Thiotepa: uses, dosing, side effects & brands
Thiotepa is a medicine sold in the U.S. under 2 brand and generic names, for adenocarcinoma, urinary bladder neoplasms and breast neoplasms. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Adenocarcinoma, Urinary Bladder Neoplasms and Breast Neoplasms
- Available as
- Injectable
- Sold as
- 2 products — Tepylute and Thioplex
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How thiotepa is dosed
From the FDA label for Tepylute (application NDA216984). Other thiotepa products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The recommended dose of TEPYLUTE for treatment of adenocarcinoma of the breast or ovary is 0.3 mg/kg to 0.4 mg/kg intravenously. ( 2.1 ) See full prescribing information for preparation instructions. ( 2.2 ) 2.1 Recommended Dosage Adenocarcinoma of the Breast or Ovary The recommended dose of TEPYLUTE for treatment of adenocarcinoma of the breast or ovary is 0.3 mg/kg to 0.4 mg/kg intravenously. Doses should be given at 1 to 4 week intervals. Initially the higher dose in the given range is commonly administered. The maintenance dose should be adjusted weekly on the basis of pretreatment control blood counts and subsequent blood counts. Maintenance doses should not be administered more frequently than weekly. 2.2 Preparation Instructions TEPYLUTE is a hazardous drug. Follow applicable special handling and disposal procedures 1 . Use aseptic technique to prepare TEPYLUTE. Dilution in the infusion bag Remove vial from refrigerated conditions 1 hour prior to dilution. Dilute the solution in an appropriate volume of 0.9% Sodium Chloride Injection to obtain a final TEPYLUTE concentration between 0.5 mg/mL and 1 mg/mL. Use a 16G needle with a Luer-lock syringe to dilute the solution. Use the diluted TEPYLUTE infusion solution immediately. If the solution is not used immediately, store refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours, or at room temperature 25°C (77°F) for…
Thiotepa side effects
The following clinically significant adverse reactions are described elsewhere in other sections of the label: Myelosuppression [ see Warnings and Precautions ( 5.1 ) ] Infection [ see Warnings and Precautions ( 5.1 ) ] Hypersensitivity [ see Warnings and Precautions ( 5.2 ) ] Cutaneous Toxicity [ see Warnings and Precautions ( 5.3 ) ] Hepatic Veno-Occlusive Disease [ see Warnings and Precautions ( 5.5 ) ] Central Nervous System Toxicity [ see Warnings and Precautions ( 5.6 ) ] Carcinogenicity [ see Warnings and Precautions ( 5.7 ) ] The most common adverse reactions (incidence greater than 10%) are neutropenia, anemia, thrombocytopenia, elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated bilirubin, mucositis, cytomegalovirus infection, hemorrhage, diarrhea, hematuria and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Shorla Oncology at 844-9-SHORLA or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions with Treatment of adenocarcinoma of the breast and adenocarcinoma of the ovary Gastrointestinal: Nausea, vomiting, abdominal…
Who shouldn’t take thiotepa
TEPYLUTE is contraindicated in: Patients with severe hypersensitivity to thiotepa [see Warnings and Precautions ( 5.2 )] Concomitant use with live or attenuated vaccines [see Warnings and Precautions ( 5.4 )] Hypersensitivity to the active substance. ( 4 ) Concomitant use with live or attenuated vaccines. ( 4 )
Thiotepa drug interactions
7.1 Effect of Cytochrome CYP3A Inhibitors and Inducers In vitro studies suggest that thiotepa is metabolized by CYP3A4 and CYP2B6 to its active metabolite TEPA. Avoid coadministration of strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ritonavir) and strong CYP3A4 inducers (e.g., rifampin, phenytoin) with thiotepa due to the potential effects on efficacy and toxicity [see Clinical Pharmacology ( 12.3 )]. Consider alternative medications with no or minimal potential to inhibit or induce CYP3A4. If concomitant use of strong CYP3A4 modulators cannot be avoided, closely monitor for adverse drug reactions. 7.2 Effect of TEPYLUTE on Cytochrome CYP2B6 Substrates In vitro studies suggest that thiotepa inhibits CYP2B6. Thiotepa may increase the exposure of drugs that are substrates of CYP2B6 in patients; however, the clinical relevance of this in vitro interaction is unknown [see Clinical Pharmacology ( 12.3 )] . The administration of thiotepa with cyclophosphamide in patients reduces the conversion of cyclophosphamide to the active metabolite, 4-hydroxycyclophosphamide; the effect appears sequence dependent with a greater reduction in the conversion to 4-hydroxycyclophosphamide when thiotepa is administered 1.5 hours prior to the intravenous administration of cyclophosphamide compared to administration of thiotepa after intravenous cyclophosphamide [see Clinical Pharmacology ( 12.3 )] . The reduction in 4-hydroxycyclophosphamide levels may potentially reduce efficacy of cyclophosphamide treatment.
Every thiotepa product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Injectable | No data | — | View → | |
| 2 | Not yet rated | Prescription | Injectable | No data | — | View → |
How long thiotepa keeps
The date on a sealed pack is not the only one: some thiotepa labels start a second clock once the product is opened or mixed, as short as 4 hours.
Does thiotepa expire? The in-use limits and storage rules from its labelsWhat people report to the FDA about thiotepa
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 9,117 reports naming thiotepa, and the FDA flagged 98% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- febrile neutropenia767 reports
- mucosal inflammation767 reports
- cytomegalovirus infection525 reports
- pyrexia494 reports
- acute graft versus host disease444 reports
- acute graft versus host disease in skin429 reports
- infection418 reports
- cytomegalovirus infection reactivation396 reports
Read these as a signal, not a rate. A report does not mean thiotepa caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
Related calculators
Frequently asked questions
What is thiotepa?
Tepylute (Thiotepa) is a medication used to treat Adenocarcinoma, Urinary Bladder Neoplasms, Breast Neoplasms, Lymphoma.
Can you take thiotepa with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run thiotepa against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is thiotepa sold under?
We track 2 thiotepa-containing products in the U.S.: Tepylute and Thioplex. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does thiotepa come in?
Across the brands we track, thiotepa is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic thiotepa?
We do not currently list a generic-labelled thiotepa product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Thiotepa: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/thiotepa
- MLA
- “Thiotepa: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/thiotepa.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for thiotepa on DailyMed (NIH) ↗ — including its boxed warning in full.