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Thiotepa

Published: July 26, 2026Updated: August 24, 2026

Thiotepa is an alkylating agent chemotherapy medication used to treat various cancers including breast cancer, ovarian cancer, bladder cancer, and lymphoma. It works by interfering with DNA function in cancer cells, preventing their ability to divide and grow. This medication may also be used as part of conditioning regimens before bone marrow or stem cell transplantation.

Quick summary

Thiotepa is an alkylating chemotherapy agent used to treat several types of cancer and prepare patients for bone marrow transplants.

Medically reviewed by WellAlly Editorial TeamLast reviewed August 24, 2026Editorial policy

Key facts at a glance

ATC
L01AC01
RxNorm
10473
Generic
Thiotepa
Class
atc-l01
Brands
Tepadina, Tepylute
Availability
rx
Pregnancy
D
Lactation
unsafe
Routes
—
Forms
injection, solution
Regions
US, EU, CN, JP
Monitoring
—

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
500mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
250mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
400mg daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Single dose exceeding 1000 mg in adults may cause serious toxicity
Chronic overdose: Cumulative doses above 1000 mg over multiple treatment cycles can lead to severe and potentially fatal bone marrow suppression
Immediate actions
discontinue drug immediately, provide supportive care, monitor vital signs, intravenous fluids, antiemetics, monitor complete blood count
Antidote
no specific antidote(supportive care is the mainstay of treatment; no specific antidote available)
Poison Control: 1-800-222-1222

Special Populations

10 groups
✗

pregnancy

first trimester
contraindicated
FDA Category
D
Dose Adjustment

avoid use

Key Recommendations

thiotepa is contraindicated during pregnancy due to known teratogenic effects. it should not be used in women of childbearing potential unless absolutely necessary

Monitor

regular fetal monitoring, pregnancy testing before and during treatment

Use of this medication in this population requires careful consideration of risks and benefits.

✗

pregnancy

second trimester
contraindicated
FDA Category
D
Dose Adjustment

avoid use

Key Recommendations

avoid use unless benefits significantly outweigh risks

Monitor

fetal ultrasound monitoring

Use of this medication in this population requires careful consideration of risks and benefits.

✗

pregnancy

third trimester
unsafe
FDA Category
D
Dose Adjustment

avoid if possible

Key Recommendations

consider alternative therapy if possible; if used, plan for delivery management

Monitor

fetal monitoring, biophysical profiles

Use of this medication in this population requires careful consideration of risks and benefits.

✗

lactation

n/a
contraindicated
FDA Category
N
Dose Adjustment

discontinue breastfeeding

Key Recommendations

thiotepa is excreted in breast milk. breastfeeding must be discontinued during treatment and for appropriate period after last dose

Monitor

n/a

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

pediatric_age

children
caution
FDA Category
N
Dose Adjustment

weight-based dosing required

Key Recommendations

used in pediatric oncology for certain cancers. doses calculated based on body surface area. close monitoring for toxicity required. consider long-term effects on growth and development

Monitor

frequent blood counts, organ function monitoring, growth and developmental assessment

Use with caution and monitor for adverse effects.

⚠

geriatric

over 65
caution
FDA Category
N
Dose Adjustment

consider dose reduction

Key Recommendations

elderly patients may have reduced hepatic and renal function. start at lower end of dosing range. assess organ function before treatment. monitor for increased toxicity

Monitor

regular monitoring of hepatic function, renal function, and blood counts

Use with caution and monitor for adverse effects.

⚠

renal_impairment

mild
caution
FDA Category
N
Dose Adjustment

monitor renal function

Key Recommendations

use with caution. monitor renal function closely. dose adjustment may be needed based on clinical response and toxicity

Monitor

regular serum creatinine, creatinine clearance monitoring

Use with caution and monitor for adverse effects.

⚠

renal_impairment

moderate to severe
caution
FDA Category
N
Dose Adjustment

dose reduction recommended

Key Recommendations

reduce initial dose in patients with moderate to severe renal impairment. close monitoring required. consider risks versus benefits

Monitor

frequent renal function monitoring, drug level monitoring if available

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

mild
caution
FDA Category
N
Dose Adjustment

monitor liver function

Key Recommendations

use with caution. monitor hepatic function closely. dose adjustment may be required based on toxicity

Monitor

regular liver function tests including ast, alt, bilirubin

Use with caution and monitor for adverse effects.

✗

hepatic_impairment

moderate to severe
unsafe
FDA Category
N
Dose Adjustment

avoid or significantly reduce dose

Key Recommendations

use with extreme caution in moderate to severe hepatic impairment. consider alternative therapy. if used, substantial dose reduction and intensive monitoring required

Monitor

frequent liver function tests, bilirubin, coagulation studies

Use of this medication in this population requires careful consideration of risks and benefits.

Statistics and clinical data

drug_classWHO
2023

Drug class

Value:Alkylating agent (nitrogen mustard analog)

Thiotepa belongs to the alkylating agent class of chemotherapeutic drugs

prescribingFDA
2023

FDA approval year

Value:1959

Initial FDA approval date for Thiotepa

usageNCI
2023

Common indications

Value:Breast cancer, ovarian cancer, bladder cancer, conditioning for hematopoietic stem cell transplantation

Primary therapeutic indications for Thiotepa

mechanismPubChem
2023

Mechanism of action

Value:Cross-links DNA strands by forming alkyl bonds, inhibiting DNA replication and cell division

Pharmacodynamic mechanism of action

Thiotepa is used to treat breast cancer, ovarian cancer, bladder cancer, Hodgkin's lymphoma, and non-Hodgkin's lymphoma. It is also used as part of conditioning regimens prior to bone marrow or stem cell transplantation.

As an alkylating agent, Thiotepa works by adding alkyl groups to DNA strands, which cross-links DNA and prevents cancer cells from reproducing. This interferes with the cell's ability to divide and grow, ultimately leading to cell death.

Thiotepa is a potent chemotherapy agent that requires careful handling by trained healthcare professionals. Common side effects include bone marrow suppression, increased risk of infection, bleeding, nausea, and hair loss. Patients should be monitored regularly for blood counts and liver function. It may cause infertility and is not recommended during pregnancy. Close adherence to safety guidelines is essential due to its cytotoxic nature.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed August 24, 2026. · Read our editorial policy