Package leaflet: Information for the user

Plerixafor Biofar, 20 mg/mL, solution for injection
Plerixafor
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 side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Plerixafor Biofar 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 (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 Biofar 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 from 1 year to less than 18 years of age with lymphoma or solid tumours.

2. Important information before using Plerixafor Biofar

When not to use Plerixafor Biofar
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 Biofar, 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 of the medicine
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 up, or before or during injections.

The doctor may order regular blood tests to monitor the patient's blood counts.
Plerixafor Biofar is not recommended for the mobilization of haematopoietic stem cells in patients with leukaemia (a cancer of the blood or bone marrow).
Plerixafor Biofar with 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 patients should not use Plerixafor Biofar, 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 become pregnant, she should consult her doctor before using this medicine. It is recommended that women of childbearing age use contraception.
Breastfeeding should be avoided during treatment with Plerixafor Biofar, as it is not known whether Plerixafor Biofar passes into human milk.
Driving and operating machinery
Plerixafor Biofar may cause dizziness and fatigue. Therefore, if the patient experiences dizziness, fatigue, or impaired well-being, he or she should not drive or operate machinery.
Plerixafor Biofar contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to use Plerixafor Biofar

Plerixafor Biofar will be administered by injection by a doctor or nurse.
First, G-CSF will be given, followed by Plerixafor Biofar
The cell mobilization procedure begins with the administration of another medicine known as G-CSF (granulocyte colony-stimulating factor). G-CSF helps enhance the effect of Plerixafor Biofar. If further information about G-CSF is needed, please consult your doctor and read the appropriate patient leaflet.
What is the dose of Plerixafor Biofar?
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 determined based on the patient's body weight, which should be measured in the week prior to the first dose. If the patient has moderate renal impairment, the doctor will reduce the dose.
How is Plerixafor Biofar administered?
Plerixafor Biofar is administered by subcutaneous injection (under the skin).
When is the first dose of Plerixafor Biofar given?
The first dose is administered 6 to 11 hours before the start of apheresis (collection of hematopoietic stem cells).
How long will Plerixafor Biofar be given?
The medicine will be administered 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, the collection of hematopoietic stem cells may fail, requiring termination of the procedure.
If you have any further questions or uncertainties regarding the use of this medicine, please consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
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, feeling faint or fainting occurs shortly after administration of Plerixafor Biofar
pain in the upper left part of the abdomen or shoulder area occurs
Very common adverse reactions (may occur in 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 adverse reactions (may occur in up to 1 in 10 people)
headache
dizziness, feeling tired or generally unwell
difficulty sleeping
bloating, constipation, indigestion, vomiting
abdominal symptoms such as pain, bloating or discomfort
dry mouth, numbness around the mouth
sweating, generalized skin redness, joint pain, muscle and bone pain
Uncommon adverse reactions (may occur in 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 (diarrhea, vomiting, abdominal pain and nausea) may rarely occur.
Myocardial infarction
In clinical studies, uncommon cases of myocardial infarction occurred in patients receiving Plerixafor Biofar and G-CSF who had risk factors for heart attack. Tell your doctor as soon as possible if you experience discomfort in the chest.
Tingling, pricking sensations and numbness
Tingling, pricking sensations and numbness commonly occur in patients receiving anticancer treatment. These symptoms were observed in approximately 1 in 5 patients; however, they do not appear to occur more frequently with the use of Plerixafor Biofar.
Blood tests in patients may also show an increased white blood cell count (leukocytosis).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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: http://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Plerixafor Biofar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging and on the vial after: EXP. The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Plerixafor Biofar 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. Following this advice helps protect the environment.

6. Contents of the package and other information

What Plerixafor Biofar contains

The active substance is plerixafor. One mL of injection 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, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections.

What Plerixafor Biofar looks like and contents of the pack
Plerixafor Biofar is supplied as a clear, colourless injection solution in a vial made of colourless type I glass, with a chlorobutyl rubber stopper, aluminium seal and plastic flip-off cap. Each vial contains 1.2 mL of solution.
Each pack contains 1 vial.
Marketing Authorisation Holder
Biofar Sp. z o.o. Sp. k.
Kopernika 38
90-552 Łódź
Poland
e-mail: [email protected]
Importer
Seacross Pharma (Europe) Limited
POD 13, The Old Station House
15A Main Street, Blackrock
Dublin, A94 T8P8
Ireland
This medicinal product is authorised in the European Economic Area countries under the following names:
Germany Plerixafor Seacross 20 mg/ml Injektionslösung
Spain Plerixafor Seacross 20 mg/ml solución inyectable
Italy, Portugal, Norway, Sweden, Denmark Plerixafor Seacross
Finland Plerixafor Seacross 20 mg/ml injektioneste, liuos
Netherlands Plerixafor Seacross 20 mg/ml oplossing voor injectie
France PLERIXAFOR SEACROSS 20 mg/ml, solution injectable
Hungary Plerixafor Onkogen
Czech Republic Pleforbil
Slovakia Plerixafor Onkogen 20 mg/ml injekčný roztok
Slovenia Pleriksafor Onkogen 20 mg/ml raztopina za injiciranje
Croatia Pleriksafor Onkogen 20 mg/ml otopina za injekciju
Romania Plerixafor Onkogen 20 mg/ml soluţie injectabilă
Estonia Plerixafor Auxilia
Lithuania Plerixafor Auxilia 20 mg/ml injekcinis tirpalas
Ireland Plerixafor Seacross 20 mg/ml Solution for Injection
Poland Plerixafor Biofar

Information intended exclusively for medical professionals:

Detailed information about this medicinal product can be found in the Summary of Product Characteristics.