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Carboplatin Injection:
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10 mg/mL, 5 mL multi-dose vial (MDV)
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10 mg/mL, 15 mL multi-dose vial (MDV)
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10 mg/mL, 45 mL multi-dose vial (MDV)
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10 mg/mL, 60 mL multi-dose vial (MDV)
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INDICATIONS AND USAGE
Initial Treatment of Advanced Ovarian Carcinoma: Carboplatin Injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination
with other approved chemotherapeutic agents. One established combination regimen consists of Carboplatin Injection and cyclophosphamide. Two randomized
controlled studies conducted by the NCIC and SWOG with carboplatin vs. cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall
survival between the two groups (see CLINICAL STUDIES).
There is limited statistical power to demonstrate equivalence in overall 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: Carboplatin Injection 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.
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WARNING
Carboplatin Injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate
management of therapy and complications is possible only when adequate treatment facilities are readily available.
Bone marrow suppression is dose related and may be severe, resulting in infection and/or bleeding. Anemia may be cumulative and may require transfusion
support. Vomiting is another frequent drug-related side effect.
Anaphylactic-like reactions to Carboplatin Injection have been reported and may occur within minutes of Carboplatin Injection administration. Epinephrine,
corticosteroids, and antihistamines have been employed to alleviate symptoms.
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Please refer to full prescribing information.
Important Safety Information
Do not use any needles, administration sets, catheters or syringes with aluminum as precipitation and loss of potency will occur.
Common side effects include nausea, vomiting, gastrointestinal pain, bone marrow suppression, decreased serum electrolyte values, and abnormal liver and renal function tests. Patients older than 65 years and/or previously treated with cisplatin appear to have an increased risk (10%) for peripheral neuropathies.
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