Thiotepa Injection

Thiotepa injection 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.

Thiotepa comes as a solution (liquid) or 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. 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.

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

Before receiving thiotepa injection,

• 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 prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving thiotepa injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• The following nonprescription or herbal products may interact with avapritinib: St. John's wort. Be sure to let your healthcare provider know that you are taking this medication before you start receiving thiotepa injection. Do not start this medication while receiving thiotepa injection without talking to your healthcare provider.
• tell your doctor if you have or have ever had kidney or liver disease. Your doctor may not want you not to receive thiotepa injection.
• 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). However, you should not assume that you or your partner cannot become pregnant. Tell your doctor if you are pregnant or plan to become pregnant. You or your partner should not become pregnant while you are receiving thiotepa injection. If you can become pregnant, you should use birth control to prevent pregnancy during your treatment and for 6 months after your final dose. If your partner can become pregnant, you and your partner should use birth control during your treatment and for 1 year after your final dose. If you or your partner become pregnant while receiving thiotepa injection, call your doctor immediately. Thiotepa may harm the fetus.
• tell your doctor if you are breast-feeding. You should not breast-feed while you are receiving thiotepa injection and for 1 week after your final dose.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while receiving this medication.

Thiotepa injection 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 or those listed in the IMPORTANT WARNING section, 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

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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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

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.