Thiotepa

What it is used for

Thiotepa for Injection, USP has been tried with varying results in the palliation of a wide variety of neoplastic diseases. However, the most consistent results have been seen in the following tumors: 1. Adenocarcinoma of the breast. 2. Adenocarcinoma of the ovary. 3. For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities.

4. For the treatment of superficial papillary carcinoma of the urinary bladder. While now largely superseded by other treatments, thiotepa has been effective against other lymphomas, such as lymphosarcoma and Hodgkin’s disease.

Side effects, and when to stop

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 ) ]

Who should not take it

TEPYLUTE is contraindicated in:

• Patients with severe hypersensitivity to thiotepa
• Concomitant use with live or attenuated vaccines

Storing it

Storage and Handling

TEPYLUTE injection vials must be stored and transported refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze.

TEPYLUTE injection is a hazardous drug. Follow applicable special handling and disposal procedures 1.