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MITOXANTRONE 2 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): MITOXANTRONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Mitoxantrone 2mg/ml
Concentrate for solution for infusion
Mitoxantrone 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, please ask your doctor, nurse or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Mitoxantrone is and what it is used for
Before you receive Mitoxantrone
Receiving your medicine
Possible side effects
How to store Mitoxantrone
Further information

1.

WHAT MITOXANTRONE IS AND WHAT IT IS USED FOR



Your medicine is used to treat metastatic breast cancer, non-Hodgkins lymphoma, leukaemia and to
relieve symptoms in liver cancer when an operation is not suitable.

2.

BEFORE YOU RECEIVE MITOXANTRONE

Do not take Mitoxantrone if you:


Are allergic to any of the ingredients in your medicine (See Section 6 Further Information).

Mitoxantrone will not be given to you as an injection into your spine.

Take special care with Mitoxantrone






If you have heart disease
If you are being treated with other types of cancer chemotherapy and/or radiotherapy
If you have problems with your bone marrow
If you have problems with your liver
If you have an infection (a temperature or fever, chills or aches).

Vaccinations are not recommended whilst you are undergoing treatment with Mitoxantrone. Some vaccines
may not be effective if you are taking Mitoxantrone at the same time.
Taking other medicines

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Mitoxantrone when given with other medicines used in the treatment of cancers and/or radiotherapy may
cause a certain type of blood cancer (leukaemia) or bone marrow disorder called myelodysplasia.
There is no evidence to show that using Mitoxantrone with corticosteroids will be harmful.
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
If you are pregnant, planning to become pregnant or breast-feeding you should not be given Mitoxantrone
unless your doctor has specifically recommended it. Breast- feeding should be stopped before starting
treatment and your doctor will tell you when you can restart after the treatment has finished. It is
recommended that you should avoid getting pregnant for at least 6 months after the treatment has finished.
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
Mitoxantrone has been reported to cause drowsiness and confusion. Do not drive or operate machinery or
take part in activities where these symptoms could put themselves or others at risk.
Important information about some of the ingredients of Mitoxantrone
This medicinal product contains 3.1 mg of sodium per 1 ml of solution. This should be taken into
consideration by patients on a controlled sodium diet.

3.

RECEIVING YOUR MEDICINE

Mitoxantrone is a powerful drug and your doctor will want to do a number of tests on you before you start
your treatment. These will continue during the course of your treatment and will include both blood tests to
monitor your liver and kidney function, and also heart tests such as an ECG.
Your medicine will be given to you in hospital. It will be diluted with a saline or dextrose solution and given
as a drip into a vein. The dose will depend on your medical condition, whether other drugs are to be given at
the same time and on a measure of your body size.
The duration of your treatment will depend on your condition and how you respond to the treatment.
For Breast cancer, non-Hodgkins lymphoma or cancer of the liver: You will usually receive a starting
dose of 14 mg/m2 of your body surface area. This dose may be varied depending on your condition or
whether you have previously received anti cancer treatment. The time between treatments is not normally
less than 21 days and will depend on your response to the drug, which will be monitored by your doctor. If
mitoxantrone is used with other drugs the starting dose may be reduced to between 10 and 12 mg/m2 of your
body surface area.
For Leukaemia: You will normally receive a dose of 12 mg/m2. If used in combination with other drugs the
dose and the period between doses may be reduced.
If you have more Mitoxantrone than you should
As a doctor or nurse will be giving you your medicine, it is unlikely that you will receive an overdose.
However, if you have any concerns you should let your doctor or nurse know immediately.

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4.

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POSSIBLE SIDE EFFECTS

Like all medicines, Mitoxantrone can have side effects.
A few people may develop an allergic reaction. This is an uncommon but very serious side effect. If you
experience any of the following symptoms you should tell your doctor immediately:


Swelling of the lips, face and neck leading to severe difficulty in swallowing or breathing, or to shock.

The most frequent side effects are:
 Feeling sick and being sick (these symptoms usually disappear a short time after treatment)
 Hair loss (your hair should grow back after treatment)
 Your urine may become discoloured and turn blue-green. This should only last for about 24 hours after
each dose is given.
Other side effects which have been occasionally reported:
 Shortness of breath
 Rashes
 Lack of periods in women
 Loss of appetite
 Stomach pains, constipation or diarrhoea, abdominal pain
 Tiredness, weakness
 Fever
 Black tarry stools.
 Chest pains, palpitations (abnormality of the rhythm or rate of the heart beat).
 Inflammation or ulceration of the mouth (e.g. mouth ulcers and cold sores)
 Swelling of the lining of the nose, mouth or vagina
 Conjunctivitis
 Sleepiness, confusion, anxiousness, pins and needles
 Blue discolouration of the skin or nails
 Soreness and swelling at the site of injection, which may result in burning and/or blue discolouration of
the skin.
When used with other anticancer treatments it has been associated with abnormal blood disorders, including
leukaemia.
Infrequently, there may be changes in the results of some laboratory test results (blood tests, liver function
tests).
Rarely, certain heart conditions have been reported.
Very rarely, a deterioration of the condition of the nails, or a blue discolouration of the whites of the eye may
occur, though these effects should disappear when treatment is stopped.
If you notice these or any side effects not mentioned in this leaflet, please inform your doctor.

5.

HOW TO STORE MITOXANTRONE

Keep out of the reach and sight of children. Do not store above 25º C. Do not freeze. Do not use
Mitoxantrone after the expiry date shown on the vial and outer packaging.

Chemical and physical stability of the diluted product has been demonstrated for 24 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
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would normally not be longer than 24 hours at 2 to 8º C, unless dilution has taken place in controlled and
validated aseptic conditions.

6.

FURTHER INFORMATION





The name of your medicine is Mitoxantrone 2 mg/ml concentrate for solution for infusion.
The active ingredient is mitoxantrone hydrochloride.
The other ingredients are sodium chloride, anhydrous sodium acetate, glacial acetic acid and water for
injections.
Each vial contains 2 mg/ml of mitoxantrone (as hydrochloride).
The product is available in pack sizes of 1vial. Each vial contains 5, 10, 12.5 or 15 ml of solution.




Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne,
East Sussex, BN22 9AG, UK
The company responsible for manufacture is Pharmachemie BV, Swensweg 5-2031, GA Haarlem, The
Netherlands
This leaflet was last revised: November 2013

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PRESCRIBER INFORMATION LEAFLET

1.

NAME OF THE MEDICINAL PRODUCT
Mitoxantrone 2 mg/ml concentrate for solution for infusion

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 2 mg mitoxantrone as mitoxantrone hydrochloride.
For excipients, see 6.1

3.

PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Mitoxantrone 2 mg/ml Infusion is a dark blue aqueous concentrate for solution for infusion,
packaged in type 1 glass vials.

4.

CLINICAL PARTICULARS

4.1

Therapeutic Indications
Mitoxantrone is indicated in the treatment of metastatic breast cancer, non-Hodgkin's lymphoma and
adult acute non-lymphocytic leukaemia.
Mitoxantrone has also been used in the palliation of non-resectable primary hepatocellular
carcinoma.

4.2

Posology and Method of Administration
Mitoxantrone should be given by intravenous infusion.
For single use only. Any unused solution should be discarded.
Syringes containing this product should be labelled ’FOR INTRAVENOUS USE ONLY’.
Metastatic Breast Cancer, Non-Hodgkin's Lymphoma, Hepatoma:
(a) Single Agent Dosage
The recommended initial dosage of Mitoxantrone used as a single agent is 14 mg/m2 of body surface
area, given as a single intravenous dose which may be repeated at 21-day intervals. A lower initial
dosage (12 mg/m2 or less) is recommended in patients with inadequate bone marrow reserves, e.g.
due to prior chemotherapy or poor general condition.
Dosage modification and the timing of subsequent dosing should be determined by clinical
judgement depending on the degree and duration of myelosuppression. For subsequent courses the
prior dose can usually be repeated if white blood cell and platelet counts have returned to normal
levels after 21 days. The following table is suggested as a guide to dosage adjustment, in the
treatment of metastatic breast cancer, non-Hodgkin's lymphoma and hepatoma according to
haematological nadir (which usually occurs about 10 days after dosing).
Nadir after Prior Dose

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WBC
(per mm3)

Platelets
(per mm3)

Time to Recovery

> 1,500 AND

> 50,000

< 21 days

> 1,500 AND

> 50,000

>21 days

< 1,500 OR

< 50,000

Any duration

< 1,000 OR

< 25,000

Any duration

Subsequent dose after
adequate haematological
recovery
Repeat
prior dose
after recovery or increase
by 2 mg/m2 if
myelosupression is not
considered adequate.
Withhold until recovery
then repeat prior dose .
Decrease by 2 mg/m2 from
prior dose after recovery.
Decrease by 4 mg/m2 from
prior dose after recovery.

(b) Combination Therapy
Mitoxantrone has been given as part of combination therapy. In metastatic breast cancer,
combinations of Mitoxantrone with other cytotoxic agents including cyclophosphamide and 5fluorouracil or methotrexate and mitomycin C have been shown to be effective. Reference should be
made to the published literature for information on dosage modifications and administration.
Mitoxantrone has also been used in various combinations for non-Hodgkin's lymphoma, however
data is presently limited and specific regimens cannot be recommended.
As a guide, when Mitoxantrone is used in combination chemotherapy with another myelosuppressive
agent, the initial dose of Mitoxantrone should be reduced by 2-4mg/m2 below the doses
recommended for single agent usage; subsequent dosing, as outlined in the table above, depends on
the degree and duration of myelosuppression.
Acute Non-Lymphocytic Leukaemia
(a)

Single Agent Dosage in Relapse

The recommended dosage for remission induction is 12 mg/m2 of body surface area, given as a single
intravenous dose daily for five consecutive days (total of 60 mg/m2). In clinical studies with a
dosage of 12 mg/m2 daily for 5 days, patients who achieved a complete remission did so as a result
of the first induction course.
(b)

Combination Therapy

Mitoxantrone has been used in combination regimens for the treatment of ANLL. Most clinical
experience has been with Mitoxantrone combined with cytosine arabinoside. This combination has
been used successfully for primary treatment of ANLL as well as in relapse.
An effective regimen for induction in previously untreated patients has been Mitoxantrone 10-12
mg/m2 IV for 3 days combined with cytosine arabinoside 100 mg/m2 IV for 7 days (by continuous
infusion). This is followed by second induction and consolidation courses as thought appropriate by
the treating clinician. In clinical studies, duration of therapy in induction and consolidation courses
with Mitoxantrone have been reduced to 2 days and that of cytosine arabinoside to 5 days. However,
modification to the above regimen should be carried out by the treating clinician depending on
individual patient factors.
Efficacy has also been demonstrated with Mitoxantrone in combination with etoposide in patients
who had relapsed or who were refractory to primary conventional chemotherapy. The use of
Mitoxantrone in combination with etoposide as with other cytotoxics may result in greater
myelosuppression than with Mitoxantrone alone.
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Reference should be made to the published literature for information on specific dosage regimens.
Mitoxantrone should be used by clinicians experienced in the use of chemotherapy regimens.
Dosage adjustments should be made by the treating clinician as appropriate, taking into account
toxicity, response and individual patient characteristics. As with other cytotoxic drugs,
Mitoxantrone should be used with caution in combination therapy until wider experience is
available.
(c)

Paediatric Leukaemia

As experience with Mitoxantrone in paediatric leukaemia is limited, dosage recommendations in this
patient population cannot at present be given.

4.3

Contraindications
Not for intrathecal use.
Demonstrated hypersensitivity to the drug or any of its components.

4.4

Special Warnings and Precautions for use
There may be an increased risk of leukaemia when Mitoxantrone is used as adjuvant treatment of
non metastatic breast cancer. In the absence of sufficient efficacy data, Mitoxantrone must not be
used as adjuvant treatment of non metastatic breast cancer.
Mitoxantrone should be used with caution in patients with myelosuppression or poor general
condition.
Cases of functional cardiac changes, including congestive heart failure and decreases in left
ventricular ejection fraction have been reported. The majority of these cardiac events have occurred
in patients who have had risk factors such as prior treatment with anthracyclines, prior
mediastinal/thoracic radiotherapy, or with pre-existing heart disease may increase the risk of
cardiotoxicity. It is recommended that patients in these categories are treated with Mitoxantrone at
full cytotoxic dosage and schedule. However, added caution is required in these patients and careful
regular cardiac examinations are recommended from the initiation of treatment.
As experience of prolonged treatment with Mitoxantrone is presently limited, it is suggested that
cardiac examinations also be performed in patients without identifiable risk factors during therapy
exceeding a cumulative dose of 160 mg/m2.
Careful supervision is recommended when treating patients with severe hepatic insufficiency.
Mitoxantrone is mutagenic in vitro and in vivo in the rat. In the same species there was a possible
association between administration of the drug and development of malignant neoplasia.
Topoisomerase II inhibitors, including Mitoxantrone, when used concomitantly with other
antineoplastic agents and/or radiotherapy, have been associated with the development of Acute
Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS).
Mitoxantrone is not indicated for intra-arterial injection. There have been reports of local/regional
neuropathy, some irreversible, following intra-arterial injection. Safety for intrathecal use has not
been established. There have been reports of neuropathy, including paralysis and bowel and bladder
dysfunction following intrathecal injection.

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Mitoxantrone is an active cytotoxic drug which should be used by clinicians familiar with the use of
antineoplastic agents, and having the facilities for regular monitoring of clinical, haematological and
biochemical parameters during and after treatment.
Full blood counts should be undertaken serially during a course of treatment. Dosage adjustments
may be necessary based on these counts.
Immunisation may be ineffective when given during Mitoxantrone therapy. Immunisation with live
virus vaccines is generally not recommended.
4.5

Interaction with other Medicinal Products and other Forms of Interaction
Concomitant use of Mitoxantrone with other antineoplastic agents and/or radiotherapy has been
associated with the development of Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome
(MDS). (See also section 4.4 Special Warnings and Precautions for Use.)
Combination treatment with other antineoplastic drugs are more likely to result in potent toxic
effects, in particular, increased myelotoxic and cardiotoxic effects are to be expected.
Literature reviews reveal no evidence of a drug interaction following concurrent administration of
Mitoxantrone with corticosteroids.

4.6

Pregnancy and Lactation
The effects of Mitoxantrone on human fertility or pregnancy have not been established. As with
other antineoplastic agents, patients and their partners should be advised to avoid conception for at
least six months after cessation of therapy. Mitoxantrone should not normally be administered to
patients who are pregnant.
During Mitoxantrone Injection treatment and for at least six months after termination of
chemotherapy, effective contraception should be practised by patients of reproductive age, of either
sex. Patients’ partners capable of conception should also avoid pregnancy for 6 months after the
partner's treatment cessation.
Mitoxantrone is excreted in human milk and significant concentrations (18 ng/ml) have been
reported for 28 days after the last administration. Because of the potential for serious adverse
reactions in infants, breast-feeding should be discontinued before starting treatment.

4.7

Effects on Ability to Drive and Use Machines
Drowsiness and confusion have been reported. Patients should be advised not to drive, operate
machinery or take part in activities where these symptoms could put themselves or others at risk.

4.8

Undesirable Effects
Some degree of leucopenia is to be expected following recommended doses of Mitoxantrone. With
the single dose every 21 days, suppression of WBC count below 1000/mm3 is infrequent; leucopenia
is usually transient reaching its nadir at about 10 days after dosing with recovery usually occurring
by the 21st day. Thrombocytopenia can occur and anaemia occurs less frequently.
Myelosuppression may be more severe and prolonged in patients having had extensive prior
chemotherapy or radiotherapy or in debilitated patients.
When Mitoxantrone is used as a single infusion given every 21 days in the treatment of metastatic
breast cancer and lymphomas, the most commonly encountered side effects are nausea and vomiting,
although in the majority of cases these are mild and transient. Alopecia may occur, but is most
frequently of minimal severity and reversible on cessation of therapy.
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Other side effects which have occasionally been reported include skin rashes,
anaphylactic/anaphylactoid reactions (including shock), amenorrhoea, anorexia, constipation,
abdominal pain, diarrhoea, dyspnoea, fatigue and weakness, fever, gastrointestinal bleeding,
stomatitis/mucositis/conjunctivitis and non-specific neurological side effects such as somnolence,
confusion, anxiety and mild paraesthesia. Tissue necrosis following extravasation has been reported
rarely. In patients with leukaemia, the pattern of side effects is generally similar, although there is an
increase in both frequency and severity, particularly of stomatitis and mucositis.
Changes in laboratory test values have been observed infrequently e.g. elevated serum creatinine and
blood urea nitrogen levels, increased liver enzyme levels (with occasional reports of severe
impairment of hepatic function in patients with leukaemia). Hyperuricaemia has also been reported.
Cardiovascular effects, which have occasionally been of clinical significance, include decreased left
ventricular ejection fraction, ECG changes and acute arrhythmia. Congestive heart failure has been
reported and has generally responded well to treatment with digitalis and/or diuretics. In patients
with leukaemia an increase in the frequency of adverse cardiac events has been observed; the direct
role of Mitoxantrone in these cases is difficult to assess as most patients had received prior therapy
with anthracyclines and since the clinical course in leukaemic patients is often complicated by
anaemia, fever, sepsis and intravenous fluid therapy.
Extravasation at the infusion site has been reported, which may result in erythema, swelling, pain,
burning and/or blue discolouration of the skin. Extravasation can result in tissue necrosis with
resultant need for debridement and skin grafting. Phlebitis has also been reported at the site of
infusion.
Mitoxantrone may impart a blue-green colouration to the urine for 24 hours after administration and
patients should be advised that this is to be expected. Blue discolouration of skin and nails has been
reported occasionally. Nail dystrophy or reversible blue coloration of the sclerae may be seen very
rarely.
Topoisomerase II inhibitors, including Mitoxantrone, when used concomitantly with other
antineoplastic agents, and/or radiotherapy, have been associated with the development of Acute
Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS).
Rare reports of cardiomyopathy have been received.

4.9

Overdose
There is no known specific antidote for Mitoxantrone. Haemopoietic, gastrointestinal, hepatic or
renal toxicity may be seen depending on dosage given and the physical condition of the patient. In
cases of overdosage the patient should be monitored closely and management should be symptomatic
and supportive.
Fatalities have occurred on rare occasions as a result of severe leucopenia with infection in patients
accidentally given single bolus injections of Mitoxantrone at over ten times the recommended
dosage. Mitoxantrone is extensively tissue-bound and peritoneal dialysis or haemodialysis is unlikely
to be effective in managing overdose.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
ATC Code: L01DB07

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Although its mechanism of action has not been determined, Mitoxantrone is a DNA-reactive agent.
It has a cytocidal effect on proliferating and non-proliferating cultured human cells, suggesting
activity against rapidly proliferating and slow-growing neoplasms.

5.2.

Pharmacokinetic Properties
Animal pharmacokinetic studies in rats, dogs and monkeys given radiolabeled Mitoxantrone indicate
rapid, extensive dose proportional distribution into most tissues. Mitoxantrone does not cross the
blood-brain barrier to any appreciable extent. Distribution into testes is relatively low. In pregnant
rats the placenta is an effective barrier. Plasma concentrations decrease rapidly during the first two
hours and slowly thereafter. Animal data established biliary excretion as the major route of
elimination. In rats, tissue elimination half-life of radioactivity ranged from 20 days to 25 days as
compared with plasma half-life of 12 days. Mitoxantrone is not absorbed significantly in animals
following oral administration.
Pharmacokinetic studies in patients following intravenous administration of Mitoxantrone
demonstrated a triphasic plasma clearance. Distribution to tissues is rapid and extensive.
Elimination of the drug is slow with a mean half-life of 12 days (range 5-18) and persistent tissue
concentrations. Similar estimates of half-life were obtained from patients receiving a single dose of
Mitoxantrone every 21 days and patients dosed on 5 consecutive days every 21 days.
Mitoxantrone is excreted via the renal and hepatobiliary systems. Only 20-32% of the administered
dose was excreted within the first five days after dosing (urine 6-11%, faeces 13-25%). Of the
material recovered in the urine 65% was unchanged mitoxantrone and the remaining 35% is
primarily comprised of two inactive metabolites and their glucuronide conjugates. Approximately
two thirds of the excretion occurred during the first day.

5.3.

Pre-clinical Safety Data
There is nothing of relevance to the prescriber that has not been included elsewhere in the SPC.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of Excipients
Sodium chloride
Anhydrous sodium acetate
Glacial acetic acid
Water for injections.

6.2

Incompatibilities
Mitoxantrone must not be mixed in the same infusion as heparin since a precipitate may form.
Because specific compatibility data are not available, it is recommended that Mitoxantrone should
not be mixed in the same infusion with other drugs.

6.3

Shelf-Life
24 months.

6.4

Special Precautions for Storage

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Do not store above 25ºC. Do not freeze.
Chemical and physical stability of the diluted product has been demonstrated for 24 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 8º C unless dilution has taken place in controlled
and validated aseptic conditions.
6.5

Nature and content of container
5ml Type 1 glass vials filled to 5 ml, 14 ml Type I glass vials, filled to 10 or 12.5 ml, or a 20 ml
Type I glass vial filled to 15 ml. Each vial is sealed with a grey bromobutyl rubber stopper,
aluminium seal and plastic flip-off cap. The 14 ml size containers are colour coded with blue plastic
caps for the 10 ml fill and red for the 12.5 ml fill. Mitoxantrone is presented in packs of 1 vial.

6.6

Instructions for use, handling and disposal
a) Instructions for use
Mitoxantrone should be given by intravenous infusion.
For single use only. Any unused solution should be discarded.
Syringes containing this product should be labelled ‘FOR INTRAVENOUS USE ONLY’
Care should be taken to avoid contact of Mitoxantrone with the skin, mucous membranes, or eyes.
Vials should be dispensed in the upright position in order to prevent drops of Mitoxantrone
collecting in the stopper during preparation and leading to potential aerosolisation of the solution.
Dilute the required volume of Mitoxantrone injection to at least 50 ml using a solution of Sodium
Chloride 0.9%, Glucose 5%. 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. Administer the resulting solution over not less than 3
minutes via the tubing of 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.
b) Handling Cytotoxic drugs
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.

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c) Spillage disposal
The following clean-up procedure is recommended if Mitoxantrone 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. Appropriate
protective equipment should be worn during the clean-up procedure.
For single use only. Any unused solution should be discarded.
All Mitoxantrone contaminated items (e.g, syringes, needles, tissues, etc) should be treated as toxic
waste and disposed of accordingly. Incineration is recommended.
7.

MARKETING AUTHORISATION HOLDER
TEVA UK Limited,
Brampton Road,
Hampden Park,
Eastbourne,
East Sussex,
BN22 9AG,
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
PL 00289/1370

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
20/03/2009

10.

DATE OF REVISION OF THE TEXT
To be completed upon approval

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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