HYMPAVZI Medication Guide

(marstacimab-hncq)

Patient Package Insert

This Patient Information has been approved by the U.S. Food and Drug Administration.          Issued: 10/2024

PATIENT INFORMATION

HYMPAVZI (him-PAV-zee)

(marstacimab-hncq)

injection, for subcutaneous use

Important information: Before you start using HYMPAVZI, it is very important to talk to your healthcare provider about using factor VIII and factor IX products (products that help blood clot but work in a different way than HYMPAVZI). You may need to use factor VIII or factor IX medicines to treat episodes of breakthrough bleeding during treatment with HYMPAVZI. Carefully follow your healthcare provider’s instructions regarding when to use factor VIII or factor IX medicines and the prescribed dose during your treatment with HYMPAVZI.

What is HYMPAVZI?

HYMPAVZI is a prescription medicine used to prevent or reduce the frequency of bleeding episodes in adults and children 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors.

It is not known if HYMPAVZI is safe and effective in children younger than 12 years old.

Before using HYMPAVZI, tell your healthcare provider about all of your medical conditions, including if you:

•
have a planned surgery. Your healthcare provider may stop treatment with HYMPAVZI before your surgery. Talk to your healthcare provider about when to stop using HYMPAVZI and when to start it again if you have a planned surgery.
•
have a severe short-term (acute) illness such as an infection or injury.
•
are pregnant or plan to become pregnant. HYMPAVZI may harm your unborn baby.
 
Females who are able to become pregnant:
o
Your healthcare provider will do a pregnancy test before you start your treatment with HYMPAVZI.
o
You should use effective birth control (contraception) during treatment with HYMPAVZI and for 2 months after the last dose of HYMPAVZI.
o
Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with HYMPAVZI.
•
are breastfeeding or plan to breastfeed. It is not known if HYMPAVZI passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over‑the‑counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use HYMPAVZI?

See the detailed “Instructions for Use” that comes with your HYMPAVZI for information on how to inject a dose of HYMPAVZI, and how to properly throw away (dispose of) used HYMPAVZI prefilled syringe or HYMPAVZI prefilled pen.

•
Use HYMPAVZI exactly as prescribed by your healthcare provider.
•
Your healthcare provider will provide instructions for stopping (discontinuing) your current treatment when switching from factor- or non-factor-based medicines to HYMPAVZI.
•
HYMPAVZI is given as an injection under your skin (subcutaneous injection) by you or your caregiver.
•
Your healthcare provider should show you or your caregiver how to inject HYMPAVZI before you inject yourself for the first time.
•
Do not attempt to inject yourself or another person unless you have been taught how to do so by a healthcare provider.
•
Your first dose (loading dose) of HYMPAVZI is 300 mg (two 150 mg injections). Then you will inject a weekly (maintenance) dose as prescribed by your healthcare provider.
•
Inject HYMPAVZI 1 time a week on the same day each week. Inject HYMPAVZI at any time of day.
•
Your healthcare provider will provide information on the treatment of breakthrough bleeding during your treatment with HYMPAVZI. Do not use HYMPAVZI to treat breakthrough bleeding.
•
If you miss a maintenance dose of 150 mg of HYMPAVZI:
o
Give the dose as soon as possible before the next scheduled dose, and then continue with your usual 150 mg weekly dosing schedule. You may inject your next dose at your regularly scheduled time or continue dosing based on the new day you injected your missed dose. In case you are not sure when to inject HYMPAVZI, call your healthcare provider.
o
If more than 13 days have passed since your last dose was given, call your healthcare provider right away for dosing instructions.
•
If you miss 1 or more doses of maintenance dose of 300 mg of HYMPAVZI:
o
Give a dose as soon as possible, and then continue with your 300 mg weekly dosing schedule. You may inject your next dose at your regularly scheduled time or continue dosing based on the new day you injected your missed dose. In case you are not sure when to inject HYMPAVZI, call your healthcare provider.

What are the possible side effects of HYMPAVZI?

HYMPAVZI may cause serious side effects, including:

•
blood clots (thromboembolic events). HYMPAVZI may increase the risk for your blood to clot in blood vessels in your arm, leg, lung, or head and can be life-threatening. Get medical help right away if you develop any of these signs or symptoms of blood clots:
o
swelling or pain in arms or legs
o
redness or discoloration in your arms or legs
o
shortness of breath
o
pain in chest or upper back
o
fast heart rate
o
cough up blood
o
feel faint
o
headache
o
numbness in your face
o
eye pain or swelling
o
trouble seeing
•
allergic reactions. Allergic reactions, including rash and itching have happened in people treated with HYMPAVZI. Stop using HYMPAVZI and get medical help right away if you develop any of the following symptoms of a severe allergic reaction:
o
swelling of your face, lips, mouth, or tongue
o
trouble breathing
o
wheezing
o
dizziness or fainting
o
fast heartbeat or pounding in your chest
o
sweating

The most common side effects of HYMPAVZI are injection site reactions, including:

•
itching
•
swelling
•
hardening
•
redness
•
bruising
•
pain

These are not all of the possible side effects of HYMPAVZI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store HYMPAVZI?

•
Store HYMPAVZI in a refrigerator at 36°F to 46°F (2°C to 8°C).
•
Store HYMPAVZI 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 for up to 7 days. Do not return HYMPAVZI to the refrigerator after storing at room temperature.
•
Throw away (dispose of) HYMPAVZI that has been left out of the refrigerator for more than 7 days.
•
Do not freeze HYMPAVZI.
•
Do not shake HYMPAVZI.

Keep HYMPAVZI and all medicines out of the reach of children.

General information about the safe and effective use of HYMPAVZI.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use HYMPAVZI for a condition for which it was not prescribed. Do not give HYMPAVZI to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about HYMPAVZI that is written for health professionals.

What are the ingredients in HYMPAVZI?

Active ingredient: marstacimab‑hncq

Inactive ingredients: edetate disodium, histidine, L-histidine monohydrochloride, polysorbate 80, sucrose, and water for injection

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

Pfizer logo
US License No. 2001
Distributed by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001
LAB-1575-1.0
For more information, go to website www.HYMPAVZI.com or call 1-800-438-1985.

Find HYMPAVZI medical information:

Find HYMPAVZI medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

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Prescribing Information
Download Prescribing Information

Health Professional Information

Medication Guide

Patient Package Insert

This Patient Information has been approved by the U.S. Food and Drug Administration.          Issued: 10/2024

PATIENT INFORMATION

HYMPAVZI (him-PAV-zee)

(marstacimab-hncq)

injection, for subcutaneous use

Important information: Before you start using HYMPAVZI, it is very important to talk to your healthcare provider about using factor VIII and factor IX products (products that help blood clot but work in a different way than HYMPAVZI). You may need to use factor VIII or factor IX medicines to treat episodes of breakthrough bleeding during treatment with HYMPAVZI. Carefully follow your healthcare provider’s instructions regarding when to use factor VIII or factor IX medicines and the prescribed dose during your treatment with HYMPAVZI.

What is HYMPAVZI?

HYMPAVZI is a prescription medicine used to prevent or reduce the frequency of bleeding episodes in adults and children 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors.

It is not known if HYMPAVZI is safe and effective in children younger than 12 years old.

Before using HYMPAVZI, tell your healthcare provider about all of your medical conditions, including if you:

•
have a planned surgery. Your healthcare provider may stop treatment with HYMPAVZI before your surgery. Talk to your healthcare provider about when to stop using HYMPAVZI and when to start it again if you have a planned surgery.
•
have a severe short-term (acute) illness such as an infection or injury.
•
are pregnant or plan to become pregnant. HYMPAVZI may harm your unborn baby.
 
Females who are able to become pregnant:
o
Your healthcare provider will do a pregnancy test before you start your treatment with HYMPAVZI.
o
You should use effective birth control (contraception) during treatment with HYMPAVZI and for 2 months after the last dose of HYMPAVZI.
o
Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with HYMPAVZI.
•
are breastfeeding or plan to breastfeed. It is not known if HYMPAVZI passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over‑the‑counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use HYMPAVZI?

See the detailed “Instructions for Use” that comes with your HYMPAVZI for information on how to inject a dose of HYMPAVZI, and how to properly throw away (dispose of) used HYMPAVZI prefilled syringe or HYMPAVZI prefilled pen.

•
Use HYMPAVZI exactly as prescribed by your healthcare provider.
•
Your healthcare provider will provide instructions for stopping (discontinuing) your current treatment when switching from factor- or non-factor-based medicines to HYMPAVZI.
•
HYMPAVZI is given as an injection under your skin (subcutaneous injection) by you or your caregiver.
•
Your healthcare provider should show you or your caregiver how to inject HYMPAVZI before you inject yourself for the first time.
•
Do not attempt to inject yourself or another person unless you have been taught how to do so by a healthcare provider.
•
Your first dose (loading dose) of HYMPAVZI is 300 mg (two 150 mg injections). Then you will inject a weekly (maintenance) dose as prescribed by your healthcare provider.
•
Inject HYMPAVZI 1 time a week on the same day each week. Inject HYMPAVZI at any time of day.
•
Your healthcare provider will provide information on the treatment of breakthrough bleeding during your treatment with HYMPAVZI. Do not use HYMPAVZI to treat breakthrough bleeding.
•
If you miss a maintenance dose of 150 mg of HYMPAVZI:
o
Give the dose as soon as possible before the next scheduled dose, and then continue with your usual 150 mg weekly dosing schedule. You may inject your next dose at your regularly scheduled time or continue dosing based on the new day you injected your missed dose. In case you are not sure when to inject HYMPAVZI, call your healthcare provider.
o
If more than 13 days have passed since your last dose was given, call your healthcare provider right away for dosing instructions.
•
If you miss 1 or more doses of maintenance dose of 300 mg of HYMPAVZI:
o
Give a dose as soon as possible, and then continue with your 300 mg weekly dosing schedule. You may inject your next dose at your regularly scheduled time or continue dosing based on the new day you injected your missed dose. In case you are not sure when to inject HYMPAVZI, call your healthcare provider.

What are the possible side effects of HYMPAVZI?

HYMPAVZI may cause serious side effects, including:

•
blood clots (thromboembolic events). HYMPAVZI may increase the risk for your blood to clot in blood vessels in your arm, leg, lung, or head and can be life-threatening. Get medical help right away if you develop any of these signs or symptoms of blood clots:
o
swelling or pain in arms or legs
o
redness or discoloration in your arms or legs
o
shortness of breath
o
pain in chest or upper back
o
fast heart rate
o
cough up blood
o
feel faint
o
headache
o
numbness in your face
o
eye pain or swelling
o
trouble seeing
•
allergic reactions. Allergic reactions, including rash and itching have happened in people treated with HYMPAVZI. Stop using HYMPAVZI and get medical help right away if you develop any of the following symptoms of a severe allergic reaction:
o
swelling of your face, lips, mouth, or tongue
o
trouble breathing
o
wheezing
o
dizziness or fainting
o
fast heartbeat or pounding in your chest
o
sweating

The most common side effects of HYMPAVZI are injection site reactions, including:

•
itching
•
swelling
•
hardening
•
redness
•
bruising
•
pain

These are not all of the possible side effects of HYMPAVZI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store HYMPAVZI?

•
Store HYMPAVZI in a refrigerator at 36°F to 46°F (2°C to 8°C).
•
Store HYMPAVZI 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 for up to 7 days. Do not return HYMPAVZI to the refrigerator after storing at room temperature.
•
Throw away (dispose of) HYMPAVZI that has been left out of the refrigerator for more than 7 days.
•
Do not freeze HYMPAVZI.
•
Do not shake HYMPAVZI.

Keep HYMPAVZI and all medicines out of the reach of children.

General information about the safe and effective use of HYMPAVZI.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use HYMPAVZI for a condition for which it was not prescribed. Do not give HYMPAVZI to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about HYMPAVZI that is written for health professionals.

What are the ingredients in HYMPAVZI?

Active ingredient: marstacimab‑hncq

Inactive ingredients: edetate disodium, histidine, L-histidine monohydrochloride, polysorbate 80, sucrose, and water for injection

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

Pfizer logo
US License No. 2001
Distributed by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001
LAB-1575-1.0
For more information, go to website www.HYMPAVZI.com or call 1-800-438-1985.
Medication Guide

Health Professional Information

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