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Basic Drug Info
Drug Name:Thiotepa
Manufacturer:Bedford Laboratories
Other Info:

Patients with papillary carcinoma of the bladder are dehydrated for 8 to 12 hours prior to treatment.

Then 60 mg of thiotepa in 30 to 60 mL of Sodium Chloride Injection is instilled into the bladder by catheter.

For maximum effect, the solution should be retained for 2 hours.

If the patient finds it impossible to retain 60 mL for 2 hours, the dose may be given in a volume of 30 mL.

If desired, the patient may be positioned every 15 minutes for maximum area contact.

The usual course of treatment is once a week for 4 weeks.

The course may be repeated if necessary, but second and third courses must be given with caution since bone-marrow depression may be increased.

Deaths have occurred after intravesical administration, caused by bone-marrow depression from systemically absorbed drug.



Clinical Trials:


Indications and Usage

Thiotepa 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:Adenocarcinoma of the breast.Adenocarcinoma of the ovary.For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities.For the treatment of superficial papillary carcinoma of the urinary bladder.While now largely superseded by other treatments, thiotepa has been effective against other lymphomas, such as lymphosarcoma and Hodgkin's disease.
Neoplasms -- New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.

Adenocarcinoma -- A malignant epithelial tumor with a glandular organization.

effusion -- A collection of fluid in a body cavity. It may be the result of a non-neoplastic disorder (e.g. heart failure) or a tumor (e.g. carcinoma of the lung). -- 2003

Localized Disease -- A disease that is confined to a specific organ or tissue and has not spread to other anatomic sites.

Papillary Carcinoma -- A malignant neoplasm characterized by the formation of numerous, irregular, finger-like projections of fibrous stroma that is covered with a surface layer of neoplastic epithelial cells. (Stedman, 25th ed)

Lymphoma -- A general term for various neoplastic diseases of the lymphoid tissue.

Lymphoma, Diffuse -- malignant lymphoma in which neoplastic cells diffusely infiltrate the entire lymph node without any definite organized pattern; patients whose lymphomas present a diffuse pattern generally have a more unfavorable survival outlook than those presenting with a follicular or nodular pattern.

Hodgkins Disease -- A malignant disease characterized by progressive enlargement of the lymph nodes, spleen, and general lymphoid tissue. In the classical variant, giant usually multinucleate Hodgkin's and REED-STERNBERG CELLS are present; in the nodular lymphocyte predominant variant, lymphocytic and histiocytic cells are seen.

Contraindications

Thiotepa is contraindicated in patients with a known hypersensitivity (allergy) to this preparation.Therapy is probably contraindicated in cases of existing hepatic, renal, or bone-marrow damage.

However, if the need outweighs the risk in such patients, thiotepa may be used in low dosage, and accompanied by hepatic, renal and hemopoietic function tests.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Immediate hypersensitivity -- Hypersensitivity reactions which occur within minutes of exposure to challenging antigen due to the release of histamine which follows the antigen-antibody reaction and causes smooth muscle contraction and increased vascular permeability.

Warnings

Death has occurred after intravesical administration, caused by bone-marrow depression from systematically absorbed drug.Death from septicemia and hemorrhage has occurred as a direct result of hematopoietic depression by thiotepa.Thiotepa is highly toxic to the hematopoietic system.

A rapidly falling white blood cell or platelet count indicates the necessity for discontinuing or reducing the dosage of thiotepa.

Weekly blood and platelet counts are recommended during therapy and for at least 3 weeks after therapy has been discontinued.Thiotepa can cause fetal harm when administered to a pregnant woman.

Thiotepa given by the intraperitoneal (IP) route was teratogenic in mice at doses ? 1 mg/kg (3.2 mg/m2), approximately 8-fold less than the maximum recommended human therapeutic dose (0.8 mg/kg, 27 mg/m2), based on body-surface area.

Thiotepa given by the IP route was teratogenic in rats at doses ? 3 mg/kg (21 mg/m2), approximately equal to the maximum recommended human therapeutic dose, based on body-surface area.

Thiotepa was lethal to rabbit fetuses at a dose of 3 mg/kg (41 mg/m2), approximately two times the maximum recommended human therapeutic dose based on body-surface area.Effective contraception should be used during thiotepa therapy if either the patient or partner is of childbearing potential.

There are no adequate and well-controlled studies in pregnant women.

If thiotepa is used during pregnancy, or if pregnancy occurs during thiotepa therapy, the patient and partner should be apprised of the potential hazard to the fetus.Thiotepa is a polyfunctional alkylating agent, capable of cross-linking the DNA within a cell and changing its nature.

The replication of the cell is, therefore, altered, and thiotepa may be described as mutagenic.

An in vitro study has shown that it causes chromosomal aberrations of the chromatid type and that the frequency of induced aberrations increases with the age of the subject.Like many alkylating agents, thiotepa has been reported to be carcinogenic when administered to laboratory animals.

Carcinogenicity is shown most clearly in studies using mice, but there is some evidence of carcinogenicity in man.

In patients treated with thiotepa, cases of myelodysplastic syndromes and acute non-lymphocytic leukemia have been reported.
Branded Drugs
The following US Branded drugs contain Thiotepa


THIOPLEX -- IMMUNEX CORP


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