Document: leaflet MAH GENERIC_PL 04515-0127 change

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• leaflet MAH GENERIC_PL 04569-1540
• leaflet MAH GENERIC_PL 20075-0412

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Hospira

PACKAGE LEAFLET:

INFORMATION FOR THE USER

Mitoxantrone 2 mg/ml Concentrate for Solution for Infusion

The active substance is mitoxantrone (as hydrochloride)

Read all of this leaflet carefully before you start taking this medicine.

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

•    If you have any further questions, ask your doctor.

•    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 pharmacist.

In this leaflet:

1.    What Mitoxantrone Concentrate for Solution for Infusion is and what it is used for

2.    Before you use Mitoxantrone Concentrate for Solution for Infusion

3.    How to use Mitoxantrone Concentrate for Solution for Infusion

4.    Possible side effects

5.    How to store Mitoxantrone Concentrate for Solution for Infusion

6.    Further information

1. WHAT MITOXANTRONE CONCENTRATE FOR SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR

Mitoxantrone Concentrate for Solution for Infusion is an anti-cancer medicine. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy.

Mitoxantrone Concentrate for Solution for Infusion is used in the treatment of a number of different types of cancer such as breast cancer, liver cancer, adult leukaemia and non-Hodgkin's lymphoma.

2. BEFORE YOU USE MITOXANTRONE CONCENTRATE FOR SOLUTION FOR INFUSION

Do not use Mitoxantrone Concentrate for Solution for Infusion

•    if you are allergic (hypersensitive) to mitoxantrone hydrochloride, similar drugs on previous occasions or any of the other ingredients of this drug (see section 6)

•    if you have breast cancer that has not spread and you are receiving treatment with other anticancer medicines. The use of mitoxantrone with certain other treatments for this condition could increase the risk of developing leukaemia

•    if you are pregnant or trying to become pregnant

•    if you are breast-feeding

Take special care with Mitoxantrone Concentrate for Solution for Infusion

•    if you have myelosuppression (bone marrow that is not working properly)

•    if you have poor body condition

•    if you have certain heart problems

•    if you are taking any medicines that may cause damage to the heart, as this may increase the risk of mitoxantrone affecting the way your heart works

•    if you have liver disease

•    if you are to have radiotherapy or any other anti-cancer medicine, as these may increase your risk of developing leukaemia (acute myeloid leukaemia) or problems with your bone marrow (myelodysplastic syndrome)

•    if you receive a high dose of mitoxantrone and/or treatment for a long time

•    if you need to have a vaccination. Vaccines given during treatment with mitoxantrone may not work properly in which case you will not be fully protected. It is recommended that you do not receive vaccinations whilst you are being treated with mitoxantrone

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Special care will be taken if you are to receive the following medicines whilst being treated with mitoxantrone and your heart and blood will be tested regularly.

•    medicines that may damage your heart

•    radiotherapy

•    other anti-cancer medicines

Pregnancy and breast-feeding

This medicinal product should not be used during pregnancy or breast-feeding.

Men and women undergoing treatment with Mitoxantrone Concentrate for Solution for Infusion should use effective contraception during treatment and for at least 6 months after treatment has stopped.

Driving and using machines

Do not drive or use machines if you feel drowsy or if you experience any other effect which may affect your ability to drive or use machines.

Important information about some of the ingredients of Mitoxantrone Concentrate for Solution for Infusion

This medicine contains sodium metabisulphite, which can cause an allergic type reaction (skin rash, swelling of eyelids, face or lips, or difficulty in breathing). This is rare but you may be more at risk if you suffer from allergies or asthma.

This medicine contains 1.4 mmol sodium per 10 ml vial. To be taken into consideration by patients on a controlled sodium diet.

3. HOW TO USE MITOXANTRONE CONCENTRATE FOR SOLUTION FOR INFUSION

The dose of medicine given to you and how often you are given it will depend upon your medical condition, whether other drugs are being used at the same time, the general state of your health and your body surface area. Your doctor will be able to explain exactly what drugs you will be given and when.

This medicine will be diluted with a solution such as sodium chloride 0.9% before it is given to you. It will be given to you as a slow injection (over at least 3 minutes) via a drip into a vein.

During treatment, blood samples may be taken and heart tests performed. Your dose may be adjusted depending on the results of these tests.

Any unused product or waste materials should be disposed of in accordance with local requirements.

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The following information is intended for medical or healthcare professionals only:

Single use only. Discard any unused contents. Any unused product or waste materials should be disposed of in accordance with local requirements.

Mitoxantrone, in common with other potentially hazardous cytotoxic drugs, should only be handled by adequately trained personnel. Pregnant staff should not be involved in the reconstitution or administration of mitoxantrone.

Care should be taken to avoid contact of mitoxantrone with the skin, mucous membranes, or eyes. The use of goggles, gloves and protective gowns is recommended during preparation, administration and disposal and the work surface should be covered with disposable plastic-backed absorbent paper.

Aerosol generation should be minimised. Mitoxantrone can cause staining. Skin accidentally exposed to mitoxantrone should be rinsed copiously with warm water and if the eyes are involved standard irrigation techniques should be used.

Instructions for dilution and administration

Mitoxantrone should be given by intravenous infusion.

Syringes containing this product should be labelled ‘MITOXANTRONE, FOR INTRAVENOUS USE ONLY.

Care should be taken to avoid contact of mitoxantrone with skin, mucous membranes or eyes.

Dilute the required volume of Mitoxantrone Concentrate for Solution for Infusion to at least 50 ml in either of the following infusion solutions: sodium chloride 0.9%, glucose 5%, or sodium chloride 0.18% and glucose 4%. Use luer-lock fittings on all syringes and sets. Large bore needles are recommended to minimise pressure and the possible formation of aerosols. The latter may also be reduced by the use of a venting needle.    H03571

Component Specification

If you are given more Mitoxantrone Concentrate for Solution for Infusion than you should

As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however tell your doctor or a healthcare professional immediately if you have any concerns.

If you have any further questions on the use of this product, ask your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Mitoxantrone Concentrate for Solution for Infusion can cause side effects, although not everybody gets them.

If any of the following happen, tell the doctor immediately:

•    breathing difficulties

•    chest pain

•    abnormal heart beats

•    severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint.

The above are very serious side effects. You may need urgent medical attention.

All of these very serious side effects are rare.

If you experience any of the following tell your doctor as soon as possible:

•    weakness

•    fatigue

•    fever

•    nausea

•    vomiting

•    inflammation of lining of your mouth or nasal passages

•    loss of hair, this should grow back when your treatment has finished

•    skin rash

•    blue colouration or pigmentation (paler or darker patches) of skin and nails

•    loosening of the nails

•    whites of the eye temporarily turning blue in colour

•    conjunctivitis (inflammation of the eye)

•    shortness of breath

•    diarrhoea

•    constipation

•    severe weight loss

•    black stools

•    blood in your urine or stools

•    stomach pain

•    changes to the way food and drink tastes

•    women may find that their periods will stop

•    confusion, sleepiness, anxiety

•    swelling, soreness, inflammation or blue discolouration where the injection was given

•    if the medicine leaks outside the vein whilst it is being injected, the surrounding tissue may be severely damaged and may need to be operated on or require a skin graft

•    a pins and needles feeling

Please note that your urine may turn a blue-green colour for up to 24 hours after your medicine has been given, this is an expected reaction.

Alterations in the blood may also occur - your doctor will monitor for these (low white cells and, less frequently, anaemia and/or low platelets, abnormal levels of uric acid, calcium, potassium and phosphate). Alteration in your liver enzymes or kidney function will also be monitored.

Some side effects, particularly heart problems and some leukaemias, may occur after treatment with mitoxantrone has stopped.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly (see below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie

5. HOW TO STORE MITOXANTRONE CONCENTRATE FOR SOLUTION FOR INFUSION

Keep out of the reach and sight of children.

Do not use Mitoxantrone Concentrate for Solution for Infusion after the expiry date which is stated on the vial label and carton.

Do not store above 25°C. Do not refrigerate or freeze.

This medicine will be prepared and administered to you by healthcare staff. Any unused medicine must be disposed of by the healthcare staff.

6. FURTHER INFORMATION

What Mitoxantrone Concentrate for Solution for Infusion contains

•    The active substance is mitoxantrone (as hydrochloride).

•    The other ingredients are glacial acetic acid, sodium acetate trihydrate, sodium chloride, sodium metabisulphite (E223) and Water for Injections.

Each 10 ml vial contains 20 mg of mitoxantrone (as hydrochloride).

What Mitoxantrone Concentrate for Solution for Infusion looks like and contents of the pack

This medicinal product is an anti-cancer medicine, in the form of a concentrate for solution for infusion (concentrated solution which is diluted to make a solution which can be given as a slow injection via a drip).

Mitoxantrone Concentrate for Solution for Infusion is a clear, dark blue solution.

It is available in packs containing 1 vial.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder and manufacturer is Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead,

SL6 6RJ, United Kingdom

This leaflet was last revised in 02/2016

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Administer the resulting solution over not less than 3 minutes via the tubing of a freely running intravenous infusion of the above fluids. Mitoxantrone should not be mixed with other drugs in the same infusion.

If extravasation occurs the administration should be stopped immediately and restarted in another vein. The non-vesicant properties of mitoxantrone minimise the risk of severe local reaction following extravasation.

Spillage disposal: The following clean-up procedure is recommended if Mitoxantrone Concentrate for Solution for Infusion is spilled on equipment or environmental surfaces. Prepare a 50% solution of fresh concentrated bleach (any recognised proprietary brand containing either sodium or calcium hypochlorite) in water. Wet absorbent tissues in the bleach solution and apply the wetted tissues to the spillage. The spillage is deactivated when the blue colour has been fully discharged. Collect up the tissues with dry tissues. Wash the area with water and soak up the water with dry tissues. Appropriate protective equipment should be worn during the clean-up procedure. All mitoxantrone contaminated items (e.g. syringes, needles, tissues etc.) should be treated as toxic waste and disposed of accordingly. Incineration is recommended.

Storage

As packaged for sale

Do not store above 25°C. Do not refrigerate or freeze.

In use

Mitoxantrone Sterile Concentrate does not contain an antimicrobial preservative.

Chemical and physical stability of the diluted product has been demonstrated for 72 hours when stored at room temperature.

From a microbiological point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

HD3S71

Component Specification