PLERIXAFOR TILLOMED 20 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

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

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

Plerixafor Tillomed contains the active substance plerixafor, which blocks a protein on the surface of hematopoietic stem cells. This protein "anchors" the blood 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 transplantation.

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 type of white blood cell cancer) or multiple myeloma (a type of cancer that affects the 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 you use Plerixafor Tillomed

Do not usePlerixafor Tillomed:

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

Warnings and precautions

Talk to your doctor before you start using plerixafor.

Tell your doctor:

• 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 the mobilization of stem cells if you have leukemia (a type of blood or bone marrow cancer).

UsingPlerixafor Tillomedwith other medicines

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

Pregnancy and breastfeeding

You should not use plerixafor if you are pregnant, as there is no data 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. The use of contraceptive methods is recommended if you are of childbearing age.

You should not breastfeed if you are using plerixafor, 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 Tillomedcontainssodium

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

3. How to use Plerixafor Tillomed

Your doctor or nurse will give you the injection.

First, you will receive G-CSF and then you will be givenPlerixafor Tillomed

Mobilization will start by giving you another medicine called G-CSF (granulocyte-colony stimulating factor). 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 muchPlerixafor Tillomedis 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 may reduce the dose.

How isPlerixafor Tillomedgiven?

Plerixafor Tillomed is given by subcutaneous injection (under the skin).

When isPlerixafor Tillomedgiven 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 ofPlerixafor Tillomedlast?

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 stopped.

4. Possible side effects

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

Tell your doctor immediately if

• you experience a rash, swelling around the eyes, difficulty breathing, or a lack of oxygen, dizziness while standing or sitting, or fainting, shortly after receiving plerixafor;
• 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 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 rash, swelling around the eyes, difficulty breathing;
• anaphylactic reactions, including anaphylactic shock;
• disturbed dreams, nightmares.

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

Myocardial infarction

In clinical trials, patients with risk factors for myocardial infarction rarely 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 (leucocytosis).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Plerixafor Tillomed

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 vial after EXP. The expiry date is the last day of the month stated.

Store below 25°C. Once the vial is opened, Plerixafor Tillomed must 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. This will help protect the environment.

6. Contents of the pack and other information

Composition of Plerixafor Tillomed

• 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 (excipients) are sodium chloride, hydrochloric acid, and sodium hydroxide to adjust the pH, water for injections, and nitrogen.

Appearance of the product and pack contents

Plerixafor Tillomed is presented as a clear, colorless, or pale yellow solution for injection in a glass vial with a rubber stopper. Each vial contains 1.2 ml of solution.

Each pack contains 1 vial.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Tillomed Spain, S.L.U.

C/ Cardenal Marcelo Spínola 8, 1st floor, door F, 28016 Madrid, Spain

Manufacturer(1)

MIAS Pharma Limited

Suite 1, First floor, Stafford House, Strand Road, Portmarnock, Co. Dublin, D13 WC83, Ireland

Tillomed Malta Limited

Malta Life Sciences Park, LS2.01.06 Industrial Estate, San Gwann SGN 3000, Malta

1 only the manufacturer of the product is indicated in the package leaflet

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

Date of last revision of this leaflet: March 2023

Other sources of information

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/