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TREOSULFAN INJECTION

Active substance(s): TREOSULFAN / TREOSULFAN

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Treosulfan Injection · 80310-VBGB · CA · 10.16 · Pharma-Code: 533
Format: 444 x 150 mm · HKS 44 · Corrective action: KV01_osc_27.04.16 / KV02_osc_08.09.16 / KV03_osc_09.09.16 / KV04_uma_25.11.16

Package leaflet: Information for the user

Treosulfan Injection has been prescribed by your doctor
for the treatment of ovarian cancer.

Treosulfan Injection
Treosulfan
Read all of this leaflet carefully before you are
given 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 or
pharmacist.
• This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1. What Treosulfan Injection is and what it is used for
2. What you need to know before you are given Treosulfan
Injection
3. How you are given Treosulfan Injection
4. Possible side effects
5. How to store Treosulfan Injection
6. Contents of the pack and other information

1. What Treosulfan Injection is and what it is used for
Treosulfan belongs to the group of anticancer medicines
called bifunctional alkylating agents. These agents inhibit
tumour growth.

2. What you need to know before you are given
Treosulfan Injection
You are not given Treosulfan Injection
• if you are allergic to treosulfan.
• if you do not have enough blood cells (severe bone
marrow depression).
Before each administration, you will have blood tests
to check that you have enough blood cells to receive
Treosulfan Injection.
Warnings and precautions
Talk to your doctor or pharmacist before using
Treosulfan Injection.
• if you experience reduction in blood cells as this may
become worse with ongoing treatment. Blood tests
will be performed at shorter intervals starting with the
third course of treatment. This is especially important
if combined with other forms of therapy that suppress
the bone marrow function such as radiotherapy.
• if you develop inflammation of the lungs which causes
shortness of breath (allergic alveolitis or pulmonary
fibrosis); treatment with treosulfan should then be
stopped.
Be also aware of the following:
• the risk of getting different types of infections is
increased.
• different types of blood cancer may occur after
long-term treatment.

• as treosulfan is excreted via your kidney your blood counts
should be carefully monitored and your dose adjusted
accordingly if you suffer from impaired kidney function.
• treatment with anticancer medicines may increase the
risk of generalised infection after some vaccinations.
Therefore, you should not receive vaccination with live
vaccines.
• because of the possible development of bladder
inflammation with pain, more frequent or urgent
urination with or without bloody urine (haemorrhagic
cystitis) you are advised to drink more fluids than usual
for up to 24 hours after your treosulfan infusion.
• when treosulfan is not carefully given into a blood
vessel, painful inflammation of the surrounding tissue
may occur.

Driving and using machines
Your ability to drive or operate machines may be
influenced in case of nausea and vomiting. If you are
affected in this way do not drive or operate machines.

3. How you are given Treosulfan Injection
Treosulfan will be given to you by a drip given into a vein
over 15 to 30 minutes (intravenous infusion) in a dose
which is fixed by a doctor individually for you.
For single use only.

The effect of ibuprofen/chloroquine treatment may be
reduced when given in combination with treosulfan.

Your doctor will calculate your treosulfan dose on the basis
of your blood counts measured. Your doctor will reduce
the dose if other anticancer medicines or radiotherapy
have been given. The dose you are given also depends on
your size and varies with your body surface area (BSA).
Technically, this is measured in square metres (m²), but
actually is worked out from your height and weight. Usual
doses for treosulfan alone are 6-8 g/m² BSA. In combination
with cisplatin, treosulfan is usually dosed at 5 g/m² BSA.

It is not advisable to use any medicines without telling your
doctor as there may be interactions between treosulfan
and other medicines.

During the course of treosulfan therapy the infusions will
usually be given every 3 to 4 weeks. In general, 6 courses
of treatment are given.

Pregnancy and breast-feeding
Do not use treosulfan if you are pregnant or breastfeeding
unless your doctor considers it as absolutely necessary.
You must use effective contraception during therapy,
e.g. birth control pill.

Your doctor may change the dose and frequency of dosing
depending on your blood tests, your general condition,
further therapies and your response to treosulfan. If you
have any questions about your treatment, ask your doctor,
nurse or hospital pharmacist.

If you are planning to become pregnant or thinking of
breast-feeding discuss it with your doctor first.

If you experience pain at the site of injection, please tell
your doctor or nurse immediately.

Other medicines and Treosulfan Injection
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Use in children
This medicine is not recommended for use in children.
If you are given more Treosulfan Injection than you should
If too much of this medicine has been given to you,
you may get sick or your blood cells may be reduced.
Your doctor may give you a blood transfusion and will
undertake other measures if necessary.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them. Your doctor will
discuss these with you and will explain the risks and
benefits of your treatment.
Contact your doctor straight away if you notice any of
the following:
• Allergic reactions: if you develop itching, rash, swelling
of the face, lips, tongue and/or throat, which may cause
difficulties in swallowing or breathing, drop of blood
pressure.
• Fever or infection: if you have a body temperature of
38 °C or higher, sweating or other signs of infection (since
you might have fewer white blood cells than normal).
• Weakness, becoming easily breathless or if you look pale
(since you might have fewer red blood cells than normal).
• Bleedings from gums, mouth or nose, unexpected bruising
(since you might have fewer platelets than normal).
• Difficulty in breathing (since you might have an allergic
reaction, inflammation or infection of the lung).

Treosulfan Injection · 80310-VBGB · CA · 10.16 · Pharma-Code: 533
Format: 444 x 150 mm · HKS 44 · Corrective action: KV01_osc_27.04.16 / KV02_osc_08.09.16 / KV03_osc_09.09.16 / KV04_uma_25.11.16

Very common (may affect more than 1 in 10 people):
• Reduction in white blood cells (which makes infections
more likely), platelets (which may cause bleeding from
gums, mouth or nose and unexpected bruising) or red
blood cells (which can make the skin pale and cause
weakness or breathlessness) – hence the need for
regular blood tests.
• Stomach upsets including nausea (feeling sick) with or
without vomiting (being sick).
• Mild loss of hair. After your treatment, normal hair
growth should return.
• Bronze discolouration of the skin.
Common (may affect up to 1 in 10 people):
• Infections caused by fungi, viruses or bacteria.
Uncommon (may affect up to 1 in 100 people):
• Different types of blood cancer (after long-term
treatment).
Rare (may affect up to 1 in 1,000 people):
• Allergic reactions (e.g. itching, rash, swelling of the face,
lips, tongue and/or throat with difficulties in swallowing
or breathing, drop of blood pressure).
• Severe reduction of red blood cells, white blood
cells and platelets at the same time which can cause
weakness, bruising or make infections more likely
(pancytopenia).

• Sweating, trembling and hunger as a result of
the decreased amount of glucose in your blood
(hypoglycaemia).
• Pins and needles and a feeling of numbness
(paraesthesia).
• Weakening of the heart muscle caused by a structural
change (cardiomyopathy).
• Difficulty in breathing (inflammation and scarring of the
lungs and infection of the lungs).
• Urticaria or hives, an itchy rash; inflammation of the skin
with or without scale formation (scleroderma and psoriasis).
• Inflammation of the bladder with pain, more frequent
and urgent urination and with or without bloody urine
(haemorrhagic cystitis).
• Feeling of getting ill (flu-like complaints).
• Painful local redness and swelling at the injection
site (in case of leakage of treosulfan solution into the
surrounding tissue).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Treosulfan Injection
Very rare (may affect up to 1 in 10,000 people):
• Severe generalised infection (sepsis)
• Addison's disease, a condition where the adrenal glands
do not work properly, leading to bronzed skin, stomach
upset, low blood pressure (feeling faint) and a general
feeling of weakness.

Once brought into solution the injection should be used
immediately.

6. Contents of the pack and other information

medac
Gesellschaft für klinische Spezialpräparate mbH
Scion House
Stirling University Innovation Park
Stirling FK9 4NF
Tel.: 01786/ 458 086
Fax: 01786/ 458 032
-------------------------------------------------------------------

What Treosulfan Injection contains
The active substance is treosulfan.

The following information is intended for healthcare
professionals only:

Do not store the reconstituted or the diluted product in
a refrigerator (2 8 °C) as this might cause precipitation.
Solutions showing any sign of precipitation should not be
used.

What Treosulfan Injection looks like and contents of
the pack
A white crystalline powder.
Each glass vial contains 1 g or 5 g of treosulfan.
The dry-powder in its vial is mixed with water for injection
to form a solution before it is given to you.
Treosulfan vials are packed in boxes, each containing
5 vials.
Marketing Authorisation Holder and Manufacturer
medac
Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany

Keep out of the sight and reach of children.
This leaflet was last revised in 10/2016.
Do not use this medicine after the expiry date which is
stated on the vial after EXP. The expiry date refers to the
last day of that month.

Full information is available on request from

Following these instructions, the whole reconstitution
procedure should take no longer than 2 minutes.

Instructions for reconstitution of Treosulfan Injection
To avoid solubility problems during reconstitution the
following aspects should be regarded.
1. The solvent, water for injection, is warmed to 25 - 30 °C
(not higher!) by using a water bath.
2. The treosulfan is carefully removed from the inner
surface of the infusion bottle by shaking.
This procedure is very important, because moistening
of powder that sticks to the surface results in caking.
In case caking occurs the bottle has to be shaken long
and vigorously.
3. One side of the double sided cannula is put into the
rubber stopper of the water bottle. The treosulfan bottle
is then put on the other end of the cannula with the
bottom on top.
The whole construction is converted and the water let run
into the lower bottle while the bottle is shaken gently.

80310-VBGB
CA

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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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