Generic Name


Therapeutic Class

Cytotoxic Chemotherapy
Initial Treatment of Advanced Ovarian Carcinoma: Carbotor is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimenconsists of Carbotor and cyclophosphamide. Two randomizedcontrolled studies conducted by the NCIC and SWOG with Carbotor versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups.

There is limited statistical power to demonstrate equivalence in overal  pathologic complete response rates and long-term survival ( ≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.

Secondary Treatment of Advanced Ovarian Carcinoma: Carbotor is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin.

Within the group of patients previously treated with cisplatin, those who have developed progressive disease while receiving cisplatin therapy may have a decreased response rate.

Carboplatin is an alkylating agent which binds covalently to DNA. It modifies the cell cycle by interfering with DNA structure and function.

Dosage & Administration
Previously untreated patients: 400 mg/m2 as single short term IV infusion over 15-60 min. Therapy should not be repeated until 4 wk after the previous course and/or until the neutrophil count is at least 2,000 cells/mm3 and the platelet count is at least 100,000 cells/mm3.

Patients previously treated with myelosuppresive therapy or patients with poor performance status: Reduce initial dosage by 20-25% (300-320 mg/m2).

Administration of a liver vaccine may be dangerous during treatment with Carbotor. The renal effects of nephrotoxic compounds may be potentiated by Carbotor.

Carboplatin injection should not be employed in patients with severe bone marrow depression or significant bleeding. It is contraindicated in patients with a history of severe allergic reactions to cisplatin or other platinum containing compounds.

Side Effects
Bone marrow suppression, gastrointestinal effects, nephrotoxicity, nervous system, ototoxicity, allergic reactions, alopecia, mucositis.

Pregnancy & Lactation
Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk.

Precautions & Warnings
Much less renal toxicity than cisplatin so no need for a vigorousm hydration schedule or forced diuresis. If AUC dosing is not used, dose should be reduced to 250 mg/m2 for creatinine clearance of 41 to 59 ml/min and to 200 mg/m2 for clearance of 16 to 40 ml/min. Corticosteroids & antihistamines are employed to alleviate symptoms.

Use in Special Populations
Renal Impairment:
CrCl (16-40 ml/min)- 200 mg/m2.
CrCl (41-59 ml/min)- 250 mg/m2.

150 mg injection should be reconstituted with 15 ml of sodium chloride solution (0.9%) or water for injection.

450 mg injection should be reconstituted with 45 ml of sodium chloride solution (0.9%) or water for injection.

The reconstituted solution should be diluted by 300 ml (for 150 mg) & 900 ml (for 450 mg) of 5% glucose for injection or 0.9% sodium chloride solution for infusition.

Storage Conditions
Store at 25° C. Protect from light.
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