Thiotepa

THIOTEPA — thiotepa injection, powder, for solution
MSN LABORATORIES PRIVATE LIMITED

WARNING: SEVERE MYELOSUPPRESSION, CARCINOGENICITY
• Thiotepa may cause severe marrow suppression, and high doses may cause marrow ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters. Hematopoietic progenitor (stem) cell transplantation (HSCT) is required to prevent potentially fatal complications of the prolonged myelosuppression after high doses of thiotepa [see Warnings and Precautions (5.1)]
• Thiotepa should be considered potentially carcinogenic in humans [see Warnings and Precautions (5.7)]

1 INDICATIONS AND USAGE

1.2 Adenocarcinoma of the Breast or Ovary

Thiotepa for injection is indicated for treatment of adenocarcinoma of the breast or ovary.

1.3 Malignant Effusions

Thiotepa for injection is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities.

1.4 Superficial Papillary Carcinoma of the Urinary Bladder

Thiotepa for injection is indicated for treatment of superficial papillary carcinoma of the urinary bladder.
Pediatric use information is approved for Adienne SA ‘s TEPADINA (thiotepa) for Injection. However, due to Adienne SA ‘s marketing exclusivity rights, the drug product is not labeled with that information.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Adenocarcinoma of the Breast or Ovary
The recommended dose of thiotepa for injection for treatment of adenocarcinoma of the breast or ovary is 0.3 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.
Malignant Effusions
The recommended dose of thiotepa for injection for treatment of malignant effusions is 0.6 to 0.8 mg/kg intracavitary. Administration is usually effected through the same tubing which is used to remove the fluid from the cavity involved. 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.
Superficial Papillary Carcinoma of the Urinary Bladder
The recommended dose of thiotepa for injection for treatment of superficial papillary carcinoma of the urinary bladder is 60 mg in 30 to 60 mL of Sodium Chloride Injection into the bladder by catheter. 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. The patient may be repositioned 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.
Pediatric use information is approved for Adienne SA ‘s TEPADINA (thiotepa) for Injection. However, due to Adienne SA ‘s marketing exclusivity rights, the drug product is not labeled with that information.

2.2 Preparation Instructions

Thiotepa for injection is a cytotoxic drug. Follow applicable special handling and disposal procedures1.
Reconstitution
Reconstitute thiotepa for injection 15 mg with 1.5 ml of sterile water for injection. Using a syringe fitted with a needle, aseptically withdraw 1.5 ml of sterile water for injection. Inject the content of the syringe into the vial through the rubber stopper.
Remove the syringe and needle, and mix manually by repeated inversions.
Reconstitute thiotepa for injection 100 mg with 10 ml of sterile water for injection. Using a syringe fitted with a needle, aseptically withdraw 10 ml of sterile water for injection. Inject the content of the syringe into the vial through the rubber stopper.
Remove the syringe and needle, and mix manually by repeated inversions.
The reconstituted solution is hypotonic and must be diluted in saline prior to administration. Reconstituted solutions, free of visible particulate matter, may occasionally show opalescence; such solutions can still be used for further dilution.
If not used immediately after reconstitution, the product is stable for 8 hours when stored at 2°C to 8°C (36° to 46°F).
Dilution in the infusion bag
Prior to administration, dilute the reconstituted solution further with an appropriate volume of sodium chloride 0.9% solution for injection to obtain a final thiotepa for injection concentration between 0.5 and 1 mg/mL. Dilute thiotepa for injection as recommended in Table 2.Table 2: Dilution of Thiotepa for Injection in the infusion bag

Calculated Thiotepa for Injection Dose Dilution Volume (Sodium Chloride 0.9% solution for injection)
Less than 250 mg Appropriate volume to obtain a final concentration of 0.5 to 1 mg/mL
250 mg to 500 mg 500 mL or appropriate volume to obtain a final concentration of 0.5 to 1 mg/mL
Greater than 500 mg 1000 mL or appropriate volume to obtain a final concentration of 0.5 to 1 mg/mL

After dilution the product is stable for 24 hours when stored at 2°C to 8°C (36° to 46°F) and for 4 hours when stored at 25°C (77°F). From a microbiological point of view, the product should be used immediately.
Inspect the diluted solution visually for particulate matter and discoloration prior to administration. Use thiotepa for injection diluted solutions only if free of visible particulate matter. Filter using a 0.2 micron filter prior to administration. Filtering does not alter solution potency

3 DOSAGE FORMS AND STRENGTHS

  • For injection, 15 mg, lyophilized white powder in single-dose vial for reconstitution
  • For injection, 100 mg, lyophilized white powder in single-dose vial for reconstitution

4 CONTRAINDICATIONS

Thiotepa for injection is contraindicated in:

5 WARNINGS AND PRECAUTIONS

5.1 Myelosuppression

The consequence of treatment with high doses of thiotepa together with other chemotherapy is profound myelosuppression occurring in all patients. Monitor complete blood counts, and provide supportive care for infections, anemia and thrombocytopenia until there is adequate hematopoietic recovery.
For patients receiving thiotepa for treatment of adenocarcinoma of the breast, adenocarcinoma of the ovary, malignant effusions and superficial papillary carcinoma of the urinary bladder, if the bone marrow has been compromised by prior irradiation or chemotherapy, or is recovering from chemotherapy, the risk of severe myelosuppression with thiotepa may be increased. Perform periodic complete blood counts during the course of treatment with thiotepa. Provide supportive care for infections, bleeding, and symptomatic anemia [see Adverse Reactions (6.1)] .
Pediatric use information is approved for Adienne SA’s TEPADINA (thiotepa) for Injection. However, due to Adienne SA’s marketing exclusivity rights, the drug product is not labeled with that information.

5.2 Hypersensitivity

Clinically significant hypersensitivity reactions, including anaphylaxis, have occurred following administration of thiotepa. If anaphylactic or other clinically significant allergic reaction occurs, discontinue treatment with thiotepa, initiate appropriate therapy, and monitor until signs and symptoms resolve [see Contraindications (4), Adverse Reactions (6.1)].

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