Thiotepa

DRUG DESCRIPTION

Thiotepa (thiotepa (thiotepa injection) injection) for Injection USP is an ethylenimine-type compound. It is supplied as a non-pyrogenic, sterile Iyophilized powder for intravenous, intracavitary or intravesical administration, containing 15 mg of thiotepa (thiotepa injection) . Thiotepa (thiotepa (thiotepa injection) injection) is a synthetic product with antitumor activity. The chemical name for thiotepa is Tris (1-aziridinyl) phosphine sulfide. Thiotepa (thiotepa (thiotepa injection) injection) has the following structural formula:

Thiotepa Structural Formula Illustration

Thiotepa (thiotepa (thiotepa injection) injection) has the molecular formula C6H12N3PS, and a molecular weight of 189.22. When reconstituted with Sterile Water for Injection, the resulting solution has a pH of approximately 5.5 to 7.5. Thiotepa (thiotepa (thiotepa injection) injection) is stable in alkaline medium and unstable in acid medium.

What are the possible side effects of thiotepa (Thioplex)?

If you experience any of the following serious side effects from thiotepa, seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
  • tissue or vein reactions near the site of administration;
  • liver...

Read All Potential Side Effects and See Pictures of Thiotepa

What are the precautions when taking thiotepa injection (Thiotepa)?

Before using thiotepa, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially: bone marrow problems (e.g., low white blood cell count/platelets from previous chemotherapy/radiation treatment), kidney disease, liver disease.

Wash your hands well to prevent the spread of infections. Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

To lower your risk of...

Read All Potential Precautions of Thiotepa


Thiotepa Consumer (continued)

SIDE EFFECTS: Pain/redness at the injection site, dizziness, headache, blurred vision, fever, nausea, vomiting, stomach/abdominal pain, or loss of appetite may occur. Changes in diet such as eating several small meals or limiting activity may help lessen some of these effects. In some cases, drug treatment may be necessary to prevent or relieve nausea and vomiting. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Temporary hair loss is another common side effect. Normal hair growth should return after treatment has ended.

Many people using this medication have serious side effects. However, remember that your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Painful sores on the lips, mouth, and throat may occur. To decrease the risk, limit hot foods and drinks, brush your teeth carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water.

This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

This medication may also cause very serious bleeding. Tell your doctor immediately if any signs of serious bleeding occur, including: easy bruising/bleeding, bloody/black/tarry stools, coughing up blood, nosebleeds that are frequent or hard to stop, dizziness/fainting, fast/irregular heartbeat, pale/gray/bluish skin, unusual tiredness/weakness, vomit that is bloody or looks like coffee grounds.

Tell your doctor right away if you have any serious side effects, including: severe stomach/abdominal pain, lower back/side pain, painful/difficult urination, pink/dark urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using thiotepa, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially: bone marrow problems (e.g., low white blood cell count/platelets from previous chemotherapy/radiation treatment), kidney disease, liver disease.

Wash your hands well to prevent the spread of infections. Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist that you are using this medication.

This medication is not recommended for use during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. Males and females must use 2 reliable forms of birth control (e.g., condoms and birth control pills) during treatment with this drug. Talk with your doctor about effective forms of birth control.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Thiotepa Patient Information Including Side Effects

Brand Names: Thioplex

Generic Name: thiotepa (Pronunciation: THYE oh TEP a)

  • What is thiotepa (Thiotepa)?
  • What are the possible side effects of thiotepa (Thiotepa)?
  • What is the most important information I should know about thiotepa (Thiotepa)?
  • What should I discuss with my healthcare provider before using thiotepa (Thiotepa)?
  • How should I use thiotepa (Thiotepa)?
  • What happens if I miss a dose (Thiotepa)?
  • What happens if I overdose (Thiotepa)?
  • What should I avoid while using thiotepa (Thiotepa)?
  • What other drugs will affect thiotepa (Thiotepa)?
  • Where can I get more information?

What is thiotepa (Thiotepa)?

Thiotepa is a cancer (antineoplastic) medication. Thiotepa interferes with the growth of cancer cells and slows their growth and spread in the body.

Thiotepa is used in the treatment of cancers of the breast, ovary, bladder, and others.

Thiotepa may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of thiotepa (Thiotepa)?

If you experience any of the following serious side effects from thiotepa, seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
  • tissue or vein reactions near the site of administration;
  • liver damage (abdominal pain, yellowing of the skin or eyes);
  • severe nausea, vomiting, or loss of appetite;
  • fever, chills, or other signs of infection; or
  • painful or difficult urination.

Other, less serious side effects may be more likely to occur. Continue taking thiotepa and talk to your doctor if you experience:

  • fatigue or weakness;
  • mild to moderate nausea, vomiting, or loss of appetite;
  • redness or inflammation of the eyes;
  • dizziness, headache, or blurred vision;
  • temporary hair loss;
  • a loss of skin coloration; or
  • decreased menstruation in women and decreased sperm production in men.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about thiotepa (Thiotepa)?

Thiotepa should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of thiotepa including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); severe heart damage with prolonged use; decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection); severe nausea, vomiting, diarrhea, and loss of appetite; and others. Talk to your doctor about the possible side effects from treatment with thiotepa.

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