TEPYLUTE 10 mg/mL
thiotepa · INJECTION · Shorla Oncology Inc.
TEPYLUTE is a injection containing thiotepa at 10 mg/mL, taken intravenous. Manufactured by Shorla Oncology Inc..
Key Facts
- Brand Name
- TEPYLUTE
- Generic Name
- thiotepa
- NDC Code (Product)
81927-106- Manufacturer
- Shorla Oncology Inc.
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA216984
- Drug Class
- Alkylating Drug [EPC]
- Marketing Start
- 03/31/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE TEPYLUTE is an alkylating drug indicated for treatment of adenocarcinoma of the breast or ovary. ( 1.1 ) 1.1 Adenocarcinoma of the Breast or Ovary TEPYLUTE is indicated for treatment of adenocarcinoma of the breast or ovary.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 t…
Contraindications
4 CONTRAINDICATIONS 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 )
Drug Interactions
7 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-hy…
Adverse Reactions
6 ADVERSE REACTIONS 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 tr…
Frequently Asked Questions
What is TEPYLUTE used for?
TEPYLUTE contains thiotepa. It is a injection taken intravenous. Consult your doctor for specific uses.
Is TEPYLUTE a controlled substance?
TEPYLUTE is not classified as a controlled substance by the DEA.
What is the generic name for TEPYLUTE?
The generic name for TEPYLUTE is thiotepa. There are 11 other brand versions of thiotepa.
What is the NDC code for TEPYLUTE 10 mg/mL?
The NDC (National Drug Code) for TEPYLUTE 10 mg/mL is 81927-106, listed by Shorla Oncology Inc..