Mozobil

Основна информация

  • Търговско наименование:
  • Mozobil
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Mozobil
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Immunostimulants,
  • Терапевтична област:
  • Multiple Myeloma, Hematopoietic Stem Cell Transplantation, Lymphoma
  • Терапевтични показания:
  • Mozobil is indicated in combination with granulocyte-colony-stimulating factor to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly.
  • Каталог на резюме:
  • Revision: 18

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/001030
  • Дата Оторизация:
  • 30-07-2009
  • EMEA код:
  • EMEA/H/C/001030
  • Последна актуализация:
  • 04-04-2020

Доклад обществена оценка

Official address

Domenico Scarlattilaan 6

1083 HS Amsterdam

The Netherlands

An agency of the European Union

Address for visits and deliveries

Refer to www.ema.europa.eu/how-to-find-us

Send us a question

Go to www.ema.europa.eu/contact

Telephone

+31 (0)88 781 6000

© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.

EMA/254533/2019

EMEA/H/C/001030

Mozobil (plerixafor)

An overview of Mozobil and why it is authorised in the EU

What is Mozobil and what is it used for?

Mozobil is a medicine used to mobilise blood stem cells from a patient’s bone marrow so that they can

be collected and used later for transplantation in the same patient.

Mozobil is used together with the hormone granulocyte-colony stimulating factor (G-CSF) and is only

for patients in whom collection of stem cells is difficult.

The patients who are given Mozobil are:

adults with lymphoma or multiple myeloma (types of blood cancer);

children from 1 year of age who have lymphoma or solid tumours.

Mozobil contains the active substance plerixafor.

The number of patients that need mobilisation and collection of haematopoietic stem cells for

transplantation is low and Mozobil was designated an ‘orphan medicine’ (a medicine used in rare

diseases) on 20 October 2004. Further information on the orphan designation can be found on here:

ema.europa.eu/medicines/human/orphan-designations/eu304227

How is Mozobil used?

Mozobil is given as an injection under the skin. The medicine can only be obtained with a prescription

and treatment should only be started and supervised by a doctor who has experience in treating

cancer or blood disorders. After the patient has been given Mozobil, the patient’s stem cells are

extracted from the blood and stored before transplantation. Because of this, treatment should be

carried out in collaboration with a specialised centre that has experience with this type of procedure

and can monitor the stem cells.

Mozobil is used together with G-CSF. G-CSF is used on its own for 4 days before Mozobil is added.

Mozobil is given 6 to 11 hours before the patient’s blood is taken and the stem cells are extracted. It

can be used for up to 7 consecutive days. The dose depends on the bodyweight of the patient.

For more information about using Mozobil, see the package leaflet or contact your doctor or

pharmacist.

Mozobil (plerixafor)

EMA/254533/2019

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How does Mozobil work?

Mozobil is used to mobilise the stem cells from the bone marrow so they can be released into the

blood. The active substance in Mozobil, plerixafor, works by blocking the activity of a protein called the

‘CXCR4 chemokine receptor’. This protein normally helps to keep stem cells within the bone marrow.

By blocking its activity, Mozobil allows the stem cells to be released into the blood, so that they can be

collected.

What benefits of Mozobil have been shown in studies?

In two main studies involving 298 adults with non-Hodgkin’s lymphoma and 302 adults with multiple

myeloma, more patients who received Mozobil achieved the target number of stem cells and had

successful engraftment of stem cells (the cells started growing and producing normal blood cells after

transplantation) than patients who received placebo (a dummy treatment). In both studies the patients

were also receiving G-CSF.

Among the adults with lymphoma, 59% (89 out of 150) of those receiving Mozobil achieved the target

number of stem cells within 4 collection days, compared with 20% (29 out of 148) of the patients

receiving placebo. Among the adults with multiple myeloma, 72% (106 out of 148) of those receiving

Mozobil achieved the target number of stem cells within 4 collection days, compared with 34% (53 out

of 154) of the patients receiving placebo.

In a main study involving 45 children with lymphoma or solid tumours, 80% (24 out of 30) of patients

who received Mozobil had at least a doubling of the number of stem cells in the blood, compared with

29% (4 out of 14) patients who received standard mobilisation treatment alone.

What are the risks associated with Mozobil?

The most common side effects with Mozobil (which may affect more than 1 patient in 10) are

diarrhoea, nausea (feeling sick) and reactions at the site of injection. For the full list of side effects and

restrictions with Mozobil, see the package leaflet.

Why is Mozobil authorised in the EU?

The European Medicines Agency decided that Mozobil’s benefits are greater than its risks and it can be

authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of

Mozobil?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Mozobil have been included in the summary of product characteristics and the

package leaflet.

As for all medicines, data on the use of Mozobil is continuously monitored. Side effects reported with

Mozobil are carefully evaluated and any necessary action taken to protect patients.

Other information about Mozobil

Mozobil received a marketing authorisation valid throughout the EU on 31 July 2009.

Mozobil (plerixafor)

EMA/254533/2019

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Further information on Mozobil can be found on the Agency’s website:

ema.europa.eu/en/medicines/human/EPAR/mozobil.

This overview was last updated in 05-2019.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Mozobil 20 mg/ml solution for injection

Plerixafor

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.

What is in this leaflet

What Mozobil is and what it is used for

What you need to know before you use Mozobil

How to use Mozobil

Possible side effects

How to store Mozobil

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 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 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 reintroduction (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 tumours.

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 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.

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).

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 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 6 to 11 hours before apheresis (collection of your blood stem cells).

How long 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 stopped.

4.

Possible side effects

Like all medicines, this medicine 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 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 discomfort

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, shortness 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 white blood cells count (leucocytosis), in your blood tests.

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 information

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.

Paasheuvelweg 25

1105 BP Amsterdam

The Netherlands.

Manufacturer

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

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

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

UAB SANOFI-AVENTIS LIETUVA“

Tel. +370 5 275 5224

България

SANOFI BULGARIA EOOD

Tел: +359 2 9705300

Magyarország

SANOFI-AVENTIS Zrt.

Tel: +36 1 505 0050

Česká republika

sanofi-aventis, s.r.o.

Tel: +420 233 086 111

Malta

Sanofi S.p.A

Tel: +39 02 39394275

Danmark

sanofi A/S

Tlf: +45 45 16 70 00

Nederland

Genzyme Europe B.V.

Tel: +31 20 245 4000

Deutschland

Sanofi-Aventis Deutschland GmbH

Tel: +49 (0)180 2 222010

Norge

sanofi-aventis Norge AS

Tlf: + 47 67 10 71 00

Eesti

sanofi-aventis Estonia OÜ

Tel. +372 6 273 488

Österreich

sanofi-aventis GmbH

Tel: + 43 1 80 185 - 0

Ελλάδα

sanofi-aventis 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-aventis France

Tél : 0 800 222 555

Appel depuis l’étranger : +33 1 57 63 23 23

România

Sanofi Romania SRL

Tel: +40 (0) 21 317 31 36

Hrvatska

sanofi-aventis Croatia d.o.o.

Tel: +385 1 600 34 00

Slovenija

sanofi-aventis d.o.o.

Tel: +386 1 560 4800

Ireland

sanofi-aventis Ireland Ltd T/A SANOFI

Tel: +353 (0) 1 4035 600

Slovenská republika

sanofi-aventis Pharma Slovakia s.r.o.

Tel.: +421 2 33 100 100

Ísland

Vistor hf.

Sími: +354 535 7000

Suomi/Finland

Sanofi Oy

Puh/Tel: + 358 201 200 300

Italia

Sanofi S.p.A.

Tel: +800536389

Sverige

Sanofi AB

Tel: +46 (0)8 634 50 00

Latvija

sanofi-aventis Latvia SIA

Tel: +371 67 33 24 51

Κύπρος

sanofi-aventis Cyprus Ltd.

Τηλ: +357 22 871600

United Kingdom

Sanofi

Tel: +44 (0) 845 372 7101

This leaflet was last approved in.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.