Description
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.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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.
Pediatric
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.
Appropriate studies have not been performed on the relationship of age to the effects of thiotepa injection to treat breast or ovary cancer in children. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of thiotepa injection in the elderly. 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.
Breastfeeding
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.
Drug Interactions
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
- Ebola Zaire 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 Monkeypox Vaccine, Live Non-Replicating
- 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
- Apalutamide
- Avacopan
- Boceprevir
- Bupropion
- Carbamazepine
- Ceritinib
- Clarithromycin
- Cobicistat
- Enzalutamide
- Fedratinib
- Fexinidazole
- Fosnetupitant
- Fosphenytoin
- Hexaminolevulinate
- Idelalisib
- Indinavir
- Itraconazole
- Ivacaftor
- Ivosidenib
- Ketoconazole
- Lonafarnib
- Lumacaftor
- Mavacamten
- Meperidine
- Methadone
- Mifepristone
- Mitotane
- Nefazodone
- Nelfinavir
- Netupitant
- Omaveloxolone
- Paritaprevir
- Phenobarbital
- Phenytoin
- Posaconazole
- Primidone
- Ribociclib
- Rifampin
- Rifapentine
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
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. It is given through an IV catheter that is place into one of your veins, 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.
Missed Dose
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
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.
Receiving this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Female patients should use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use an effective birth control during treatment with this medicine and for 1 year after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.
Do not receive live or attenuated vaccines without your doctor's approval while you are using this medicine.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require 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 2 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.
This medicine may cause serious liver problems (eg hepatic veno-occlusive disease). Tell your doctor right away if you have bloated stomach, pain in the upper right abdomen, or yellow skin or eyes.
This medicine may increase your risk for other cancers. Talk to your doctor if you have concerns about this.
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. These maybe symptoms of central nervous system (CNS) problems.
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
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 stomach
- chest tightness
- cough or hoarseness
- discouragement
- fast heartbeat
- feeling sad or empty
- fever or chills
- hives or welts, itching, or skin rash
- inability to move the legs or arms
- irritability
- joint or muscle pain
- lack of appetite
- loss of interest or pleasure
- lower back or side pain
- pain and fullness in the right upper abdomen or stomach
- painful or difficult urination
- pale skin
- paralysis of one side of the body
- 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
- trouble breathing
- trouble concentrating
- trouble sleeping
- 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
- Blistering, burning, crusting, dryness, or flaking of the skin
- deafness
- itching, scaling, severe redness, soreness, or swelling of the skin
- loss of appetite
- loss or thinning of the hair
- pain at the injection site
- stomach pain
- 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.
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