PLERIXAFOR EUGIA 20 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Plerixafor Eugia 20 mg/ml Solution for Injection EFG

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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Plerixafor Eugia and what is it used for
2. What you need to know before you use Plerixafor Eugia
3. How to use Plerixafor Eugia
4. Possible side effects
5. Storage of Plerixafor Eugia
6. Contents of the pack and further information

1. What is Plerixafor Eugia and what is it used for

Plerixafor Eugia contains the active substance plerixafor, which blocks a protein on the surface of hematopoietic stem cells. This protein "fixes" the stem cells to the bone marrow. Plerixafor improves the release of stem cells into the bloodstream (mobilization). The stem cells can then be collected using a machine that separates the components of the blood (apheresis machine), then frozen and stored until they are transplanted.

If mobilization is poor, plerixafor is given to help collect stem cells from the patient's blood for collection, storage, and re-infusion (transplantation):

• In adult patients with lymphoma (a cancer of white blood cells) or multiple myeloma (a cancer that affects the plasma cells of the bone marrow).
• In children from 1 to less than 18 years with lymphoma or solid tumors.

2. What you need to know before you use Plerixafor Eugia

Do not usePlerixafor Eugia

• If you are allergic to plerixafor or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with plerixafor:

• If you have or have had any heart problems.
• If you have kidney problems. Your doctor may adjust your dose.
• If you have a high number of white blood cells.
• If you have a low number of platelets.
• If you have a history of feeling faint or dizzy while standing or sitting, or if you have fainted after injections in the past.

Your doctor may perform blood tests periodicallyto monitor the number of blood cells.

Plerixafor is not recommended for stem cell mobilization if you have leukemia (a cancer of the blood or bone marrow).

Other medicines andPlerixafor Eugia

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

Pregnancy and breast-feeding

Do not use plerixafor if you are pregnant, as there are no data on the effects of plerixafor in pregnant women. It is important that you inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. The use of contraceptive methods is recommended if you are of childbearing age.

Do not breast-feed if you are using this medicine, as it is not known whether plerixafor passes into breast milk.

Driving and using machines

Plerixafor may cause dizziness and fatigue. Therefore, you should avoid driving if you feel dizzy, tired, or unwell.

Plerixafor Eugia contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

3. How to use Plerixafor Eugia

A doctor or nurse will inject your medicine.

First, you will receive G-CSF and then plerixafor will be administered

Mobilization will begin by administering another medicine called G-CSF (granulocyte colony-stimulating factor) first. G-CSF will help plerixafor work properly in your body. If you want more information about G-CSF, ask your doctor and read the corresponding package leaflet.

How much Plerixafor Eugia is administered?

The recommended dose in adults is 20 mg (fixed dose) or 0.24 mg/kg body weight/day.

The recommended dose in children, from 1 to less than 18 years, is 0.24 mg/kg body weight/day.

Your dose will depend on your body weight, which must be measured the week before you receive the first dose. If you have moderate or severe kidney problems, your doctor will reduce the dose.

How is Plerixafor Eugia administered?

Plerixafor is administered by subcutaneous injection (under the skin).

When is Plerixafor Eugia administered for the first time?

You will receive the first dose between 6 and 11 hours before apheresis (collection of stem cells from your blood).

How long will the administration of Plerixafor Eugia last?

Treatment lasts from 2 to 4 consecutive days (in some cases up to 7 days), until enough stem cells have been collected for transplantation. In some cases, it may not be possible to collect enough stem cells, so the collection attempt will be interrupted.

4. Possible side effects

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

Tell your doctor immediately if:

• after receiving plerixafor, you experience a skin rash, swelling around the eyes, difficulty breathing, or a lack of oxygen, feeling dizzy while standing or sitting, feeling faint, or fainting.
• you feel pain in the upper left part of your abdomen (stomach) or in your left shoulder.

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

• diarrhea, nausea, redness, or irritation at the injection site.
• low red blood cell count in laboratory tests (anemia in children).

Common side effects(may affect up to 1 in 10 people)

• headache.
• dizziness, feeling tired, or feeling unwell.
• difficulty sleeping.
• flatulence, constipation, indigestion, vomiting.
• stomach symptoms such as pain, swelling, or discomfort.
• dry mouth, numbness around the mouth.
• sweating, generalized redness of the skin, joint pain, muscle and bone pain.

Uncommon side effects(may affect up to 1 in 100 people)

• allergic reactions, such as skin rash, swelling around the eyes, difficulty breathing.
• anaphylactic reactions, including anaphylactic shock.
• abnormal dreams, nightmares.

In rare cases, gastrointestinal side effects can be severe (diarrhea, vomiting, stomach pain, and nausea).

Myocardial infarction

In clinical trials, with low frequency, patients with risk factors for myocardial infarction experienced a myocardial infarction after administration of plerixafor and G-CSF. Tell your doctor immediately if you experience chest discomfort.

Numbness and tingling

Numbness and tingling are common in patients receiving cancer treatment. About one in five patients experience them. However, these effects do not seem to occur more frequently when plerixafor is used.

You may also have an increased number of white blood cells in your blood tests (leukocytosis).

Reporting of side effects

If you experience 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 through the Spanish Medicines Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Plerixafor Eugia

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 carton and on the vials after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

After opening the vial, the medicine should be used immediately.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition ofPlerixafor Eugia

• The active substance is plerixafor. Each ml of solution for injection contains 20 mg of plerixafor. Each vial contains 24 mg of plerixafor in 1.2 ml of solution.
• The other ingredients are: sodium chloride, sodium hydroxide (pH adjustment), hydrochloric acid (pH adjustment), and water for injections.

Appearance of the productand pack contents

Plerixafor Eugia is a clear, colorless or pale yellow solution, free from visible particles, in a transparent glass vial closed with a gray bromobutyl rubber stopper and sealed with an aluminum cap with a polypropylene disk.

Each vial contains 1.2 ml of solution.

Each pack contains 1 vial.

Marketing authorization holder and manufacturer

Marketing authorization holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19, Venda Nova

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Plerixafor PUREN 20 mg/ml Injektionslösung

Spain: Plerixafor Eugia 20 mg/ml solución inyectable EFG

France: Plerixafor Arrow 20 mg/ml, solution pour injection

Italy: Plerixafor Aurobindo

Portugal: Plerixafor Generis

Date of last revision of this leaflet: January 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).