Plerixafor eugia 20 mg/ml soluciÓn inyectable efg

Prospecto: information for the user

Plerixafor Eugia 20 mg/ml injectable solution EFG

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 doctoror pharmacist.

-This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

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

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

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

3.How to use Plerixafor Eugia

4.Possible adverse effects

5.Storage of Plerixafor Eugia

6.Contents of the package and additional information

Plerixafor Eugia 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 re-introduction (transplantation):

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

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

Do not usePlerixafor Eugia

•If you are allergic toplerixaforor to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use plerixafor:

•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.

Plerixaforis not recommended for use in mobilizing stem cells if you have leukemia (a blood or bone marrow cancer).

Other medications andPlerixafor Eugia

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 plerixaforif you are pregnant, as there is no data on the effects of plerixaforin pregnant women. It is essential to inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. It is recommended to use contraceptive methods if you are of childbearing age.

You should not breastfeed while using this medicationas it is unknown whether plerixaforpasses into breast milk.

Driving and operating machinery

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

Plerixafor Eugia contains sodium

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

A doctor or nurse will inject your medication.

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

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

How much Plerixafor Eugia 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 Eugia administered?

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

When is Plerixafor Eugia 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 Eugia 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 may not be possible to collect a sufficient number of stem cells, and the attempt to collect will be interrupted.

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.

Rare 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.

•abnormal 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 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 seem to occur more frequently when plerixafor is used.

You may also experience 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, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. 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 medicationafter the expiration date that appears on the box and on the vials after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

After opening the vial, the medication must be used immediately.

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

Composition ofPlerixafor Eugia

-The active ingredient 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, sodium hydroxide (pH adjustment), concentrated hydrochloric acid (pH adjustment), and water for injection preparations.

Appearance of the productand contents of the packaging

Plerixafor Eugia is a transparent, colorless, or pale yellow solution, free of visible particles, packaged in a transparent glass vialclosed with a gray bromobutyl rubber stopper and sealed with an aluminum capsule with a polypropylene disc.

Each vial contains 1.2 ml of solution.

Each package contains 1 vial.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19, Venda Nova

2700-487 Amadora

Portugal

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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

Germany:Plerixafor PUREN 20 mg/ml Injektionslösung

Spain:Plerixafor Eugia 20 mg/ml injectable solution EFG

France:Plerixafor Arrow 20 mg/ml, solution for injection

Italy:Plerixafor Aurobindo

Portugal:Plerixafor Generis

Last review date of this leaflet: January 2023

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