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THIOTEPA INJECTION

Active substance(s): THIOTEPA / THIOTEPA / THIOTEPA

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Package leaflet: Information for the patient
Thiotepa 15mg Sterile Powder for Solution for Injection
Read all 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 nurse.
If you get any side effects talk to your doctor or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
The name of your medicine is Thiotepa 15mg Sterile Powder for Solution for Injection. It
will be referred to as “Thiotepa” for ease of use hereafter.
What is in this leaflet
1. What Thiotepa is and what it is used for
2. What you need to know before you are given Thiotepa
3. How you will be given Thiotepa
4. Possible side effects
5. How to store Thiotepa
6. Contents of the pack and other information

1

What Thiotepa is and what it is used for

Thiotepa belongs to a group of medicines known as cytotoxic agents and is used alone, or in
combination with other drugs or surgery, to treat various forms of cancer. It treats cancer by
stopping the harmful cancer cells from growing, eventually killing them.
2. What you need to know before you are given Thiotepa
Do not use Thiotepa:
• if you are allergic to Thiotepa
• if you have very low numbers of white blood cells or platelets in your blood; your doctor
will often test your blood before giving you this medicine
• if you are under 12 years of age.
Warning and precautions
Talk to your doctor or nurse before you are given Thiotepa.
• If you are pregnant, think you might be pregnant or are breast feeding
• If you are taking or have recently taken, any other medicines including those bought at the
chemist
• If you have had radiotherapy for bladder cancer before, since Thiotepa may be more toxic to
you than usual
• If you suffer from liver, kidney or bone marrow disease
• If you are given Thiotepa by injection, your doctor will take a blood sample from you 12 24 hours before you receive your injection, to ensure that you have enough white blood cells
in your blood
• If you get any Thiotepa on your skin you should wash it off immediately.

Other medicines and Thiotepa
Tell your doctor if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription.
• Phenytoin, used for epilepsy (fits)
• Digoxin, a drug used to treat heart failure accompanied by irregular heart beats
• Medicines used to treat cancer, such as cyclophosphamide
• Suxamethonium used to induce muscle relaxation.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor for advice before using this medicine.
3. How you will be given Thiotepa
The doctor will usually give Thiotepa as an injection. However, it may also be diluted and
given as eyedrops, or mixed with a gel for application to the skin or instilled into the bladder
through a catheter inserted into the urethra (the tube through which urine is passed).
The dose of Thiotepa and how it is given to you will depend on your condition and your
response to treatment. You may receive a single dose, or a course of several doses, which
may need to be repeated at intervals over a period of weeks or months.
You may be given Thiotepa with other drugs or in addition to surgery.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon: may affect up to 1 in 100 people
• nausea, vomiting, headache
• reduced appetite (anorexia)
• allergic reactions (seen as rash, itching, shortness of breath or swollen face)
• tiredness
• feeling weak
• dizziness
• skin rash and irritation at the injection site
• stomach pain
• diarrhoea
• pain during urination
• inability to pass urine
• blurred vision and sore eyes
• high blood pressure (pulmonary arterial hypertension).
Thiotepa may cause side effects like:
• Inflammation and ulceration of the covering of the mouth (oral mucositis)
• Blood clots that form, within the vein (venous thromboembolism)
• Complications caused by the breakdown products of dying cancer cells (tumour lysis
syndrome). This may lead to abnormal levels of electrolytes (salts) in the blood
• Abnormal blood cell counts or local destruction of tissues may occur
• Kidney damage
• Irregular heartbeats.

Rare: may affect up to 1 in 10,000 people
• some hair loss, but normal hair growth should return once treatment has stopped
• if Thiotepa is given into your bladder you may feel some irritation in that area after
treatment
• you may also see some blood in your urine. This may occur after Thiotepa is injected into a
vein as well as directly into the bladder
• following the use of Thiotepa mixed with a gel on your skin, you may see some
discolouration
• some patients have also reported slight changes in the colour of the skin surrounding the
eyes after receiving Thiotepa eye drops
• if you or your partner is of child bearing potential, you should use effective contraception
while taking Thiotepa. It is advisable to avoid conception (becoming pregnant or fathering
children), as Thiotepa may harm the unborn baby
• as with other drugs used to treat cancer, women may find that their periods stop, and in men
sperm production and fertility may be affected. Thiotepa can also increase the risk of getting
other cancers such as leukaemia
• thiotepa can lower the number of white blood cells so increasing the chance of infections.
Check with your doctor immediately if you experience any of the following:
- cough or hoarseness
- fever or chills
- lower back or side pain
- painful or difficult urination
- unexplained bruising or bleeding (e.g. nose bleeds)
Your doctor will test your blood routinely and change your treatment if this becomes a
problem.
You should tell your doctor if any of the above, or any other unwanted effects, become severe
or troublesome.
Reporting of side effects
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 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 Thiotepa
Keep this medicine out of the sight and reach of children.
Thiotepa must be stored in a refrigerator (2°C to 8°C) in the original container. Once
Thiotepa has been mixed with water it should be used immediately or be kept in a fridge (2°C
to 8°C) and used within 24 hours.
Do not use this medicine after the expiry date which is stated on the label. The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.
6. Contents of the pack and other information
What Thiotepa contains

- The active substance is Thiotepa. Each vial contains 15mg of Thiotepa.
- The other ingredient is water for injection.
What Thiotepa looks like and contents of the pack

Thiotepa is white powder supplied in small glass bottles (called vials) containing 15mg
thiotepa and packed in a cardboard carton.
Marketing Authorisation Holder
Mercury Pharmaceuticals Ltd.,
Capital House, 85 King William Street,
London EC4N 7BL, UK
Manufacturer
Wyeth Lederle SpA
Via Franco Gorgone
Zona Industriale
Catania Italy
This leaflet was last revised in June 2017.

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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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