Plerixafor Seacross 20 mg/ml solution for injection EFG

Package leaflet: Information for the user

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 questions, ask your doctor.
• If you get any side effects, talk to your doctor or nurse, even if it is not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Plerixafor Seacross 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 inadequate, 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 year to less than 18 years of age with lymphoma or solid tumors.

2. What you need to know before starting to use Plerixafor Seacross

Do not use Plerixafor Seacross

• 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 before starting to use plerixafor.

Inform 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 fainting or dizziness when 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 Seacross

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 are planning to become pregnant. Contraceptive methods are 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 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 unit, which is essentially “sodium-free”.

3. How to use Plerixafor Seacross

Your doctor or a nurse will inject your medicine.

You will first receive G-CSF and then Plerixafor Seacross 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 Seacross 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, aged 1 to less than 18 years, is 0.24 mg/kg body weight/day.

Your dose will depend on your body weight, which should 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 Seacross administered?

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

When is Plerixafor Seacross 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 Seacross 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 discontinued.

If you have any further questions about 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

• 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 you faint.
• 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)

• diarrhoea, nausea, redness or irritation at the injection site.
• low red blood cell count in laboratory tests (anaemia 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, bloating or discomfort.
• dry mouth, numbness around the mouth.
• sweating, generalised skin redness, 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 may be severe (diarrhoea, 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 experience these symptoms. However, these effects do not appear to occur more frequently when plerixafor is used.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side 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 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 stated on the carton and vial 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, this 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 no longer required. This helps protect the environment.

6. Contents of the pack and other information

Composition of Plerixafor Seacross

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

Nature of the product and contents of the container

Plerixafor Seacross is supplied as a clear, colourless injectable solution in a glass vial with a chlorobutyl rubber stopper and an aluminium seal with a plastic cap. Each vial contains 1.2 ml of solution.

Each pack contains 1 vial.

Marketing Authorisation Holder and Manufacturer Responsible

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 medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of the last review of this leaflet: June 2023

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

This information is intended for healthcare professionals only:

Refer to the summary of product characteristics for further information.