HYMPAVZI 150 mg Инъекционный Раствор В Преднаполненном Шприце

Содержание инструкции

1. Hympavzi 150 mg injectable solution in pre-filled syringe
   1. What is Hympavzi and what is it used for
   2. What you need to know before using Hympavzi
   3. How to use Hympavzi
   4. Possible side effects
   5. How to store Hympavzi
   6. Contents of the pack and other information
2. Hympavzi 150 mg injectable solution in pre-filled syringe
3. Hympavzi 150 mg injectable solution in pre-filled pen
   1. What is Hympavzi and what is it used for
   2. What you need to know before using Hympavzi
   3. How to use Hympavzi
   4. Possible side effects
   5. How to store Hympavzi
   6. Contents of the pack and other information
4. Hympavzi 150 mg solution for injection in pre-filled pen

Hympavzi 150 mg injectable solution in pre-filled syringe

marstacimab

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicinal product. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as 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 only for you or for the child in your care. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Hympavzi is and what it is used for
• 2. What you need to know before you use Hympavzi
• 3. How to use Hympavzi
• 4. Possible side effects
• 5. How to store Hympavzi
• 6. Contents of the pack and other information

1. What is Hympavzi and what is it used for

Hympavzi contains the active substance marstacimab. Marstacimab is a monoclonal antibody, a type
of protein designed to recognize 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 or older, weighing 35 kg or more, with:

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

Haemophilia A is a hereditary blood clotting disorder caused by a lack of factor VIII.
Haemophilia B is a hereditary blood clotting disorder caused by a lack of factor IX. Factor VIII and factor IX are proteins for blood coagulation to stop any
bleeding. Some patients with haemophilia may develop inhibitors of factor VIII or factor IX (antibodies in the blood that act against factor VIII or factor IX replacement products and prevent them from working properly).
The active substance contained in Hympavzi, marstacimab, recognizes and binds to TFPI, a protein that
prevents excessive blood clotting. By binding to TFPI, marstacimab limits its effectiveness
in functioning, promoting the formation of thrombin (a protein that plays a role
fundamental in blood coagulation in case of injury or damage to the body).
This helps to increase coagulation 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 any of the other ingredients of this medicine (listed in section 6). If you are not sure if you are allergic, ask your doctor, pharmacist or nurse before using Hympavzi.

Warnings and precautions
Talk to your doctor before using Hympavzi.

Before starting to use Hympavzi, it is very important to talk to your doctor about the use of other
products containing factor VIII and factor IX(products that help blood clotting, but
work differently from Hympavzi) during the use of Hympavzi. It may be necessary to
use other products containing factor VIII or factor IX to treat episodes of bleeding during
therapy/treatment with Hympavzi. Carefully follow your doctor's instructions regarding when and
how to use these products containing factor VIII or factor IX during the use of Hympavzi.
Blood clots (thromboembolic events)
Hympavzi increases how easily your blood clots. Medicines similar to Hympavzi are
known to cause blood clots in blood vessels (so-called thromboembolic events). Blood clots
can be life-threatening. Talk to your doctor if you have had problems with blood clots in the past 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 the narrowing or blockage of blood vessels that carry blood to the heart muscle);
• history of ischemic disease (reduced blood flow due to the 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 seek immediate medical attentionif you notice any symptoms of
a possible blood clot, including the following side effects:

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

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

• skin rash, hives, widespread itching
• swelling of the face, lips, tongue or throat
• difficulty breathing or swallowing
• dizziness

Children under 12 years of age
Hympavzi should not be used in children under 1 year of age and is not recommended in
subjects under 12 years of age. The safety and benefits of this medicine are not yet known
in this population.

Other medicines and Hympavzi
Tell 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 to become pregnant, ask your doctor for advice
before using this medicine. The doctor will assess the benefit of using
Hympavzi against the risk to the fetus.
If you are breastfeeding, ask your doctor whether to stop breastfeeding or stop using Hympavzi. The doctor will assess the benefit of using
Hympavzi against the benefits for the infant.

Driving and using machines
Hympavzi does not or negligibly alters the ability to drive and use machines.

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

Hympavzi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 1 mL, that is to say essentially ‘sodium-free’.

3. How to use Hympavzi

Treatment will be started under the supervision of a qualified physician for the care of patients affected
by hemophilia. Use this medicine following exactly the instructions of your physician. If you have any doubts
consult your physician or pharmacist.
Your healthcare provider will provide you with instructions for stopping the current treatment when switching from
factor-based or non-factor-based drugs to Hympavzi. Contact your healthcare provider if you do not
know how to proceed.
If you are seriously ill or are to undergo major surgery, inform your
healthcare provider that you are using Hympavzi.

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

How Hympavzi is administered

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

Before using the syringe for the first time, the physician, nurse or pharmacist will show you and/or
your caregiver how to inject Hympavzi. If you inject Hympavzi yourself or if the injection is
performed by your caregiver, you or your caregiver must read carefully and follow the detailed instructions
for use on the back of this leaflet.
Where to inject Hympavzi

• The physician or nurse will show you and/or your caregiver in which areas of the body Hympavzi must be injected. The best place to administer Hympavzi is the abdominal area (abdomen) or the thigh. Injections into the upper arm should only be performed by a caregiver, a physician or a nurse.
• The injection site should be changed with each injection.
• If more than one injection is needed to administer a complete dose, each injection must be performed at a different site.
• If you are taking other medicines that need to be injected under the skin, these injections should be performed at a different site.

How much Hympavzi to use
Treatment will begin with a loading dose which will then be followed by a maintenance dose
administered every week:

• 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 must 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 remember to inject the medicine
once a week.
Depending on your response to Hympavzi, your physician may adjust the maintenance dose
as needed, up to a maximum of 300 mg per week.

Use in adolescents
Hympavzi can be used in adolescents aged 12 years and over. An adolescent may
self-inject the medicine with the consent of the physician or nurse caring for the adolescent and
the parent or caregiver and after being instructed on the procedure.

If you use more Hympavzi than you should
If you have used more Hympavzi than you should have, inform your physician immediately. You may
be at risk of developing adverse effects such as blood clots and require medical attention. Always use
Hympavzi exactly as your physician has told you and if you are not sure, consult your physician, your
pharmacist or your nurse.

If you forget to use Hympavzi

• If you forget the scheduled dose, inject the forgotten dose as soon as possible before the day of the next scheduled dose. Then continue to inject the medicine as scheduled. Do not inject a double dose to make up for the missed dose.
• If you forget two scheduled doses in a row (i.e., if more than 13 days have passed since the last injection), contact your physician as soon as possible and ask what to do.
• If you are not sure what to do, consult your physician, pharmacist or nurse.

If you stop using Hympavzi
Do not stop using Hympavzi without talking to your physician. If you stop using Hympavzi, you may
no longer be protected from bleeding.
If you have any doubts about using this medicine, consult your physician, 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 may be severe. Contact your doctor immediately if you have 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 signs or symptoms of a possible blood clot. See section 2 “What you need to know before you use Hympavzi”
for a list of possible symptoms of a blood clot (thromboembolic event).

Other side effects
Tell your doctor or nurse if you get any of these side effects.

Very common(may affect more than 1 in 10 people)

• a 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 effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system detailed in Appendix V. By reporting side effects you can help to 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 which is stated on the label of the pre-filled syringe
and on the cardboard packaging 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 the original packaging to protect the medicine from light.
Hympavzi can be removed from the refrigerator and stored in the original packaging for a maximum
of 7 days at room temperature (up to 30 °C). Do not return Hympavzi to the refrigerator after having kept it
at room temperature. If Hympavzi has been at room temperature for more than 7 days, discard it even if it contains unused medicine.
Do not shake.
Remove Hympavzi from the refrigerator before use. For a more comfortable injection, Hympavzi may
be warmed to room temperature in the packaging for approximately 15-30 minutes away from
direct sunlight before use.
Before using the medicine, check the solution for the presence of particles or changes
in color. Do not use the medicine if you notice that it is cloudy, dark yellow in color, or contains flakes or
particles.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Hympavzi contains

• The active substance is marstacimab.
• The other ingredients 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 Hympavzi and contents of the pack
Hympavzi is a clear and colourless to pale yellow injection solution in a prefilled syringe.
Each pack of Hympavzi contains 1 prefilled 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 on this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +370 5 251 4000

България
Пфайзер Люксембург САРЛ, Клон България
Teл.: +359 2 970 4333

Magyarország
Pfizer Kft.
Tel.: + 36 1 488 37 00

Česká republika
Pfizer, spol. s r.o.
Tel: +420 283 004 111

Malta
Vivian Corporation Ltd.
Tel: +356 21344610

Danmark
Pfizer ApS
Tlf.: +45 44 20 11 00

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055-51000

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
Pfizer Ελλάς A.E.
Τηλ: +30 210 6785800

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

España
Pfizer, S.L.
Tel: +34 91 490 99 00

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500

France
Pfizer
Tél: +33 (0)1 58 07 34 40

România
Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Ireland
Pfizer Healthcare Ireland
Tel: +1800 633 363 (toll free)
Tel: +44 (0)1304 616161

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: + 421 2 3355 5500

Ísland
Icepharma hf.
Sími: +354 540 8000

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Κύπρος
Pfizer Ελλάς A.E. (Cyprus Branch)
Τηλ: +357 22817690

United Kingdom (Northern Ireland)
Pfizer Limited
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 European Medicines Agency website, https://www.ema.europa.eu

INSTRUCTIONS FOR USE

Hympavzi 150 mg injectable solution 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 medicine as new information may have been added.
Your doctor, nurse or pharmacist should show you or your caregiver how to prepare and
inject a dose of Hympavzi correctly before the first use.

Do not practice an injection or inject the medicine into others until you have been shown how
to inject Hympavzi.
Important information

• Each pre-filled syringe of Hympavzi is a single-dose pre-filled syringe (called “syringe” in these Instructions for Use). The Hympavzi pre-filled syringe contains 150 mg of Hympavzi for injection under the skin (subcutaneous route).
• Do notinject Hympavzi into a vein or muscle.
• Do notshake Hympavzi.
• As an aid to remembering when to inject Hympavzi, you can mark the days of administration in advance on your calendar. Contact your doctor, nurse or pharmacist if you or your caregiver has questions about how to inject Hympavzi correctly.

How to store Hympavzi

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

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

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

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

Preparation steps
Step 1: initial preparation

• Removethe syringe from its packaging and keep it away from direct sunlight.
• Make surethat the name Hympavzi is printed on the packaging and on the syringe label.
• Check the syringefor any visible damage such as cracks or leaks.
• Wash and dryyour hands.
• Do not remove the needle cover until you are ready to perform the injection.
• Dispose of (discard)the syringe if it is damaged or if the syringe or its packaging has been dropped.
• Do notuse the syringe if: it has been stored in direct light. Exposure to ambient light during dose preparation and injection is acceptable; or it has been frozen or thawed or has been outside the refrigerator for more than 7 days.
• Do notshake the syringe. Shaking may damage Hympavzi.

Note:to make injection more comfortable, allow the syringe to warm to room temperature
in its packaging for about 15-30 minutes away from direct sunlight.

Do notuse other methods to heat the syringe, such as a microwave or hot water.

Step 2: check the date (Exp.)

• Checkthe expiry date (Exp.) printed on the syringe label.
• Do notuse the medicine if the expiry date has passed.

Step 3: check the medicine

• Gently tiltthe syringe back and forth.
• Observethe medicine in the syringe carefully. o The medicine should be clear and colorless to pale yellow. o Do notuse the syringe if the medicine 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, contact your doctor, nurse or pharmacist.
Step 4: select and clean the injection site

• Choosean injection site in the stomach (abdomen) or thigh area, unless your doctor, nurse or pharmacist has suggested a different site. Hympavzi can also be injected into the upper arm only by a doctor, nurse, pharmacist or caregiver. Keep at least 5 cm away from the navel.
• Changethe injection site each time you give a Hympavzi injection. You can use the same area of the body, but it is important to choose a different injection site in that area.
• Cleanthe injection site with soap and water or, if appropriate, with an alcohol-soaked swab.
• Letit dry. Do nottouch the cleaned injection site or wave or blow on the area.
• Do notinject Hympavzi into bony areas or areas of the skin that are bruised, red, painful or hardened. Avoid injecting into areas with scars or stretch marks.
• Do notinject Hympavzi into a vein or muscle.
• Do notinject Hympavzi through clothing.

Step 5: remove the cover

• Holdthe syringe by the barrel.
• Carefully removethe needle cover by pulling in a straight line.
• Immediately placethe needle cover in a sharps disposal container. You will not need it again.
• Do nottouch the needle and make sure it does not come into contact with any surface.

Note:it is normal to see some drops of medicine on the tip of the needle.

Caution:handle the syringe carefully to avoid accidental needle injury.

Injection procedure
Step 6: insert the needle

• Pinch upa fold of skin between your thumb and fingers to create a firm surface.
• Insertthe needle fully into the skin at a 45° angle, as shown.

Keep the skin pinched throughout the injection.
Caution:if you change your mind about where to give the injection after inserting the needle into the skin, you will need to
discard the syringe and get a new Hympavzi pre-filled syringe.

Step 7: inject the medicine

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

Note:it is recommended to count slowly to 5 after the plunger rod has been fully
pushed down before removing the needle from the skin.

Step 8: remove the needle

• Withdrawthe needle from the skin keeping the same angle as it was inserted.

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

Step 9: check the syringe

• Checkthe syringe to make sure the gray stopper of the plunger is in the position shown.

If the gray stopper of the plunger is not in the position shown, a full
dose has not been administered. Ask for help from your doctor, nurse or pharmacist.
Never reinsert the needle.
Do not inject another dose.
Step 10: after the injection

• If you see a drop of blood, presslightly on the injection site for a few seconds with a clean cotton ball or gauze.
• Do notrub the area.

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

Step 11: disposal

• Placethe used syringe in a sharps disposal container as directed by your doctor, nurse or pharmacist and in accordance with local health and safety regulations.

Do not put the cover back on the needle.

• Do notdispose of syringes in household waste.

Hympavzi 150 mg injectable solution in pre-filled pen

marstacimab

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as 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 only for you or for the child in your care. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Hympavzi is and what it is used for
• 2. What you need to know before you use Hympavzi
• 3. How to use Hympavzi
• 4. Possible side effects
• 5. How to store Hympavzi
• 6. Contents of the pack and other information

1. What is Hympavzi and what is it used for

Hympavzi contains the active substance marstacimab. Marstacimab is a monoclonal antibody, a type
of protein designed to recognize 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 or older, weighing 35 kg or more, with:

• severe hemophilia A (congenital deficiency of factor VIII, when the level of factor VIII in the blood is less than 1%) who have not developed inhibitors of factor VIII or
• severe hemophilia B (congenital deficiency of factor IX, when the level of factor IX in the blood is less than 1%) who have not developed inhibitors of factor IX.

Hemophilia A is a hereditary bleeding disorder caused by a lack of factor VIII.
Hemophilia B is a hereditary bleeding disorder caused by a lack of factor IX. Factor VIII and factor IX are proteins for blood coagulation to stop any
bleeding. Some patients aged 12 years or older with hemophilia A or B may
develop inhibitors of factor VIII or factor IX (antibodies in the blood that act against factor VIII or factor IX replacement products preventing them from working properly).
The active substance contained in Hympavzi, marstacimab, recognizes and binds to TFPI, a protein that
prevents excessive blood clotting. By binding to TFPI, marstacimab reduces its effectiveness
in functioning, promoting the formation of thrombin (a protein that plays a role
fundamental in blood coagulation in case of injury or damage to the body). This
helps to increase coagulation and stop bleeding in patients with hemophilia.

2. What you need to know before using Hympavzi

Do not use Hympavzi

• if you are allergic to marstacimab or any of the other ingredients of this medicine (listed in section 6). If you are not sure if you are allergic, ask your doctor, pharmacist or nurse before using Hympavzi.

Warnings and precautions
Talk to your doctor before using Hympavzi.

Before starting to use Hympavzi, it is very important to talk to your doctor about the use of other
products containing factor VIII and factor IX(products that help blood clotting, but
work differently from Hympavzi) during the use of Hympavzi. You may need to
use other products containing factor VIII or factor IX to treat episodes of bleeding
during therapy/treatment with Hympavzi. Carefully follow your doctor's instructions regarding
when and how to use these products containing factor VIII or factor IX during the use of
Hympavzi.
Blood clots (thromboembolic events)
Hympavzi increases how easily your blood clots. Medicines similar to Hympavzi are
known to cause blood clots in blood vessels (so-called thromboembolic events). Blood clots
can be life-threatening. Talk to your doctor if you have had problems with blood clots in the past 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 the narrowing or blockage of blood vessels that carry blood to the heart muscle);
• history of ischemic disease (reduced blood flow due to the 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 seek immediate medical attentionif you notice any symptoms of
a possible blood clot, including the following side effects:

• swelling or pain in the arms or legs
• redness or discoloration of the arms or legs
• shortness of breath
• chest pain or upper back pain
• rapid heartbeat
• blood in your sputum
• feeling faint
• headache
• numbness of the face
• pain or swelling in the eyes
• vision problems

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

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

Children under 12 years of age
Hympavzi should not be used in children under 1 year of age and is not recommended in
subjects under 12 years of age. The safety and benefits of this medicine are not yet known
in this population.

Other medicines and Hympavzi
Tell 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 get pregnant, you should use effective 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 are pregnant or are planning to become pregnant, ask your doctor for advice
before using this medicine. The doctor will assess the benefit of using Hympavzi
compared to the risk to the fetus.
If you are breastfeeding, ask your doctor whether to stop breastfeeding or stop using
Hympavzi. The doctor will assess the benefit of using
Hympavzi compared to the benefits for the infant.

Driving and using machines
Hympavzi does not or negligibly alters the ability to drive and operate machines.

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

Hympavzi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 1 mL, that is to say essentially ‘sodium-free’.

3. How to use Hympavzi

Treatment will be started under the supervision of a qualified physician for the care of patients affected
by hemophilia. Use this medicine following the doctor's instructions exactly at all times. If you have doubts
consult your doctor or pharmacist.
Your healthcare provider will give you instructions on how to stop the current treatment when switching from
factor-based or non-factor-based medications to Hympavzi. Contact your healthcare provider if you do not
know how to proceed.
If you are seriously ill or need to undergo major surgery, tell your
healthcare provider that you are using Hympavzi.

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

How Hympavzi is administered

• Hympavzi is administered by injection under the skin (subcutaneous injection). Do not inject it into a vein or a muscle.
• For a more comfortable injection, Hympavzi can be warmed to room temperature in its protective packaging away from direct sunlight for about 15-30 minutes before use. Hympavzi

should not be heated in any other way. For example, it should not be heated in hot water
or in the microwave.
Before using the pen for the first time, the doctor, nurse or pharmacist will show you and/or
your caregiver how to inject Hympavzi. If you inject Hympavzi yourself or if the injection is
performed by your caregiver, you or your caregiver must read and follow the detailed instructions
for use on the back of this leaflet carefully.
Where to inject Hympavzi

• The doctor or nurse will show you and/or your caregiver in which areas of the body Hympavzi should be injected. The best place to administer Hympavzi is the abdominal area (abdomen) or the thigh. Injections into the buttocks should only be performed by a caregiver, a doctor or a nurse.
• The injection site must 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 need to be injected under the skin, these injections should be given at a different site.

How much Hympavzi to use
Treatment will begin with a loading dose which will then be followed by a maintenance dose
administered weekly:

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

You must 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 remember to inject the medicine
once a week.
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 can be used in adolescents aged 12 years and older. An adolescent can
self-inject the medicine with the consent of the doctor or nurse caring for the adolescent and
the parent or caregiver and after being instructed on the procedure.

If you use more Hympavzi than you should
If you have used more Hympavzi than you should, tell your doctor immediately. You may
be at risk of developing unwanted effects such as blood clots and require medical attention. Always use
Hympavzi exactly as your doctor has told you and if you are not sure, consult your doctor, pharmacist or nurse.

If you forget to use Hympavzi

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

If you stop using Hympavzi
Do not stop using Hympavzi without talking to your doctor. If you stop using
Hympavzi, you may no longer be protected from bleeding.
If you have any doubts about using 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 may be severe. Contact your doctor immediately if you have 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 signs or symptoms of a possible blood clot. See section 2 “What you need to know before you use Hympavzi”
for a list of possible symptoms of a blood clot (thromboembolic event).

Other side effects
Tell your doctor or nurse if you get any of these side effects.

Very common(may affect more than 1 in 10 people)

• a 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 effects, even 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. 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 which is stated on the pen label and the 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 prefilled pen in the original packaging to protect the medicine from light.
Hympavzi can be removed from the refrigerator and stored in the original packaging for a maximum of 7 days at room temperature (up to 30 °C). Do not return Hympavzi to the refrigerator after having kept it at room temperature. If Hympavzi has been at room temperature for more than 7 days, discard it even if it contains unused medicine.
Do not shake.
Remove Hympavzi from the refrigerator before use. For a more comfortable injection, Hympavzi can be warmed to room temperature in the packaging for approximately 15-30 minutes away from direct sunlight before use.
Before using the medicine, check the solution for the presence of particles or colour change. Do not use the medicine if you notice that it is cloudy, dark yellow in colour, or contains flakes or particles.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Hympavzi contains

• The active substance is marstacimab.
• The other ingredients 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 Hympavzi and contents of the pack
Hympavzi is a clear, colorless to pale yellow solution for injection (injection) in a prefilled
pen.
Each pack of Hympavzi contains 1 prefilled 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, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +370 5 251 4000

България
Пфайзер Люксембург САРЛ, Клон България
Teл.: +359 2 970 4333

Magyarország
Pfizer Kft.
Tel.: + 36 1 488 37 00

Česká republika
Pfizer, spol. s r.o.
Tel: +420 283 004 111

Malta
Vivian Corporation Ltd.
Tel: +356 21344610

Danmark
Pfizer ApS
Tlf.: +45 44 20 11 00

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055-51000

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
Pfizer Ελλάς A.E.
Τηλ: +30 210 6785800

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

España
Pfizer, S.L.
Tel: +34 91 490 99 00

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500

France
Pfizer
Tél: +33 (0)1 58 07 34 40

România
Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Ireland
Pfizer Healthcare Ireland
Tel: +1800 633 363 (toll free)
Tel: +44 (0)1304 616161

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: + 421 2 3355 5500

Ísland
Icepharma hf.
Sími: +354 540 8000

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Κύπρος
Pfizer Ελλάς A.E. (Cyprus Branch)
Τηλ: +357 22817690

United Kingdom (Northern Ireland)
Pfizer Limited
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 pen

These Instructions for Use contain information on how to inject Hympavzi.
Read these Instructions for Use carefully before using the Hympavzi pre-filled pen and
each time you receive a new supply of medicine, as new information may have been added.
Your doctor, nurse or pharmacist should show you or your caregiver how to prepare and
inject a dose of Hympavzi correctly before the first use.

Do not practice an injection or inject the medicine into others until you have been shown how to
inject Hympavzi
Important information

• Each pre-filled pen of Hympavzi is a single-dose pre-filled pen (called “pen” in these Instructions for Use). The Hympavzi pre-filled pen contains 150 mg of Hympavzi for injection under the skin (subcutaneous route).
• Do notinject Hympavzi into a vein or muscle.
• Do notshake Hympavzi.
• As an aid to remembering when to inject Hympavzi, you can mark the days of administration in advance on a calendar. Contact your doctor, nurse or pharmacist if you or your caregiver have questions about how to inject Hympavzi correctly.

How to store Hympavzi

• Store unused quantities of Hympavzi in a refrigerator at a temperature between 2 °C and 8 °C. Do not freeze Hympavzi. Store Hympavzi in the original packaging to protect the medicine from direct light.
• If necessary, Hympavzi can be stored in the original packaging at room temperature up to 30 °C for a maximum of 7 days. Do notuse Hympavzi if it has been left out of the refrigerator for more than 7 days. Discard (dispose of) any quantity of Hympavzi that has been stored at room temperature for more than 7 days.
• Do notuse the medicine after the expiry date printed on the Hympavzi pre-filled pen.
• Keep Hympavzi and all medicines out of the reach of children.

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

• 1 Hympavzi pre-filled pen.
• 1 alcohol swab (not included).
• 1 cotton ball or gauze (not included).
• 1 sharps disposal container for disposing of the pen (not included).

Preparation steps
Step 1: initial preparation
Removethe pen from its case and keep it away from direct sunlight.

• Make surethat the name Hympavzi is printed on the case and on the pen label.
• Check the penfor any visible damage such as cracks or leaks.
• Wash and dryyour hands.
• Do not remove the cap until you are ready to perform the injection.
• Discard (dispose of)the pen if it is damaged or if the pen or its case has been dropped.
• Do notuse the pen if: o it has been stored in direct light. Exposure to ambient light during dose preparation and injection is acceptable; o it has been frozen or thawed or has been left out of the refrigerator for more than 7 days.
• Do notshake the pen. Shaking may damage Hympavzi.

Note:For a more comfortable injection, allow the pen to warm to room temperature
in the case for about 15-30 minutes away from direct sunlight.

Do notuse other methods to heat the pen, such as a microwave or hot water.

Step 2: check the date (Exp.)

• Checkthe expiry date (Exp.) printed on the pen label.
• Do notuse the medicine if the expiry date has passed.

Step 3: check the medicine

• Carefully observethe medicine through the pen window. o The medicine should be clear and colourless to pale yellow. o Do notuse the pen if the medicine is cloudy, dark yellow or contains flakes or particles.

Note:The presence of air bubbles in the window is normal.

If you have any questions about the medicine, ask your doctor, nurse or pharmacist.
Step 4: select and clean the injection site

• Choosean injection site in the stomach (abdomen) or thigh area, unless your doctor, nurse or pharmacist has suggested a different site. Hympavzi can also be injected into the buttocks only by a doctor, nurse, pharmacist or caregiver. Stay at least 5 cm away from the navel.
• Changethe injection site each time you give a Hympavzi injection. You can use the same area of the body, but it is important to choose a different injection site in that area.
• Cleanthe injection site with soap and water or, if appropriate, with an alcohol swab.
• Letit dry. Do nottouch the cleaned injection site and do not wave or blow on it.
• Do notinject Hympavzi into bony areas or areas of the skin that are bruised, red, painful or hardened. Avoid injecting into areas with scars or stretch marks.
• Do notinject Hympavzi into a vein or muscle.
• Do notinject Hympavzi through clothing.

Step 5: remove the cap

• Rotate and removethe cap.
• Immediately placethe cap in a sharps disposal container. You will not need it again.

Note:
o It is normal to see a few drops of medicine on the tip of the needle.
o The needle cover will remain inside the cap after the cap is removed.

Caution:Handle the pen carefully as it contains a needle.

Do notput or press your hand on the needle guard, as this could cause needle injury.

Injection procedure
Step 6: inject the medicine

• Pressthe pen firmly downagainst the skin at a 90° angle and continue to pressuntil the injection is complete (Step 7). You will feel the first clickwhen the injection starts.
• Continue to pressthe pen firmly against the skin while the yellow bar moves in the window. You will feel a second clickwhen the injection is almostcomplete.
• Count slowly to 5 after hearing the second clickto ensure you receive a full dose.

Do not remove the pen from the skin until you have counted slowly to 5 after hearing the
2nd click and until the yellow mark completely fills the window.
Note:The needle penetrates the skin as you push the pen down. Your doctor, nurse or
pharmacist may suggest gently pinching the skin during the injection.

Note:If you do not feel a click when pushing the pen against the skin, try pressing harder. If
you continue to be unable to start the injection, take a new pre-filled Hympavzi pen.

Caution:If you change your mind about where to inject after inserting the needle into the skin, you must
discard (dispose of) the pen and get a new pre-filled Hympavzi pen.

Step 7: remove the pen

• Removethe pen from the skin. o If you see a small drop of medicine on the skin, wait a little longer before removing the pen for the next injection.

Note:After removing the pen from the skin, the needle will be automatically covered and the needle
guard will lock into place.

The pen cannot be reused.
Step 8: check the window

• Checkthe window to make sure all the medicine has been injected.

If the yellow bar is not in the position shown, a full dose has not been administered.
Ask for help from your doctor, nurse or pharmacist.
Do not inject another dose.
Step 9: after the injection

• If you see a drop of blood, presslightly on the injection site for a few seconds with a clean cotton ball or gauze.
• Do notrub the area.

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

Step 10: disposal

• Placethe used pen in a sharps disposal container as directed by your doctor, nurse or pharmacist and in accordance with local health and safety regulations.
• Do notdispose of pens in household waste.