Carboplatin

Preview FDA label, Natco Pharma USA LLC, intravenous, effective 2026-07-21. Full label on DailyMed

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using. Not yet reviewed by a ClinDose pharmacist.

Dosing in kidney impairment

Blood counts were done weekly, and the recommendations are based on the lowest post-treatment platelet or neutrophil value. [See table below.] Carboplatin injection is usually administered by an infusion lasting 15 minutes or longer. No pre- or post-treatment hydration or forced diuresis is required. Patients with Impaired Kidney Function Patients with creatinine clearance values below 60 mL/min are at increased risk of severe bone marrow suppression.

In renally-impaired patients who received single agent carboplatin therapy, the incidence of severe leukopenia, neutropenia, or thrombocytopenia has been about 25% when the dosage modifications in the table below have been used. [See table below.] The data available for patients with severely impaired kidney function (creatinine clearance below 15 m L/min) are too limited to permit a recommendation for treatment.

These dosing recommendations apply to the initial course of treatment. Subsequent dosages should be adjusted according to the patient's tolerance based on the degree of bone marrow suppression. Formula Dosing Another approach for determining the initial dose of carboplatin injection is the use of mathematical formulae, which are based on a patient's pre-existing renal function or renal function and desired platelet nadir.

Renal excretion is the major route of elimination for carboplatin (See CLINICAL PHARMACOLOGY.) The use of dosing formulae, as compared to empirical dose calculation based on body surface area, allows compensation for patient variations in pretreatment renal function that might otherwise result in either underdosing (in patients with above average renal function) or overdosing (in patients with impaired renal function). min using single agent carboplatin appears to provide the most appropriate dose range in previously treated patients.

This study also showed a trend between the AUC of single agent carboplatin administered to previously treated patients and the likelihood of developing toxicity. [See table below.] Geriatric Dosing Because renal function is often decreased in elderly patients, formula dosing of carboplatin injection based on estimates of GFR should be used in elderly patients to provide predictable plasma carboplatin injection AUCs and thereby minimize the risk of toxicity.

Baseline Creatinine Clearance Recommended Dose on Day 1
41 - 59 mL/min 250 mg/m2
16 - 40 mL/min 200 mg/m2

Preparation and administration

PREPARATION OF INTRAVENOUS SOLUTIONS Carboplatin injection is a premixed aqueous solution of 10 mg/mL carboplatin. Carboplatin injection can be further diluted to concentrations as low as 0.5 mg/mL with 5% Dextrose in Water (D5W) in this subscript the digit 5 or 0.9% Sodium Chloride Injection USP. 5 When prepared as directed, carboplatin injection is stable for 8 hours at room temperature (25°C).

Since no antibacterial preservative is contained in the formulation, it is recommended that carboplatin injection be discarded 8 hours after dilution