Mozobil 20 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mozobil 20 mg/ml injection solution

plerixafor

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Mozobil is and what it is used for

2. What you need to know before using Mozobil

3. How to use Mozobil

4. Possible side effects

   1. How to store Mozobil

5. 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 hematopoietic stem cells. This protein "anchors" 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 device that separates the components of the blood (apheresis machine), subsequently frozen and stored until transplantation.

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

• In adult patients with lymphoma (a cancer of white blood cells) or multiple myeloma (a cancer affecting plasma cells in the bone marrow).
• In children from 1 to less than 18 years of age 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 components of this medicine (listed in section 6).

Warnings and precautions

Talk to 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 white blood cell count.
• if you have a low platelet count.
• if you have a history of fainting or dizziness while standing or sitting, or have previously fainted after injections.

Your doctor may carry out 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).

Use of Mozobil with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

You must not use Mozobil if you are pregnant, as there are no data available 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 are planning to become pregnant. Contraceptive methods are recommended if you are of childbearing age.

You must not breast-feed while using Mozobil, as it is unknown whether Mozobil passes into breast milk.

Driving and use of 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 and is therefore considered essentially “sodium-free”.

3. How to use Mozobil

Your doctor or a nurse will inject your medication.

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

Mobilization will begin by first giving you 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 ask your doctor and read the corresponding patient information leaflet.

How much Mozobil is given?

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 of age, is 0.24 mg/kg 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 reduce your dose.

How is Mozobil given?

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

When is Mozobil given 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 treatment last?

Treatment lasts for 2 to 4 consecutive days (in some cases up to 7 days), until enough stem cells have been collected for your transplant. In some cases, it may not be possible to collect a sufficient number of stem cells, in which case the collection attempt will be stopped.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Tell your doctor immediately if

• shortly after receiving Mozobil, you develop a rash, swelling around the eyes, difficulty breathing or lack of oxygen, dizziness when 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 adverse effects (may affect more than 1 in 10 people)

• diarrhoea, nausea, redness or irritation at the injection site
• low red blood cell count in laboratory tests (anaemia in children)

Common adverse 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, generalized skin redness, joint pain, muscle and bone pain

Uncommon adverse 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

On rare occasions, gastrointestinal adverse effects may be severe (diarrhoea, vomiting, stomach pain and nausea).

Myocardial infarction

In clinical trials, myocardial infarction occurred infrequently in patients with risk factors for myocardial infarction after administration of Mozobil and G-CSF. Inform your doctor immediately if you experience chest discomfort.

Tingling and numbness

Tingling and numbness are common in patients receiving cancer treatment. Approximately one in five patients experiences these symptoms. However, these effects do not appear to occur more frequently with the use of Mozobil.

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the packaging and vial.

This medicine does not require any special storage conditions.

Once the vial has been opened, Mozobil must be used immediately.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mozobil

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

Appearance of the product and contents of the container

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

Each pack contains 1 vial.

Marketing Authorization Holder

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

Manufacturer

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

More information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

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