Thiotepa is used to treat cancer of the breast, ovary, bladder, and certain body cavities.

Thiotepa may also be used for purposes not listed in this medication guide.

Thiotepa can increase your risk of bleeding or infection. Call your doctor if you have unusual bruising or bleeding, or new signs of infection (fever, chills, mouth sores, pale skin, tiredness, feeling short of breath).

Thiotepa is given as an infusion into a vein, or injected directly into the bladder or other body cavity. A healthcare provider will give you this injection.

When injected into the bladder, you will need to hold the medicine inside your bladder for 2 hours. Tell your caregivers if this causes you a great deal of discomfort. You may need to receive a smaller amount of the medicine to hold it comfortably in your bladder.

Thiotepa is usually given once every 1 to 4 weeks. Follow your doctor's dosing instructions very carefully.

Thiotepa can increase your risk of bleeding or infection. You will need frequent medical tests.

Thiotepa can be dangerous if it gets in your mouth, eyes, or nose, or on your skin. If this happens, wash your skin with soap and water or rinse your eyes with water.

Being treated with thiotepa may cause itching, blistering, peeling, or discoloration (especially in the skin folds of your groin, underarms, or neck). Bathe or shower and wash your skin with soap and water at least 2 times per day for at least 48 hours after each time you receive this medicine.

If you cover the skin with any bandaging, change the dressing and clean the covered skin at 2 times per day for 48 hours after each time you receive thiotepa.

Change your bed sheets every day during treatment.

Thiotepa can increase your risk of bleeding or infection. You will need frequent medical tests.

You should not be treated with thiotepa if you are allergic to it, or if you have recently received a vaccine.

Tell your doctor if you have ever had:

• a weak immune system; or

• liver disease.

Tell your doctor about all other cancer treatments you have recently received, including chemotherapy and radiation.

Using thiotepa may increase your risk of developing other cancers, such as leukemia. Ask your doctor about this risk.

Tell your doctor if you are planning a pregnancy. Both men and women must prevent pregnancy during treatment with thiotepa and for several months afterward.

Thiotepa can harm an unborn baby if the mother or the father is using thiotepa.

• If you are a woman, you may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 1 year after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using thiotepa.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because thiotepa can harm an unborn baby.

You should not breastfeed while using thiotepa.

Call your doctor for instructions if you miss an appointment for your thiotepa injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include signs of infection such as fever or chills.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using thiotepa, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Thiotepa may cause serious side effects. Call your doctor at once if you have:

• sores or white patches in or around your mouth, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;

• confusion, hallucinations;

• headache, drowsiness, changes in behavior or personality;

• problems with memory, speech, or thought;

• a seizure;

• twitching muscles, overactive reflexes, problems with coordination or movement;

• blood in your urine;

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or

• liver problems--rapid weight gain, stomach pain and bloating, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of thiotepa may include:

• low blood cell counts;

• signs of infection (fever, chills, sore throat, muscle aches);

• blood in your urine;

• mouth sores; or

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect thiotepa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.