Thiotepa Injection

WHY is this medicine prescribed?

Thiotepa is used to treat certain types of ovarian cancer (cancer that begins in the female reproductive organs where eggs are formed), breast, and bladder cancer. It is also used to treat malignant effusions (a condition when fluid collects in the lungs or around the heart) that are caused by cancerous tumors. Thiotepa is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in your body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Thiotepa comes as a powder to be mixed with liquid to be injected intravenously (into a vein) by a doctor or nurse in a medical facility. It may also be injected intraperitoneally (into the abdominal cavity), intrapleurally (into the chest cavity), or intrapericardially (into the lining of the heart). The schedule for your treatment depends on your condition and on how you respond to thiotepa.

When used for bladder cancer, thiotepa is infused (injected slowly) into your bladder through a tube or catheter once a week for 4 weeks. Avoid drinking fluids for 8 to 12 hours before your treatment. You should keep the medication in your bladder for 2 hours. If you cannot keep the medication in your bladder for the entire 2 hours, tell your health care provider.

What SPECIAL PRECAUTIONS should I follow?

Before receiving thiotepa,

• tell your doctor and pharmacist if you are allergic to thiotepa, any other medications, or any of the ingredients in thiotepa injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you have or have ever had kidney or liver disease. Your doctor may not want you not to receive thiotepa.

• tell your doctor if you have previously received or will be receiving radiation (x-ray) therapy or other chemotherapy and if you have or have ever had any medical conditions.

• you should know that thiotepa may interfere with the normal menstrual cycle (period) in women, may stop sperm production in men, and may cause infertility (difficulty becoming pregnant). Women who are pregnant should tell their doctors before they begin receiving this drug. You or your partner should not become pregnant while you are receiving thiotepa. You should use birth control to prevent pregnancy in yourself or your partner during your treatment with thiotepa injection.

• tell your doctor if you are breast-feeding. You should not breast-feed while you are receiving thiotepa.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Thiotepa may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• loss of appetite
• stomach pain
• unusual tiredness or weakness
• dizziness
• headache
• blurry vision
• sore or red eyes
• hair loss
• pain in the place where the medication was injected

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:

• hives
• rash
• itching
• difficulty breathing or swallowing
• frequent, urgent, or painful urination
• blood in the urine
• fever, sore throat, chills, or other signs of infection
• unusual bleeding or bruising
• black and tarry stools
• red blood in stools
• bloody vomit; vomited material that looks like coffee grounds
• nosebleed

Thiotepa may increase the risk that you will develop other cancers. Talk to your doctor about the risks of receiving thiotepa injection.

Thiotepa may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• fever, sore throat, chills, or other signs of infection
• unusual bleeding or bruising
• black and tarry stools
• red blood in stools
• bloody vomit; vomited material that looks like coffee grounds

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to thiotepa.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.