PLATINOL (cisplatin for injection, USP) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.
Cumulative renal toxicity associated with PLATINOL is severe. Other major dose-related toxicities are myelosuppression, nausea, and vomiting.
Ototoxicity, which may be more pronounced in children, and is manifested by tinnitus, and/or loss of high frequency hearing and occasionally deafness, is significant.
Anaphylactic-like reactions to PLATINOL have been reported. Facial edema, bronchoconstriction, tachycardia, and hypotension may occur within minutes of PLATINOL administration. Epinephrine, corticosteroids, and antihistamines have been effectively employed to alleviate symptoms (see
Exercise caution to prevent inadvertent PLATINOL overdose. Doses greater than 100 mg/m2/cycle once every 3 to 4 weeks are rarely used. Care must be taken to avoid inadvertent PLATINOL overdose due to confusion with PARAPLATIN® (carboplatin) or prescribing practices that fail to differentiate daily doses from total dose per cycle.
PLATINOL® (cisplatin for injection, USP) is a white to light yellow lyophilized powder. Each vial of PLATINOL contains 50 mg cisplatin, 450 mg Sodium Chloride, USP, and 500 mg Mannitol, USP.
The active ingredient, cisplatin, is a yellow to orange crystalline powder with the molecular formula PtCl2H6N2, and a molecular weight of 300.1. Cisplatin is a heavy metal complex containing a central atom of platinum surrounded by two chloride atoms and two ammonia molecules in the cis position. It is soluble in water or saline at 1 mg/mL and in dimethylformamide at 24 mg/mL. It has a melting point of 207° C.
PLATINOL (cisplatin for injection, USP) is indicated as therapy to be employed as follows:
Metastatic Testicular Tumors
In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures.
Metastatic Ovarian Tumors
In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of PLATINOL and cyclophosphamide. PLATINOL, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received PLATINOL therapy.
Advanced Bladder Cancer
PLATINOL is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments, such as surgery and/or radiotherapy.
Media Articles Related to Platinol (Cisplatin)
Lung Cancer: Expanded Alimta Label
Source: MedPage Today Product Alert [2012.10.19]
WASHINGTON -- The FDA has expanded the indication for the cancer drug pemetrexed injection to act as a maintenance therapy with cisplatin for nonsquamous non-small cell lung cancer.
Published Studies Related to Platinol (Cisplatin)
Bevacizumab plus capecitabine and cisplatin in Chinese patients with inoperable
locally advanced or metastatic gastric or gastroesophageal junction cancer:
randomized, double-blind, phase III study (AVATAR study). 
cancer... CONCLUSIONS: Addition of bevacizumab to capecitabine-cisplatin in Chinese
The protective effect of theophyline in cisplatin nephrotoxicity. 
Cisplatin is a potent and a major anti-neoplastic drug in the treatment of a
broad spectrum of malignancies. However, its clinical use is limited by renal
tubular dysfunction that occurs in a significant percent of patients...
Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and
vomiting following high-dose cisplatin in Chinese patients: a randomized,
double-blind, placebo-controlled phase III trial. 
(HEC) in Asian countries... CONCLUSIONS: The addition of aprepitant to standard antiemetic treatment regimens
Simvastatin plus capecitabine-cisplatin versus placebo plus
capecitabine-cisplatin in patients with previously untreated advanced gastric
cancer: a double-blind randomised phase 3 study. 
patients with previously untreated advanced gastric cancer (AGC)... CONCLUSIONS: Addition of 40 mg simvastatin to XP does not increase PFS in our
Protective effect of selenium on cisplatin induced nephrotoxicity: A double-blind
controlled randomized clinical trial. 
BACKGROUND: Renal injury is common following cisplatin infusion... Conclusions :selenium could probably prevent cisplatin-induced acute kidney
injury, when it is added to hydration therapy in cancerous patients.
Clinical Trials Related to Platinol (Cisplatin)
Induction Study of Cisplatin, Docetaxel, and Nintedanib Stage IB-IIIA Non-Small Cell Lung Cancer (NCLC) [Recruiting]
The goal of this clinical research study is to learn if it is safe to give nintedanib in
combination with cisplatin and docetaxel before surgery to patients with NSCLC. Researchers
also want to learn if the drug combination can help to control NSCLC before surgery.
Irinotecan and Cisplatin for High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract [Completed]
1. Assess the clinical activity defined by response rate of irinotecan and cisplatin in
untreated patients with metastatic or unresectable high grade neuroendocrine carcinoma of
the gastrointestinal tract.
1. To assess the safety profile of irinotecan and cisplatin in untreated patients with
metastatic or unresectable high grade neuroendocrine carcinoma of the gastrointestinal
Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers [Recruiting]
The goal of this clinical research study is to learn if adding abraxane (nab-paclitaxel) to
gemcitabine and cisplatin can help to control metastatic or unresectable biliary cancer. The
safety of this drug combination will also be studied.
Cisplatin, Pemetrexed, and Imatinib Mesylate in Malignant Mesothelioma [Completed]
- To determine the maximum tolerated dose of the combination of cisplatin, imatinib
mesylate, and pemetrexed in metastatic malignant mesothelioma.
- To explore the biologic effects of cisplatin, imatinib mesylate, and pemetrexed on
tumor tissue by:
- histologic analysis of biopsy tissue
- by non-invasive assessments of tumor vascularity performed before, during and after
- electron microscopy analysis of endothelial cell architecture after patient treatment
with imatinib mesylate
- To explore the effects of cisplatin, imatinib mesylate, and pemetrexed on surrogate
markers in serum.
- To assess the rate of response to therapy.
- To determine the doses of the combination regimen of cisplatin, imatinib mesylate, and
pemetrexed that enables de-phosphorylation of platelet derived growth factor receptor
(PDGF-R) on malignant mesothelioma tumor cells.
- To determine the pharmacokinetic interaction between agents in this combination
Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury [Recruiting]
Cisplatin is a potent chemotherapeutic agent, however, its nephrotoxicity manifested by
acute kidney injury (AKI) often limits applicability. Dipeptidylpeptidase-4 (DPP4)
inhibitors are well known to improve glucose intolerance by augmentation of endogenous
glucagon like peptide (GLP-1) and glucose-dependent insulinotropic peptide (GIP). DPP4
inhibitor also has the potential anti-apoptotic and renoprotective effect in a mouse model
of cisplatin-induced AKI. This is a single-center, randomized, double-blind, parallel-group,
placebo-controlled, prospective study to investigate the renoprotective effect of DPP4
inhibitor on cisplatin-induced AKI. A total 182 patients, who are scheduled to treat with
cisplatin, will be recruited and randomly assigned to either Gemigliptin or placebo groups.
Subjects will take study drugs for 8 days starting from one day before cisplatin treatment.
Serum creatinine (Cr) and estimated glomerular filtration rate (eGFR) will be measured at 7
days after cisplatin treatment.
Page last updated: 2015-08-10