Package leaflet: Information for the user

Plerixafor Zentiva, 20 mg/mL, injection solution
Plerixaforum
Please read all of this leaflet carefully before 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 further questions, please ask your doctor.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of contents of the leaflet

What Plerixafor Zentiva is and what it is used for
Important information before using Plerixafor Zentiva
How to use Plerixafor Zentiva
Possible side effects
How to store Plerixafor Zentiva
Contents of the pack and other information

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

Plerixafor Zentiva contains the active substance plerixafor, which blocks a protein on the surface of haematopoietic stem cells. This protein "binds" haematopoietic stem cells within the bone marrow. Plerixafor facilitates the release (mobilization) of haematopoietic stem cells into the bloodstream. Haematopoietic stem cells are collected using a device designed to separate different blood components (apheresis device), then frozen and stored until transplantation. Plerixafor Zentiva is used in cases of inadequate mobilization, to facilitate the collection of haematopoietic stem cells (for collection, storage and transplantation)

in adult patients with lymphoma (a cancer of white blood cells) or multiple myeloma (a cancer involving plasma cells in the bone marrow)
in children aged 1 year to less than 18 years with lymphoma or solid tumours.

2. Important information before using Plerixafor Zentiva

When not to use Plerixafor Zentiva

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

Warnings and precautions
Before starting treatment with Plerixafor Zentiva, please discuss this with your doctor.
Tell your doctor if:

the patient has had or currently has heart conditions
the patient has kidney disease; in this case, the doctor may adjust the dose
the patient has a high number of white blood cells
the patient has a low number of platelets
the patient has previously experienced fainting or dizziness when standing up or sitting down, either before or during injections.

Your doctor may order regular blood tests to monitor the patient's blood counts.
Plerixafor Zentiva is not recommended for the mobilization of haematopoietic stem cells in patients with leukaemia (a cancer of the blood or bone marrow).
Plerixafor Zentiva and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Pregnancy and breastfeeding
Plerixafor Zentiva must not be used during pregnancy, as there is insufficient experience with the use of this medicine in pregnant women. If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine. It is recommended that women of childbearing potential use contraception.
Breastfeeding must not be undertaken during treatment with Plerixafor Zentiva, as it is unknown whether Plerixafor Zentiva passes into human milk.
Driving and using machines
Plerixafor Zentiva may cause dizziness and fatigue. Therefore, if the patient experiences dizziness, fatigue, or impaired well-being, driving or operating machinery should be avoided.
Plerixafor Zentiva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Plerixafor Zentiva

Plerixafor Zentiva will be administered by injection by a doctor or nurse.
First, G-CSF will be given, followed by Plerixafor Zentiva
The cell mobilization procedure begins with the administration of another medicine known as G-CSF (granulocyte colony-stimulating factor). G-CSF helps the action of Plerixafor Zentiva. If further information about G-CSF is needed, please consult your doctor and read the appropriate patient information 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 aged 1 year to less than 18 years is 0.24 mg per kilogram of body weight per day.
The dose of the medicine is based on the patient's body weight, which should be measured in the week before the first dose is administered. If the patient has moderate renal 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 first administered?
The first dose is given 6 to 11 hours before the start of apheresis (collection of haematopoietic stem cells).
How long will Plerixafor Zentiva be administered?
The medicine will be given for 2 to 4 consecutive days (sometimes up to 7 days), until a sufficient number of stem cells have been collected for transplantation. In rare cases, collection of haematopoietic stem cells may fail, requiring discontinuation of the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
You should tell your doctor as soon as possible if:

after receiving Plerixafor Zentiva you develop a rash, swelling around the eyes, breathlessness or difficulty breathing, dizziness when sitting or standing up, feeling faint or fainting
you experience pain in the upper left side of your abdomen or shoulder area

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

diarrhoea, nausea (feeling sick), redness or irritation at the injection site
low number of red blood cells in laboratory tests (anaemia in children)

Common side effects (may affect up to 1 in 10 people)

headache
dizziness, feeling tired or unwell
difficulty sleeping
bloating, constipation, indigestion, vomiting
abdominal symptoms such as pain, feeling of fullness or discomfort
dry mouth, numbness around the mouth
sweating, generalised 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, breathlessness
anaphylactic reactions, including anaphylactic shock
unusual dreams, nightmares

Severe gastrointestinal side effects (diarrhoea, vomiting, abdominal pain and nausea) may rarely occur.
Heart attacks
In clinical studies, uncommon cases of heart attacks occurred in patients treated with Plerixafor Zentiva and G-CSF who had risk factors for heart attack. You should tell your doctor immediately if you experience discomfort in the chest.
Tingling, pricking and numbness
Tingling, pricking sensations and numbness are commonly observed in patients receiving anticancer treatment. These symptoms were reported in approximately 1 in 5 patients; however, they do not appear to occur more frequently with the use of Plerixafor Zentiva.
Blood tests in patients may also show an increased number of white blood cells (leukocytosis).
Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, tell your doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Plerixafor Zentiva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and on the vial after EXP. The expiry date refers to the last day of the stated month.
Store below 25 ℃.
Plerixafor Zentiva should be administered immediately after opening the vial.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 injection solution contains 20 mg of plerixafor. Each 1.2 mL vial contains 24 mg of plerixafor.
The other ingredients are: sodium chloride, hydrochloric acid, concentrated (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.

What Plerixafor Zentiva looks like and contents of the pack
Plerixafor Zentiva is supplied as a clear, colourless to pale yellow solution in a glass vial.
Each pack contains 1 vial with 1.2 mL of solution.
Marketing Authorisation Holder
Zentiva, k.s.,
U kabelovny 130,
Dolní Měcholupy,
102 37 Prague 10,
Czech Republic
Manufacturer/Importer:
Pharmadox Healthcare Limited
KW20A, Kordin Industrial Park
Paola, PLA 3000
Malta
This medicinal product is authorised in the European Economic Area countries 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 Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel.: +48 22 375 92 00