Carboplatin

Indications

INDICATIONS 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 versus 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.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION NOTE: Aluminum reacts with carboplatin causing precipitate formation and loss of potency, therefore, needles or intravenous sets containing aluminum parts that may come in contact with the drug must not be used for the preparation or administration of Carboplatin Injection. Single Agent Therapy Carboplatin Injection, as a single agent, has been shown to be effective in patients with recurrent ovarian carcinoma at a dosage of 360 mg/m 2 IV on day 1 every 4 weeks (alternatively see Formula Dosing ).

Contraindications

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

Warnings and precautions

WARNINGS Bone marrow suppression (leukopenia, neutropenia, and thrombocytopenia) is dose-dependent and is also the dose-limiting toxicity. Peripheral blood counts should be frequently monitored during carboplatin treatment and, when appropriate, until recovery is achieved. Median nadir occurs at day 21 in patients receiving single agent carboplatin. In general, single intermittent courses of carboplatin should not be repeated until leukocyte, neutrophil, and platelet counts have recovered.

Pregnancy

Pregnancy (see WARNINGS ).

Storage and supply

STORAGE Unopened vials of Carboplatin Injection are stable to the date indicated on the package when stored at 25°C (77°F); excursions permitted from 15°–30°C (59°–86°F) . Protect from light. Carboplatin Injection multiple-dose vials maintain microbial, chemical, and physical stability for up to 14 days at 25°C following multiple needle entries.

Source: Carboplatin (Carboplatin) — US FDA prescribing information, 2024-08-21, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.