Thioplex (Injection)

Thiotepa injection is used to reduce the risk of graft rejection when combined with other medicines (such as high-dose busulfan, cyclophosphamide) as part of a treatment plan for stem cell transplantation in children with class 3 beta-thalassemia. It is also used to treat cancer in the breast, ovary, and urinary bladder. Additionally, this medicine is used to treat malignant effusions (fluid buildup in the body cavity) caused by cancer.

Thiotepa is in the group of medicines called alkylating agents. It affects the growth of cancer cells, which are eventually killed off. Because thiotepa can also impact the growth of normal body cells, other side effects may occur. Some of these side effects can be serious and should be reported to your doctor. Other side effects, like hair loss, may not be serious but can still be concerning. Some side effects may not show up until months or years after using the medicine.

This medicine should only be given by or under the close supervision of your doctor.

Your doctor will monitor your progress closely while you are receiving this medicine. This will help your doctor determine if the medicine is working properly and if you should continue receiving it. Blood tests may be necessary 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 avoid becoming pregnant. Men should not father a child for at least 1 year after treatment ends. If you think you may be pregnant while using this medicine, inform your doctor immediately.

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

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

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

• If possible, avoid people with infections. Contact your doctor immediately if you suspect you are getting an infection or if you experience fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Contact 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 suggest other ways to clean your teeth and gums. Consult 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 cautious when using sharp objects such as a safety razor or fingernail or toenail cutters to avoid cutting yourself.
• Avoid contact sports or any 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 for 48 hours after receiving this medicine. Change occlusive dressings and clean the covered skin at least two times a day for 48 hours after receiving this medicine. Change your bedsheets daily while you are receiving this medicine. If other skin reactions occur, wash the area with water and soap immediately.

Hepatic veno-occlusive disease may occur while using this medicine. Inform your doctor immediately if you experience a bloated abdomen or stomach, pain in the upper right abdomen, or yellowing of your skin or eyes after receiving this medicine.

Contact your doctor immediately if you experience a headache, confusion, dizziness or drowsiness, seizures, memory problems, or hallucinations (seeing, hearing, or feeling things that are not there) after receiving this medicine.

Discuss 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.

In deciding to use a medicine, you and your doctor need to consider the risks of taking it against the benefits it may provide. Here are some important points to consider:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other types of allergies you may have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems that would limit the use of thiotepa injection in children with class 3 beta-thalassemia. However, the safety and effectiveness of thiotepa injection for treating malignant effusions, breast, ovary, and urinary bladder cancer in children have not been established.

Geriatric

While studies on how age affects the effects of thiotepa injection in older adults have not been done, no specific problems for elderly patients have been documented so far. However, older patients are more likely to have age-related kidney, liver, or heart issues, which may require caution and adjustments in the dose for those receiving thiotepa injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together, even if an interaction might happen. If you are receiving this medicine, it is important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on 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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both 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 increase the risk of certain side effects, but using both medicines may be the best treatment option for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both medicines.

• Cyclophosphamide

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

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

• Infection—May reduce 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 stronger because the medicine is removed from the body more slowly.

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.

In the U.S.

• Tepadina
• Thioplex

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Alkylating Agent

Chemical Class: Nitrogen Mustard

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.