Andembry 200 mg solution for injection in pre-filled pen

Patient Information Leaflet

Introduction

Patient Information Leaflet

ANDEMBRY 200 mg injection solution in a pre-filled pen
garadacimab

This medicinal product is subject to additional monitoring, which will allow for faster detection of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is provided at the end of section 4.

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

• Keep this leaflet as you may need to read it again.

• If you have any questions, consult your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.

  • If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. See section 4.

Leaflet Contents

1. What ANDEMBRY is and what it is used for
2. What you need to know before using ANDEMBRY
3. How to use ANDEMBRY
4. Possible adverse reactions
5. How to store ANDEMBRY
6. Contents of the pack and other information
7. Instructions for use

1. What ANDEMBRY is and what it is used for

ANDEMBRY contains the active substance garadacimab.

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

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

• hands and feet;
• face, eyelids, lips, or tongue;
• larynx and throat, which may make breathing difficult;
• genitals;
• stomach and intestines.

HAE attacks can be painful and disabling. Attacks affecting the throat or larynx can be dangerous or even life-threatening.

Although HAE often runs in families, some people may not have a family history. Three types of HAE are known, depending on the type of genetic defect and its effect on a protein circulating in the blood called C1 esterase inhibitor (C1-INH). A person may have low levels of C1-INH in the body (HAE type I), dysfunctional C1-INH (HAE type II), or HAE with normal C1-INH function (HAE type III). The latter type is extremely rare. All three types produce the same clinical symptoms of localized 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 inhibiting FXIIa activity, garadacimab reduces bradykinin levels, thereby preventing HAE attacks. Some subcategories of HAE with normal C1-INH 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 using ANDEMBRY

Do not use ANDEMBRY

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

Warnings and precautions

• Consult your doctor, pharmacist, or nurse before starting to use ANDEMBRY.
• If you experience a severe allergic reaction to ANDEMBRY with symptoms such as hives, chest tightness, difficulty breathing, wheezing, hypotension, or anaphylaxis, inform your doctor, pharmacist, or nurse immediately.
• Treat an attack of hereditary angioedema with your usual rescue medication without taking additional doses of ANDEMBRY.

Keep a record

It is strongly recommended that each time ANDEMBRY is administered, you record the name and batch number of the medicine. This will help you keep a record of the batches used.

Laboratory tests

Inform your doctor if you are using ANDEMBRY before undergoing laboratory tests to measure your blood coagulation. This is because ANDEMBRY may interfere with certain laboratory tests and lead to inaccurate results.

Children and adolescents

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

Other medicines and ANDEMBRY

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

It is not known that ANDEMBRY affects other medicines or is affected by other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using ANDEMBRY. There is limited information on the safety of using ANDEMBRY during pregnancy and breastfeeding. As a precautionary measure, it is preferable to avoid using ANDEMBRY during pregnancy. Your doctor will discuss with you the risks and benefits of taking this medicine.

Driving and using machines

The effect of this medicine on the ability to drive and use machines is none or negligible.

ANDEMBRY contains proline.

This medicine contains 19.3 mg of proline per pre-filled pen, equivalent to 16.1 mg/mL. Proline may be harmful in patients with hyperprolinemia, a rare genetic disorder in which proline accumulates in the body. If you (or your child) have hyperprolinemia, do not use this medicine unless recommended by your doctor.

ANDEMBRY contains polysorbate 80.

This medicine contains 0.24 mg of polysorbate 80 per pre-filled pen, equivalent to 0.2 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use ANDEMBRY

ANDEMBRY is supplied in a single-use, pre-filled pen. Your treatment will begin under the supervision and management of a healthcare professional.

Follow exactly the instructions for administering the medicine provided in this leaflet or as directed by your doctor, pharmacist, or nurse. If you have any doubts or further questions about the use of this medicine, consult your doctor, pharmacist, or nurse again.

How much ANDEMBRY to use

The recommended dose of ANDEMBRY is an initial loading dose of 400 mg administered as two injections of 200 mg on the first day of treatment, followed by a monthly dose of 200 mg.

How to inject ANDEMBRY

You may self-administer ANDEMBRY or have a caregiver administer it to you. In either case, you or your caregiver must carefully read and follow the instructions in section 7, “Instructions for use”.

• ANDEMBRY is administered subcutaneously (under the skin) in the abdomen, thigh, or upper arm.
• A doctor, pharmacist, or nurse must show you how to correctly administer ANDEMBRY before you use it for the first time. Do not self-administer or allow a caregiver to administer the medicine until you have received proper training on how to inject it.
• Use each pre-filled pen only once.
• If the pen does not work as intended, inform your doctor, pharmacist, or nurse as soon as possible.
• It is recommended to rotate injection sites.

If you use more ANDEMBRY than you should

Inform your doctor, pharmacist, or nurse if you use too much ANDEMBRY.

If you forget to use ANDEMBRY

If you miss a dose of ANDEMBRY, administer your dose as soon as possible. If you are unsure about when to inject ANDEMBRY after a missed dose, consult your doctor, pharmacist, or nurse.

If you stop treatment with ANDEMBRY

It is important that you continue to take ANDEMBRY as directed 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Frequent (may affect up to 1 in 10 people):

• Reactions at the site of administration including redness, bruising, itching, and urticaria
• Headache
• Abdominal pain

Reporting of adverse effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national system included in Appendix V.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ANDEMBRY

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the outer carton and label after EXP. The expiry date refers to the last day of the month indicated.

Store in the refrigerator (between 2 °C - 8 °C). Do not freeze. Keep the pre-filled pen in the outer packaging to protect it from light.

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.

Do not return ANDEMBRY to the refrigerator after it has been stored at room temperature.

Do not use this medicine if you notice signs of deterioration, such as particles or a change in the solution's colour.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of ANDEMBRY

• The active substance is garadacimab. Each pre-filled pen contains 200 mg of garadacimab in 1.2 ml of solution.
• The other components are histidine, arginine monohydrochloride, proline, polysorbate 80 and water for injections; see section 2 “ANDEMBRY contains proline and polysorbate 80”.

Appearance of ANDEMBRY and contents of the pack

ANDEMBRY is presented as a yellowish-brown to yellow, slightly opalescent to clear, injectable solution in a pre-filled pen.

ANDEMBRY is available in individual packs containing one 1.2 ml pre-filled pen, and in multiple packs of 3 cartons, each containing 1 pre-filled pen.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

CSL Behring GmbH

Emil-von-Behring-Strasse 76

D-35041 Marburg

Germany

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

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu. There are also links to other websites about rare diseases and orphan medicines.

7. Instructions for use

ANDEMBRY injectable solution in

pre-filled pen

for subcutaneous use

Important:

Parts of the pen ( see Figure A):

Proceed to the following sections to prepare and administer the injection.

Read the following safety information:

• Keep the pre-filled pen in its original carton until use to protect it from light.
• Do not remove the transparent pen cap before the time of injection.
• Do not reattach the transparent cap of the pre-filled pen after removal, as this could initiate the injection and cause injury.
• The pre-filled pen contains 1 dose and is for single use only. Do not reuse the same pre-filled syringe.
• Do not use the pre-filled pen if the expiration date has passed.
• The pre-filled pen is for subcutaneous injection (under the skin) only.
• Do not use the pre-filled pen if it appears damaged, has cracks, leaks medication, or has been dropped. In such cases, dispose of the pre-filled pen as described in step 11 and use a new one.
• Do not administer the medication through clothing.
• Do not touch or attempt to remove the gray needle shield at any time.
• Keep ANDEMBRY out of sight and reach of children.

Contact your healthcare provider if you have any questions.

How should I store ANDEMBRY?

• Store the ANDEMBRY pre-filled pen in the refrigerator at 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 it even if it has thawed.
• Remove the pre-filled pen from the refrigerator 30 minutes before use to allow it to reach room temperature.

Alternative storage (room temperature):

• If necessary, 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 expiration date.
• If you choose to store the pre-filled pen at room temperature:
  • In the space provided on the carton, write the date when you first removed the pre-filled pen from the refrigerator to help track how long it has been stored at room temperature.
  • Do not return the pre-filled pen to the refrigerator after it has reached room temperature.
  • Dispose of the pre-filled pen if it has been stored at room temperature for more than 2 months (see step 11. Disposal of the pre-filled pen).

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

Included in the carton:

• 1 single-dose pre-filled pen

Supplies needed but not included in the carton:

• 1 alcohol swab
• 1 cotton ball or gauze pad
• 1 sharps container or puncture-resistant container for disposal (see step 11. Disposal of the pre-filled pen).

Preparation for administration

Do not remove the transparent pen cap until immediately before administration.

Step 1. Allow the pre-filled pen to reach room temperature.

• Remove the pre-filled pen from the carton and place it on a clean, flat surface.
• Wait 30 minutes for the medication to reach room temperature if it has been refrigerated (see Figure C).
• Injecting cold medication may cause discomfort.
• Do not attempt to speed up the warming process in any way. For example, do not heat it in a microwave, in warm water, or leave it in direct sunlight.

Step 2. Check the expiration date

• Check the expiration date on the label of the pre-filled pen (see Figure D).
• Do not use the pre-filled pen if the expiration date has passed.
• Do not use the pre-filled pen if it has been stored at room temperature for more than 2 months.
• If the expiration date has passed or if it has been stored at room temperature for more than 2 months, safely dispose of the pre-filled pen and take a new one (see step 11. Disposal of the pre-filled pen).

Step 3. Inspect the pre-filled pen and medication

• Check that the pre-filled pen is not damaged.

• Inspect the medication through the viewing window of the pre-filled pen (see Figure E).

• It is normal to see air bubbles; do not attempt to remove them.

• The medication should be brownish-yellow to yellow and may appear slightly opalescent to clear.

• Do not use the pre-filled pen, dispose of it safely, and take a new one (see step 11. Disposal of the pre-filled pen) if:

• The medication is discolored or contains particles.

• The pre-filled pen appears damaged or has cracks.

• The pre-filled pen is leaking.

• The pre-filled pen has been dropped on a hard surface, even if it does not appear damaged.

Choose and prepare an injection site

Step 4. Wash your hands.

• Wash your hands with soap and water or use a disinfectant solution (see Figure F).

Step 5. Select the subcutaneous (SC) injection site

• Inject into the thigh or abdomen, but stay at least 2 cm away from the navel (see Figure G).
• If another person (caregiver) is administering the injection, the upper arm may also be used. Do not attempt to self-inject into the upper arm.
• Rotate the injection site with each injection. Do not inject repeatedly into the same area if the skin is damaged.
• Do not inject into the navel, moles, scars, or bruises, or in areas where the skin is tender, red, hard, or injured.

Step 6. Prepare the injection site

• Clean the injection site with an alcohol swab (see Figure H).
• Allow the skin to air dry.
• Do not touch this area again before administration.
• Do not fan or blow on the cleaned skin area.

Administering the medication with the pre-filled pen

Step 7. Remove and discard the transparent cap from the pre-filled pen

• Hold the pre-filled pen with one hand and remove the transparent cap by pulling it off with the other hand.
• Do not twist the transparent cap (see Figure I). If you cannot remove the transparent cap, seek help from a doctor or contact your healthcare professional.
• The transparent cap has a metallic part inside; this is normal.
• Do not reattach the transparent cap after removing it, as this could start the injection and cause injury.
• Dispose of the needle cap in a sharps or puncture-resistant container.

Step 8. Pinch the skin and place the pre-filled pen at the injection site

Immediately after removing the clear cap from the pre-filled pen, complete the following steps without delay:

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

Step 9. Injecting the Medication (see figure K)

Figure K

• Do not remove the pre-filled pen until the yellow plunger stops moving and completely fills the viewing window, and 5 seconds have passed after the second “click.”
• Do not remove, tilt, or rotate the pre-filled pen during injection.

Step 10. Release the skin pinch and remove the pre-filled pen

• Release the pinched skin and remove the pre-filled pen from the skin at a 90º angle (see Figure L).
• As the pre-filled pen is lifted from the skin, the gray needle shield will return to its original position (before use) and lock into place to cover the needle.

Important: If you think you did not receive the full dose, contact your healthcare provider immediately.

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

Residual

Step 11. Disposal of the pre-filled pen

• Do not reuse the pre-filled pen.
• After administering the dose, place the pre-filled pen in a sharps container or in a puncture-resistant, closed container (see Figure M).

• If you do not have a sharps container or a closed, puncture-resistant container, you may use a household container that:
  • Is made of heavy-duty plastic.
  • Can be closed with a tight, puncture-resistant lid, preventing sharp parts from coming out.
  • Remains stable in an upright position during use.
  • Is leak-resistant.
  • Is properly labeled to warn of hazardous waste inside the container.
• When your sharps container is nearly full, follow local guidelines for proper disposal. Ask your pharmacist or healthcare professional for more information on how to dispose of your sharps container.
• Do not dispose of used sharps containers in household trash unless local guidelines permit it.
• Do not recycle your used sharps container.

Step 12. Treatment follow-up

• If required by your doctor, record the administration in a diary to help track your medication.