PLERIXAFOR SEACROSS 20 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Plerixafor Seacross 20 mg/ml Solution for InjectionEFG

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, even if you have read it in this leaflet. See section 4.

Contents of the pack

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

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

Plerixafor Seacross 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 be collected with 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 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 Seacross

Do not use Plerixafor Seacross

• 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.

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

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

Other medicines and Plerixafor Seacross

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 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.

You should not breastfeed 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 Seacross contains sodium

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

3. How to use Plerixafor Seacross

Your doctor or nurse will inject the medicine into you.

First, you will receive G-CSF and then you will be given Plerixafor Seacross

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 much Plerixafor Seacross 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, 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 is Plerixafor Seacross given?

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

When is Plerixafor Seacross given 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 Seacross 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 is not possible to collect enough stem cells, so the collection attempt will be interrupted.

If you have any further questions on 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 immediately if

• after receiving plerixafor, you have a skin rash, swelling around the eyes, difficulty breathing, or 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 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.
• disturbed 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 had a myocardial infarction after administration of plerixafor and G-CSF. Tell your doctor immediately if you have 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 using plerixafor.

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 or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Plerixafor Seacross

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 shown.

This medicine does not require any special storage conditions.

Once the vial is opened, this medicine 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

What Plerixafor Seacross contains

• 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, hydrochloric acid, and sodium hydroxide to adjust the pH, and water for injections.

Appearance and pack contents

Plerixafor Seacross is supplied as a clear, colorless solution for injection in a glass vial with a rubber stopper and an aluminum seal with a plastic cap. Each vial contains 1.2 ml of solution.

Each pack contains 1 vial.

Marketing authorization holder and manufacturer

Seacross Pharma (Europe) Limited

POD 13, The Old Station House

15A Main Street, Blackrock

Dublin, A94 T8P8

Ireland

Local representative

Pharmavic Ibérica, S.L.

C/ Compositor Lehmberg Ruiz

6 Edificio Ibiza, Oficina 7

29007 Málaga, (Spain)

Tel: 676295501

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

Date of last revision of this leaflet:June2023

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

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This information is intended only for healthcare professionals:

Consult the summary of product characteristics for more information.