PLERIXAFOR 20 mg /Ml Roztwór Do Wstrzykiwań
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Treść ulotki
Plerixafor Tillomed
20 mg/ml injectable solution
Generic medicine
Read this leaflet carefully before using this medicine as 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 any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. 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 you use 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 is Plerixafor Tillomed and what is it 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 improves the release of stem cells into the bloodstream (mobilization). The stem cells can then be
collected by a machine that separates the components of the blood
(apheresis machine) to be frozen and stored until transplantation.
If mobilization is poor, plerixafor is used to promote the collection of stem cells in the
blood from the patient, for collection, storage and reintroduction (transplantation)
- in adults with lymphoma (a cancer of white blood cells) or multiple myeloma (a cancer that attacks plasma cells in the bone marrow).
- in children aged between 1 and 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.
Tell your doctor:
- if you have or have had heart problems;
- if you have kidney problems. Your doctor may 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 when standing up or sitting down, or if you have fainted during injections;
Your doctor may perform blood tests on a regular basisto check the number of your blood cells.
The use of plerixafor for stem cell mobilization is not recommended if you suffer from
leukemia (a cancer of the blood or bone marrow).
Other medicines and Plerixafor Tillomed
Tell 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 regarding the effects of
plerixafor in pregnant women. It is important that you inform your doctor if you are pregnant, if you think you might be or if you are planning a pregnancy. It is recommended to use
contraception if you are a woman of childbearing potential.
Do not breastfeed while using Plerixafor Tillomed, as it is not known whether plerixafor is excreted in
human milk.
Driving and operating machinery
Plerixafor can cause dizziness and fatigue. Therefore, you should not drive if you experience dizziness,
tiredness or feeling unwell.
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 medication will be injected by a doctor or nurse.
You will first receive G-CSF, then you will be administered Plerixafor Tillomed
Mobilization will be initiated by first administering another medicine called G-CSF (granulocyte colony-stimulating factor). The G-CSF will promote the correct action of plerixafor in your body.
How much Plerixafor Tillomed is administered?
The recommended dose for adults is 20 mg (fixed dose) or 0.24 mg/kg of body weight per day.
The recommended dose for children between 1 and less than 18 years of age is 0.24 mg/kg of body weight/day.
The dose will therefore 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 the dose .
How is Plerixafor Tillomed administered?
Plerixafor Tillomed is administered by subcutaneous injection (under the skin).
When is Plerixafor Tillomed 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).
How long will Plerixafor Tillomed be administered to you?
Treatment lasts for 2 to 4 consecutive days (in some cases up to 7 days), until a sufficient amount of stem cells has been collected for transplantation. In limited cases, not enough stem cells may be collected, so the collection attempt will be stopped.
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 skin rash, swelling around the eyes, shortness of breath or lack of oxygen, a feeling of dizziness when standing up or sitting down, a feeling of fainting or fainting
- if you have pain in the upper left side of your abdomen (stomach) or in your left shoulder
Very common side effects(may affect more than 1 in 10 people)
- diarrhoea
- 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 symptoms such as pain, bloating or discomfort
- dry mouth, numbness around the mouth
- sweating
- general skin redness
- 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
- abnormal dreams, nightmares
Rarely, gastrointestinal side effects can be serious (diarrhoea, vomiting, stomach pain and nausea).
Heart attacks
In clinical studies, patients with risk factors for a heart attack have experienced, with uncommon frequency, heart attacks after receiving plerixafor and G-CSF. Tell your doctor immediately if you experience chest discomfort.
Tingling and numbness
Tingling and numbness are common in patients treated for cancer. About one in five patients experience these sensations. However, these effects do not appear to occur more frequently when taking plerixafor.
Blood tests may show an increase in white blood cell count (leukocytes).
Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. You can also report side effects directly through 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 which is stated on the label of the vial or
on the carton after Exp. The expiry date refers to the last day of that month.
Store at a temperature below 25° C. After opening the vial, Plerixafor Tillomed must
be used immediately.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack 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 ingredients are: sodium chloride, hydrochloric acid and sodium hydroxide for pH adjustment, water for injections and nitrogen.
Description of the appearance of Plerixafor Tillomedand contents of the pack
Plerixafor Tillomed is supplied as a clear, colorless to pale yellow injectable solution inside
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:
MIAS Pharma Limited
Suite 1, First floor,
Stafford House, Strand Road,
Portmarnock,
Co. Dublin, D13 WC83
Ireland
This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
| State | Medicinal product name |
| Germany: | c Plerixafor Tillomed 20 mg/ml Injektionslösung |
| Italy: | Plerixafor Tillomed |
| France: | a PLERIXAFOR TILLOMED 20 mg/ml, solution injectable |
| Spain: | PLERIXAFOR TILLOMED 20 MG/ML SOLUCIÓN INYECTABLE EFG |
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- Kraj rejestracji
- Postać farmaceutycznaInjectable solution, 20 MG/ML
- Kod ATCL03AX16
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki PLERIXAFOR TILLOMEDPostać farmaceutyczna: Injectable solution, 20 MG/MLSubstancja czynna: plerixaforProducent: SANOFI B.V.Wymaga receptyPostać farmaceutyczna: Injectable solution, 20 mg/mlSubstancja czynna: plerixaforProducent: ACCORD HEALTHCARE, S.L.U.Wymaga receptyPostać farmaceutyczna: Injectable solution, 20 MG/MLSubstancja czynna: plerixaforProducent: EG S.P.A.Wymaga recepty
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PLERIXAFOR TILLOMED wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w PLERIXAFOR TILLOMED jest plerixafor. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
PLERIXAFOR TILLOMED jest produkowany przez TILLOMED ITALIA SRL. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie PLERIXAFOR TILLOMED jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić PLERIXAFOR TILLOMED w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (plerixafor) to m.in. MOTSOBIL, PLERIXAFOR AKKORD, PLERIXAFOR EG. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
