"The U.S. Food and Drug Administration today expanded the approved uses of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) to treat patients with late-stage (metastatic) pancreatic cancer.
Thiotepa (thiotepa (thiotepa injection) injection) 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While now largely superseded by other treatments, thiotepa (thiotepa (thiotepa injection) injection) has been effective against other lymphomas, such as lymphosarcoma and Hodgkin's disease.
DOSAGE AND ADMINISTRATION
Since absorption from the gastrointestinal tract is variable, thiotepa (thiotepa (thiotepa injection) injection) should not be administered orally.
Dosage must be carefully individualized. A slow response to thiotepa (thiotepa (thiotepa injection) injection) does not necessarily indicate a lack of effect. Therefore, increasing the frequency of dosing may only increase toxicity. After maximum benefit is obtained by initial therapy, it is necessary to continue the patient on maintenance therapy (1 to 4 week intervals). In order to continue optimal effect, maintenance doses should not be administered more frequently than weekly in order to preserve correlation between dose and blood counts.
Preparation and Administration Precautions: Thiotepa (thiotepa (thiotepa injection) injection) is a cytotoxic anticancer drug and as with other potentially toxic compounds, caution should be exercised in handling and preparation of thiotepa (thiotepa (thiotepa injection) injection) . Skin reactions associated with accidental exposure to thiotepa (thiotepa (thiotepa injection) injection) may occur. The use of gloves is recommended. If thiotepa (thiotepa (thiotepa injection) injection) solution contacts the skin, immediately wash the skin thoroughly with soap and water. If thiotepa (thiotepa (thiotepa injection) injection) contacts mucous membranes, the membranes should be flushed thoroughly with water.
Preparation of Solution: Thiotepa (thiotepa (thiotepa injection) injection) for injection should be reconstituted with 1.5 mL of Sterile Water for Injection resulting in a drug concentration of approximately 10 mg/mL. The actual withdrawable quantities and concentration achieved are illustrated in the following table:
|Label Claim (mg/vial)||Actual Content
|Amount of Diluent to be Added (mL)||Approximate Withdrawable Volume (mL)||Approximate Withdrawable Amount (mg/vial)||Approximate Reconstituted Concentration (mg/mL)|
The reconstituted solution is hypotonic and should be further diluted with Sodium Chloride Injection (0. 9% sodium chloride) before use.
When reconstituted with Sterile Water for Injection, solutions of thiotepa (thiotepa (thiotepa injection) injection) should be stored in a refrigerator and used within 8 hours. Reconstituted solutions further diluted with Sodium Chloride Injection should be used immediately.
In order to eliminate haze, filter solutions through a 0.22 micron filter* prior to adminstration. Filtering does not alter solution potency. Reconstituted solutions should be clear. Solutions that remain opaque or precipitate after filtration should not be used.
*Polysulfone membrane (Gelman's Sterile Aerodisc®, Single Use) or triton-free mixed ester of cellulose/PVC (Millipore's MILLEX®-GS Filter Unit).
Initial and Maintenance Doses: 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.
Intravenous Administration: Thiotepa (thiotepa (thiotepa injection) injection) may be given by rapid intravenous administration in doses of 0.3 to 0.4 mg/kg. Doses should be given at 1 to 4 week intervals.
Intracavitary Administration: The dosage recommended is 0.6 to 0.8 mg/kg. Administration is usually effected through the same tubing which is used to remove the fluid from the cavity involved.
Intravesical Administration: Patients with papillary carcinoma of the bladder are dehydrated for 8 to 12 hours prior to treatment. Then 60 mg of thiotepa (thiotepa (thiotepa injection) injection) 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.
Handling and Disposal: Follow safe cytotoxic agent handling procedures. Several guidelines on this subject have been published.1-7 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Thiotepa (thiotepa (thiotepa injection) injection) for Injection USP, for single use only, is available in vials containing 15 mg of nonpyrogenic, sterile lyophilized powder, supplied as follows:
NDC 55390-030-10. Unit carton contains 1 x 15 mg single dose vial thiotepa (thiotepa (thiotepa injection) injection) .
Store in a refrigerator between 2° to 8°C (36° to 46°F). PROTECT FROM LIGHT AT ALL TIMES.
Manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146. Manufactured for: Bedford Laboratories, Bedford, OH 44146. April 2001. FDA Rev date: 4/2/200
1. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621. For sale by the Superintendent of Documents, US Government Printing Office, Washington, DC 20402.
2. AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA. 1985; 253(11):1590-1592.
3. National Study Commission on Cytotoxic Exposure - Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, Sc D, Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.
4. Clinical Oncological Society of Australia: Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia. 1983; 1:426-428.
5. Jones RB, et al. Safe handling of chemotherapeutic agents: A report from the Mount Sinai Medical Center. Ca - A Cancer Journal for Clinicians. Sept/Oct 1983; 258-263.
6. American Society of Hospital Pharmacists technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990; 47:1033-1049.
7. Controlling Occupational Exposure to Hazardous Drugs. (OSHA WORK-PRACTICE GUIDELINES). AM J Health-Syst Pharm. 1996:53:1669-1685.
Last reviewed on RxList: 11/20/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Thiotepa Information
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