Thiotepa

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Generic Name: Thiotepa Brand Name(s): Generics only. No brands available.

Uses

What is Thiotepa used for?

Thiotepa is used to treat cancer. It works by slowing or stopping the growth of cancer cells. Thiotepa is often given into the bladder to treat bladder cancer.

Thiotepa is also used with other medications to prevent rejection of a stem cell transplant.

How should I take Thiotepa?

This medication is given by injection into a vein by a health care professional. Sometimes, thiotepa is injected directly into the tumor. Tell your doctor or nurse right away if you experience pain, burning, or redness at the injection site.

For treatment of bladder cancer, thiotepa is usually given into the bladder through a tube (catheter). Your doctor may direct you to limit fluids for 8 to 12 hours before the medication is given. The solution is usually left in place for 2 hours and then drained out through the bladder tube. Your doctor may direct you to change positions every 15 minutes while the solution is in your bladder to make sure the solution treats all parts of your bladder.

If you are using this medication to prevent rejection of a stem cell transplant, you should receive 2 doses of this medication 12 hours apart. During treatment, skin problems may occur. To reduce the risk of skin problems, shower or bathe with water and change any bandages or dressings at least twice a day until 48 hours after stopping treatment. Also, change your bed sheets daily while receiving treatment.

The dosage and how often the medication is given is based on your medical condition and response to treatment. Your doctor will do blood tests (complete blood count) to find the right dose for you. Your next dose may need to be rescheduled if your white blood cell count or platelets are too low.

Learn how to handle, use, and discard chemotherapy and medical supplies safely. Consult your pharmacist. Wear gloves and wash your hands carefully after handling this drug. Avoid getting this medication in your eyes or on your skin. If the medication gets in your eye, wash the affected eye(s) well with water and contact your doctor. If the medication gets on your skin, wash the area well with soap and water.

How do I store Thiotepa?

Store in a refrigerator between 2° to 8°C (36° to 46°F). PROTECT FROM LIGHT AT ALL TIMES.

When reconstituted with sterile water for injection, solutions of Thiotepa should be stored in a refrigerator and used within 8 hours. Reconstituted solutions further diluted with sodium chloride injection should be used immediately.

There may be different brands of Thiotepa that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Thiotepa down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using 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.

Thiotepa can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as 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 about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using thiotepa. Thiotepa may harm an unborn baby. Women should ask about reliable forms of birth control while using this medication and for 6 months after stopping treatment. Women should also take a pregnancy test before starting treatment. Men should ask about reliable forms of birth control while using this medication and for 1 year after stopping treatment. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication 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.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Thiotepa during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Thiotepa. Thiotepa is pregnancy risk category D according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Thiotepa?

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.

People using this medication may have serious side effects. However, 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 may also cause very serious bleeding. Tell your doctor right away if any signs of serious bleeding occur, including: bloody/black/tarry stools, coughing up blood, nosebleeds that are frequent or hard to stop, dizziness/fainting, fast/irregular heartbeat, pale/gray/bluish skin, 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.

If you are using this medication to prevent rejection, tell your doctor right away if you have any serious side effects, including: signs of skin problems (such as changes in skin color, skin peeling/blisters), signs of liver problems (such as nausea/vomiting that doesn’t stop, loss of appetite, stomach/abdominal pain, yellowing of eyes/skin), mental/mood changes (such as confusion, hallucinations, changes in behavior).

This medication can affect sperm production, an effect that may lower male fertility. Consult your doctor for more details.

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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Thiotepa?

Some products that may interact with this drug include: aspirin and other NSAIDs (e.g., ibuprofen), drugs that may harm the immune system (e.g., chemotherapy, corticosteroids such as prednisone), live virus vaccines (e.g., oral polio vaccine, flu vaccine inhaled through the nose), nalidixic acid.

Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, or aspirin) that may increase your risk of bleeding. Low-dose aspirin should be continued if prescribed by your doctor for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day). Consult your doctor or pharmacist for more details.

Thiotepa may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Thiotepa?

Thiotepa may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Thiotepa?

Thiotepa may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Thiotepa.

What is the dose of Thiotepa for an adult?

Usual Adult Dose for Breast Cancer

0.3 to 0.4 mg/kg by rapid IV administration once.

Usual Adult Dose for Ovarian Cancer

0.3 to 0.4 mg/kg by rapid intravenous administration once.

Usual Adult Dose for Serosal Cavity Neoplastic Disease

0.6 to 0.8 mg/kg by intracavitary injection once

Usual Adult Dose for Bladder Cancer

30 to 60 mg by intravesical instillation once, for the treatment of superficial bladder tumors

Usual Adult Dose for Lymphoma

500 to 1000 mg intravenously once, for the treatment of refractory lymphomas

Usual Adult Dose for Malignant Disease

0.3 to 0.4 mg/kg by rapid IV administration once.

or

0.6 to 0.8 mg/kg by intracavitary injection once.

or

0.6 to 0.8 mg/kg by intratumor injection once.

or

30 to 60 mg by intravesical instillation once.

or

10 to 15 mg by intrathecal injection once.

or

500 to 1000 mg IV once.

Renal Dose Adjustments

The manufacturer states that therapy is probably contraindicated in cases of existing renal damage. However, if the need outweighs the risk, thiotepa may be used in low dosage, accompanied by appropriate testing.

Liver Dose Adjustments

The manufacturer states that therapy is probably contraindicated in cases of existing hepatic damage. However, if the need outweighs the risk, thiotepa may be used in low dosage, accompanied by appropriate testing.

Dose Adjustments

In patients receiving intravenous administration, treatment should be discontinued if the white blood cell count is less than or equal to 3000/mm3 or if platelets are less than or equal to 150,000/mm3.

Precautions

The manufacturer states that therapy is probably contraindicated in cases of existing bone marrow damage. However, if the need outweighs the risk, thiotepa may be used in low dosage, accompanied by appropriate testing.

Dialysis

The manufacturer states that therapy is probably contraindicated in cases of existing renal damage. However, if the need outweighs the risk, thiotepa may be used in low dosage, accompanied by appropriate testing.

Other Comments

Dosages are calculate by actual body weight.

Dosages must be carefully individualized. Dosages of thiotepa may depend upon the specific indication for its use, and whether other cytotoxic agents are coadministered. Reference to specific protocols is recommended.

Intratumor injections can be mixed with 2% procaine or 0.1% epinephrine injection in order to decrease pain.

A slow response to thiotepa does not necessarily indicate a lack of effect. Therefore, increasing the frequency of dosing may only increase toxicity. After maximum benefit is obtained by initial therapy, it is necessary to continue the patient on maintenance therapy, generally at approximately 1 to 4 week intervals. The maintenance dose should be adjusted on the basis of pretreatment control blood count and subsequent blood counts. In order to continue optimal effect, maintenance doses should not be administered more frequently than once weekly, in order to preserve correlation between dose and blood counts.

What is the dose of Thiotepa for a child?

Usual Pediatric Dose for Malignant Disease

Sarcomas: 25 to 65 mg/m2 IV as a single dose every 3 to 4 weeks.

Autologous bone marrow transplantation: 300 mg/m2 IV over 3 hours, repeat every 24 hours for 3 doses. The maximum tolerated dose is 1125 mg/m2 over 3 days.

How is Thiotepa available?

Thiotepa is available in the following dosage forms and strengths:

  • Injectable powder for injection.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Thiotepa, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: May 10, 2018 | Last Modified: May 10, 2018

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