PATIENT INFORMATION LEAFLET THIOTEPA INJECTION 15mg/ml

Please read this leaflet carefully before you receive Thiotepa. It provides important information about this medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

WHAT IS IN THIS MEDICINE?

The name of this medicine is Thiotepa Injection. It is supplied in small glass bottles (called vials) and packed in a cardboard carton. Each vial contains 15mg of the active ingredient which is thiotepa. Thiotepa is supplied in boxes containing 1 vial.

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

WHAT DOES THIS MEDICINE DO?

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.

BEFORE TAKING THIS MEDICINE

YOU SHOULD NOT BE GIVEN 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.

•    You are under 12 years of age.

•    You have ever had an allergic reaction to Thiotepa.

TELL YOUR DOCTOR OR PHARMACIST IF:

•    You are pregnant, think you might be pregnant, or are breast feeding.

•    You are taking, or have recently taken, any other medicines including those bought at the chemist.

•    You have had radiotherapy for bladder cancer before, since Thiotepa may be more toxic to you than usual.

•    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.

TAKING OTHER MEDICINES

A large number of drugs can significantly interact with thiotepa which can significantly alter their effects.

•    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

HOW IS THIOTEPA GIVEN?

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.

THINGS TO BE AWARE OF WHILST TAKING THIS MEDICINE

As with all medicines, Thiotepa may cause unwanted effects in some patients.

Symptoms which are occasionally experienced by patients after receiving treatment with Thiotepa are nausea, vomiting, headache and 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.

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 (tumourlysis 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

On rare occasions patients have suffered 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.

PHARMACEUTICAL PRECAUTIONS FOR THIS MEDICINE

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.

This medicine should not be used after the expiry date which is printed on the label.

All medicines should be kept in a safe place, where children cannot reach them. This medicine could harm them.

OTHER INFORMATION

The information in this leaflet applies only to Thiotepa. If you would like more information about Thiotepa, have any questions, or you are not sure about anything you should ask your doctor.

This leaflet was last revised in December 2013.