Plerixafor Biofar

Package Leaflet: Information for the User

Plerixafor Biofar, 20 mg/mL, Solution for Injection

Plerixafor

Read All of This Leaflet Carefully Before Using This Medicine Because It Contains Important Information for You.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

• 1. What is Plerixafor Biofar and What is it Used For
• 2. Before You Use Plerixafor Biofar
• 3. How to Use Plerixafor Biofar
• 4. Possible Side Effects
• 5. How to Store Plerixafor Biofar
• 6. Contents of the Pack and Other Information

1. What is Plerixafor Biofar and What is it Used For

Plerixafor Biofar 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 Biofar 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. Before You Use Plerixafor Biofar

When Not to Use Plerixafor Biofar

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

Warnings and Precautions

Before starting treatment with Plerixafor Biofar, you should discuss it with your doctor.

Tell your doctor if:

• you have ever had or currently have heart disease
• you have kidney disease; your doctor may change the dose of the medicine
• you have a high white blood cell count
• you have a low platelet count
• you have ever had fainting or dizziness when standing or sitting, or before or during injections.

Your doctor may order regular blood teststo monitor your blood cell count.

Plerixafor Biofar should not be used to mobilize hematopoietic stem cells in patients with leukemia (a cancer of the blood or bone marrow).

Plerixafor Biofar and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and Breastfeeding

Women who are pregnant should not use Plerixafor Biofar, as there is not enough experience with the use of this medicine during pregnancy. If you are pregnant, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine. Women of childbearing potential should use contraception.

Do not breastfeed while using Plerixafor Biofar, as it is not known whether Plerixafor Biofar passes into human milk.

Driving and Using Machines

Plerixafor Biofar may cause dizziness and fatigue, so if you experience dizziness, fatigue, or worsening of your condition, you should not drive.

Plerixafor Biofar 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 Biofar

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

First, G-CSF Will Be Administered, Then Plerixafor Biofar

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 Biofar. If you need more information about G-CSF, ask your doctor and read the relevant patient information 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 from 1 year to less than 18 years of age is 0.24 mg per kilogram of body weight per day.

How is Plerixafor Biofar Administered?

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

When is Plerixafor Biofar Administered for the First Time?

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

How Long Will Plerixafor Biofar 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 may not be successful, and the procedure may need to be discontinued.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell Your Doctor as Soon as Possible if:

shortly after administration of Plerixafor Biofar, you experience a rash, swelling around the eyes, shortness of breath, or difficulty breathing, dizziness when sitting or standing, or fainting

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, feeling tired or unwell, 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, unusual dreams, nightmares

Heart Attacks

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

Paresthesia and Hypoaesthesia

Paresthesia and hypoaesthesia often occur in patients receiving cancer treatment. These symptoms were reported in about one in five patients, but it does not seem that they occur more frequently with Plerixafor Biofar.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. You can also report side effects directly to the national reporting system.

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 which is stated on the carton and on the vial after EXP. The expiry date refers to the last day of that month.

There are no special storage instructions for this medicine.

Plerixafor Biofar 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 Biofar Contains

• The active substance is plerixafor. One mL of solution for injection contains 20 mg of plerixafor. Each vial contains 24 mg of plerixafor in 1.2 mL of solution.
• The other ingredients 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 a clear, colorless solution for injection in a vial made of type I glass, with a chlorobutyl rubber stopper and an aluminum seal and a plastic flip-off cap.

Each pack contains 1 vial.

Marketing Authorization 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 Authorized in the Member States of the European Economic Area 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

Date of Last Revision of the Leaflet:October 2023

Information Intended for Healthcare Professionals Only:

Detailed information on this medicinal product is available on the summary of product characteristics.