• Antineoplastic

Thiotepa ( thye-oh-TEP-a) belongs to the group of medicines called alkylating agents. It is used to treat some kinds of cancer.

Thiotepa interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by thiotepa, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects do not occur for months or years after the medicine is used.

Before you begin treatment with thiotepa, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Thiotepa is to be administered only by or under the immediate supervision of your doctor. It is available in the following dosage form:

Parenteral
• Injection (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For thiotepa, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to thiotepa.

Pregnancy—Tell your doctor if you are pregnant or if you intend to have children. There is a chance that this medicine may cause birth defects if either the male or female is using it at the time of conception or if it is used during pregnancy. Studies have shown that thiotepa causes birth defects in humans. In addition, many cancer medicines may cause sterility which could be permanent. Although this is uncommon with this medicine, the possibility should be kept in mind.

Be sure that you have discussed this with your doctor before using this medicine. It is best to use some kind of birth control while you are receiving thiotepa. Tell your doctor right away if you think you have become pregnant while receiving thiotepa.

Breast-feeding—Tell your doctor if you intend to breast-feed. Because this medicine may cause serious side effects, breast-feeding is generally not recommended while you are receiving it. It is not known whether thiotepa passes into the breast milk.

Children—There is no specific information about the use of thiotepa in children.

Older adults—Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information about the use of thiotepa in the elderly.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving thiotepa, it is especially important that your health care professional know if you are taking any of the following:

• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Flucytosine (e.g., Ancobon) or
• Interferon (e.g., Intron A, Roferon-A) or
• Plicamycin (e.g., Mithracin) or
• Zidovudine (e.g., Retrovir) or
• If you have ever been treated with x-rays or cancer medicines—Thiotepa may increase the effects of these medicines or radiation therapy on the blood

• Probenecid (e.g., Benemid) or
• Sulfinpyrazone (e.g., Anturane)—Thiotepa may increase the concentration of uric acid in the blood, which these medicines are used to lower

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Gout (history of) or
• Kidney stones (history of)—Thiotepa may increase levels of uric acid in the body, which can cause gout or kidney stones

• Infection—Thiotepa can reduce immunity to infection

• Kidney disease or
• Liver disease—Effects may be increased because of slower removal of thiotepa from the body

While you are using thiotepa, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

Thiotepa sometimes causes nausea, vomiting, and loss of appetite. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

Dosing—

The dose of thiotepa will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, the patient's weight, and whether or not other medicines are also being taken. If you are receiving thiotepa at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of thiotepa, ask your doctor.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Before having any kind of surgery, including dental surgery, make sure the medical doctor or dentist in charge knows that you are taking this medicine.

While you are being treated with thiotepa, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Thiotepa may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. Other people living in your household should not take or should not have recently taken oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken oral polio vaccine. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Thiotepa can lower the number of white blood cells in your blood temporarily, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Along with their needed effects, medicines like thiotepa can sometimes cause unwanted effects such as blood problems, loss of hair, and other side effects. These and others are described below. Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Less common
  • Black, tarry stools;  blood in urine or stools;  cough or hoarseness;  fever or chills;  lower back or side pain;  painful or difficult urination;  pinpoint red spots on skin;  unusual bleeding or bruising 
  
  

• Rare
  • Skin rash;  tightness of throat;  wheezing 
  
  

Check with your health care professional as soon as possible if any of the following side effects occur:

• Less common
  • Joint pain;  pain at place of injection or instillation;  swelling of feet or lower legs 
  
  

• Rare
  • Sores in mouth and on lips 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Less common
  • Dizziness;  hives;  loss of appetite;  missing menstrual periods;  nausea and vomiting 
  
  

This medicine may cause a temporary loss of hair in some people. After treatment with thiotepa has ended, normal hair growth should return.

After you stop receiving thiotepa, it may still produce some side effects that need attention. During this period of time, check with your doctor if you notice any of the following:

• Black, tarry stools;  blood in urine or stools;  cough or hoarseness;  fever or chills;  lower back or side pain;  painful or difficult urination;  pinpoint red spots on skin;  unusual bleeding or bruising 

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, thiotepa is used in certain patients with the following medical conditions:

• Cancer in the membranes that cover and protect the brain and spinal cord (the meninges)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.