Pronunciation:

thye-oh-TEP-a

Brand Names:

• Tepadina
• Thioplex

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Alkylating Agent

Chemical—

Nitrogen Mustard

Uses of This Medicine:

Thiotepa injection is used to lower risk of graft rejection when used with other medicines (eg, high-dose busulfan, cyclophosphamide) as a preparative regimen for stem cell transplantation in children with class 3 beta-thalassemia. It is also used to treat cancer of the breast, ovary, and urinary bladder. This medicine is also used to treat malignant effusions (accumulation of fluid in the body cavity) caused by cancer.

Thiotepa belongs to the group of medicines called alkylating agents. It 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.

This medicine is to be given only by or under the immediate supervision of your doctor.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of thiotepa injection in children with class 3 beta-thalassemia. However, safety and efficacy of thiotepa injection to treat malignant effusions, breast, ovary, and urinary bladder cancer in children have not been established in children.

Older adults—

Although appropriate studies on the relationship of age to the effects of thiotepa injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving thiotepa injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Boceprevir
• Bupropion
• Carbamazepine
• Clarithromycin
• Cobicistat
• Conivaptan
• Enzalutamide
• Fedratinib
• Fexinidazole
• Fosnetupitant
• Fosphenytoin
• Hexaminolevulinate
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lopinavir
• Lumacaftor
• Mavacamten
• Mitotane
• Nefazodone
• Nelfinavir
• Netupitant
• Omaveloxolone
• Phenobarbital
• Phenytoin
• Posaconazole
• Primidone
• Rifampin
• Ritonavir
• Saquinavir
• St John's Wort
• Telaprevir
• Telithromycin
• Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cyclophosphamide

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or
• Seizures—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight infection.

• Kidney disease, moderate to severe or
• Liver disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A doctor or other trained health professional will give you this medicine in a hospital. This medicine is given as a shot into a vein, body cavity, or urinary bladder.

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 doctor for ways to lessen these effects.

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control for at least 6 months after treatment ends to keep from getting pregnant. Men should not father a child for at least 1 year after treatment ends. If you think you have become pregnant while using this medicine, tell your doctor right away.

Do not receive live vaccines without your doctor's approval while you are using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

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 the 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.

This medicine may cause skin discoloration, itching, blistering or peeling skin in the groin, underarms, skin folds, in the neck, and under dressings. Shower or bathe with water at least two times a day 48 hours after receiving this medicine. Change occlusive dressing and clean the covered skin at least two times a day 48 hours after receiving this medicine. Change bedsheets daily while receiving this medicine. If other skin reactions occur, wash it with water and soap immediately.

Hepatic veno-occlusive disease may occur while you are using this medicine. Tell your doctor right away if you have bloated abdomen or stomach, pain in the upper right abdomen, or yellow skin or eyes after receiving this medicine.

Tell your doctor right away if you have a headache, confusion, dizziness or drowsiness, seizures, problems with memory, or seeing, hearing, or feeling things that are not there after receiving this medicine.

Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. 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:

More common

Bleeding gums

blood in the urine

blurred or double vision

confusion

coughing up blood

cracked lips

diarrhea

difficulty with breathing or swallowing

difficulty with walking

dizziness

drooping eyelids

headache, sudden, severe

increased menstrual flow or vaginal bleeding

jaw pain

nausea and vomiting

nosebleeds

numbness or tingling in the fingers and toes

pain in the fingers and toes

paralysis

prolonged bleeding from cuts

red or black, tarry stools

red or dark brown urine

sores, ulcers, or white spots on the lips, tongue, or inside the mouth

weakness

Incidence not known

Absent, missed, or irregular menstrual periods

blistering, peeling, or loosening of the skin

bloated abdomen

cough or hoarseness

fast heartbeat

fever or chills

hives or welts, itching, or skin rash

joint or muscle pain

lower back or side pain

pain and fullness in the right upper abdomen or stomach

painful or difficult urination

pale skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

redness of the skin

stopping of menstrual bleeding

tightness in the chest

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

weight gain

yellow eyes and skin

Some 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:

Incidence not known

Abdominal or stomach pain

blistering, burning, crusting, dryness, or flaking of the skin

hair loss or thinning of the hair

itching, scaling, severe redness, soreness, or swelling of the skin

loss of appetite

pain at the injection site

stopping of menstrual bleeding

weight loss

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.