Package leaflet: Information for the user

Plerixafor MSN, 20 mg/mL, solution for injection
Plerixaforum
Please read all of this leaflet carefully before 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.
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Leaflet contents:

What Plerixafor MSN is and what it is used for
What you need to know before you use Plerixafor MSN
How to use Plerixafor MSN
Possible side effects
How to store Plerixafor MSN
Contents of the pack and other information

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

Plerixafor MSN contains the active substance plerixafor, which blocks a protein on the surface of haematopoietic stem cells. This protein "anchors" haematopoietic stem cells within the bone marrow. Plerixafor facilitates the release (mobilisation) of haematopoietic stem cells into the bloodstream. Haematopoietic stem cells are collected using a device that separates different blood components (apheresis device), then frozen and stored until transplantation.
Plerixafor MSN is used in cases of insufficient mobilisation, 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 MSN

When not to use Plerixafor MSN

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 MSN, discuss this with your doctor.
Tell your doctor if:

the patient has had or currently has heart diseases
the patient has kidney diseases; the doctor may then 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, or before or during injections.

The treating physician may order regular blood tests to monitor the patient's blood count.
Plerixafor MSN is not recommended for the mobilization of haematopoietic stem cells in patients with leukaemia (a blood or bone marrow cancer).
Plerixafor MSN and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pregnancy and breastfeeding
Pregnant women should not use Plerixafor MSN, as there is insufficient experience regarding the use of this medicine during pregnancy. If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine. It is recommended that women of childbearing age use contraception.
Breastfeeding should not be performed during treatment with Plerixafor MSN, as it is unknown whether Plerixafor MSN passes into human milk.
Driving and operating machinery
Plerixafor MSN may cause dizziness and fatigue. Therefore, if the patient experiences dizziness, fatigue, or worsening well-being, he or she should not drive or operate machinery.
Plerixafor MSN 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 MSN

Plerixafor MSN will be administered by injection by a doctor or nurse.
First, G-CSF will be given, followed by Plerixafor MSN
The cell mobilization procedure begins with the administration of another medicine known as G-CSF
(granulocyte colony-stimulating factor). G-CSF helps Plerixafor MSN work. 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 MSN?
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 is determined based on the patient's body weight, so the patient will be weighed in the week preceding the first dose. If the patient has moderate or severe kidney impairment, the doctor will reduce the dose.
How is Plerixafor MSN administered?
Plerixafor MSN is given as a subcutaneous injection (under the skin).
When is the first dose of Plerixafor MSN given?
The first dose is administered 6 to 11 hours before the start of apheresis (collection of hematopoietic stem cells).
How long will Plerixafor MSN 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 has been collected for transplantation. In rare cases, collection of hematopoietic stem cells may fail, requiring termination of the procedure.

4. Possible adverse reactions

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

a rash, swelling around the eyes, shortness of breath or difficulty breathing, dizziness when sitting or standing up, feeling faint, or fainting occur shortly after administration of Plerixafor MSN
pain occurs in the upper left part of the abdomen or in the area of the left shoulder

Very common adverse reactions (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 adverse reactions (may affect up to 1 in 10 people)

headache
dizziness, feeling tired or feeling 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 skin redness, joint pain, muscle and bone pain

Uncommon adverse reactions (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
unusual dreams, nightmares

Severe gastrointestinal adverse reactions (diarrhoea, vomiting, abdominal pain and nausea) may rarely occur.
Heart attacks
In clinical studies, uncommon cases of heart attacks occurred in patients with risk factors for heart attack after administration of Plerixafor MSN and G-CSF. You should tell your doctor as soon as possible if you experience discomfort in the chest.
Tingling, pricking and numbness
Tingling, pricking and numbness commonly occur in patients receiving anticancer treatment. These symptoms were observed in approximately one out of five patients, but do not appear to occur more frequently with the use of Plerixafor MSN.
In blood tests, an increase in the number of white blood cells (leukocytosis) may also occur in the patient.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Plerixafor MSN

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial label after:
EXP. The expiry date refers to the last day of the stated month.
Store below 25ºC.
Plerixafor MSN should be administered immediately after opening the packaging.
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 MSN contains

The active substance is plerixafor. Each mL of injection solution contains 20 mg of plerixafor. Each vial contains 24 mg of plerixafor in 1.2 mL of solution.
Other components are: sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.

What Plerixafor MSN looks like and contents of the pack
Plerixafor MSN is 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 and Manufacturer
Marketing Authorisation Holder:
MSN Labs Europe Limited
KW20A, Corradino Park
Paola, PLA 3000
Malta
Tel.: (+48) 699 711 147

Manufacturer/Importer:
Pharmadox Healthcare Limited
KW20A, Kordin Industrial Park
Paola, PLA 3000
Malta
MSN Labs Europe Limited
KW20A, Corradino Park
Paola, PLA 3000
Malta

This medicinal product is authorised in the European Economic Area under the following names:
Germany: Plerixafor Vivanta Generics 20 mg/ml Injektionslösung, ENR: 7006277
Czech Republic: Plerixafor MSN
Hungary: Plerixafor MSN 20 mg/ml oldatos injekció
Poland: Plerixafor MSN
Romania: Plerixafor MSN 20 mg/ml soluţie injectabilă
Slovakia: Plerixafor MSN
Bulgaria: Плериксафор MSN 20 mg/ml инжекционен разтвор