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Platinol (Cisplatin) - Summary



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 WARNINGS and ADVERSE REACTIONS).

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.

See all Platinol indications & dosage >>


Media Articles Related to Platinol (Cisplatin)

CK5 marks cisplatin-resistant ovarian cancer
Source: Breast Cancer News From Medical News Today [2015.11.05]
A University of Colorado Cancer Center study recently published in the International Journal of Gynecological Cancer shows that protein cytokeratin 5 (CK5), known to be a marker of poor prognosis in...

Chemotherapy-induced hearing loss affects cognition in pediatric brain tumor survivors
Source: Hearing / Deafness News From Medical News Today [2015.11.05]
More children are surviving malignant brain tumors than in the past, thanks to the use of intense treatments using platinum-based chemotherapy (cisplatin and high-dose carboplatin).

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.

more news >>

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). [2015]
cancer... CONCLUSIONS: Addition of bevacizumab to capecitabine-cisplatin in Chinese

The protective effect of theophyline in cisplatin nephrotoxicity. [2014]
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. [2014]
(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. [2014]
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. [2013]
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.

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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]
Primary Objective: 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. Secondary Objective: 1. To assess the safety profile of irinotecan and cisplatin in untreated patients with metastatic or unresectable high grade neuroendocrine carcinoma of the gastrointestinal tract.

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]
Primary Objective:

- To determine the maximum tolerated dose of the combination of cisplatin, imatinib

mesylate, and pemetrexed in metastatic malignant mesothelioma. Secondary Objectives:

- 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.

more trials >>

Page last updated: 2015-11-05

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