PLERIXAFOR TARBIS 20 mg/mL INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

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

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

Plerixafor 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 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 Tarbis

Do not use Plerixafor Tarbis

• 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 white blood cell count.
• if you have a low platelet count.
• 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 stem cell mobilization if you have leukemia (a cancer of the blood or bone marrow).

Using Plerixafor Tarbis with other medicines

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

Pregnancy and breastfeeding

Do not use Plerixafor Tarbis if you are pregnant, as there are no data on the effects of Plerixafor Tarbis 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 breastfeed if you are using Plerixafor Tarbis, as it is not known whether plerixafor passes into breast milk.

Driving and using machines

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

Plerixafor Tarbis 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 Tarbis

Your doctor or nurse will inject the medicine into you.

First, you will receive G-CSF and then Plerixafor Tarbis will be administered

Mobilization will start by giving you another medicine called G-CSF (granulocyte-colony stimulating factor). G-CSF will help Plerixafor Tarbis 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 Tarbis 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, 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 will reduce the dose.

How is Plerixafor Tarbis administered?

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

When is Plerixafor Tarbis 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 the administration of Plerixafor Tarbis 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

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 Tarbis, you experience a 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 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 suffered a myocardial infarction after administration of Plerixafor Tarbis 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 Tarbis.

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 side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Plerixafor Tarbis

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 Tarbis 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 Tarbis

The active substance is plerixafor.

Each milliliter of solution for injection contains 20 mg of plerixafor.

Each vial contains 24 mg of plerixafor in 1.2 milliliters 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

Sterile solution without preservatives, transparent, colorless to pale yellow, free from visible particles, with a pH of 6.0-7.5 and an osmolality of 260-320 mOsm/Kg.

Plerixafor Tarbis is supplied in a 2-milliliter transparent glass vial, with a 13-millimeter rubber stopper and a 13-millimeter yellow-gold flip-off seal. Each vial contains 1.2 milliliters of solution.

Each pack contains 1 vial.

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

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

Germany: Plerixafor Amarox 20 mg/ml Injektionslösung

Netherlands: Plerixafor Amarox 20 mg/ml oplossing voor injectie

Spain: Plerixafor Tarbis 20 mg/ml solución inyectable EFG

Date of last revision of this leaflet:

April 2023

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/