Package leaflet: Information for the patient

Hympavzi 150 mg solution for injection in pre-filled syringe

marstacimab

Solid black triangle pointing downward on a white background

Medicinal product subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you or for the child in your care only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

What Hympavzi is and what it is used for
What you need to know before using Hympavzi
How to use Hympavzi
Possible side effects
How to store Hympavzi
Contents of the pack and other information

1. What Hympavzi is and what it is used for

Hympavzi contains the active substance marstacimab. Marstacimab is a monoclonal antibody, a type of protein designed to recognise and bind to a specific target in the body called tissue factor pathway inhibitor (TFPI).
Hympavzi is a medicine used to prevent or reduce bleeding in patients aged 12 years and older, weighing 35 kg or more, who have:

severe haemophilia A (congenital factor VIII deficiency, when factor VIII levels in the blood are less than 1%) who have not developed factor VIII inhibitors, or
severe haemophilia B (congenital factor IX deficiency, when factor IX levels in the blood are less than 1%) who have not developed factor IX inhibitors.

Haemophilia A is an inherited bleeding disorder caused by a lack of factor VIII.
Haemophilia B is an inherited bleeding disorder caused by a lack of factor IX. Factor VIII and factor IX are clotting proteins that help stop bleeding. Some patients with haemophilia may develop inhibitors to factor VIII or factor IX (antibodies in the blood that act against replacement factor VIII or factor IX products, preventing their proper function).
The active substance in Hympavzi, marstacimab, recognises and binds to TFPI, a protein that prevents excessive blood clotting. By binding to TFPI, marstacimab reduces its activity, thereby promoting thrombin formation (a protein that plays a key role in blood clotting following injury or damage to the body).
This helps enhance blood clotting and control bleeding in patients with haemophilia.

2. What you need to know before using Hympavzi

Do not use Hympavzi

if you are allergic to marstacimab or to any of the other ingredients of this medicine (listed in section 6). If you are unsure whether you are allergic, consult your doctor, pharmacist, or nurse before using Hympavzi.

Warnings and precautions
Talk to your doctor before using Hympavzi.
Before starting Hympavzi, it is very important to discuss with your doctor the use of other
factor VIII and factor IX products (products that help blood clotting but work differently from Hympavzi) during treatment with Hympavzi. You may need to use other factor VIII or factor IX products to treat bleeding episodes while on Hympavzi therapy. Follow your doctor's instructions carefully regarding when and how to use these factor VIII or factor IX products during treatment with Hympavzi.

Blood clots (thromboembolic events)
Hympavzi increases how easily your blood clots. It is known that medicines similar to Hympavzi can cause blood clots in blood vessels (so-called thromboembolic events). Blood clots can be life-threatening. Consult your doctor if you have previously had blood clotting problems or if you have a condition that increases your risk of blood clots. This includes the following:

history of coronary artery disease (heart disease caused by narrowing or blockage of blood vessels supplying blood to the heart muscle);
history of ischemic disease (reduced blood flow due to narrowing or blockage of blood vessels);
history of blood clots in veins or arteries;
presence of severe infections;
presence of sepsis (blood poisoning);
presence of trauma or crush injuries;
presence of cancer.

Stop using Hympavzi and contact a doctor immediately if you notice any symptoms of a possible blood clot, including the following side effects:

swelling or pain in arms or legs – feeling faint
redness or color change in arms or legs – numbness of the face
shortness of breath – eye pain or swelling
chest or upper back pain – vision problems
rapid heartbeat
blood in sputum

Allergic reactions
Symptoms of an allergic reaction have been observed in people using Hympavzi. Stop using Hympavzi and seek immediate medical help if you experience symptoms of a possible severe allergic reaction, including:

skin rash, hives, generalized itching – difficulty breathing or swallowing
swelling of face, lips, tongue, or throat
dizziness

Children under 12 years of age
Hympavzi must not be used in children under 1 year of age and is not recommended in individuals under 12 years of age. The safety and benefits of this medicine have not yet been established in this population.

Other medicines and Hympavzi
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, contraception, and breastfeeding
If you are able to become pregnant, you should use an effective method of contraception (birth control) during treatment with Hympavzi and for at least 1 month after the last injection.
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before using this medicine. Your doctor will assess the benefit of using Hympavzi against the risk to the fetus.
If you are breastfeeding, consult your doctor about whether to discontinue breastfeeding or discontinue use of Hympavzi. Your doctor will evaluate the benefit of using Hympavzi against the benefits of breastfeeding.

Driving and using machines
Hympavzi has no or negligible influence on the ability to drive and use machines.

Hympavzi contains polysorbate 80
This medicine contains 0.2 mg of polysorbate 80 per mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

Hympavzi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 1 mL, i.e., essentially 'sodium-free'.

3. How to use Hympavzi

Treatment will be initiated under the supervision of a qualified physician experienced in managing patients with haemophilia. Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your healthcare provider will give you instructions on how to discontinue your current treatment when switching from factor-based or non-factor-based therapies to Hympavzi. Contact your healthcare provider if you are unsure how to proceed.
If you are seriously ill or require major surgery, inform your healthcare provider that you are using Hympavzi.

Keep a record
Each time you use Hympavzi, record the name and batch number of the medicine.

How Hympavzi is administered

Hympavzi is administered by subcutaneous injection (injection under the skin). Do not inject it into a vein or muscle.
For a more comfortable injection, Hympavzi may be warmed to room temperature by leaving it in its packaging, away from direct sunlight, for approximately 15–30 minutes before use. Hympavzi must not be warmed in any other way. For example, do not warm it in hot water or in a microwave.

Before using the syringe for the first time, your doctor, nurse, or pharmacist will show you and/or your caregiver how to inject Hympavzi. If you self-inject Hympavzi or if the injection is administered by your caregiver, you or your caregiver must carefully read and follow the detailed instructions for use provided on the reverse of this leaflet.

Where to inject Hympavzi

Your doctor or nurse will show you and/or your caregiver the appropriate body areas for injecting Hympavzi. The best sites for administering Hympavzi are the abdominal area (abdomen) or the thigh. Injections in the upper arm should only be performed by a caregiver, doctor, or nurse.
The injection site should be changed with each injection.
If more than one injection is needed to administer a full dose, each injection must be given at a different site.
If you are taking other medicines that require subcutaneous injection, these injections should be administered at a different site.

How much Hympavzi to use
Treatment will start with a loading dose, followed by a maintenance dose administered weekly:

Loading dose (an initial higher dose to rapidly increase levels in the body): the recommended dose is 300 mg.
Maintenance dose: the recommended dose is 150 mg.

You should use this medicine once a week (at any time of day), on the same day each week.
Make a note of the day of the week you use Hympavzi to help you remember to inject the medicine once weekly.
Depending on your response to Hympavzi, your doctor may adjust the maintenance dose as needed, up to a maximum of 300 mg per week.

Use in adolescents
Hympavzi may be used in adolescents aged 12 years and older. An adolescent may self-inject the medicine provided they have been trained in the procedure and have the consent of the doctor or nurse responsible for their care, as well as the consent of a parent or caregiver.

If you use more Hympavzi than you should
If you have used more Hympavzi than prescribed, inform your doctor immediately. You may be at risk of developing adverse effects such as blood clots and may require medical treatment. Always use Hympavzi exactly as directed by your doctor. If you are unsure, consult your doctor, pharmacist, or nurse.

If you forget to use Hympavzi

If you miss a scheduled dose, inject the missed dose as soon as possible before the next scheduled dose day. Then continue injecting the medicine as planned. Do not inject a double dose to make up for the missed dose.
If you miss two consecutive scheduled doses (i.e., more than 13 days have passed since your last injection), contact your doctor as soon as possible and ask for advice.
If you are unsure what to do, consult your doctor, pharmacist, or nurse.

If you stop using Hympavzi
Do not stop using Hympavzi without first talking to your doctor. If you stop using Hympavzi, you may no longer be protected against bleeding episodes.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Hympavzi may cause a skin rash (reported in up to 1 out of 100 people), which could be severe. Contact your doctor immediately if you develop a severe rash; some rashes may be serious. Do not use Hympavzi again until you have spoken to your doctor about the rash.
Stop using Hympavzi and contact your doctor immediately if you notice any sign or symptom of a possible blood clot. See section 2, “What you should know before using Hympavzi”, for a list of possible symptoms of a blood clot (thromboembolic event).
Other side effects
Tell your doctor or nurse if you experience any of these side effects.
Very common (may affect more than 1 in 10 people)

reaction at the injection site (including itching, swelling, redness, pain, bruising, hardening)

Common (may affect up to 1 in 10 people)

headache
high blood pressure
itching

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hympavzi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the pre-filled syringe and on the outer carton after "Exp.". The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C–8 °C). Do not freeze.
Keep the pre-filled syringe in its original packaging to protect the medicine from light.
Hympavzi may be removed from the refrigerator and stored in its original packaging for up to 7 days at room temperature (up to 30 °C). Do not return Hympavzi to the refrigerator after it has been kept at room temperature. If Hympavzi has been kept at room temperature for more than 7 days, discard it even if there is unused medicine remaining.
Do not shake.
Remove Hympavzi from the refrigerator before use. For more comfortable injection, Hympavzi may be warmed to room temperature by leaving it in its packaging for approximately 15–30 minutes away from direct sunlight before use.
Before using the medicine, check the solution for particles or discoloration. Do not use the medicine if it appears cloudy, dark yellow, or contains flakes or particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Hympavzi contains

The active substance is marstacimab.
The other components are disodium edetate, L-histidine, L-histidine monohydrochloride, polysorbate 80 (E 433), sucrose, water for injections (see section 2 “Hympavzi contains polysorbate 80” and “Hympavzi contains sodium”).

Description of the appearance of Hympavzi and contents of the pack
Hympavzi is a clear, colourless to slightly yellow injectable solution (injection) in a pre-filled syringe.
Each pack of Hympavzi contains 1 pre-filled syringe.

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Luxembourg/Luxemburg Pfizer Luxembourg SARL filialas Lietuvoje
Pfizer NV/SA Tel: +370 5 251 4000
Tél/Tel: +32 (0)2 554 62 11

България Magyarország
Пфайзер Люксембург САРЛ, Клон България Pfizer Kft.
Teл.: +359 2 970 4333 Tel.: + 36 1 488 37 00

Česká republika Malta
Pfizer, spol. s r.o. Vivian Corporation Ltd.
Tel: +420 283 004 111 Tel: +356 21344610

Danmark Nederland
Pfizer ApS Pfizer bv
Tlf.: +45 44 20 11 00 Tel: +31 (0)800 63 34 636

Deutschland Norge
PFIZER PHARMA GmbH Pfizer AS
Tel: +49 (0)30 550055-51000 Tlf: +47 67 52 61 00

Eesti Österreich
Pfizer Luxembourg SARL Eesti filiaal Pfizer Corporation Austria Ges.m.b.H.
Tel: +372 666 7500 Tel: +43 (0)1 521 15-0

Ελλάδα Polska
Pfizer Ελλάς A.E. Pfizer Polska Sp. z o.o.
Τηλ: +30 210 6785800 Tel.: +48 22 335 61 00

España Portugal
Pfizer, S.L. Laboratórios Pfizer, Lda.
Tel: +34 91 490 99 00 Tel: +351 21 423 5500

France România
Pfizer Pfizer Romania S.R.L.
Tél: +33 (0)1 58 07 34 40 Tel: +40 (0) 21 207 28 00

Hrvatska Slovenija
Pfizer Croatia d.o.o. Pfizer Luxembourg SARL
Tel: +385 1 3908 777 Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Ireland Slovenská republika
Pfizer Healthcare Ireland Pfizer Luxembourg SARL, organizačná zložka
Tel: +1800 633 363 (toll free) Tel: + 421 2 3355 5500
Tel: +44 (0)1304 616161

Ísland Suomi/Finland
Icepharma hf. Pfizer Oy
Sími: +354 540 8000 Puh/Tel: +358 (0)9 430 040

Italia Sverige
Pfizer S.r.l. Pfizer AB
Tel: +39 06 33 18 21 Tel: +46 (0)8 550 520 00

Κύπρος United Kingdom (Northern Ireland)
Pfizer Ελλάς Α.Ε. (Cyprus Branch) Pfizer Limited
Τηλ: +357 22817690 Tel: +44 (0) 1304 616161

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: + 371 670 35 775

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu

INSTRUCTIONS FOR USE

Hympavzi 150 mg solution for injection in pre-filled syringe

These Instructions for Use contain information on how to inject Hympavzi.
Read these Instructions for Use carefully before using the Hympavzi pre-filled syringe and each time you receive a new supply of the medicine, as there may be new information added.
Your doctor, nurse, or pharmacist should show you or your caregiver how to properly prepare and inject a dose of Hympavzi before your first use.
Do not perform an injection or inject the medicine to others unless you have been shown how to inject Hympavzi.
Important information

Each Hympavzi pre-filled syringe is a single-dose pre-filled syringe (referred to as "syringe" in these Instructions for Use). The Hympavzi pre-filled syringe contains 150 mg of

Hympavzi for subcutaneous injection (under the skin).

Do not inject Hympavzi into a vein or muscle.
Do not shake Hympavzi.
To help you remember when to inject Hympavzi, you may mark the administration days in advance on a calendar. Contact your doctor, nurse, or pharmacist if you or your caregiver have any questions about the correct way to inject Hympavzi.

How to store Hympavzi

Store unused Hympavzi in the refrigerator at a temperature between 2 °C and 8 °C. Do not freeze Hympavzi. Keep Hympavzi in its original packaging to protect it from direct light.
If necessary, Hympavzi may be stored in its original packaging at room temperature up to 30 °C for a maximum of 7 days. Do not use Hympavzi if it has been kept outside the refrigerator for more than 7 days. Discard (dispose of) any Hympavzi that has been stored at room temperature for longer than 7 days.
Do not use the medicine after the expiry date stated on the Hympavzi pre-filled syringe.
Keep Hympavzi and all other medicines out of the reach of children.

Materials needed to administer the Hympavzi injection
Place the following materials on a clean, flat surface:

1 pre-filled syringe of Hympavzi.
1 alcohol swab (not included).
1 cotton ball or gauze pad (not included).
1 sharps disposal container for used syringes (not included).

Always hold the pre-filled syringe by the barrel to avoid damage.

Medical diagram showing a syringe prior to

Preparation steps
Step 1: Initial preparation

Remove the syringe from its carton and keep it away from direct sunlight.
Ensure that the name Hympavzi appears on both the carton and syringe label.
Inspect the syringe for any visible damage such as cracks or leaks.
Wash and dry your hands.
Do not remove the needle cap until you are ready to administer the injection.
Discard (dispose of) the syringe if it is damaged or if the syringe or its carton has been dropped.
Do not use the syringe if: it has been exposed to direct light. Exposure to ambient light during dose preparation and injection is acceptable; it has been frozen and thawed; or it has been kept outside the refrigerator for more than 7 days.
Do not shake the syringe. Shaking may damage Hympavzi.

Note: For a more comfortable injection, allow the syringe to warm to room temperature in its carton for approximately 15–30 minutes, away from direct sunlight.
Do not use other methods to warm the syringe, such as a microwave or hot water.

Step 2: Check the expiry date (Exp.)

Illustration showing a hand holding an injection pen to check the expiration date and lot number printed on the device body

Check the expiry date (Exp.) printed on the syringe label.
Do not use the medicine if the expiry date has passed.

Step 3: Check the medicine

Illustration of step 3 for checking the medication, with a hand holding an injection pen above an inspection circle

Gently tilt the syringe forward and backward.
Examine the medicine in the syringe carefully.
- The solution should be clear and colorless to pale yellow.
- Do not use the syringe if the solution is cloudy, dark yellow, or contains flakes or particles.

Note: The presence of air bubbles is normal.
If you have any questions about the medicine, consult your doctor, nurse, or pharmacist.

Step 4: Select and clean the injection site

Medical diagram indicating injection sites on the

Choose an injection site in the abdominal (stomach) area or thigh, unless your doctor, nurse, or pharmacist has advised you to use a different site. Hympavzi may also be injected into the upper arm, but only by a doctor, nurse, pharmacist, or caregiver. Stay at least 5 cm away from the navel.
Change the injection site each time you administer a Hympavzi injection. You may use the same body area, but be sure to select a different injection site within that area.
Clean the injection site with water and soap or, if appropriate, with an alcohol swab.
Allow the area to dry. Do not touch the cleaned site, and do not fan or blow on it.
Do not inject Hympavzi into bony areas or into areas of skin that are bruised, red, painful, or hardened. Avoid injecting into areas with scars or stretch marks.
Do not inject Hympavzi into a vein or muscle.
Do not inject Hympavzi through clothing.

Step 5: Remove the cap

Medical illustration showing step 5 for removing the cap from a vial, with blue arrows indicating downward movement

Hold the syringe by the barrel.
Carefully remove the needle cap by pulling it straight off.
Immediately place the needle cap into a sharps disposal container. You will no longer need it.
Do not touch the needle and ensure it does not come into contact with any surface.

Note: It is normal to see a few drops of medicine at the tip of the needle.
Caution: Handle the syringe carefully to avoid accidental needle-stick injuries.

Injection procedure
Step 6: Insert the needle

Lift a skin fold between your thumb and fingers to create a firm surface.
Insert the needle fully into the skin at a 45° angle, as shown.

Keep the skin lifted throughout the injection.
Caution: If you change your mind about the injection site after inserting the needle into the skin, you must
discard (dispose of) the syringe and obtain a new pre-filled syringe of Hympavzi.

Step 7: Inject the medicine

Medical illustration of step 7 showing two hands gripping a syringe for the

Push the plunger rod completely down with slow, steady pressure until the barrel is empty.

Note: It is recommended to slowly count to 5 after fully pushing down the plunger rod before removing the needle from the skin.

Step 8: Remove the needle

Medical illustration showing a hand holding a syringe and lifting it upward with a blue arrow pointing up

Remove the needle from the skin, maintaining the same angle used for insertion.

Note: If you see a small drop of medicine on the skin, wait a little longer before removing the needle during your next injection.

Step 9: Check the syringe

Illustration of step 9 for checking the syringe, with a close-up view of the tip and body of the medical device

Check the syringe to ensure the grey plunger stopper is in the position shown.

If the grey plunger stopper is not in the position shown, a full dose has not been administered. Seek help from your doctor, nurse, or pharmacist.
Never reinsert the needle.
Do not inject another dose.

Step 10: After the injection

A hand pressing a white gauze pad on the injection site

If you see a drop of blood, gently press on the injection site for several seconds using a clean cotton ball or gauze pad.
Do not rub the area.

Note: If bleeding does not stop, contact your doctor, nurse, or pharmacist.

Step 11: Disposal

Technical drawing of step 11 for disposal, showing a hand inserting the

Place the used syringe into a sharps disposal container as instructed by your doctor, nurse, or pharmacist and in accordance with local health and safety regulations.

Do not recap the needle.

Do not dispose of syringes in household waste.

Patient Information Leaflet

Hympavzi 150 mg solution for injection in a pre-filled pen

marstacimab

This medicinal product is subject to additional monitoring. This will allow for rapid identification of
new safety information. You can help by reporting any side effects you experience while using this
medicinal product. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicinal product, as it contains important
information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicinal product has been prescribed for you or for the child under your care only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Hympavzi is and what it is used for
What you need to know before using Hympavzi
How to use Hympavzi
Possible side effects
How to store Hympavzi
Contents of the pack and other information

1. What Hympavzi is and what it is used for

Hympavzi contains the active substance marstacimab. Marstacimab is a monoclonal antibody, a type
of protein designed to recognise and bind to a specific target in the body called
tissue factor pathway inhibitor (TFPI).
Hympavzi is a medicine used to prevent or reduce bleeding in patients aged 12 years and older, weighing 35 kg or more, with:

severe haemophilia A (congenital factor VIII deficiency, when factor VIII levels in the blood are less than 1%) who have not developed factor VIII inhibitors, or
severe haemophilia B (congenital factor IX deficiency, when factor IX levels in the blood are less than 1%) who have not developed factor IX inhibitors.

Haemophilia A is an inherited bleeding disorder caused by the lack of factor VIII.
Haemophilia B is an inherited bleeding disorder caused by the lack of factor IX. Factor VIII and factor IX are clotting proteins that help stop bleeding. Some patients aged 12 years and older with haemophilia A or B may develop factor VIII or factor IX inhibitors (antibodies in the blood that act against factor VIII or factor IX replacement products, preventing them from working properly).
The active substance in Hympavzi, marstacimab, recognises and binds to TFPI, a protein that prevents excessive blood clotting. By binding to TFPI, marstacimab reduces its functional activity, thereby promoting thrombin formation (a protein that plays a key role in blood clotting in response to injury or damage in the body). This helps enhance blood clotting and stop bleeding in patients with haemophilia.

2. What you need to know before using Hympavzi

Do not use Hympavzi

if you are allergic to marstacimab or to any of the other ingredients of this medicine (listed in section 6). If you are unsure whether you are allergic, consult your doctor, pharmacist, or nurse before using Hympavzi.

Warnings and precautions
Talk to your doctor before using Hympavzi.
Before starting Hympavzi, it is very important to discuss with your doctor the use of other
factor VIII and factor IX products (products that help blood clotting but work differently from
Hympavzi) during treatment with Hympavzi. You may need to use other factor VIII or factor IX
products to treat bleeding episodes while on treatment with Hympavzi. Follow your doctor’s
instructions carefully regarding when and how to use these factor VIII or factor IX products during
treatment with Hympavzi.

Blood clots (thromboembolic events)
Hympavzi increases how easily blood clots. It is known that medicines similar to Hympavzi can cause
blood clots in blood vessels (so-called thromboembolic events). Blood clots can be life-threatening.
Contact your doctor if you have previously had blood clotting problems or if you have a condition that
increases the risk of blood clots. This includes the following:

history of coronary artery disease (heart disease caused by narrowing or blockage of blood vessels supplying the heart muscle);
history of ischemic disease (reduced blood flow due to narrowing or blockage of blood vessels);
history of blood clots in veins or arteries;
presence of severe infections;
presence of sepsis (blood poisoning);
presence of traumatic or crush injuries;
presence of cancer.

Stop using Hympavzi and contact a doctor immediately if you notice any symptoms of a possible
blood clot, including the following side effects:

swelling or pain in arms or legs – feeling faint
redness or color change in arms or legs – facial numbness
shortness of breath – eye pain or swelling
chest or upper back pain – vision problems
rapid heartbeat
blood in sputum

Allergic reactions
Symptoms of an allergic reaction have been observed in people using Hympavzi. Stop using
Hympavzi and seek immediate medical help if you experience symptoms of a possible severe
allergic reaction, including the following:

skin rash, hives, generalized itching – difficulty breathing or swallowing
swelling of face, lips, tongue, or throat
dizziness

Other medicines and Hympavzi
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, contraception, and breastfeeding
If you are able to become pregnant, you must use an effective method of contraception (birth control) during treatment with Hympavzi and for at least 1 month after the last injection of Hympavzi.
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before using this medicine. Your doctor will assess the benefit of using Hympavzi against the risk to the fetus.
If you are breastfeeding, consult your doctor about whether to stop breastfeeding or stop using Hympavzi. Your doctor will weigh the benefit of using Hympavzi against the benefits to the breastfed infant.

Driving and using machines
Hympavzi does not affect or has a negligible effect on the ability to drive vehicles and use machines.

Hympavzi contains polysorbate 80
This medicine contains 0.2 mg of polysorbate 80 per mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

Hympavzi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 1 mL, i.e., essentially ‘sodium-free’.

3. How to use Hympavzi

Treatment will be initiated under the supervision of a qualified physician experienced in the management of patients with haemophilia. Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your healthcare provider will give you instructions on how to discontinue your current treatment when switching from factor-based or non-factor-based therapies to Hympavzi. Contact your healthcare provider if you are unsure how to proceed.
If you are seriously ill or require major surgery, inform your healthcare provider that you are using Hympavzi.

Keep a record
Each time you use Hympavzi, record the medicine’s name and batch number.

How Hympavzi is administered

Hympavzi is administered by subcutaneous injection (injection under the skin). Do not inject it into a vein or muscle.
For a more comfortable injection, Hympavzi may be warmed to room temperature by leaving it in its original packaging, protected from direct sunlight, for approximately 15–30 minutes before use. Hympavzi must not be warmed in any other way. For example, do not warm it in hot water or in a microwave.

Before using the pen for the first time, your doctor, nurse, or pharmacist will show you and/or your caregiver how to inject Hympavzi. If you are self-injecting Hympavzi or if the injection is administered by your caregiver, you or your caregiver must carefully read and follow the detailed instructions for use provided on the reverse of this leaflet.

Where to inject Hympavzi

Your doctor or nurse will show you and/or your caregiver the appropriate body areas for injecting Hympavzi. The best sites for administering Hympavzi are the abdominal area (abdomen) or the thigh. Injections into the buttocks should only be performed by a caregiver, doctor, or nurse.
The injection site should be changed with each injection.
If more than one injection is needed to administer a full dose, each injection should be given at a different site.
If you are taking other medicines that require subcutaneous injection, these should be administered at a different site.

How much Hympavzi to use
Treatment will start with a loading dose, followed by a weekly maintenance dose:

Loading dose (an initial higher dose to rapidly increase levels in the body): the recommended dose is 300 mg.
Maintenance dose: the recommended dose is 150 mg.

You should use this medicine once a week (at any time of day), on the same day each week.
You should note which day of the week you use Hympavzi, to help you remember to inject the medicine once weekly.
Depending on your response to Hympavzi, your doctor may adjust the maintenance dose as needed, up to a maximum of 300 mg per week.

Use in adolescents
Hympavzi may be used in adolescents aged 12 years and older. An adolescent may self-inject the medicine only after approval by the doctor or nurse responsible for the adolescent’s care, consent from the parent or caregiver, and proper training in the injection procedure.

If you forget to use Hympavzi

If you miss a scheduled dose, inject the missed dose as soon as possible before the next scheduled dose day. Then continue injecting the medicine as planned. Do not inject a double dose to make up for a missed dose.
If you miss two consecutive scheduled doses (i.e., more than 13 days have passed since your last injection), contact your doctor as soon as possible and ask for advice.
If you are unsure what to do, consult your doctor, pharmacist, or nurse.

If you stop treatment with Hympavzi
Do not stop using Hympavzi without first talking to your doctor. If you stop using Hympavzi, you may no longer be protected against bleeding episodes.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Hympavzi may cause a skin rash (reported in up to 1 in 100 people), which could be severe. Contact your doctor immediately if you develop a severe rash; some rashes may be serious. Do not use Hympavzi again until you have spoken to your doctor about the rash.
Stop using Hympavzi and contact your doctor immediately if you notice any sign or symptom of a possible blood clot. See section 2, “What you need to know before using Hympavzi”, for a list of possible symptoms of a blood clot (thromboembolic event).
Other side effects
Tell your doctor or nurse if you experience any of these side effects.
Very common (may affect more than 1 in 10 people)

reaction at the injection site (including itching, swelling, redness, pain, bruising, hardening)

Common (may affect up to 1 in 10 people)

headache
high blood pressure
itching

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Hympavzi

Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the pre-filled pen label and carton after “Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C–8 °C). Do not freeze.
Keep the pre-filled pen in the original packaging to protect the medicinal product from light.
Hympavzi may be removed from the refrigerator and stored in the original packaging for up to 7 days at room temperature (up to 30 °C). Do not return Hympavzi to the refrigerator after it has been stored at room temperature. If Hympavzi has been kept at room temperature for more than 7 days, dispose of it even if there is unused medicinal product remaining.
Do not shake.
Remove Hympavzi from the refrigerator before use. For a more comfortable injection, Hympavzi may be warmed to room temperature in its packaging for approximately 15–30 minutes, away from direct sunlight, prior to use.
Before using the medicinal product, inspect the solution for particles or discoloration. Do not use the medicinal product if it appears cloudy, dark yellow, or contains flakes or particles.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Hympavzi contains

The active substance is marstacimab.
The other components are disodium edetate, L-histidine, L-histidine monohydrochloride, polysorbate 80 (E 433), sucrose, water for injections (see section 2 “Hympavzi contains polysorbate 80” and “Hympavzi contains sodium”).

Description of the appearance of Hympavzi and contents of the pack
Hympavzi is a clear, colourless to pale yellow injectable solution (injection) in a pre-filled pen.
Each pack of Hympavzi contains 1 pre-filled pen.

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder: