Mozobil 20 mg/ml solution for injection

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 stem cells can then be collected by an apheresis machine, and subsequently frozen and stored until your transplant.

If mobilisation is poor, Mozobil is used to help collect blood stem cells for transplantation in patients with lymphoma (a cancer of the white blood cells) and multiple myeloma (a cancer that affects plasma cells in the bone marrow).

DO NOT use Mozobil

• if you are allergic (hypersensitive) to plerixafor or any of the other ingredients of Mozobil (listed in section 6, ?What Mozobil contains?)

Take special care with 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.
• if you are under 18 years of age. The effects of Mozobil on children and adolescents have not been studied.

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 leukaemia (a cancer of the blood or bone marrow).

Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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.

Important information about some of the ingredients of Mozobil

Mozobil is essentially sodium-free. It contains less than 1 mmol sodium (23 mg) per dose.

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 usual dose is 0.24 mg/kg body weight/day. Your Mozobil 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 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 of Mozobil 6 to 11 hours before apheresis (collection of your blood stem cells).

How long will Mozobil be given?

Treatment with Mozobil 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 stopped.

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

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 at the tip of your shoulder.

Side effects may occur with certain frequencies, which are defined as follows:

• very common: affects more than 1 user in 10
• common: affects 1 to 10 users in 100
• uncommon: affects 1 to 10 users in 1,000
• rare: affects 1 to 10 users in 10,000
• very rare: affects less than 1 user in 10,000
• not known: frequency cannot be estimated from the available data.

Very common side effects

• diarrhoea, nausea (feeling sick), injection site redness or irritation

Common side effects

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

Uncommon side effects

• allergic reactions such as skin rash, swelling around the eyes, shortness of breath

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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

Keep out of the reach and sight of children.

Do not use Mozobil after the expiry date which is stated on the carton and vial.

This medicinal product does not require any special storage conditions.

After opening the vial, Mozobil should be used immediately.

Medicines should not be disposed of via wastewater or household waste. The pharmacist will dispose of medicines no longer required. These measures will help to protect the environment.

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) and 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 contains 1.2 ml solution.

Each pack contains 1 vial.

Marketing Authorisation Holder

Genzyme Europe B.V., Gooimeer 10, NL-1411 DD Naarden, The Netherlands.

Manufacturer

Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

ItaliaMalta Genzyme Srl ItaliaItalja Tel 39 059 349 811 BelgiëBelgiqueBelgien LuxemburgLuxembourg Genzyme Belgium N.V. TelTél 32 2 714 17 11

Magyarország Genzyme Europe B.V. Képviselet Tel 36 1 310 7440 Genzyme CEE GmbH . 359 2 971 1001

eská RepublikaSlovenská RepublikaSlovenija Genzyme Czech, s.r.o. Tel 420 227 133 665 Nederland Genzyme Europe B.V. Tel 31 35 699 1200

Österreich Genzyme Austria GmbH Tel 43 1 774 65 38 DanmarkNorgeSverigeSuomiFinland Ísland Genzyme AS, DanmarkTanskaDanmörk TlfPuh.Sími 45 32 71 2600

Deutschland Genzyme GmbH Tel 49 610236740 PolskaEestiLatvijaLietuva Genzyme Polska Sp. z o.o. PoolaPolijaLenkija Tel 48 22 24 60 900

Genzyme Hellas Ltd 30 210 99 49 270 Portugal Genzyme Portugal S.A. Tel 351 21 422 0100

España Genzyme, S.A. Tel 34 91 6591670 România Genzyme CEE GmbH- Reprezentana pentru România Tel 40 21 24 34 228

France Genzyme S.A.S. Tél 33 0 825 825 863 United KingdomIreland Genzyme Therapeutics Ltd. United Kingdom Tel 44 1865 405200

This leaflet was last approved in