069-2151-01 Prefilled Syringe Each carton contains a single-dose prefilled syringe (Type I glass) with a plunger stopper (chlorobutyl elastomer) and a stainless steel 27 gauge, ½ inch staked needle with a rigid needle shield (thermoplastic elastomer).
Prefilled Pen Each carton contains a single-dose prefilled pen with needle guard. The syringe inside the pen is made from Type I glass with a plunger stopper (chlorobutyl elastomer) and a stainless steel 27 gauge, ½ inch staked needle with a rigid needle shield (thermoplastic elastomer). HYMPAVZI is not made with natural rubber latex.
📦 Storage and Handling ▾
16.2Recommended Storage and Handling • Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. • If needed, HYMPAVZI may be stored one time at room temperature [up to 86°F (30°C)] in its original carton to protect from light for up to 7 days. Once stored at room temperature, do not return to the refrigerator and discard after 7 days. • Do not freeze. • Do not shake.
📋 Description ▾
11 DESCRIPTION Marstacimab‑hncq is a tissue factor pathway inhibitor (TFPI) antagonist, human monoclonal immunoglobulin G Type 1 (IgG1) antibody. Marstacimab‑hncq is produced by Chinese hamster ovary (CHO) cells by recombinant DNA technology and has a molecular mass of approximately 146 kDa. HYMPAVZI (marstacimab‑hncq) injection is supplied as a sterile, preservative-free solution for subcutaneous administration.
The drug product is supplied as either a single-dose prefilled syringe or as a single‑dose prefilled pen. The solution of marstacimab‑hncq is clear and colorless to light yellow with a pH of 5.8. Each 150 mg/mL prefilled syringe or prefilled pen delivers 1 mL of HYMPAVZI.
Each 1 mL of HYMPAVZI contains 150 mg of marstacimab‑hncq, and the inactive ingredients edetate disodium (0.05 mg), histidine (1.12 mg), L-histidine monohydrochloride (2.67 mg), polysorbate 80 (0.2 mg), and sucrose (85 mg), in Water for Injection, USP. Each 75 mg/0.5 mL prefilled syringe or prefilled pen delivers 0.5 mL of HYMPAVZI. Each 0.5 mL of HYMPAVZI contains 75 mg of marstacimab‑hncq, and the inactive ingredients edetate disodium (0.03 mg), histidine (0.56 mg), L‑histidine monohydrochloride (1.34 mg), polysorbate 80 (0.1 mg), and sucrose (43 mg), in Water for Injection, USP.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION • Advise the patient and/or caregivers to read the FDA-approved patient labeling (Patient Information and Instructions for Use). • Ensure that patients and caregivers who will administer HYMPAVZI receive appropriate training and instruction on the proper storage, use and handling of HYMPAVZI from a healthcare professional. Thromboembolic Events Inform patients and/or caregivers that HYMPAVZI increases coagulation potential. Discuss the appropriate dosing of concomitant agents such as FVIII or FIX with the patient prior to starting on HYMPAVZI prophylaxis.
Advise the patient to discontinue HYMPAVZI and seek immediate medical attention if any signs or symptoms of thromboembolism occur [see Warnings and Precautions (5.1) ] . Hypersensitivity Inform patients and/or caregivers that hypersensitivity reactions such as rash and pruritus are possible. Advise patients to discontinue HYMPAVZI and seek immediate emergency treatment if a severe hypersensitivity reaction occurs [see Warnings and Precautions (5.2) ] .
Pregnancy Advise female patients of reproductive potential to use effective contraception during treatment with HYMPAVZI and for 2 months after the last dose. Advise patients to report known pregnancies [see Warnings and Precautions (5.3) , Use in Specific Populations (8.1 , 8.3) ]. This product’s labeling may have been updated.
For the most recent prescribing information, please visit www.pfizer.com . US License No. 2001 Distributed by Pfizer Labs Division of Pfizer Inc.
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