DepoCyte
cytarabine
Cytarabine
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 DepoCyte is and what it is given for
What 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
DepoCyte is used to treat lymphomatous meningitis.
Medicinal product no longer authorised
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.
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.
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.
Please tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
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.
Do not drive during treatment.
Do not operate any tools or machines during treatment.
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 should be warmed 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.
Medicinal product no longer authorised
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 accidental 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 further 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:
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.
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 (affects 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:
Nausea and/or vomiting
Weakness
Confusion
Fever
Headaches
Dizziness
Medicinal product no longer authorised
Shaking
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.
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.
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 wastewater. DepoCyte contains cytarabine, and should be disposed of in a manner consistent with local requirements.
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.
Medicinal product no longer authorised
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.
Pacira Limited, Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom.
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.
KBM Pharma OÜ Tel. +372 733 8080
ТП Мундифарма Медикъл ООД
Тел. +359 2 962 13 56/54
Mundipharma Ges.m.b.H. Austria
Organizační složka ČR
Tel : +420 222 318 221
Medis Hungary Kft Információsvonal: +36 2 380 1028
Pacira Limited
Wessex House, Marlow Road Bourne End, Buckinghamshire
SL8 5SP - Renju Unit
Τel: +44 (0) 1628 530554
Medicinal product no longer authorised
Mundipharma Pharmaceuticals B.V.
Tel: +31 (0) 33 450 8270
KBM Pharma OÜ
Tel: +372 733 8080
Mundipharma AS
Tlf: +47 67 51 89 00
Pacira Limited
Wessex House, Marlow Road Bourne End, Buckinghamshire
SL8 5SP
Ηνωμένο Βασίλειο
Τηλ: +44 (0) 1628 530554
Mundipharma Gesellschaft.m.b.H. Tel: + 43 (0) 1 523 25 05
Mundipharma Pharmaceuticals, S.L. Tel: +34 91 3821870
Mundipharma Polska Sp.z o.o. Tel: +48(0) 22 866 87 12
Mundipharma
Tel: +33 (0) 1 40 65 29 29
Companhia Portuguesa Higiene Pharma – Produtos Farmacêuticos, S.A.
Tel: +351 214 449 600
Medis Adria d.o.o.
Kolarova 7,
10000 Zagreb
Tel.: +385 1 2303 446
Mundipharma Gesellschaft m.b.H., Austria
Tel: +40 751 121 222
Mundipharma Pharmaceuticals Limited Tel: +353 1 2063800
Medis, d.o.o.
Tel: +386 158969 00
Mundipharma A/S Tel: +45 45 17 48 00
mundipharma@ mundipharma.dk
Medicinal product no longer authorised
Mundipharma Pharmaceuticals Srl Tel: + 39.02.318288216
Italy.InfoMedica@mundipharma.it
Mundipharma Oy
Puh/Tel: +358 (0)9 8520 2065
Mundipharma Pharmaceuticals Ltd
Τηλ: +357 22 81 56 56
Mundipharma AB
Tel: + 46 (0)31 773 75 30
Institute of Innovative Biomedical Technology
Tel: +371 7 800810
Napp Pharmaceuticals Limited
Tel: +44 (0) 1223 424444