MOZOBIL 20 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Mozobil 20mg/ml solution for injection

plerixafor

Read all of this leaflet carefully before you start usingthismedicine 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 experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is Mozobil and what is it used for
2. What you need to know before you use Mozobil
3. How to use Mozobil
4. Possible side effects
   1. Storage of Mozobil

1. Contents of the pack and other information

1. What is Mozobil and what is it used for

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

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

• In adult patients with lymphoma (a type of blood cancer) or multiple myeloma (a type of cancer that affects the plasma cells in the bone marrow).
• In children from 1 to less than 18 years with lymphoma or solid tumors.

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 precautions

Talk to your doctor before you start using Mozobil.

Tell 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 white blood cell count.
• if you have a low platelet count.
• if you have a history of feeling faint or dizzy while standing or sitting, or if you have fainted after injections in the past.

Your doctor may perform blood tests periodicallyto monitor your blood cell count.

Mozobil is not recommended for stem cell mobilization if you have leukemia (a type of blood or bone marrow cancer).

Using Mozobil with other medicines

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 if you are pregnant, as there is no data on 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 plan to become pregnant. The use of contraceptive methods is recommended if you are of childbearing age.

Do not breastfeed if you are using Mozobil, as it is not known whether Mozobil passes into breast 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 of sodium (23 mg) per dose, which is considered essentially "sodium-free".

3. How to use Mozobil

Your doctor or nurse will inject the medicine into you.

First, you will receive G-CSF and then Mozobil will be administered

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

How much Mozobil is administered?

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

The recommended dose in children from 1 to less than 18 years is 0.24 mg/kg 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 by 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 apheresis (collection of stem cells from your blood).

How long will Mozobil administration last?

Treatment lasts from 2 to 4 consecutive days (in some cases up to 7 days), until enough stem cells have been collected for transplantation. In some cases, it may not be possible to collect enough stem cells, so the collection attempt will be interrupted.

4. Possible side effects

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

Tell your doctor immediately if

• soon after receiving Mozobil, you experience a rash, swelling around the eyes, difficulty breathing, or a lack of oxygen, dizziness while standing or sitting, feeling faint, or fainting
• you feel pain in the upper left part 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, bloating, or discomfort
• dry mouth, numbness around the mouth
• sweating, flushing, 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, difficulty breathing
• anaphylactic reactions, including anaphylactic shock
• disturbed dreams, nightmares

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

Myocardial infarction

In clinical trials, patients with risk factors for myocardial infarction rarely experienced a myocardial infarction after administration of Mozobil and G-CSF. Tell your doctor immediately if you experience chest discomfort.

Numbness and tingling

Numbness and tingling are common in patients receiving cancer treatment. About one in five patients experience them. However, these effects do not seem to occur more frequently when Mozobil is used.

You may also have an increased white blood cell count in your blood tests.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are 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. Storage of 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.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Mozobil contains

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

Appearance and packaging

Mozobil is a clear, colorless or pale yellow solution for injection 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, Netherlands.

Manufacturer

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

You can request more information about this medicine from the local representative of the Marketing Authorisation Holder:

Date of last revision of thisleaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.