Cisplatin

CISPLATIN- cisplatin injection
BluePoint Laboratories

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

Nephrotoxicity: cisplatin 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 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 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 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 injection is indicated for the treatment of advanced testicular cancer.

1.2 Advanced Ovarian Cancer

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

1.3 Advanced Bladder Cancer

Cisplatin 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 injection must receive appropriate pre-treatment hydration. Maintain adequate hydration and urinary output for 24 hours after cisplatin 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 injection has been administered at 20 mg/m 2 intravenously daily for 5 days per cycle. Other doses and combination regimens have been used.

2.3 Advanced Ovarian Cancer

Cisplatin injection has been administered at 75 mg/m 2 to 100 mg/m 2 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 injection has been administered at 50 mg/m 2 to 70 mg/m 2 intravenously per cycle once every 3 to 4 weeks. For heavily pretreated patients, an initial dose of 50 mg/m 2 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 injection during preparation or administration. Aluminum reacts with cisplatin injection, causing precipitate formation and a loss of potency.

Cisplatin injection is a cytotoxic drug. Follow applicable special handling and disposable procedures. 1

Instructions for Preparation

The aqueous solution should be used intravenously only and should be administered by IV infusion over a 6- to 8-hour period (see DOSAGE AND ADMINISTRATION).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

NOTE TO PHARMACIST: Exercise caution to prevent inadvertent cisplatin overdosage. Please call prescriber if dose is greater than 100 mg/m 2 per cycle. Aluminum flip-off seal of vial have been imprinted with the following statement:
CALL DR. IF DOSE > 100 MG/M 2 /CYCLE.

Administration

Administer cisplatin injection by slow intravenous infusion.

3 DOSAGE FORMS AND STRENGTHS

Cisplatin injection, is a clear, colorless to pale yellow, sterile aqueous solution available in sterilie multiple-dose vials containing

50 mg/50 mL (1 mg/mL)
100 mg/100 mL (1 mg/mL)

4 CONTRAINDICATIONS

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

5 WARNINGS AND PRECAUTIONS

5.1 Nephrotoxicity

Cisplatin 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 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 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 injection for patients with baseline renal impairment or who develop significant reductions in creatinine clearance during treatment with cisplatin injection according to clinical treatment guidelines [see Dosage and Administration( 2.5)].

5.2 Peripheral Neuropathy

Cisplatin 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 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 injection, at appropriate intervals during therapy, and after completion of therapy. Consider discontinuation of cisplatin 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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