PLERIXAFOR EUGIA 20 MG/ML SOLUTION FOR INJECTION EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Plerixafor Eugia 20 mg/ml injection solution EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

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

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

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

2. What you need to know before using Plerixafor Eugia

Do not use Plerixafor Eugia

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using 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 white blood cell count.
• If you have a low platelet count.
• If you have a history of feeling faint or dizzy while standing or sitting, or if you have previously fainted after injections.

Your doctor may carry out regular blood tests to monitor your blood cell counts.

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

Other medicines and Plerixafor Eugia

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

Pregnancy and breastfeeding

You must not use plerixafor if you are pregnant, as there are no data available on the effects of plerixafor in pregnant women. It is important that you inform your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant. Use of contraception is recommended if you are of childbearing age.

You must not breastfeed while using this medicine, as it is unknown whether plerixafor passes into breast milk.

Driving and use of 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 unit; essentially, it is "sodium-free".

3. How to use Plerixafor Eugia

A doctor or nurse will inject your medicine.

You will first receive G-CSF and then plerixafor will be administered

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

How much Plerixafor Eugia is given?

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 of age, 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 given 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 Plerixafor Eugia administration last?

Treatment lasts for 2 to 4 consecutive days (in some cases up to 7 days), until enough stem cells have been collected for your transplant. In some cases, it may not be possible to collect a sufficient number of stem cells, in which case the collection attempt will be stopped.

4. Possible adverse effects

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

Tell your doctor immediately if:

• shortly after receiving plerixafor, you develop a rash, swelling around the eyes, difficulty breathing or shortness of breath, dizziness when 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 adverse 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 adverse effects (may affect up to 1 in 10 people)

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

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

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

Occasionally, gastrointestinal adverse effects may be severe (diarrhea, vomiting, stomach pain and nausea).

Myocardial infarction

In clinical trials, myocardial infarction occurred infrequently in patients with risk factors for myocardial infarction after administration of plerixafor and G-CSF. Inform your doctor immediately if you experience chest discomfort.

Tingling and numbness

Tingling and numbness are common in patients receiving cancer treatment. Approximately one in five patients experiences these symptoms. However, these effects do not appear to occur more frequently with the use of plerixafor.

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Plerixafor Eugia Storage

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

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

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 and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Plerixafor Eugia

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

Appearance of the product and contents of the container

Plerixafor Eugia is a clear, colourless or pale yellow solution, free from visible particles, contained in a clear glass vial closed with a grey bromobutyl rubber stopper and sealed with an aluminum cap with a polypropylene disc.

Each vial contains 1.2 ml of solution.

Each pack contains 1 vial.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

Further information on this medicinal product is available by contacting the local representative of the Marketing Authorisation Holder:

Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain

This medicinal product is authorised 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 the most recent review of this leaflet: January 2023

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