Cisplatin

Use in Patients with Renal Impairment Patients with baseline renal impairment may be more susceptible to nephrotoxicity [see Warnings and Precautions] . Ensure adequate hydration before, during, and after cisplatin for injection administration [see Dosage and Administration]. Measure serum creatinine, blood urea nitrogen, creatinine clearance, and serum electrolytes prior to initiating therapy, and as clinically indicated.

Consider alternative treatments or reduce the dose of cisplatin for injection for patients with baseline renal impairment or who develop significant reductions in creatinine clearance during treatment with cisplatin for injection according to clinical treatment guidelines [see Dosage and Administration].

Preparation, Handling, and Administration Do not use needles or intravenous sets containing aluminum parts that can come in contact with cisplatin for injection during preparation or administration. Aluminum reacts with cisplatin for injection, causing precipitate formation and a loss of potency. Cisplatin for injection is a cytotoxic drug.

Follow applicable special handling and disposable procedures. 1 Reconstitution Reconstitute 50 mg vials with 50 mL of Sterile Water for Injection, USP. Each mL of the resulting solution will contain 1 mg of cisplatin for injection. Reconstitution results in a clear or colorless to slight yellow solution. Do not refrigerate the reconstituted solution.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted solution is stable for 20 hours at controlled room temperature [20°C to 25°C (68°F to 77°F)]. Solution removed from the amber vial should be protected from light if it is not to be used within six hours.

Dilution For preparation of the infusion solution, it is recommended that the reconstituted solution be further diluted in 1 to 2 L of a compatible infusion solution with or without 37.5 g of mannitol. Refer to detailed references for specific infusion solution stability and compatibility information. Administration Administer cisplatin for injection by slow intravenous infusion.