Plerixafor EG

Patient Information Leaflet: Information for the User

PLERIXAFOR EG 20 mg/mL injection solution

Generic medicine
Please read 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 questions, ask your doctor.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Plerixafor EG is and what it is used for
2. What you need to know before using Plerixafor EG
3. How to use Plerixafor EG
4. Possible side effects
5. How to store Plerixafor EG
6. Contents of the pack and other information

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

Plerixafor EG contains the active substance plerixafor, which blocks a protein on the surface of blood stem cells. This protein "binds" blood stem cells to the bone marrow. Plerixafor enhances the release of stem cells into the bloodstream (mobilization). The stem cells can then be collected using a machine that separates blood components (apheresis machine), frozen and stored until transplantation.
If mobilization is poor, Plerixafor EG is used to facilitate the collection of stem cells from the patient's blood, for harvesting, storage, and subsequent reinfusion (transplantation),

• in adults with lymphoma (a cancer of white blood cells) or multiple myeloma (a cancer affecting plasma cells in the bone marrow);
• in children aged 1 to less than 18 years with lymphoma or solid tumors.

2. What you need to know before using Plerixafor EG

Do not use Plerixafor EG

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

Warnings and precautions
Talk to your doctor before using Plerixafor EG.
Inform your doctor:

• if you have or have had heart problems;
• if you have kidney problems. Your doctor may need to adjust the dose;
• if you have a high number of white blood cells;
• if you have a low number of platelets;
• if you have previously experienced feelings of fainting or dizziness while standing or sitting, or if you have ever fainted during injections.

Your doctor may perform regular blood tests to monitor your blood cell counts.
The use of Plerixafor EG for stem cell mobilization is not recommended if you have leukemia (a cancer of the blood or bone marrow).
Other medicines and Plerixafor EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Do not use Plerixafor EG if you are pregnant, as there is no experience regarding the effects of Plerixafor EG in pregnant women. It is important that you inform your doctor if you are pregnant, think you may be pregnant, or are planning a pregnancy. You are advised to use contraception if you are a woman of childbearing age.
Do not breastfeed while using Plerixafor EG, as it is not known whether Plerixafor EG is excreted in human milk.
Driving and using machines
Plerixafor EG may cause dizziness and fatigue. Therefore, you must not drive if you feel unwell, tired, or dizzy.
Plerixafor EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to use Plerixafor EG

The medicine will be injected by a doctor or a nurse.
You will first receive G-CSF, then Plerixafor EG will be administered.
Mobilization will begin with the administration of another medicine called G-CSF (granulocyte colony-stimulating factor). G-CSF will help Plerixafor EG work properly in your body. If you would like more information about G-CSF, please contact your doctor and read the corresponding package leaflet.
How much Plerixafor EG is administered?
The recommended dose of Plerixafor EG for adults is 20 mg (fixed dose) or 0.24 mg/kg body weight per day. The recommended dose for children aged 1 to less than 18 years is 0.24 mg/kg body weight per day.
Therefore, the dose will depend on your body weight, which must be measured the week before you receive your first dose. If you have moderate or severe kidney problems, your doctor will reduce your dose.
How is Plerixafor EG administered?
Plerixafor EG is administered by subcutaneous injection (under the skin).
When will Plerixafor EG be administered for the first time?
You will receive your first dose 6 to 11 hours before apheresis (collection of your blood stem cells).
For how long will Plerixafor EG be administered?
Treatment lasts for 2 to 4 consecutive days (in some cases up to 7 days), until a sufficient number of stem cells has been collected for transplantation. In limited cases, an insufficient number of stem cells may be collected, in which case the collection attempt will be discontinued.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Contact your doctor immediately if

• shortly after receiving Plerixafor EG, you develop a rash, swelling around the eyes, shortness of breath or difficulty breathing, dizziness when standing or sitting, feeling faint or fainting;
• you have pain in the upper left side of your abdomen (stomach) or left shoulder.

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

• diarrhoea, nausea (feeling unwell), redness or irritation at the injection site;
• low red blood cell count 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;
• flatulence, constipation, indigestion, vomiting;
• stomach-related symptoms such as pain, bloating or discomfort;
• dry mouth, numbness around the mouth;
• sweating, generalized skin redness, joint pain, muscle and bone pain.

Uncommon side effects (may affect up to 1 in 100 people)

• allergic reactions such as rash, swelling around the eyes, shortness of breath;
• anaphylactic reactions, including anaphylactic shock;
• abnormal dreams, nightmares.

Rarely, gastrointestinal side effects can be severe (diarrhoea, vomiting, stomach pain, and nausea).
Heart attacks
In clinical studies, patients with risk factors for heart attack experienced heart attacks with uncommon frequency after receiving plerixafor and G-CSF. Contact your doctor immediately if you experience chest discomfort.
Tingling and numbness
Tingling and numbness are common in cancer patients undergoing treatment. About 1 in 5 patients experience these sensations. However, such effects do not appear to occur more frequently when taking Plerixafor EG.
Blood tests may show an increased white blood cell count (leucocytes).
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Plerixafor EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial.
This medicine requires no special storage conditions.
After opening the vial, Plerixafor EG must be used immediately.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Plerixafor EG contains

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

Description of the appearance of Plerixafor EG and contents of the pack
Plerixafor EG is a clear, colourless or pale yellow injectable solution contained in a transparent Type I Fiolax glass vial closed with a chlorobutyl/butyl fluorotec stopper and sealed with an aluminium/polypropylene flip-off cap. Each vial contains 1.2 mL of solution.
Each pack contains 1 vial.
Marketing Authorisation Holder
EG S.p.A., via Pavia 6, 20136 Milano, Italy
Manufacturer
Pharmadox Healthcare Limited, KW20A, Kordin Industrial Park, Paola PLA 3000 - Malta
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
AT Plerixafor STADA 20 mg/ml Injektionslösung
DE Plerixafor STADA 20 mg/ml Injektionslösung
ES Plerixafor STADA 20 mg/ml solución inyectable EFG
FR Plerixafor EG 20 mg/ml, solution injectable
IT Plerixafor EG