Prospecto: information for the user

Mozobil 20mg/ml injectable solution

plerixafor

Read this prospect carefully before starting to usethismedicine, because it contains important information for you.

• Keep this prospect,as you may need to read it again.
• If you have any doubts, consult your doctor.
• Ifyou experienceadverse effects,consult your doctor or nurse,evenifthey do not appearin this prospect. See section 4.

1.What is Mozobil and for what it is used

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

3.How to use Mozobil

4.Possible adverse effects

1. Storage of Mozobil

6.Contents of the package and additional information

Mozobil contains the active ingredient plerixafor that blocks a protein on the surface of hematopoietic stem cells.This protein “fixes" the blood stem cells to the bone marrow.Plerixafor improves the release of the stem cells into the circulatory system ( mobilization). The stem cells can be collected with a device that separates the blood components (apheresis machine), and then frozen and stored until transplantation.

If mobilization is scarce, Mozobil is administered to help collect stem cells from the patient's blood for collection, storage, and re-introduction (transplantation),

• In adult patients with lymphoma (a cancer of white blood cells) or multiple myeloma (a cancer affecting bone marrow plasma cells).
• In children 1 year of age and under 18 years with lymphoma or solid tumors.

Do not use Mozobil

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

Warnings and precautions

Consult your doctor before starting to use Mozobil.

Inform your doctor:

• if you have or have had any heart problems.
• if you have kidney problems. Your doctor may adjust your dose.
• if you have a high number of white blood cells.
• if you have a low number of platelets.
• if you have a history of dizziness or lightheadedness when standing or sitting, or if you have fainted after injections.

Your doctor may performperiodic blood teststo monitor the number of blood cells.

Mozobil is not recommended for mobilizing stem cells if you have leukemia (a blood or bone marrow cancer).

Use of Mozobil with other medications

Inform your doctor or pharmacist if you are taking, have takenrecently, or may need to take any other medication.

Pregnancy and breastfeeding

You should not use Mozobil if you are pregnant, as there is no data on the effects of Mozobil in pregnant women.It is essential to inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.It is recommended to use contraceptive methods if you are of childbearing age.

You should not breastfeed while using Mozobil, as it is unknown whether Mozobil passes into breast milk.

Driving and operating machinery

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

Mozobil contains sodium

This medication contains less than 1 mmol of sodium (23mg) per dose, making it essentially “sodium-free.”

Your doctor or a nurse will administer your medication.

You will first receive G-CSF and then be administered Mozobil.

Mobilization will begin by administering another medication called G-CSF (granulocyte colony-stimulating factor) first.G-CSF will help Mozobil work properly in your body.If you would like more information about G-CSF, ask your doctor and read the corresponding leaflet.

How much Mozobil is administered?

The recommended dose in adults is 20 mg (fixed dose) or 0.24 mg/kg of body weight/day.

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

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

How is Mozobil administered?

Mozobil is administered via subcutaneous injection (under the skin).

When is Mozobil administered for the first time?

You will receive the first dose between 6 and 11 hours before the apheresis (collection of your stem cells from your blood).

How long will the Mozobil administration last?

The treatment lasts from 2 to 4 consecutive days (in some cases up to 7 days), until sufficient stem cells have been collected for your transplant.In some cases, it is not possible to collect a sufficient number of stem cells, and the attempt to collect will be interrupted.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately if

• You experience any of the following after receiving Mozobil: skin rash, swelling around the eyes, difficulty breathing or lack of oxygen, feeling dizzy while standing or sitting, feeling faint or fainting
• You feel 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)

• Diarrhea, nausea, redness or irritation at the injection site
• Low red blood cell count in laboratory tests (anemia in children)

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

• Headache
• Dizziness, feeling tired or unwell
• Difficulty sleeping
• Flatulence, constipation, indigestion, vomiting
• Stomach symptoms such as pain, swelling, 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 skin rash, swelling around the eyes, difficulty breathing
• Anaphylactic reactions, including anaphylactic shock
• Altered dreams, nightmares

In rare cases, gastrointestinal side effects can be severe (diarrhea, vomiting, stomach pain, and nausea).

Myocardial infarction

In clinical trials, with low frequency, patients with risk factors for myocardial infarction experienced a myocardial infarction after receiving Mozobil and G-CSF.Inform your doctor immediately if you experience chest pain.

Pruritus and paresthesia

Pruritus and paresthesia are common in patients receiving cancer treatment.Approximately one in five patients experience them.However, these effects do not appear to occur more frequently when Mozobil is used.

You may also experience an increase in the number of white blood cells (leukocytes) in your

blood tests.

Reporting of side effects

If you experienceany type of side effect, consult your doctor or nurse, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and in the vial.

This medication does not require special storage conditions..

Once the vial is opened, Mozobil must be used immediately.

Medicines should not be thrown down the drains or in the trash.Ask your pharmacist how to dispose of the packaging and unused medications.By doing so,you will help protect the environment.

Composition of Mozobil

-The active ingredient is plerixafor.Each milliliter of injectable solution contains 20mg of plerixafor.Each vial contains 24mg of plerixafor in 1.2ml of solution.

-The other components are sodium chloride, hydrochloric acid (concentrated) and sodium hydroxide for pH adjustment, and water for injectable preparations.

Appearance of the product and contents of the package

Mozobil is a transparent, colorless, or pale yellow injectable solution contained in a glass vial with a latex-free rubber stopper.Each vial contains 1.2ml of solution.

Each package contains 1 vial.

Holder of the marketing authorization

Sanofi B.V.,Paasheuvelweg 25,1105 BP Amsterdam, Netherlands.

Responsible for manufacturing

Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland.

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of thisleaflet:

Other sources of information

The detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.