Skip to Content

TREOSULFAN INJECTION

Active substance(s): TREOSULFAN

View full screen / Print PDF » Download PDF ⇩
Transcript
Treosulfan Injection · 80310-VBGB · BA · 02.15 · Pharma-Code: 533
Format: 296 x 150 mm · HKS 44 · Corrective action: KV01_jem_19.02.15

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Treosulfan Injection
Treosulfan
Read all of this leaflet carefully before you are
given this medicine.
• 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.
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 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 Treosulfan Injection is and what it is
used for
2. Before you are given Treosulfan Injection
3. How you are given Treosulfan Injection
4. Possible side effects
5. How to store Treosulfan Injection
6. Further information

2. BEFORE YOU ARE GIVEN TREOSULFAN
INJECTION
You are not given Treosulfan Injection, if you
• are allergic (hypersensitive) to Treosulfan.
• do not have enough blood cells (severe bone
marrow depression).
You will have blood tests to check that you have
enough blood cells to receive Treosulfan Injection
before each administration.

Pregnancy and breast-feeding
Do not take treosulfan if you are pregnant or
planning to become pregnant. You must use
effective contraception during therapy, e.g. birth
control pill.
Do not breast-feed during treatment with treosulfan.

Take special care with 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.
• develop inflammation of the lungs which
causes shortness of breath (allergic alveolitis or
pulmonary fibrosis); treatment with treosulfan
should then be stopped.

Treosulfan belongs to the group of anticancer
medicines called bifunctional alkylating agents.
These agents inhibit tumour growth.

Be also aware that:
• the risk of getting different types of infections
is increased.
• treatment with cytostatics 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.

Treosulfan Injection has been prescribed by your
doctor for the treatment of all types of ovarian
cancer or certain types of cancer which do not
respond to usually given kind of therapy.

Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.

1. WHAT TREOSULFAN INJECTION IS
AND WHAT IT IS USED FOR

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

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

are given also depends on your size and varies with
your body surface area. Technically, this is measured
in square metres (m²), but actually is worked out
from your height and weight.
During the course of treosulfan therapy the injections
will be given usually every 1 to 3 weeks.
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.

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

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

3. HOW YOU ARE GIVEN TREOSULFAN
INJECTION

If you are given more Treosulfan than you should
If too much medication has been given to you, your
doctor may give you a blood transfusion and will
undertake other measures if necessary.

Treosulfan will be given to you
• by an injection into your vein (intravenous
injection),
• by an injection into your abdomen (intraperitoneal
injection), or
• by a drip given into a vein (intravenous infusion).

Children
This medicine is not recommended for use
in children.

If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS

Doses up to 1.5 g/m² (into abdomen) or 3 g/m² (into
vein) will be given as an injection. Larger doses
will be administered as a drip given into a vein
(intravenous infusion) at a rate of 3 g/m² every
5 – 10 minutes (8 g/m² as a 30 minutes infusion).
Your doctor will calculate your treosulfan dose on
the basis of your blood counts measured. Your
doctor reduces the dose if other cytotoxic medicines
or radiotherapy have also been given. The dose you

Like all medicines, treosulfan can cause side effects,
although not everybody gets them.
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.

Treosulfan Injection · 80310-VBGB · BA · 02.15 · Pharma-Code: 533
Format: 296 x 150 mm · HKS 44 · Corrective action: KV01_jem_19.02.15

• 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).
Very common (affect more than 1 in 10 patients):
• Reduction in white blood cells (which make
infections more likely), platelets (which can
cause bruising and bleeding from gums, mouth
and nose) and 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.
Uncommon (affect 1 to 10 in 1,000 patients):
• Different types of blood cancer (after long-term
treatment).
Not known (frequency cannot be estimated from
the available data):
• 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 different blood cells at the
same time which can cause weakness, bruising or
make infections more likely (pancytopenia).

The following side effects have also been reported:
• 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.
• 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).

6. FURTHER INFORMATION

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.

_____________________________________________

What Treosulfan Injection contains
The active substance is treosulfan.
What Treosulfan Injection looks like and contents
of the pack
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

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

This leaflet was last approved in 01/2015.

Full information is available on request from

5. HOW TO STORE TREOSULFAN

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

Keep out of the reach and sight of children.

Instructions for reconstitution of Treosulfan Injection

Do not use Treosulfan Injection after the expiry date
which is stated on the vial after EXP. The expiry date
refers to the last day of that month.

To avoid solubility problems during reconstitution the
following aspects should be regarded.

80310-VBGB
BA

Expand view ⇕

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.

Hide