InfoCons Consumer Protection informs you – ANDEMBRY – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What ANDEMBRY is and what it is used for

ANDEMBRY contains the active substance garadacimab .

ANDEMBRY is a medicine used in patients aged 12 years and older with hereditary angioedema (HAE) to prevent angioedema attacks.

HAE is a condition that causes recurrent episodes of swelling, known as HAE attacks, in different parts of the body, including the:

• hands and feet;
• face, eyelids, lips or tongue;
• voice -box (larynx) and throat, which may make breathing difficult;
• genitals;
• stomach and gut.

HAE attacks may be painful and disabling. Attacks that affect your throat or larynx may be dangerous or even life threatening.

HAE is a condition that often runs in families, but some people may not have a family history. Three types of HAE are known, based on the type of genetic defect and its effect on a protein that circulates in your blood, named C1 esterase inhibitor (C1- INH) . A person can have low levels of C1- INH in the body (type I HAE), poorly functioning C1- INH (type II HAE), or HAE with normal functioning C1- INH (type III HAE). The last type is extremely rare. All three types produce the same clinical symptoms of localiz ed swelling.

C1-INH regulates a process in the body that controls the production of an inflammatory substance called bradykinin. Overproduction of bradykinin causes swelling and inflammation in people with HAE.

The active substance in ANDEMBRY, garadacimab, blocks the activation of a protein known as factor XIIa (FXIIa), which is involved in stimulating bradykinin production. By blocking FXIIa activity, garadacimab reduces the level of bradykinin, thereby prevent ing HAE attacks. Some subcategories of normal C1 -INH HAE may not respond to treatment with garadacimab. Talk to your doctor if you have any concerns about your medicine.

⚠️ 2. What you need to know before you use ANDEMBRY

Do not use ANDEMBRY

If you are allegic to garadacimab or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Talk to your doctor, pharmacist or nurse before using ANDEMBRY.
• If you have a severe allergic reaction to ANDEMBRY with symptoms such as hives, tight chest, difficulty breathing, wheezing, hypotension or anaphylaxis, tell your doctor, pharmacist or nurse immediately .
• Treat a hereditary angioedema attack with your regular rescue medicine without taking additional doses of ANDEMBRY .

Keeping a record It is strongly recommended that every time you have a dose of ANDEMBRY, you write down the name and batch number of the medicine. This is so that you keep a record of the batches used.

Laboratory tests Tell your doctor if you are using ANDEMBRY before you have laboratory tests to measure how well your blood is clotting. This is because ANDEMBRY may interfere with some laboratory tests, leading to inaccurate results.

Children and adolescents

ANDEMBRY is not recommended for use in children under 12 years of age. This is because it has not been studied in this age group.

Other medicines and ANDEMBRY

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

ANDEMBRY is not known to affect other medicines or be affected by other medicines.

Pregnancy a nd breast -feeding If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before starting ANDEMBRY. There is limited information on the safety of ANDEMBRY use during pregnancy and breast -feeding. As a precaution, it is preferable to avoid the use of ANDEMBRY during pregnancy.Your doctor will discuss with you the risks and benefits of taking this medicine.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines.

ANDEMBRY contains proline

This medicine contains 19.3 mg of proline in each pre -filled pen which is equivalent to 16.1 mg/mL .

Proline may be harmful for patients with hyperprolinaemia, a rare genetic disorder in which proline builds up in the body. If you (or your child) have hyperprolinaemia, do not use this medicine unless your doctor has recommended it.

ANDEMBRY contains polysorbate 80

This medicine contains 0.24 mg of polysorbate 80 in each pre -filled pen which is equivalent to 0.2 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

💊 3. How to use ANDEMBRY

ANDEMBRY is provided in a single -use pre -filled pen. Your treatment will be started and managed under the supervision of a healthcare provider.

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure or have any further questions on the use of this medicine.

How much ANDEMBRY to use The recommended dose of ANDEMBRY is an initial loading dose of 400 mg given as two 200 mg injections on the first day of treatment followed by one 200 mg injection given every month .

How to inject ANDEMBRY You can self inject ANDEMBRY or a caregiver can inject it for you. In both cases, you or your caregiver must carefully read and follow the instructions in section 7, “Instructions for Use”.

• ANDEMBRY is for injection under the skin (‘subcutaneous injection’) in the tummy (abdomen), thigh or upper arm .
• A doctor, pharmacists or nurse should show you how to inject ANDEMBRY properly before you use it for the first time. Do not self -inject or allow a caregiver to inject youuntil you have been trained to inject the medicine.
• Use each pre -filled pen only once.
• If the pre -filled pen does not perform as intended, tell your doctor, pharmacist or nurse as soon as possible.
• Rotation of the injection site is recommended.

If you take more ANDEMBRY than you should

Tell your doctor, pharmacist or nurse if you take too much ANDEMBRY.

If you forget to use ANDEMBRY

If you miss a dose of ANDEMBRY, inject your dose as soon as possible. If you are not sure when to inject ANDEMBRY after a missed dose, ask your doctor, pharmacist or nurse.

If you stop using ANDEMBRY

It is important that you keep injecting ANDEMBRY as instructed by your doctor even if you feel better.

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

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor, pharmacist or nurse if you notice any of the following side effects.

Common (may affect up to 1 in 10 people)

• Injection site reactions including redness, bruising, itchiness , and urticaria
• Headache
• Abdominal pain

Reporting of side effects

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

🌡️ 5. How to store ANDEMBRY

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 outer carton and label after EXP.

The expiry date refers to the last day of that month.

Store in a refrigerator (2 ℃ – 8 ℃). Do not freeze. Keep the pre -filled pen in the outer carton in order to protect from light.

The p re-filled pen may be stored at room temperature (up to 25 ℃ ) for a single period of up to 2 months, but not beyond the expiry date.

Do not return ANDEMBRY to refrigerated storage after storage at room temperature.

Do not use this medicine if you notice signs of deterioration such as particles or changed color of the solution.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What ANDEMBRY contains

• The active substance is garadacimab. Each pre -filled pen contains 200 mg of garadacimab in 1.2 ml solution.
• The other ingredients are histidine, arginine monohydrochloride, proline, polysorbate 80 and water for injection s – see section 2 “ANDE MBRY contains proline and polysorbate 80”.

What ANDEMBRY looks like and contents of the pack

ANDEMBRY is presented as a slightly opalescent to clear, brownish- yellow to yellow solution for injection in a pre -filled pen.

ANDEMBRY is available as a single pack containing one 1.2 ml pre -filled pen and in multipacks of 3 cartons, each containing 1 pre-filled pen.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

CSL Behring GmbH Emil -von-Behring- Strasse 76 D-35041 Marburg Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien CSL Behring NV Tél/Tel: +32 15 28 89 20 Lietuva CentralPharma Communications UAB Tel: + 370 5 243 0444 България МагнаФарм България ЕАД Тел: +359 2 810 3949 Luxembourg/Luxemburg CSL Behring NV Tél/Tel: +32 15 28 89 20 Česká republika CSL Behring s.r.o.

Tel: +420 702 137 233 Magyarország CSL Behring Kft.

Tel: +36 1 213 4290 Danmark CSL Behring AB Tlf: +46 8 544 966 70 Malta AM Mangion Ltd.

Tel: +356 2397 6333 Deutschland CSL Behring GmbH Tel: +49 6190 75 84810 Nederland CSL Behring BV Tel: +31 85 111 96 00 Eesti CentralPharma Communications OÜ Tel: +3726015540 Norge CSL Behring AB Tlf: +46 8 544 966 70 Ελλάδα CSL Behring ΕΠΕ Τηλ: +30 210 7255 660 Österreich CSL Behring GmbH Tel: +43 1 80101 1040 España CSL Behring S.A.

Tel: +34 933 67 1870 Polska CSL Behring Sp. z o.o.

Tel.: +48 22 213 22 65 France CSL Behring SA Tél: +33 1 53 58 54 00 Portugal CSL Behring Lda Tel: +351 21 782 62 30 Hrvatska Marti Farm d.o.o.

Tel: +385 1 5588297 România Prisum Healthcare S.R.L.

Tel: +40 21 322 01 71 Ireland Slovenija CSL Behring GmbH Tel: +49 6190 75 84700 EMMES BIOPHARMA GLOBAL s.r.o .- podružnica v Sloveniji Tel: +386 41 42 0002 Ísland CSL Behring AB Sími: +46 8 544 966 70 Slovenská republika CSL Behring Slovakia s.r.o.

Tel: +421 911 653 862 Italia CSL Behring S.p.A.

Tel: +39 02 34964 200 Suomi/Finland CSL Behring AB Puh/Tel: +46 8 544 966 70 Κύπρος CSL Behring ΕΠΕ Τηλ: +30 210 7255 660 Sverige CSL Behring AB Tel: +46 8 544 966 70 Latvija CentralPharma Communications SIA Tel: +371 6 7450497

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

7. Instructions for Use ANDEMBRY solution for injection in pre-filled p en subcutaneous u se Important:

Parts of the pre-filled pen (see Figure A ):

Continue to next sections to prepare and perform the injection.

Figure A Read the following s afety information:

• Keep the pre -filled pen in its original carton box until use, to protect it from light.
• Do not remove the cl ear pre -filled pen cap until you are ready to inject.
• Do not put the c lear pre -filled pen cap back on the pre -filled pen after it has been removed because this could start the injection and cause injury.

Before use: Expiry date (EXP) printed on label Clear Pre-filled Pen Cap Do not remove until ready to inject Metal part inside Clear Pre -filled Pen Cap Grey Needle Shield (Caution: Needle inside. Do not touch) This pre-filled pen works differently than other injection devices. Read the Instructions for Use carefully before using it, and each time you get a new pre-filled pen . There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

In adolescent patients ANDEMBRY should be given under the supervision of an adult.

Make sure you have been trained by your healthcare provider before you use this pre -filled pen for the first time.

Viewing Window (medicine visible) Plunger Stopper After use, Grey Needle Shield will lock Yellow Plunger filling viewing window when injection is complete After use:

• The pre -filled pen contains 1 dose and is for single -use only. Do not try to reuse the same pre – filled pen.
• Do not use the pre -filled pen if the expiry date has passed.
• The pre -filled pen is for subcutaneous (under the skin) injection only.
• Do not use the pre -filled pen if it looks damaged, has cracks, is leaking medicine, or has been dropped. In these cases, throw away the pre -filled pen as described in Step 11 and use a new one.
• Do not inject through clothing.
• Do not touch or try to remove the grey needle shield at any time.
• Keep ANDEMBRY out of reach of children.

Contact your healthcare provider if you have any questions.

How s hould I store ANDEMBRY?

• Store ANDEMBRY pre -filled pen in a refrigerator, between 2 ˚C to 8 ˚C in its original carton until use, to protect it from light.
• Do not freeze. If the pre-filled pen has been frozen, do not use the pre -filled pen even if it is thawed.
• Take the pre -filled pen out of the refrigerator 30 minutes before use, allowing it to reach room temperature.

Alternative s torage (room temperature)

• If needed, for example when traveling, the pre -filled pen may be stored at room temperature (up to 25˚C ) for a single period of up to 2 months , but not beyond the expiry date .
• If you decide to store the pre-filled pen at room temperature: o In the space provided on the carton box, w rite the date you first remove d the pre-filled pen from the refrigerator to help you keep track of how long it has been stored at room temperature. o do not put the pre -filled pen back in the refrigerator after it has reached room temperature. o throw away the pre-filled pen if it has been stored at room temperature for longer than 2 months (see Step 11. Disposing of the pre -filled pen ).

Supplies needed for your pre-filled pen injection (see Figure B ):

Included in the carton box:

• 1 Single -dose pre-filled pen Required supplies but not included in the carton box:
• 1 alcohol pad
• 1 cotton ball or gauze pad
• 1 sharps container or puncture -resistant container for disposal (see Step 11. Disposing of the pre-filled pen ) Figure B Preparing for an Injection Do not remove the clear pre -filled pen cap until immediately before the injection.

Step 1. Let the p re-filled pen r each room t emperature

• Remove the pre -filled pen from the carton box and place it laying down on a clean flat surface.
• Wait 30 minutes for the medicine to reach room temperature if it was stored in the refrigerator (see Figure C ).
• Injecting the medicine cold could be uncomfortable.
• Do not try to speed up the warming process in any way. For example, do not warm it in a microwave, in hot water, or leave it in direct sunlight.

Cotton ball Alcohol Pad Sharps Container Single -dose Pre-filled pen Included Required but not Included Figure C Step 2. Check the expiry date

• Check the expiry date on the pre- filled pen label (see Figure D ).
• Do not use the pre -filled pen if the expiry date has passed.
• Do not use the pre -filled pen if it has been stored at room temperature for longer than 2 months.
• If the expiry date has passed or if stored at room temperature for longer than 2 months, then safely dispose of the pre -filled pen and take a new one (see Step 11. Disposing of the pre- filled pen ). Room temp. min s Room temp.

Figure D Step 3. Inspect the pre-filled pen and the medicine

• Check the pre -filled pen for damage .
• Check the medicine through the viewing window of the pre -filled pen (see Figure E ).
• It is normal to see air bubbles, do not try to remove the air bubbles.
• The medicine should be brownish- yellow to yellow and may appear slightly opalescent to clear.
• Do not use the pre -filled pen , safely dispose of it and take a new one (see Step 11. Disposing of the pre -filled pen ) if:

o The medicine is discoloured or contains particles

o The pre -filled pen looks damaged or has cracks o The pre -filled pen is leaking o The pre -filled pen has been dropped on a hard surface, even if it does not look damaged LOT: XXXXXX EXP: MMMYYYY Figure E Choose and p repare an i njection site Step 4. Clean your h ands

• Wash your hands well with soap and water or use hand sanitizer (see Figure F ).

Figure F Step 5. Select the injection s ite

• Inject into the thigh or belly (abdomen) area , but stay 2 cm away from the belly button (navel) (see Figure G )
• If somebody else (caregiver) gives you the injection, they can also use the upper arm. Do not try to inject into the upper arm yourself.
• Change (rotate) your injection site with each injection. Do not inject in the same place multiple times if the skin is damaged.
• Do not inject into the belly button, moles, scars or bruises, or into areas where the skin is tender, red, hard, or injured.

Figure G Step 6. Prepare the i njection s ite

• Clean the injection site with an alcohol pad (see Figure H ).
• Let your skin dry on its own.
• Do not touch this area again before injecting .
• Do not fan or blow on the skin area that you cleaned.

Figure H Injecting the Medicine with the Pre -filled pen Complete the injection without stopping. Read all steps first before beginning.

Do not remove the clear cap until you are ready to inject.

Self-injection sites Caregiver Injection sites Step 7. Remove c lear p re-filled pen cap and d ispose of the c ap

• Hold the pre -filled pen with one hand and pull the clear pre -filled pen cap straight off with the other hand.
• Do not twist the Clear Cap, (see Figure I ). If you cannot remove the Clear Cap, ask a caregiver for help or contact your healthcare provider .
• The Clear Cap has a metal part inside, this is normal.
• Do not put the Clear Cap back on after it has been removed, because this could start the injection and cause injury.
• Dispose of the Clear Cap in a sharps container or closed puncture -resistant container .

Important:

• Do not touch the grey needle shield of the pre -filled pen to avoid injury.
• Do not put the pre -filled pen down after removing the Clear Cap.

Figure I Clear Pre-filled Pen Cap Grey Needle Shield Do not touch Step 8. Pinch the s kin and place the pre-filled pen on the injection site Immediately after removing the clear pre-filled pen cap, complete the following steps without stopping:

• Gently pinch the area of cleaned skin around the injection site and hold the area firmly until the injection is complete (see Figure J ).
• Place the pre -filled pen at a 90˚ angle on the cleaned injection site (see Figure J ).
• Make sure you can see the viewing window.

Figure J Step 9. Inject Medicine (see Figure K) Figure K

• Do not remove the pre -filled pen until the yellow plunger has stopped moving and completely filled the viewing window, and 5 seconds has passed after the Second “c lick.”
• Do not remove, tilt, or rotate the pre -filled pen during the injection.

Press the grey needle shield down firmly against the pinched skin to start the injection and keep pressing down until all the steps below are complete.

Press down to start the injection and listen for a First ‘click’ .

• The First “ click” means the injection has started.
• The yellow plunger will start moving in the viewing window.

Keep pressing the pre-filled pen down. Keep pressing the pre -filled pen down and watch the viewing window.

• The window will turn yellow and
• You will hear a Second ‘click’.

Keep pressing the pre-filled pen down. Keep pressing the pre -filled pen down for 5 more seconds to make sure you get the full dose.

You must read all of Step 9 before injecting.

The injection may take up to 15 seconds.

To ensure you receive a full dose you must keep the pre -filled pen firmly pressed against your pinched skin until:

• The y ellow plunger has stopped moving and filled the viewing window , and
• 5 seconds has passed after the 2nd “click.” Watch window turn yellow First ‘Click’ Second ‘Click’ Keep pressing down Press down to start Keep pressing down for 5 more seconds Step 10. Release the p inch and r emove the p re-filled pen
• Release the pinch and remove the pre -filled pen at a 90° angle from the skin (see Figure L).
• As the pre -filled pen is lifted from the skin, the grey needle shield will return to the original (before use) position, and lock into place, covering the needle.

Figure L Important: If you think that you have not received the full dose contact your healthcare provider right away.

• If there is a little bleeding at the injection site, you can press a cotton ball or gauze over the injection site.
• Do not rub the injection site.
• If needed, you may cover the injection site with a small adhesive bandage.

66 Disposal Step 11. Disposing of the pre-filled pen

• Do not try to reuse the pre-filled pen.
• After injecting your dose, put the pre -filled pen into a sharps container or closed puncture- resistant container (see Figure M ).

Figure M

• If you do not have a sharps container or closed puncture resistant container , you may use a household container that is: o Made of heavy -duty plastic o Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out o Upright stable during use o Leak -resistant o Properly labeled to warn of hazardous waste inside the container
• When your sharps container is almost full, you will need to follow your local guidelines for the right way to dispose of your sharps container.

Ask your pharmacist / healthcare provider for more information on how to dispose of your sharps container.

• Do not dispose of your used sharps container in your household trash unless your local guidelines permit this.
• Do not recycle your used sharps container.

Sharps Container 67 Step 12. Keep track of your t reatment

• If required by your physician, record your injection in a diary to help keep track of your medicine .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information ANDEMBRY (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/24/1885).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.