PLERIXAFOR STADA 20 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Plerixafor Stada 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 pack

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

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

This medicine 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 then be collected using a machine that separates the components of the blood (apheresis machine), then frozen and stored until they are transplanted.

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 between 1 and less than 18 years old with lymphoma or solid tumors.

2. What you need to know before you use Plerixafor Stada

Do not use Plerixafor Stada

• 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 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 Stada

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

Pregnancy and breast-feeding

Do 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 may be pregnant, or plan to become pregnant. The use of contraceptive methods is recommended if you are of childbearing age.

Do not breast-feed 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 Stada contains sodium

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

3. How to use Plerixafor Stada

Your doctor or nurse will inject the medicine into you.

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

Mobilization will begin by giving you another medicine called G-CSF (granulocyte colony-stimulating factor) first. 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 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 old, 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 given?

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

When is plerixafor 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 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.

4. Possible side effects

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

Tell your doctor immediately if

• soon after receiving plerixafor, you experience a skin rash, swelling around the eyes, difficulty breathing, or a 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 experienced a myocardial infarction after administration of plerixafor and GCSF. 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 (leukocytes) in your blood tests.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Plerixafor Stada

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.

This medicine does not require any special storage conditions.

Once the vial is opened, plerixafor 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 Stada

• 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 (concentrated), and sodium hydroxide to adjust the pH, water for injections.

Appearance and pack contents

Plerixafor is a clear, colorless, or pale yellow solution for injection in a Fiolax vial with a flurotec stopper, covered with a flip-off cap made of aluminum/polypropylene. Each vial contains 1.2 ml of solution.

Each pack contains 1 vial.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Pharmadox Healthcare Limited

Kw20a, Kordin Industrial Park

3000 Paola

Malta

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

Austria: Plerixafor STADA 20 mg/ml Injektionslösung

Germany: Plerixafor STADA 20 mg/ml Injektionslösung

France: Plerixafor EG 20 mg/ml, solution injectable

Italy: Plerixafor EG

Date of last revision of this leaflet:July 2024

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/