DepoCyte

Основна информация

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

Документи

Локализация

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

Терапевтична информация

  • Терапевтична група:
  • Antineoplastic agents,
  • Терапевтична област:
  • Meningeal Neoplasms
  • Терапевтични показания:
  • Intrathecal treatment of lymphomatous meningitis. In the majority of patients such treatment will be part of symptomatic palliation of the disease.
  • Каталог на резюме:
  • Revision: 15

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/000317
  • Дата Оторизация:
  • 10-07-2001
  • EMEA код:
  • EMEA/H/C/000317
  • Последна актуализация:
  • 30-03-2019

Доклад обществена оценка

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.

EMA/273588/2011

EMEA/H/C/317

EPAR summary for the public

DepoCyte

cytarabine

This document is a summary of the European Public Assessment Report (EPAR) for DepoCyte. It

explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to

reach its opinion in favour of granting a marketing authorisation and its recommendations on the

conditions of use for DepoCyte.

What is DepoCyte?

DepoCyte is a suspension for injection that contains 50 mg of the active substance, cytarabine.

What is DepoCyte used for?

DepoCyte is used to treat lymphomatous meningitis. This is a condition in which cells from a lymphoma

(a tumour in the lymphatic system) have spread to the spinal fluid and the meninges (the membranes

that surround the brain and spinal cord). DepoCyte helps to control the symptoms of the disease.

These symptoms mainly affect the nerves, and include pain, fits, headache, problems walking, memory

problems, incontinence and unusual sensations.

The medicine can only be obtained with a prescription.

How is DepoCyte used?

DepoCyte should only be given by a doctor who has experience in the use of anticancer medicines.

DepoCyte is a ‘depot’ injection (a type of injection where the medicine is prepared so that it is

absorbed by the body very slowly). The medicine must be injected ‘intrathecally’ (directly into the

spinal fluid in the space that surrounds the spinal cord and the brain). The patient should also receive

dexamethasone (a steroid) to help control some of the medicine’s side effects.

DepoCyte is first given as a 50-mg injection every two weeks for the first five doses, followed by a

further 50 mg four weeks later. This is then followed by maintenance doses of 50 mg every four weeks

for a further four doses. The dose can be decreased to 25 mg if the patient shows signs of damage to

the nerves (such as headache, abnormal vision, muscle weakness or pain).

How does DepoCyte work?

The active substance in DepoCyte, cytarabine (also known as ara-C), is an anticancer medicine that

has been used since the 1970s. It is a cytotoxic (a medicine that kills cells that are dividing, such as

cancer cells), which belongs to the ‘anti-metabolite’ group.

Cytarabine is an analogue of pyrimidine. Pyrimidine is part of the genetic material of cells (DNA and

RNA). In the body, cytarabine takes the place of pyrimidine and interferes with the enzymes involved

in the production of new DNA. As a result, cytarabine slows down the growth of tumour cells and

eventually kills them. In DepoCyte, cytarabine is contained in liposomes (small fatty particles), from

which the medicine is released slowly.

How has DepoCyte been studied?

DepoCyte has been compared with a standard formulation of cytarabine in one main study involving 35

patients with lymphomatous meningitis. The main measure of effectiveness was the number of

patients who responded to treatment. A patient was classified as a ‘responder’ if they had no cancer

cells in the spinal fluid after treatment and if their symptoms had not got worse after four weeks. The

study also looked at how long the patients lived without their nerve disease getting worse.

What benefit has DepoCyte shown during the studies?

In the main study, 72% of the patients who received DepoCyte responded to treatment (13 out of 18),

compared with 18% of those who received the standard formulation of cytarabine (3 out of 17).

However, there was no difference between the two medicines in how long the patients lived without

their nerve disease getting worse.

What is the risk associated with DepoCyte?

The most common side effects with DepoCyte (seen in more than 1 treatment cycle in 10) are

headache, arachnoiditis (inflammation of one of the membranes protecting the spine and the brain),

confusion, nausea (feeling sick), vomiting, diarrhoea, pyrexia (fever), weakness and thrombocytopenia

(low blood platelet counts).To minimise the symptoms of arachnoiditis, patients should receive

dexamethasone by mouth or by injection at the same time as DepoCyte and must be closely

monitored. For the full list of all side effects reported with DepoCyte, see the Package Leaflet.

DepoCyte should not be given to people who may be hypersensitive (allergic) to cytarabine or any of

the other ingredients. It must not be used in patients who have an active infection in the meninges.

Why has DepoCyte been approved?

The CHMP noted that DepoCyte had shown effectiveness in lymphomatous meningitis when compared

with the standard formulation of cytarabine, and that it could improve patients’ quality of life because

fewer intrathecal injections are needed. The Committee decided that DepoCyte’s benefits are greater

than its risks and recommended that it be given marketing authorisation.

DepoCyte

EMA/273588/2011

Page 2/3

DepoCyte

EMA/273588/2011

Page 3/3

Other information about DepoCyte:

The European Commission granted a marketing authorisation valid throughout the European Union for

DepoCyte on 11 July 2001. The marketing authorisation holder is Pacira Limited. The marketing

authorisation is valid for an unlimited period.

The full EPAR for DepoCyte can be found here

. For more information about treatment with DepoCyte,

read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 04-2011.

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

B. PACKAGE LEAFLET

Package leaflet: Information for the user

DepoCyte 50 mg suspension for injection

Cytarabine

Read all of this leaflet carefully before you receive this medicine because it contains important

information for you.

Keep this leaflet. You may need to read it again.

If you have further questions, ask your doctor.

If you get any side effects, talk to your doctor. This includes any possible side effects not listed

in this leaflet. See section 4.

What is in this leaflet:

What DepoCyte is and what it is given

at you need to know before you are given DepoCyte

How DepoCyte is given

Possible side effects

How to store DepoCyte

Contents of the pack and other information

1.

What DepoCyte is and what it is given for

DepoCyte is used to treat lymphomatous meningitis.

Lymphomatous meningitis is a condition in which tumour cells have invaded the fluid or membranes

that surround the brain and spinal cord.

DepoCyte is used in adults to kill lymphoma tumour cells.

2.

What you need to know before you are given DepoCyte

DepoCyte s

hould no

t be given

if you are allergic to cytarabine or any of the other ingredients of this medicine (listed in

section 6).

if you have a meningeal infection.

Warnings and precautions

Severe neurological side effects have been reported with the use of DepoCyte. Symptoms have

included effects on the nervous system (e.g. convulsions, pain, numbness or tingling, blindness or

visual disturbances). Your doctor will check for these symptoms regularly.

Make sure you take as directed any dexamethasone tablets that you may have been prescribed, as they

reduce the risk of unwanted effects caused by DepoCyte.

If your side effects get worse or you notice any new side effects, tell your doctor.

Other medicines and DepoCyte

Please tell your doctor if you are taking or have recently taken any other medicines, including

medicines obtained without a prescription.

Pregnancy, breast-feeding and fertility

DepoCyte should not be given to pregnant women as it may harm an unborn child. Women of

childbearing potential should use a reliable contraceptive method to avoid pregnancy whilst being

treated with DepoCyte.

Male patients undergoing DepoCyte treatment should use a reliable contraceptive method.

Women should not breast-feed during treatment as DepoCyte may enter breast milk.

Driving and using machines

Do not drive during treatment.

Do not operate any tools or machines during treatment.

3.

How DepoCyte is given

A qualified and

experienced doctor or physician in the treatment of cancer will inject DepoCyte in the

spinal fluid or lumber sac. DepoCyte must not be administered by any other way. Injections are given

slowly over 1-5 minutes and you may be asked to lie flat for one hour afterwards.

You will also be given dexamethasone, usually as tablets but possibly by intravenous injection for

5 days after you receive each DepoCyte dose to help reduce any side effects which might occur.

Before DepoCyte is used the vial s

hould be w

armed to room temperature (18°C – 22°C) for at least

30 minutes. Just before withdrawing DepoCyte, the vial should be gently inverted to mix the particles

evenly. It should not be shaken vigorously.

Proper precautions should be taken for the handling and administration of a cytotoxic drug (proper

handling technique, use of a suitable designated area, protective clothing, procedures to address risk of

contamination). Staff who are pregnant or trying to conceive (male and female) should not work with

DepoCyte. In

the event of acc

idental contact with the mucous membranes, treat immediately by

copious washing with water; medical attention should be sought.

DepoCyte should be withdrawn from the vial immediately before administration; the medicinal

product should be used within 4 hours of withdrawal from the vial. Unused medicinal product must be

discarded and not used subsequently. DepoCyte must not be mixed with any other medicinal

products. In-line filters must not be used when administering DepoCyte.

DepoCyte must be used as supplied without furth

er dilution. The dose for adults is 50 mg (one vial of

DepoCyte).

For the treatment of lymphomatous meningitis, DepoCyte is given according to the following

schedules:

Start-up treatment: one vial of DepoCyte (50 mg) administered every 14 days for 2 doses (weeks 1

and 3).

Follow-up treatment: one vial of DepoCyte (50 mg) administered every 14 days for 3 doses (weeks

5, 7 and 9) followed by an additional dose at week 13.

Maintenance treatment: one vial of DepoCyte (50 mg) administered every 28 days for 4 doses

(weeks 17, 21, 25 and 29).

If you are given m

ore D

epoCyte than you should

The recommended dose will be given to you by the doctor or physician as necessary. There is no

antidote for DepoCyte. Management of overdose should be directed at maintaining vital functions.

4.

Possible side effects

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

effects may occur after each injection, usually within the first five days.

Your doctor will discuss these with you and will explain the potential risks and benefits of your

treatment.

The frequency of possible side effects listed below is defined using the following convention: 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 (aff

ects less than 1 user in

10,000); not known (frequency cannot be estimated from the available data).

The severity of adverse events of DepoCyte may be increased when DepoCyte is given in combination

with other chemotherapeutic agents.

Tell the medical staff monitoring you during this time, if you suffer from:

Very common (experienced in more than 1 in 10 patients)

Nausea and/or vomiting

Weakness

Confusion

Fever

Headaches

Dizziness

Shaking

Common (experienced in less than 1 in 10 but more than 1

in 100 patients)

Back pain

Convulsion

Neck pain

A stiff or rigid neck

Infection of the meninges

Fatigue

Pain, numbness or tingling (feeling of sensation of pins and needles)

Blindness and other visual disturbances

Hearing loss

Persistent or extreme sleepiness

Partial paralysis

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please

inform the medical staff looking after you.

Reporting of side effects

If you get any side effects, talk to your d

octor or nurs

e. 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 DepoCyte

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 on the vial after EXP.

The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).

Do not freeze.

DepoCyte should be used as soon as possible after first opening, and should normally be used within 4

hours (stored at 18-22ºC).

DepoCyte is a sterile white to off-white-suspension. Do not use this medicine if you notice severe

discolouration, a changed appearance or a defective container.

Do not throw away any medicines

via was

tewater. DepoCyte contains cytarabine, and should be

disposed of in a manner consistent with local requirements.

6.

Contents of the pack and other information

What DepoCyte contains

The active substance is cytarabine. One ml of suspension contains 10 mg cytarabine. Each 5 ml

vial contains 50 mg cytarabine

The other ingredients are cholesterol, triolein, dioleoylphosphatidylcholine,

dipalmitoylphosphatidylglycerol, sodium chloride, and water for injections.

What DepoCyte looks like and contents of the pack

DepoCyte is

a white to off-white-suspension for injection supplied in a glass vial.

Each vial contains 5 ml of suspension for a single injection.

Each pack contains a single vial.

Marketing Authorisation Holder

Pacira Limited, Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United

Kingdom.

Manufacturer

Almac Pharma Services Limited, 20 Seagoe Industrial Estate, Craigavon, Co Armagh, BT63 5QD,

United Kingdom.

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

Authorisation Holder.

België/Belgique/Belgien

Mundipharma Comm VA.

Tél/Tel: +32 (0) 15 45 11 80

info@mundipharma.be

Lietuva

KBM Pharma OÜ

Tel. +372 733 8080

kbmpharma@kbmpharma.eu

България

ТП Мундифарма Медикъл ООД

Тел. +359 2 962 13 56/54

mundipharma@mundipharma.bg

Luxembourg/Luxemburg

Mundipharma Comm VA.

Tél: +32 (0) 15 45 11 80

info@mundipharma.be

Česká republika

Mundipharma Ges.m.b.H. Austria

Organizační složka ČR

Tel : +420 222 318 221

office@mundipharma.cz

Magyarország

Medis Hungary Kft

Információsvonal: +36 2 380 1028

info@medis.hu

Danmark

Mundipharma A/S

Tlf: +45 45 17 48 00

mundipharma@mundipharma.dk

Malta

Pacira Limited

Wessex House, Marlow Road

Bourne End, Buckinghamshire

SL8 5SP - Renju Unit

Τel: +44 (0) 1628 530554

Deutschland

Mundipharma GmbH

Tel: + 49 (0) 64 31 701-0

mundipharma@mundipharma.de

Nederland

Mundipharma Pharmaceuticals B.V.

Tel: +31 (0) 33 450 8270

info@mundipharma.nl

Eesti

KBM Pharma OÜ

Tel: +372 733 8080

kbmpharma@kbmpharma.eu

Norge

Mundipharma AS

Tlf: +47 67 51 89 00

post@mundipharma.no

Eλλάδα

Pacira Limited

Wessex House, Marlow Road

Bourne End, Buckinghamshire

SL8 5SP

Ηνωμένο Βασίλειο

Τηλ: +44 (0) 1628 530554

Österreich

Mundipharma Gesellschaft.m.b.H.

Tel: + 43 (0) 1 523 25 05

office@mundipharma.at

España

Mundipharma Pharmaceuticals, S.L.

Tel: +34 91 3821870

infomed@mundipharma.es

Polska

Mundipharma Polska Sp.z o.o.

Tel: +48(0) 22 866 87 12

office@mundipharma.pl

France

Mundipharma

Tel: +33 (0) 1 40 65 29 29

infomed@mundipharma.fr

Portugal

Companhia Portuguesa Higiene Pharma –

Produtos Farmacêuticos, S.A.

Tel: +351 214 449 600

geral@ferrergrupo.com.pt

Hrvatska

Medis Adria d.o.o.

Kolarova 7,

10000 Zagreb

Tel.: +385 1 2303 446

România

Mundipharma Gesellschaft m.b.H., Austria

Tel: +40 751 121 222

office@mundipharma.ro

Ireland

Mundipharma Pharmaceuticals Limited

Tel: +353 1 2063800

oncologymedinfo@napp.co.uk

Slovenija

Medis, d.o.o.

Tel: +386 158969 00

info@medis.si

Ísland

Mundipharma A/S

Tel: +45 45 17 48 00

mundipharma@ mundipharma.dk

Slovenská republika

Mundipharma Ges.m.b.H. - o.z

Tel: +421 2 63811611

mundipharma@mundipharma.sk

Italia

Mundipharma Pharmaceuticals Srl

Tel: + 39.02.318288216

Italy.InfoMedica@mundipharma.it

Suomi/Finland

Mundipharma Oy

Puh/Tel: +358 (0)9 8520 2065

info@mundipharma.fi

Κύπρος

Mundipharma Pharmaceuticals Ltd

Τηλ: +357 22 81 56 56

info@mundipharma.com.cy

Sverige

Mundipharma AB

Tel: + 46 (0)31 773 75 30

info@mundipharma.se

Latvija

Institute of Innovative Biomedical Technology

Tel: +371 7 800810

info@ibti.lvoffice

United Kingdom

Napp Pharmaceuticals Limited

Tel: +44 (0) 1223 424444

oncologymedinfo@napp.co.uk

This leaflet was last revised in MM/YYYY

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

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