hympavzi
Pharmaranks rates Hympavzi 3.2/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Hympavzi (Marstacimab-Hncq) is a medication used to treat Hemophilia B, Hemophilia A.
Marstacimab-Hncq · by Pfizer
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Marstacimab-Hncq
- Form
- Injectable
- Strength
- MARSTACIMAB-HNCQ 300MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- hemophilia b, hemophilia a
- Manufacturer
- Pfizer
- FDA application
- BLA761369
What is Hympavzi?
From the FDA label: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.
How to use
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…
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…
Warnings
Important safety information
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).
Who should not take Hympavzi
None. None. ( 4 )
Overdose — what happens if you take too much
Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for overdose management recommendations.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
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.
Storing Hympavzi, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Once stored at room temperature, do not return to the refrigerator and discard after 7 days.”
- “After removal of HYMPAVZI from the refrigerator, use within 7 days or discard [see How Supplied/Storage and Handling (16) ] .”
- “• 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.”
- “• 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.”
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Use copay cards
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Compare alternatives
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Frequently asked questions
- What does Hympavzi treat?
- Hympavzi (Marstacimab-Hncq) may be used to treat hemophilia b, hemophilia a, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Hympavzi rated?
- pharmaranks gives Hympavzi a composite score of 3.2 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Hympavzi?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Hympavzi. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Hympavzi?
- Hympavzi is marketed by Pfizer. You can see Pfizer's full profile, rating, and other products on pharmaranks.
- Is Hympavzi a brand-name or generic drug?
- Hympavzi is a brand-name product with the active ingredient Marstacimab-Hncq.
- Is Hympavzi available over the counter?
- No. Hympavzi is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Hympavzi come in?
- Hympavzi is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Hympavzi FDA-registered?
- Hympavzi is on record with the U.S. FDA under application number BLA761369. You can verify this on its official FDA label.
- Has Hympavzi been recalled by the FDA?
- Hympavzi has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Hympavzi safe?
- There's no single safe-or-not verdict. pharmaranks gives Hympavzi a recall-safety score of 64/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Hympavzi?
- Hympavzi's side effects are taken directly from its FDA label. From the label: 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 re… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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hympavzi
64/100