CISPLATIN injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

BluePoint Laboratories

INN (International Name):

CISPLATIN

Composition:

CISPLATIN 1 mg in 1 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 teratogenicity. A published study in mice showed placental transfer of cisplatin increased with placenta maturation. The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. Risk Summary Limited data from published literature report the presence of cisplatin in human milk in low amounts. Because of the potential for serious adverse reactions from cisplatin injection in a breastfed child and because of the potential for tumorigenicity shown for cisplatin injection, advise lactating women not to breastfeed during treatment with cisplatin injection. Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiation of cisplatin injection. Contraception Females Cisplatin injection can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1)] . Advise females of reproductive potential to use effective contraception during treatment and for 14 months following the last dose of cisplatin injection. Males Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 11 months after the last dose of cisplatin injection. Infertility Females The use of cisplatin has been associated with cumulative dose-dependent ovarian failure, premature menopause, and reduced fertility. Males The use of cisplatin has been associated with a cumulative dose-dependent impairment of spermatogenesis (oligospermia, azoospermia; possibly irreversible) and reduced fertility. Ototoxic effects may be more severe and detrimental in pediatric patients receiving cisplatin injection, particularly in patients less than 5 years of age. Consider audiometric and vestibular function monitoring in all patients receiving cisplatin injection. The prevalence of hearing loss in pediatric patients is particularly high and is estimated to be 40% to 60%. Earlier detection of hearing loss can limit the potential impact of hearing impairment on a pediatric patient’s cognitive and social development [see Warnings and Precautions ( 5.6)]. For the treatment of metastatic testicular tumors or advanced bladder cancer, clinical studies of cisplatin injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In four clinical trials of combination chemotherapy for advanced ovarian carcinoma, 1,484 patients received cisplatin either in combination with cyclophosphamide or with paclitaxel. Of these, 426 (29%) were older than 65 years. In these trials, age was not found to be a prognostic factor for survival. However, in a later secondary analysis for one of these trials, geriatric patients were found to have shorter survival compared with younger patients. In all four trials, geriatric patients experienced more severe neutropenia than did younger patients. Higher incidences of severe thrombocytopenia and leukopenia were also seen in geriatric patients compared with younger patients, although not in all cisplatin-containing treatment arms. In the two trials where nonhematologic toxicity was evaluated according to age, geriatric patients had a numerically higher incidence of peripheral neuropathy than did younger patients. Other reported clinical experience suggests that geriatric patients may be more susceptible to nephrotoxicity, myelosuppression, and infectious complications than are younger patients [see Warnings and Precautions ( 5.1, 5.2, 5.4)]. Cisplatin is known to be substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored. Patients with baseline renal impairment may be more susceptible to nephrotoxicity [see Warnings and Precautions ( 5.1)] . 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 prior to initiating therapy, and as clinically indicated. 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)].

Product summary:

How Supplied Cisplatin injection, USP NDC 68001-283-24—Each multiple-dose amber vial contains 50 mg/50 mL (1 mg/mL) of cisplatin USP as a clear, colorless to pale yellow, sterile aqueous solution. NDC 68001-283-33—Each multiple-dose amber vial contains 100 mg/100 mL (1 mg/mL) of cisplatin USP as a clear, colorless to pale yellow, sterile aqueous solution. The above products are multiple dose vials packaged individually per shelf pack with NDC 68001-283-27 for 50mL and NDC 68001-283-32 for 100mL. Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not refrigerate or freeze cisplatin solution since a precipitate or crystal will form. If precipitate or crystal observed inside the vial, keep it at recommended storage condition till clear solution obtained. Protect unopened 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. Handling and Disposal Cisplatin injection, USP, 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
BLUEPOINT LABORATORIES
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CISPLATIN INJECTION, USP
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CISPLATIN
INJECTION, USP.
CISPLATIN INJECTION USP, 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:
1. Advanced testicular cancer: 20 mg/m2 daily for 5 days per cycle (
2.2)
2. Advanced ovarian cancer: 75 mg/m2 to 100 mg/m2 per cycle once every
3 to 4 weeks ( 2.3)
3. Advanced bladder cancer: 50 mg/m2 to 70 mg/m2 intravenously per
cycle once every 3 to 4 weeks (
2.4)
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
Cisplatin injection USP, is multiple-dose vials containing
50 mg/