CISPLATIN injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CISPLATIN (UNII: Q20Q21Q62J) (CISPLATIN - UNII:Q20Q21Q62J)

Available from:

Teva Parenteral Medicines, Inc.

INN (International Name):

CISPLATIN

Composition:

CISPLATIN 50 mg in 50 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cisplatin Injection is indicated for the treatment of advanced testicular cancer. Cisplatin Injection is indicated for the treatment of advanced ovarian cancer. Cisplatin Injection is indicated for the treatment of advanced bladder cancer. Cisplatin Injection is contraindicated in patients with severe hypersensitivity to cisplatin [see Warnings and Precautions (5.4)] . Risk Summary Based on human data from published literature, Cisplatin Injection can cause fetal harm when administered to pregnant women. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Data demonstrates transplacental transfer of cisplatin. Exposure of pregnant women to cisplatin-containing chemotherapy has been associated with oligohydramnios, intrauterine growth restriction, and preterm birth. Cases of neonatal acute respiratory distress syndrome, cytopenias, and hearing loss have been reported. Cisplatin Injection administration to animals during and after organogenesis resulted in teratogenicit

Product summary:

How Supplied Cisplatin Injection, is a clear, light yellow sterile aqueous solution, for intravenous use, supplied as below. NDC Numbers Strengths Size 0703-5747-11 50 mg/50 mL (1 mg/mL) 50 mL Multiple-Dose vial 0703-5748-11 100 mg/100 mL (1 mg/mL) 100 mL Multiple-Dose vial Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not refrigerate. Protect container from light. The cisplatin remaining in the amber vial following initial entry is stable for 28 days protected from light or for 7 days under fluorescent room light. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Handling and Disposal Cisplatin Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CISPLATIN- CISPLATIN INJECTION, SOLUTION
TEVA PARENTERAL MEDICINES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CISPLATIN INJECTION
SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR CISPLATIN INJECTION.
CISPLATIN INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1978
WARNING: NEPHROTOXICITY, PERIPHERAL NEUROPATHY, NAUSEA AND VOMITING,
AND
MYELOSUPPRESSION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
NEPHROTOXICITY: CISPLATIN INJECTION CAN CAUSE SEVERE RENAL TOXICITY,
INCLUDING ACUTE
RENAL FAILURE. ENSURE ADEQUATE HYDRATION. CONSIDER DOSE REDUCTIONS OR
ALTERNATIVE
TREATMENTS IN PATIENTS WITH RENAL IMPAIRMENT. (2.1, 5.1)
PERIPHERAL NEUROPATHY: CISPLATIN INJECTION CAN CAUSE DOSE-RELATED
PERIPHERAL
NEUROPATHY. (5.2)
NAUSEA AND VOMITING: CISPLATIN INJECTION CAN CAUSE SEVERE NAUSEA AND
VOMITING.
PREMEDICATE WITH ANTIEMETICS. (2.1, 5.3)
MYELOSUPPRESSION: CISPLATIN INJECTION CAN CAUSE SEVERE
MYELOSUPPRESSION WITH
FATALITIES DUE TO INFECTIONS. MONITOR BLOOD COUNTS AND INTERRUPT
THERAPY ACCORDINGLY.
(5.4)
INDICATIONS AND USAGE
Cisplatin Injection is a platinum-based drug indicated for the
treatment of:
Advanced testicular cancer (1.1)
Advanced ovarian cancer (1.2)
Advanced bladder cancer (1.3)
DOSAGE AND ADMINISTRATION
Administer pre-treatment hydration and pre- and post-treatment
antiemetics. (2.1)
Cisplatin Injection has been administered intravenously at:
Advanced testicular cancer: 20 mg/m daily for 5 days per cycle (2.2)
Advanced ovarian cancer: 75 mg/m to 100 mg/m per cycle once every 3 to
4 weeks (2.3)
Advanced bladder cancer: 50 mg/m to 70 mg/m intravenously per cycle
once every 3 to 4 weeks
(2.4)
Refer to current treatment guidelines for specific dosing information.
Administer by slow intravenous infusion. Avoid contact of Cisplatin
Injection with aluminum parts. (2.6)
DOSAGE FORMS AND STRENGTHS
Injection: 50 mg/50 mL (1 mg/mL) and 100 mg/100 mL (1 mg/mL) in
Multiple-Dose vials (3)
CONTRAINDICATIONS
Severe