Cisplatin

CISPLATIN- cisplatin injection, powder, lyophilized, for solution
WG Critical Care, LLC

WARNING: NEPHROTOXICITY, PERIPHERAL NEUROPATHY, NAUSEA AND VOMITING and MYELOSUPPRESSION.

Nephrotoxicity: cisplatin for injection can cause severe renal toxicity, including acute renal failure. Severe renal toxicities are dose-related and cumulative. Ensure adequate hydration and monitor renal function and electrolytes. Consider dose reductions or alternative treatments in patients with renal impairment [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].
Peripheral Neuropathy: cisplatin for injection can cause dose-related peripheral neuropathy that becomes more severe with repeated courses of the drug [see Warnings and Precautions (5.2)].
Nausea and Vomiting: cisplatin for injection can cause severe nausea and vomiting. Use highly effective antiemetic premedication [see Dosage and Administration (2.1) and Warnings and Precautions (5.3)].
Myelosuppression: cisplatin for injection can cause severe myelosuppression with fatalities due to infections. Monitor blood counts accordingly. Interruption of therapy may be required [see Warnings and Precautions (5.4)].

1 INDICATIONS AND USAGE

1.1 Advanced Testicular Cancer

Cisplatin for injection is indicated for the treatment of advanced testicular cancer.

1.2 Advanced Ovarian Cancer

Cisplatin for injection is indicated for the treatment of advanced ovarian cancer.

1.3 Advanced Bladder Cancer

Cisplatin for injection is indicated for the treatment of advanced bladder cancer.

2 DOSAGE AND ADMINISTRATION

2.1 Hydration and Anti-Emetic Treatment

Patients treated with cisplatin for injection must receive appropriate pre-treatment hydration. Maintain adequate hydration and urinary output for 24 hours after cisplatin for injection administration [see Warnings and Precautions (5.1)]. Administer pre-treatment and post-treatment antiemetics as appropriate [see Warnings and Precautions (5.7)].

2.2 Advanced Testicular Cancer

Cisplatin for injection has been administered at 20 mg/m2 intravenously daily for 5 days per cycle. Other doses and combination regimens have been used.

2.3 Advanced Ovarian Cancer

Cisplatin for injection has been administered at 75 mg/m2 to 100 mg/m2 intravenously per cycle once every 3 to 4 weeks on Day 1. Other doses and combination regimens have been used.

2.4 Advanced Bladder Cancer

Cisplatin for injection has been administered at 50 mg/m2 to 70 mg/m2 intravenously per cycle once every 3 to 4 weeks. For heavily pretreated patients, an initial dose of 50 mg/m2 per cycle repeated every 4 weeks is recommended. Other doses and combination in regimens have been used.

2.5 Dose Modifications

Consider alternative treatments or dose reductions for patients with impaired creatinine clearance, myelosuppression, or neuropathy. Consider permanent discontinuation for Grade 3-4 neuropathy. [See Warnings and Precautions (5.1)]

2.6 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.

3 DOSAGE FORMS AND STRENGTHS

Cisplatin for injection, USP: single-dose vials containing 50 mg of cisplatin as white to light yellow lyophilized powder for reconstitution.

4 CONTRAINDICATIONS

Cisplatin for injection is contraindicated in patients with severe hypersensitivity to cisplatin [see Warnings and Precautions (5.4)].

5 WARNINGS AND PRECAUTIONS

5.1 Nephrotoxicity

Cisplatin for injection can cause dose-related nephrotoxicity, including acute renal failure that becomes more prolonged and severe with repeated courses of the drug. Renal toxicity typically begins during the second week after a dose of cisplatin for injection. Patients with baseline renal impairment, geriatric patients, patients who are taking other nephrotoxic drugs, or patients who are not well hydrated may be more susceptible to nephrotoxicity [see Use in Specific Populations (8.5, 8.6)].

Ensure adequate hydration before, during, and after cisplatin for injection administration [see Dosage and Administration (2.1)]. Measure serum creatinine, blood urea nitrogen, creatinine clearance, and serum electrolytes including magnesium prior to initiating therapy, and as clinically indicated. Consider magnesium supplementation as clinically needed.

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 (2.5)].

5.2 Peripheral Neuropathy

Cisplatin for injection can cause dose-related peripheral neuropathy that becomes more severe with repeated courses of the drug. Neurologic symptoms have been reported to occur after a single dose. Neuropathy can also have a delayed onset from 3 to 8 weeks after the last dose of cisplatin for injection. Manifestations include paresthesias in a stocking-glove distribution, areflexia, and loss of proprioception and vibratory sensation. The neuropathy may progress further even after stopping treatment. Peripheral neuropathy may be irreversible in some patients.

Perform a neurological examination before initiating cisplatin for injection, at appropriate intervals during therapy, and after completion of therapy. Consider discontinuation of cisplatin for injection for patients who develop symptomatic peripheral neuropathy. Geriatric patients may be more susceptible to peripheral neuropathy [see Use in Specific Populations (8.5)].

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