Plerixafor Biofar
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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.
- Country of registration
- Active substance
- Prescription requiredYes
- ImporterSeacross Pharma (Europe) Limited
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to Plerixafor BiofarDosage form: Solution, 20 mg/mlActive substance: plerixaforManufacturer: MSN Labs Europe Limited Pharmadox Healthcare Ltd.Prescription requiredDosage form: Solution, 20 mg/mlActive substance: plerixaforManufacturer: Pharmadox Healthcare Ltd.Prescription requiredDosage form: Powder, min. 2x10^8 max. 3x10^9/50 mlActive substance: BCG vaccinePrescription required
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