Plerixafor Zentiva

Package Leaflet: Information for the User

Plerixafor Zentiva, 20 mg/mL, Solution for Injection

Plerixafor

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Plerixafor Zentiva and what is it used for
• 2. Important information before using Plerixafor Zentiva
• 3. How to use Plerixafor Zentiva
• 4. Possible side effects
• 5. How to store Plerixafor Zentiva
• 6. Contents of the pack and other information

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

Plerixafor Zentiva contains the active substance plerixafor, which blocks a protein on the surface of hematopoietic stem cells. This protein "binds" hematopoietic stem cells in the bone marrow. Plerixafor facilitates the release (mobilization) of hematopoietic stem cells into the bloodstream. Hematopoietic stem cells are collected using a device that separates different blood components (apheresis device), and then frozen and stored until transplantation.

Plerixafor Zentiva is used in cases of insufficient mobilization, to facilitate the collection of hematopoietic stem cells (for their collection, storage, and transplantation).

• In adult patients with lymphoma (a cancer of white blood cells) or multiple myeloma (a cancer that affects plasma cells in the bone marrow).
• In children from 1 year to less than 18 years of age with lymphoma or solid tumors.

2. Important information before using Plerixafor Zentiva

When not to use Plerixafor Zentiva

• If the patient is allergic to plerixafor or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Plerixafor Zentiva, discuss it with your doctor.

Tell your doctor if:

• The patient has a history of heart disease.
• The patient has kidney disease; the doctor may then change the dose.
• The patient has a high white blood cell count.
• The patient has a low platelet count.
• The patient has a history of fainting or dizziness when standing or sitting, and before or during injections.

The doctor may order regular blood teststo monitor the patient's blood morphology. It is not recommended to use Plerixafor Zentiva for the mobilization of hematopoietic stem cells in patients with leukemia (a cancer of the blood or bone marrow).

Plerixafor Zentiva and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding

Pregnant women should not use Plerixafor Zentiva, as there is limited experience with the use of this medicine during pregnancy. If the patient is pregnant, thinks she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine. Women of childbearing age should use contraception.

While using Plerixafor Zentiva, do not breastfeed, as it is not known whether Plerixafor Zentiva passes into human milk.

Driving and using machines

Plerixafor Zentiva may cause dizziness and fatigue, so if the patient feels dizzy, tired, or unwell, they should not drive.

Plerixafor Zentiva contains sodium

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

3. How to use Plerixafor Zentiva

The medicine will be administered by injection by a doctor or nurse.

First, G-CSF will be administered, followed by Plerixafor Zentiva

The stem cell mobilization procedure starts with the administration of another medicine called G-CSF (granulocyte colony-stimulating factor). G-CSF facilitates the action of Plerixafor Zentiva. If additional information about G-CSF is needed, consult your doctor and read the relevant patient leaflet.

What is the dose of Plerixafor Zentiva?

The recommended dose for adults is either 20 mg (fixed dose) or 0.24 mg per kilogram of body weight per day.

The recommended dose for children from 1 year to less than 18 years of age is 0.24 mg per kilogram of body weight per day.

The dose of the medicine is determined based on the patient's body weight, which should be measured in the week preceding the administration of the first dose. If the patient has moderate kidney impairment, the doctor will reduce the dose.

How is Plerixafor Zentiva administered?

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

When is Plerixafor Zentiva administered for the first time?

The first dose of the medicine is administered within 6-11 hours before the start of apheresis (collection of hematopoietic stem cells).

How long will Plerixafor Zentiva be administered?

The medicine will be administered for 2 to 4 consecutive days (sometimes up to 7 days), until a sufficient number of stem cells are collected for transplantation. In rare cases, the collection of hematopoietic stem cells is not successful, and the procedure must be terminated.

4. Possible side effects

Like all medicines, Plerixafor Zentiva can cause side effects, although not everybody gets them.

Tell your doctor as soon as possible if:

• Soon after administration of Plerixafor Zentiva, a rash, swelling around the eyes, shortness of breath, or dizziness when sitting or standing, or fainting occurs.
• Pain in the upper left part of the abdomen or in the left shoulder area occurs.

Very common side effects(may affect more than 1 in 10 people)

• Diarrhea, nausea (vomiting), 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, fatigue, or malaise.
• Difficulty sleeping.
• Bloating, constipation, indigestion, vomiting.
• Abdominal symptoms, such as pain, feeling full, 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, shortness of breath.
• Anaphylactic reactions, including anaphylactic shock.
• Abnormal dreams, nightmares.

Rarely, severe gastrointestinal side effects (diarrhea, vomiting, abdominal pain, and nausea) may occur.

Myocardial infarction

In clinical trials, after administration of Plerixafor Zentiva and G-CSF, there were uncommon cases of myocardial infarction in patients with risk factors for myocardial infarction. Tell your doctor as soon as possible if you experience discomfort in the chest.

Paresthesia and numbness

Paresthesia and numbness often occur in patients undergoing anticancer treatment. These symptoms were reported in about one in five patients, but it does not seem that they occur more frequently during treatment with Plerixafor Zentiva.

In blood tests, the patient may also experience an increased white blood cell count (leukocytosis).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Plerixafor Zentiva

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

Do not use this medicine after the expiry date stated on the carton and on the vial after EXP. The expiry date refers to the last day of the month stated.

Store in a temperature below 25°C.

Plerixafor Zentiva should be administered immediately after opening the vial.

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

What Plerixafor Zentiva contains

• The active substance is plerixafor. Each 1 mL of solution for injection contains 20 mg of plerixafor. Each vial with 1.2 mL of solution contains 24 mg of plerixafor.
• The other ingredients are sodium chloride, hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH), and water for injections.

What Plerixafor Zentiva looks like and contents of the pack

Plerixafor Zentiva is a clear, colorless to pale yellow solution in a glass vial.

Each pack contains 1 vial with 1.2 mL of solution.

Marketing authorization holder

Zentiva, k.s.,

U kabelovny 130,

Dolní Mĕcholupy,

102 37 Prague 10,

Czech Republic

Manufacturer/Importer:

Pharmadox Healthcare Limited

KW20A, Kordin Industrial Park

Paola, PLA 3000

Malta

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

Germany: Plerixafor Zentiva 20 mg/ml Injektionslösung

France: PLERIXAFOR ZENTIVA 20 mg/ml, solution injectable

Poland, Portugal: Plerixafor Zentiva

For further information, please contact the representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o.

ul. Bonifraterska 17

00-203 Warsaw

Tel.: +48 22 375 92 00

Date of last revision of the leaflet:March 2024