Plerixafor Accord
Italy
Table of Contents
Package leaflet: Information for the user
Plerixafor Accord 20 mg/mL
solution for injection
plerixafor
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 or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
- If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Plerixafor Accord is and what it is used for
- What you need to know before using Plerixafor Accord
- How to use Plerixafor Accord
- Possible side effects
- How to store Plerixafor Accord
- Contents of the pack and other information
1. What Plerixafor Accord is and what it is used for
Plerixafor Accord 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 Accord is used to facilitate the collection of stem cells from the patient’s blood for harvesting, storage, and 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 year and above but less than 18 years with lymphoma or solid tumors.
2. What you need to know before using
Plerixafor Accord Do not use Plerixafor Accord
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, pharmacist or nurse before taking Plerixafor Accord.
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 Accord for stem cell mobilization is not recommended if you have leukemia (a blood or bone marrow cancer).
Other medicines and Plerixafor Accord
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 Accord if you are pregnant, as there is no experience with the effects of Plerixafor Accord 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 Accord, as it is not known whether Plerixafor Accord is excreted in human milk.
Driving and using machines
Plerixafor Accord may cause dizziness and fatigue. Therefore, you should not drive if you feel unwell, fatigued or dizzy.
Plerixafor Accord 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 Accord
The medicine will be injected by a doctor or nurse.
You will first receive G-CSF, then Plerixafor Accord will be administered to you.
Mobilization will begin by first giving you another medicine called G-CSF (granulocyte colony-stimulating factor). G-CSF will help Plerixafor Accord 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 Accord is administered?
The recommended dose of Plerixafor Accord for adults is 20 mg (fixed dose) or 0.24 mg/kg body weight per day.
The recommended dose for children aged 1 year to less than 18 years is 0.24 mg/kg body weight/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 Accord administered?
Plerixafor Accord is administered by subcutaneous injection (under the skin).
When will Plerixafor Accord be administered for the first time?
You will receive your first dose 6 to 11 hours before apheresis (the collection of your stem cells from the blood).
For how long will Plerixafor Accord 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.
Tell your doctor immediately 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) 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
insomnia
flatulence, constipation, indigestion, vomiting
gastric symptoms such as pain, bloating or discomfort
dry mouth, numbness around the mouth
sweating, generalised 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
Gastrointestinal side effects may rarely be severe (diarrhoea, vomiting, stomach pain and nausea).
Heart attacks
In clinical studies, patients with risk factors for a heart attack experienced heart attacks with uncommon frequency after receiving Plerixafor Accord and G-CSF.
Tell your doctor immediately if you experience chest discomfort.
Tingling and numbness
Tingling and numbness are common in patients being treated for cancer. About 1 in 5 patients experience these sensations. However, such effects do not appear to occur more frequently when taking Plerixafor Accord.
Blood tests may show an increased white blood cell count (leucocytes).
Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.
5. How to store Plerixafor Accord
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. After opening the vial, Plerixafor Accord 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 Accord 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), sodium hydroxide, and water for injections (see section 2 “Plerixafor Accord contains sodium”).
Description of the appearance of Plerixafor Accord and contents of the pack
Plerixafor Accord is a clear, colourless or pale yellow injectable solution
contained in a glass vial with a rubber stopper, aluminium crimp cap, and blue polypropylene plastic cap. Each vial contains 1.2 mL of solution.
Each pack contains 1 vial.
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Accord Healthcare Polska Sp.z o.o.
ul. Lutomierska 50,
95-200 Pabianice, Poland
Or
Laboratori Fundació Dau
C/ C, 12-14 Pol. Ind.
Zona Franca, Barcelona, 08040,
Spain
Or
Accord Healthcare B.V.
Winthontlaan 200, 3526KV Utrecht,
Netherlands
Or
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park, Paola
PLA 3000, Malta
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IE / IS / IT / LT / LV / LX / MT / NL / NO / PT / PL / RO / SE / SI / SK / UK(NI) / ES
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Pharmaceutical S.A.
Tel: +30 210 7488 821