Prospecto: information for the user

Plerixafor Seacross 20 mg/ml injectable solutionEFG

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor.

-If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this prospect. See section 4.

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

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

3.How to use Plerixafor Seacross

4.Possible adverse effects

5.Storage of Plerixafor Seacross

6.Contents of the package and additional information

Plerixafor Seacross contains the active ingredient plerixafor that blocks a protein on the surface of hematopoietic stem cells. This protein "fixes" the stem cells in the bone marrow. Plerixafor improves the release of the stem cells into the circulatory system ( mobilization). The stem cells can be collected with a device that separates the blood components (apheresis machine), and then frozen and stored until transplantation.

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

•In adult patients with lymphoma (a cancer of white blood cells) or multiple myeloma (a cancer that affects the plasma cells of bone marrow).

•In children 1 year and under 18 years with lymphoma or solid tumors.

Do not use Plerixafor Seacross

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

Warnings and precautions

Consult your doctor before starting to useplerixafor.

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 dizziness or lightheadedness when standing or sitting, or if you have fainted after injections.

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

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

Other medications and Plerixafor Seacross

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

Pregnancy and breastfeeding

You should not use plerixafor if you are pregnant, as there is no data on the effects ofplerixafor on pregnant women. It is essential to inform your doctor if you are pregnant, think you may be pregnant, or intend to become pregnant. Contraception is recommended if you are of childbearing age.

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

Driving and operating machinery

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

Plerixafor Seacross contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose unit, which is essentially “sodium-free”.

Your doctor or a nurse will administer your medication.

You will first receive G-CSF and then be administered Plerixafor Seacross.

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

How much Plerixafor Seacross is administered?

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

The recommended dose in children, from 1 to less than 18 years, is 0.24 mg/kg of 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 Seacross administered?

Plerixafor is administered via 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 your blood stem cells).

How long will the administration of Plerixafor Seacross last?

The treatment lasts from 2 to 4 consecutive days (in some cases up to 7 days), until sufficient stem cells have been collected for your transplant. In some cases, it is not possible to collect a sufficient number of stem cells, and the attempt to collect will be interrupted.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately if

•you experience skin rash, swelling around the eyes, difficulty breathing or lack of oxygen, feeling dizzy while standing or sitting, feeling of fainting or fainting 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 skin redness, 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.

•altered 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 receiving plerixafor and G-CSF. Inform your doctor immediately if you have chest pain.

Tickling and numbness

Tickling and numbness are common in patients receiving cancer treatment. Approximately one in five patients experience them. However, these effects do notappear 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 side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the vialafter “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Once the vial is opened, this medication must be used immediately.

Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Plerixafor Seacross

-The active ingredient is plerixafor. Each ml of injectable solution contains 20 mg of plerixafor.Cada 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 the pH and water for injectable preparations.

Appearance of the product and contents of the package

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

Cada envase contains 1 vial.

Holder of the marketing authorization and responsible 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, Office 7

29007 Málaga, (Spain)

Tel: 676295501

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:June2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

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This information is intended solely for healthcare professionals:

Consult the product characteristics summary for more information.