Plerixafor tarbis 20 mg/ml soluciÓn inyectable efg

Package Leaflet: Information for the User

Plerixafor Tarbis 20 mg/ml injectable solution EFG

Read this leaflet carefully before you start using this medicine because it contains important information for you.

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

-If you have any questions, consult your doctor.

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

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

2. What you need to know before using Plerixafor Tarbis

3. How to use Plerixafor Tarbis

4. Possible side effects

5. Storage of Plerixafor Tarbis

6. Contents of the pack and additional information

Plerixafor contains the active ingredient plerixafor, which 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 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 affecting bone marrow plasma cells).
• In children 1 year and under 18 years with lymphoma or solid tumors.

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

Consult 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 feeling dizzy or lightheaded while standing or sitting, or if you have fainted after injections.

Your doctor may performperiodic blood teststo monitor the number of blood cells.

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

Use of Plerixafor Tarbis with other medicines

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

Pregnancy and breastfeeding

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

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

Driving and operating 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, making it essentially “sodium-free”.

Your doctor or a nurse will administer your medication.

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

Mobilization will begin by administering another medication called G-CSF (granulocyte-colony stimulating factor) first. G-CSF will help Plerixafor Tarbis 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 Tarbis 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 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 your stem cells from your blood).

How long will the administration of Plerixafor Tarbis 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, so the attempt to collect will be interrupted.

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

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

Inform your doctor immediately if

• you experience any of the following shortly after receiving Plerixafor Tarbis: 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 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 administration of Plerixafor Tarbis and G-CSF. Inform your doctor immediately if you experience chest pain.

Tickling and numbness

Tickling and numbness are common in cancer patients. Approximately one in five patients experience them. However, these effects do not appear to occur more frequently when using Plerixafor Tarbis.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website: 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 packaging and in the vial.

This medication does not require special storage conditions.

Once the vial is opened, Plerixafor Tarbis must be used immediately.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Plerixafor Tarbis

The active ingredient is plerixafor.

Each milliliter 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, concentrated hydrochloric acid, and sodium hydroxide for pH adjustment, and water for injectable preparations.

Appearance of the product and contents of the packaging

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

Plerixafor Tarbissupplied in a transparent glass vial of 2 ml, a 13 mm chlorobutyl rubber stopper with a 13 mm flip-off seal, golden yellow. Each vial contains 1.2 ml of solution.

Each package contains 1 vial.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

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

Germany:Plerixafor Amarox 20 mg/ml Injektionslösung

Netherlands:Plerixafor Amarox 20 mg/ml oplossing voor injectie

SpainPlerixafor Tarbis 20 mg/ml solución inyectable EFG

Last review date of this leaflet:

April 2023

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