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.

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 this medicine.

• 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.

Use Thioplex (Injectable) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

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 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.

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.