InfoCons Consumer Protection informs you – Mozobil – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start using this medicine because it contains important information for you .

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects, talk to your doctor or nurse . This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 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 “ties” blood stem cells to the bone marrow. Plerixafor improves the release of stem cells into the blood stream (mobilisation). The ste m cells can then be collected by a machine that separates blood constituents (apheresis machine ), and subsequently frozen and stored until your transplant.

If mobilisation is poor, Mozobil is used to help collect blood stem cells from the patient, for collection, storage and re introduction ( transplantation ),

• In adults who have lymphoma (a cancer of the white blood cells) or multiple myeloma (a cancer that affects plasma cells in the bone marrow ).
• In children age 1 to less than 18 years of age with lymphoma or solid tumo urs.

⚠️ 2. What you need to know before you use Mozobil

Do not use Mozobil

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

Warnings and p recautions Talk to you r doctor before using Mozobil .

Tell your doctor:

• if you have or have had any heart problems.
• if you have kidney problems. Your doctor may adjust the dose.
• if you have high white blood cell counts.
• if you have low platelet counts.
• if you have a history of feeling faint or lightheaded on standing or sitting or have fainted before upon injections.

24 Your doctor may perform regular blood tests to monitor your blood cell count.

It is not recommended to use Mozobil for stem cell mobilisation if you have leukaemi a (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 breast -feeding You should not use Mozobil if you are pregnant, since there is no experience with Mozobil in pregnant women. It is important to tell your doctor if you are, think you may be or are planning to become pregnant. It is recommended to use contraception if you are of child- bearing age.

You should not breast -feed if you are using Mozobil, since it is not known if Mozobil is excreted in human milk.

Driving and using machines

Mozobil may cause dizziness and fatigue. Therefore, you should avoid driving if you feel dizzy, tired or unwell.

Mozobil contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose , i.e. essentially ‘sodium -free’.

💊 3. How to use Mozobil

Your medicine will be injected by a doctor or a nurse.

You will first receive G -CSF, then you will be given Mozobil Mobilisation will be started by first giving you another medicine called G -CSF (granulocyte -colony stimulating factor). G -CSF will help Mozobil to work properly in your body. If you want to know more about G -CSF ask your doctor and read the corresponding package leaflet.

How much Mozobil is given?

The recommended adult dose is either a 20 mg (fixed dose) or 0.24 mg/kg body weight/day.

The recommended dose for children, 1 to less than 18 years of age is 0.24 mg/kg of body weight/day.

Your dose will depend on your body weight, which should be measured the week before you receive your first dose. If you have moderate or severe kidney problems, your doctor will r educe the dose.

How is Mozobil given?

Mozobil is given by subcutaneous injection (under your skin).

When is Mozobil given for the first time?

You will receive your first dose 6 to 11 hours before apheresis (collection of your blood stem cells).

How lon g will Mozobil be given?

Treatment lasts 2 to 4 consecutive days (in some cases up to 7 days), until enough stem cells have been collected for your transplant. In a few cases, enough stem cells may not be collected, and the collection attempt will be stopp ed.

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

25 Please tell your doctor immediately if

• shortly after receiving Mozobil, you experience rash, swelling around the eyes, shortness of breath or lack of oxygen, feeling lightheaded on standing or sitting, feeling faint or fainting
• you have pain in the upper left abdomen (belly) or your left shoulder

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

• diarrhoea, nausea (feeling sick), injection site redness or irritation
• low red blood cell count by laboratory test (anaemia in children)

Common side effects (may affect up to 1 in 10 people)

• headache
• dizziness, feeling tired or unwell
• difficulty in sleeping
• flatulence, constipation, indigestion, vomiting
• stomach symptoms such as pain, swelling or di scomfort
• dry mouth, numbness around the mouth
• sweating, generalised redness of the skin, joint pains, pains in muscles and bones

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

• allergic reactions such as skin rash, swelling around the eyes, sho rtness 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 trials, patients with risk factors for a heart attack uncommonly suffered heart attacks after being given Mozobil and G -CSF. Please inform your doctor immediately if you experience chest discomfort. Pins and needles and numbness Pins and needles and numbness are common in patients being treated for cancers. About one in five patients suffered from these feelings. However, these effects do not seem to occur more frequently when you use Mozobil.

You may also have an increase in w hite blood cells count (leucocytosis), in your blood tes ts.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 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 which is stated on the carton and vial.

This medicine does not require any special storage conditions.

After opening the vial, Mozobil should be used immediately.

Do not throw away any medicines via wastewater or household waste. The pharmacist will throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other inform ation

What Mozobil contains

• The active substance is plerixafor . Each ml solution for injection contains 20 mg plerixafor. Each vial contains 24 mg plerixafor in 1.2 ml solution.
• The other ingredients are sodium chloride, hydrochloric acid (concentrated) a nd sodium hydroxide for pH adjustment and water for injections.

What Mozobil looks like and contents of the pack

Mozobil is supplied as a clear colourless or pale yellow solution for injection in a glass vial with a non-latex rubber stopper. Each vial con tains 1.2 ml 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 27 For any information about this medicine, 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 Tел: +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. aus dem Ausland: +49 69 305 21 131 Norge sanofi -aventis Norge AS Tlf: + 47 67 10 71 00 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 Appel depuis l’étranger : +33 1 57 63 23 23 România Sanofi Rom ania 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 Κύπρος C.A. Papaellinas Ltd.

Τηλ: +357 22 741741 United Kingdom (Northern Ireland) sanofi -aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525 This leaflet was last approved in .

Other source s of information Detailed information on this medicine is availab le on the European Medicines Agency web site: http://www.ema.europa.eu.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Mozobil (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/09/537).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.