Plerixafor Tillomed

Package leaflet: Information for the user

Plerixafor Tillomed

20 mg/ml solution for injection
Generic medicine
Read this leaflet carefully before you use 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 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 this leaflet:

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

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

Plerixafor Tillomed 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 the components of the blood (apheresis machine), frozen, and stored until transplantation.
If mobilization is poor, plerixafor 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 Tillomed

Do not use Plerixafor Tillomed:
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 taking plerixafor.
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 dizziness or lightheadedness 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 for stem cell mobilization is not recommended if you have leukemia (a cancer of the blood or bone marrow).

Other medicines and Plerixafor Tillomed
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 Tillomed if you are pregnant, as there is no experience with the effects of plerixafor in pregnant women. It is important that you inform your doctor if you are pregnant, think you might be pregnant, or are planning a pregnancy. You are advised to use a contraceptive method if you are a woman of childbearing age.
Do not breastfeed while using Plerixafor Tillomed, as it is not known whether plerixafor is excreted in human milk.

Driving and using machines
Plerixafor may cause dizziness and fatigue. Therefore, you must not drive if you experience dizziness, tiredness, or malaise.

Plerixafor Tillomed 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 Tillomed

The medicine will be administered by injection by a doctor or nurse.
You will first receive G-CSF, then Plerixafor Tillomed will be given to you
Mobilization will begin with the administration of another medicine called G-CSF (granulocyte colony-stimulating factor). G-CSF will help plerixafor 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 Tillomed will be administered?
The recommended dose 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 Tillomed administered?
Plerixafor Tillomed is administered by subcutaneous injection (under the skin).
When will Plerixafor Tillomed 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 Tillomed 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 gets them.
Immediately inform your doctor if

• shortly after receiving plerixafor, 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 area) or left shoulder

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

• diarrhea
• feeling unwell (nausea)
• 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
• insomnia
• 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 (diarrhea, 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. Immediately inform your doctor if you experience chest discomfort.
Tingling and numbness
Tingling and numbness are common in cancer patients. About 1 in 5 patients experiences these sensations. However, such effects do not appear to occur more frequently with plerixafor.
Blood tests may show an increased white blood cell count (leucocytes).
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, nurse or pharmacist. 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 Tillomed

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label or
on the carton after Exp. The expiry date refers to the last day of that month.
Store below 25°C. After opening the vial, Plerixafor Tillomed must
be used immediately.
Do not dispose of medicines via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. Package contents and other information

What Plerixafor Tillomed 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 and sodium hydroxide for pH adjustment, water for injections and nitrogen.

Description of the appearance of Plerixafor Tillomed and contents of the pack
Plerixafor Tillomed is supplied as a clear, colourless or pale yellow injectable solution in a glass vial with a rubber stopper. Each vial contains 1.2 ml of solution.
Each pack contains 1 vial.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Tillomed Italia S.r.l.
Viale Giulio Richard 1, Torre A
20143 Milano (MI), Italy

Manufacturer:
Tillomed Malta Limited
Malta Life Sciences Park,
LS2.01.06 Industrial Estate,
San Gwann, SGN 3000, Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following names: