Mozobil
Italy
Table of Contents
Package leaflet: Information for the user
Mozobil, 20 mg/ml injection solution
Plerixafor
Please 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:
- What Mozobil is and what it is used for
- What you need to know before using Mozobil
- How to use Mozobil
- Possible side effects
- How to store Mozobil
- Contents of the pack and other information
1. What Mozobil is and what it is used for
Mozobil 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, Mozobil is used to facilitate the collection of blood stem cells from the patient, 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 Mozobil
Do not use Mozobil
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 Mozobil.
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 Mozobil for stem cell mobilization is not recommended if you have leukemia (a cancer of the blood or bone marrow).
Other medicines and Mozobil
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Do not use Mozobil during pregnancy, as there is no experience regarding the effects of Mozobil 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 Mozobil, as it is not known whether Mozobil is excreted in human milk.
Driving and using machines
Mozobil may cause dizziness and fatigue. Therefore, do not drive if you feel unwell, tired, or dizzy.
Mozobil contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".
3. How to use Mozobil
The medicine will be administered by a doctor or a nurse.
You will first receive G-CSF, then Mozobil 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 Mozobil 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 Mozobil will be administered?
The recommended dose of Mozobil for adults is 20 mg (fixed dose) or 0.24 mg/kg body weight per day.
The recommended dose for children aged 1 year up 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 Mozobil administered?
Mozobil is administered by subcutaneous injection (under the skin).
When will Mozobil be administered for the first time?
You will receive your first dose 6 to 11 hours before apheresis (the collection of your blood stem cells).
For how long will Mozobil 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, and therefore the collection attempt may 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 Mozobil, you develop a rash, swelling around the eyes, shortness of breath or lack of oxygen, feeling dizzy when standing or sitting, feeling faint or fainting
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, 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
Rarely, gastrointestinal side effects may 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 Mozobil and G-CSF. Tell your doctor immediately if you experience chest discomfort.
Tingling and numbness
Tingling and numbness are common in cancer patients. About 1 in 5 patients experience these sensations. However, such effects do not appear to occur more frequently when taking Mozobil.
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, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Mozobil
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 does not require any special storage conditions.
After opening the vial, Mozobil must be used immediately.
Do not dispose of medicines 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 Mozobil 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 for pH adjustment, and water for injections.
Description of the appearance of Mozobil and contents of the pack
Mozobil is a clear, colourless or pale yellow injectable solution contained in a glass vial with a latex-free rubber stopper. Each vial contains 1.2 ml of solution.
Each pack contains 1 vial.
Marketing Authorisation Holder
Sanofi B.V.
Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands
Manufacturer
Genzyme Ireland Ltd, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland.
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien/Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 2 710 54 00
Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40
България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480
Magyarország
SANOFI-AVENTIS Zrt.
Tel: +36 1 505 0050
Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111
Malta
Sanofi S.r.l.
Tel: +39 02 39394275
Danmark
sanofi A/S
Tlf: +45 45 16 70 00
Nederland
Sanofi B.V.
Tel: +31 20 245 4000
Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. from abroad: +49 69 305 21 131
Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30
Österreich
sanofi-aventis GmbH
Tel: +43 1 80 185 – 0
Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 1600
Polska
sanofi-aventis Sp. z o.o.
Tel.: +48 22 280 00 00
España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00
Portugal
Sanofi – Produtos Farmacêuticos, Lda.
Tel: +351 21 35 89 400
France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
From abroad: +33 1 57 63 23 23
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36
Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00
Ireland
sanofi-aventis Ireland Ltd T/A SANOFI
Tel: +353 (0) 1 4035 600
Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600
Ísland
Vistor hf.
Sími: +354 535 7000
Suomi/Finland
Sanofi Oy
Puh/Tel: +358 201 200 300
Italia
Sanofi S.r.l.
Tel: 800536389
Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00
Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50
United Kingdom (Northern Ireland)
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +44 (0) 800 035 2525
Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.