Hympavzi
marstacimab-hncq · Injection, Solution · Subcutaneous
Uses
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
• 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 ) 2.1 Recommended 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). 2.2 Recommended 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 subcutaneous injection (one 150 mg subcutaneous injection or two 75 mg subcutaneous injections) weekly when control of bleeding events is judged to be inadequate by the healthcare provider. Safety and efficacy of HYMPAVZI at doses above 150 mg weekly have not been established in children 6 to less than 12 years of age. 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 75 mg: If a dose is missed, administer as soon as possible before the day of the next scheduled dose, and then resume usual 75 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 150 mg by subcutaneous injection followed by a resumption of 75 mg by subcutaneous injection once weekly thereafter. For patients on a maintenance dose of 150 mg: If one or more doses are missed, administer a dose as soon as possible, and then resume 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). 2.3 Preparation and Administration
• HYMPAVZI is intended for use under the guidance of a healthcare provider. After proper instruction in subcutaneous injection technique, a patient 12 years and older may self-inject or the patient’s caregiver may administer HYMPAVZI, if a healthcare provider determines that it is appropriate.
• Refer to the Instructions for Use for complete preparation and administration instructions.
• Prior to subcutaneous administration, HYMPAVZI may be removed from the refrigerator and allowed to warm at room temperature [up to 86°F (30°C)] in the carton for 15 to 30 minutes protected from direct sunlight. Do not warm by using a heat source such as hot water or a microwave.
Dosage forms and strengths
(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
None. None. ( 4 )
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 ) 5.1 Thromboembolic 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) ] . 5.2 Hypersensitivity 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. 5.3 Embryofetal 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 1.2 Consistent 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).
Side effects
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 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
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
8.1 Pregnancy 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. 8.2 Lactation 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. 8.3 Females 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. 8.4 Pediatric 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. 8.5 Geriatric 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
8.1 Pregnancy 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
8.4 Pediatric 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
8.5 Geriatric 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
Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for overdose management recommendations.
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.
Mechanism of action
12.1 Mechanism 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
16.1 How 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. 16.2 Recommended 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. 16.1 How 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
16.2 Recommended 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.
Patient 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. New York, NY 10001 LAB-1556-4.0 Pfizer logo
Label text from the FDA structured product label by Pfizer Laboratories Div Pfizer Inc (revised Jun 22, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Marstacimab in 3 products
Hympavzi NDC products (3)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0069-0775 | Marstacimab 75 mg/.5mL Injection, Solution | Pfizer Laboratories Div Pfizer Inc | BLA |
| 0069-1510 | Marstacimab 150 mg/mL Injection, Solution | Pfizer Laboratories Div Pfizer Inc | BLA |
| 0069-2151 | Marstacimab 150 mg/mL Injection, Solution | Pfizer Laboratories Div Pfizer Inc | BLA |
Frequently asked questions
What is Hympavzi used for?
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…
What are the side effects of Hympavzi?
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… See the full label for the complete list.
Who makes Hympavzi?
Hympavzi is listed by 1 labeler in the FDA NDC directory, including Pfizer Laboratories Div Pfizer Inc.