"],"drug_interactions":["Drug Interactions Plasma levels of anticonvulsant agents may become subtherapeutic during cisplatin therapy. In a randomized trial in advanced ovarian cancer, response duration was adversely affected when pyridoxine was used in combination with altretamine (hexamethylmelamine) and cisplatin."],"how_supplied_table":["
NDC
CISplatin Injection (1 mg per mL)
Package Factor
25021-253-50
50 mg per 50 mL Multi-Dose Vial
1 vial per carton
25021-253-51
100 mg per 100 mL Multi-Dose Vial
1 vial per carton
"],"storage_and_handling":["Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate. Protect from light. Sterile, Nonpyrogenic, Preservative-free. This container closure is not made with natural rubber latex."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Plasma concentrations of the parent compound, cisplatin, decay monoexponentially with a half-life of about 20 to 30 minutes following bolus administrations of 50 or 100 mg/m 2 doses. Monoexponential decay and plasma half-lives of about 0.5 hour are also seen following 2 hour or 7 hour infusions of 100 mg/m 2 . After the latter, the total-body clearances and volumes of distribution at steady-state for cisplatin are about 15 to 16 L/h/m 2 and 11 to 12 L/m 2 . Due to its unique chemical structure, the chlorine atoms of cisplatin are more subject to chemical displacement reactions by nucleophiles, such as water or sulfhydryl groups, than to enzyme-catalyzed metabolism. At physiological pH in the presence of 0.1M NaCl, the predominant molecular species are cisplatin and monohydroxymonochloro cis -diammine platinum (II) in nearly equal concentrations. The latter, combined with the possible direct displacement of the chlorine atoms by sulfhydryl groups of amino acids or proteins, accounts for the instability of cisplatin in biological matrices. The ratios of cisplatin to total free (ultrafilterable) platinum in the plasma vary considerably between patients and range from 0.5 to 1.1 after a dose of 100 mg/m 2 . Cisplatin does not undergo the instantaneous and reversible binding to plasma proteins that is characteristic of normal drug-protein binding. However, the platinum from cisplatin, but not cisplatin itself, becomes bound to several plasma proteins, including albumin, transferrin, and gamma globulin. Three hours after a bolus injection and two hours after the end of a three hour infusion, 90% of the plasma platinum is protein bound. The complexes between albumin and the platinum from cisplatin do not dissociate to a significant extent and are slowly eliminated with a minimum half-life of five days or more. Following cisplatin doses of 20 to 120 mg/m 2 , the concentrations of platinum are highest in liver, prostate, and kidney; somewhat lower in bladder, muscle, testicle, pancreas, and spleen; and lowest in bowel, adrenal, heart, lung, cerebrum, and cerebellum. Platinum is present in tissues for as long as 180 days after the last administration. With the exception of intracerebral tumors, platinum concentrations in tumors are generally somewhat lower than the concentrations in the organ where the tumor is located. Different metastatic sites in the same patient may have different platinum concentrations. Hepatic metastases have the highest platinum concentrations, but these are similar to the platinum concentrations in normal liver. Maximum red blood cell concentrations of platinum are reached within 90 to 150 minutes after a 100 mg/m 2 dose of cisplatin and decline in a biphasic manner with a terminal half-life of 36 to 47 days. Over a dose range of 40 to 140 mg cisplatin/m 2 given as a bolus injection or as infusions varying in length from 1 hour to 24 hours, from 10% to about 40% of the administered platinum is excreted in the urine in 24 hours. Over five days following administration of 40 to 100 mg/m 2 doses given as rapid, 2 hour to 3 hour, or 6 hour to 8 hour infusions, a mean of 35% to 51% of the dosed platinum is excreted in the urine. Similar mean urinary recoveries of platinum of about 14% to 30% of the dose are found following five daily administrations of 20, 30, or 40 mg/m 2 /day. Only a small percentage of the administered platinum is excreted beyond 24 hours post-infusion and most of the platinum excreted in the urine in 24 hours is excreted within the first few hours. Platinum-containing species excreted in the urine are the same as those found following the incubation of cisplatin with urine from healthy subjects, except that the proportions are different. The parent compound, cisplatin, is excreted in the urine and accounts for 13% to 17% of the dose excreted within one hour after administration of 50 mg/m 2 . The mean renal clearance of cisplatin exceeds creatinine clearance and is 62 and 50 mL/min/m 2 following administration of 100 mg/m 2 as 2 hour or 6 hour to 7 hour infusions, respectively. The renal clearance of free (ultrafilterable) platinum also exceeds the glomerular filtration rate indicating that cisplatin or other platinum-containing molecules are actively secreted by the kidneys. The renal clearance of free platinum is nonlinear and variable and is dependent on dose, urine flow rate, and individual variability in the extent of active secretion and possible tubular reabsorption. There is a potential for accumulation of ultrafilterable platinum plasma concentrations whenever cisplatin is administered on a daily basis but not when dosed on an intermittent basis. No significant relationships exist between the renal clearance of either free platinum or cisplatin and creatinine clearance. Although small amounts of platinum are present in the bile and large intestine after administration of cisplatin, the fecal excretion of platinum appears to be insignificant."],"indications_and_usage":["INDICATIONS AND USAGE Cisplatin Injection 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 radio therapeutic 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 cisplatin and cyclophosphamide. Cisplatin Injection, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received Cisplatin Injection therapy. Advanced Bladder Cancer Cisplatin Injection 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."],"spl_unclassified_section":["SAGENT ® Rx only","OTHER TOXICITIES Vascular toxicities coincident with the use of cisplatin in combination with other antineoplastic agents have been reported. The events are clinically heterogeneous and may include myocardial infarction, cerebrovascular accident, thrombotic microangiopathy (hemolytic-uremic syndrome [HUS]), or cerebral arteritis. Various mechanisms have been proposed for these vascular complications. There are also reports of Raynaud's phenomenon occurring in patients treated with the combination of bleomycin, vinblastine with or without cisplatin. It has been suggested that hypomagnesemia developing coincident with the use of cisplatin may be an added, although not essential, factor associated with this event. However, it is currently unknown if the cause of Raynaud's phenomenon in these cases is the disease, underlying vascular compromise, bleomycin, vinblastine, hypomagnesemia, or a combination of any of these factors. Serum Electrolyte Disturbances Hypomagnesemia, hypocalcemia, hyponatremia, hypokalemia, and hypophosphatemia have been reported to occur in patients treated with cisplatin and are probably related to renal tubular damage. Tetany has been reported in those patients with hypocalcemia and hypomagnesemia. Generally, normal serum electrolyte levels are restored by administering supplemental electrolytes and discontinuing cisplatin. Inappropriate antidiuretic hormone syndrome has also been reported. Hyperuricemia Hyperuricemia has been reported to occur at approximately the same frequency as the increases in BUN and serum creatinine. It is more pronounced after doses greater than 50 mg/m 2 , and peak levels of uric acid generally occur between 3 to 5 days after the dose. Allopurinol therapy for hyperuricemia effectively reduces uric acid levels. Neurotoxicity (See WARNINGS ). Neurotoxicity, usually characterized by peripheral neuropathies, has been reported. The neuropathies usually occur after prolonged therapy (4 to 7 months); however, neurologic symptoms have been reported to occur after a single dose. Although symptoms and signs of cisplatin neuropathy usually develop during treatment, symptoms of neuropathy may begin 3 to 8 weeks after the last dose of cisplatin. Cisplatin therapy should be discontinued when the symptoms are first observed. The neuropathy, however, may progress further even after stopping treatment. Preliminary evidence suggests peripheral neuropathy may be irreversible in some patients. Elderly patients may be more susceptible to peripheral neuropathy (see PRECAUTIONS, Geriatric Use ). Lhermitte's sign, dorsal column myelopathy, and autonomic neuropathy have also been reported. Loss of taste, seizures, leukoencephalopathy, and reversible posterior leukoencephalopathy syndrome (RPLS) have also been reported. Muscle cramps, defined as localized, painful, involuntary skeletal muscle contractions of sudden onset and short duration, have been reported and were usually associated in patients receiving a relatively high cumulative dose of cisplatin and with a relatively advanced symptomatic stage of peripheral neuropathy. Ocular Toxicity Optic neuritis, papilledema, and cerebral blindness have been reported in patients receiving standard recommended doses of cisplatin. Improvement and/or total recovery usually occurs after discontinuing cisplatin. Steroids with or without mannitol have been used; however, efficacy has not been established. Blurred vision and altered color perception have been reported after the use of regimens with higher doses of cisplatin or greater dose frequencies than recommended in the package insert. The altered color perception manifests as a loss of color discrimination, particularly in the blue-yellow axis. The only finding on funduscopic exam is irregular retinal pigmentation of the macular area. Anaphylactic-Like Reactions Anaphylactic-like reactions have been reported in patients previously exposed to cisplatin. The reactions consist of facial edema, wheezing, tachycardia, and hypotension within a few minutes of drug administration. Reactions may be controlled by intravenous epinephrine with corticosteroids and/or antihistamines as indicated. Patients receiving cisplatin should be observed carefully for possible anaphylactic-like reactions and supportive equipment and medication should be available to treat such a complication. Hepatotoxicity Transient elevations of liver enzymes, especially SGOT, as well as bilirubin, have been reported to be associated with cisplatin administration at the recommended doses. Other Events Cardiac abnormalities, hiccups, elevated serum amylase, rash, alopecia, malaise, asthenia, and dehydration have been reported. Local soft tissue toxicity has been reported following extravasation of cisplatin. Severity of the local tissue toxicity appears to be related to the concentration of the cisplatin solution. Infusion of solutions with a cisplatin concentration greater than 0.5 mg/mL may result in tissue cellulitis, fibrosis, necrosis, pain, edema, and erythema.","Preparation of Intravenous Solutions Preparation Precautions Caution should be exercised in handling the aqueous solution. Procedures for proper handling and disposal of anticancer drugs should be utilized. Several guidelines on this subject have been published. 1-4 To minimize the risk of dermal exposure, always wear impervious gloves when handling vials and IV sets containing cisplatin. Skin reactions associated with accidental exposure to cisplatin may occur. The use of gloves is recommended. If cisplatin contacts the skin or mucosa, immediately and thoroughly wash the skin with soap and water and flush the mucosa with water. More information is available in the references listed below. Instructions for Preparation The aqueous solution should be used intravenously only and should be administered by IV infusion over a 6 hour 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 and flip-off seal of vial have been imprinted with the following statement: CALL DR. IF DOSE > 100 MG/M 2 /CYCLE. Stability Cisplatin is a sterile, multiple dose vial without preservatives. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate. 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."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Cisplatin is administered by slow intravenous infusion. CISPLATIN SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION. Note: Needles or intravenous sets containing aluminum parts that may come in contact with cisplatin should not be used for preparation or administration. Aluminum reacts with cisplatin, causing precipitate formation and a loss of potency. Metastatic Testicular Tumors The usual cisplatin dose for the treatment of testicular cancer in combination with other approved chemotherapeutic agents is 20 mg/m 2 IV daily for 5 days per cycle. Metastatic Ovarian Tumors The usual cisplatin dose for the treatment of metastatic ovarian tumors in combination with cyclophosphamide is 75 to 100 mg/m 2 IV per cycle once every 4 weeks (DAY 1). The dose of cyclophosphamide when used in combination with cisplatin is 600 mg/m 2 IV once every 4 weeks (DAY 1). For directions for the administration of cyclophosphamide, refer to the cyclophosphamide package insert. In combination therapy, cisplatin and cyclophosphamide are administered sequentially. As a single agent, cisplatin should be administered at a dose of 100 mg/m 2 IV per cycle once every 4 weeks. Advanced Bladder Cancer Cisplatin should be administered as a single agent at a dose of 50 to 70 mg/m 2 IV per cycle once every 3 to 4 weeks depending on the extent of prior exposure to radiation therapy and/or prior chemotherapy. For heavily pretreated patients an initial dose of 50 mg/m 2 per cycle repeated every 4 weeks is recommended. All Patients Pretreatment hydration with 1 to 2 liters of fluid infused for 8 to 12 hours prior to a cisplatin dose is recommended. The drug is then diluted in 2 liters of 5% Dextrose in 1/2 or 1/3 normal saline containing 37.5 g of mannitol, and infused over a 6 hour to 8 hour period. If diluted solution is not to be used within 6 hours, protect solution from light. Do not dilute cisplatin in just 5% Dextrose Injection. Adequate hydration and urinary output must be maintained during the following 24 hours. A repeat course of cisplatin should not be given until the serum creatinine is below 1.5 mg/100 mL, and/or the BUN is below 25 mg/100 mL. A repeat course should not be given until circulating blood elements are at an acceptable level (platelets ≥ 100,000/mm 3 , WBC ≥ 4,000/mm 3 ). Subsequent doses of cisplatin should not be given until an audiometric analysis indicates that auditory acuity is within normal limits."],"spl_product_data_elements":["Cisplatin Cisplatin Cisplatin Cisplatin Sodium Chloride Hydrochloric Acid Sodium Hydroxide"],"package_label_principal_display_panel":["PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label NDC 25021-253-50 Rx only Cisplatin Injection 50 mg per 50 mL (1 mg per mL) Cisplatin doses greater than 100 mg/m 2 once every 3 to 4 weeks are rarely used. See package insert. Caution: Cytotoxic Agent 50 mL Multi-Dose Vial For Intravenous Use PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label","PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sticker Label PLACE ON DRUG CONTAINER PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sticker Label"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility (See WARNINGS )."]},"tags":[{"label":"Platinum-based Drug","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"D(3) dopamine receptor","category":"target"},{"label":"DRD3","category":"gene"},{"label":"ADORA3","category":"gene"},{"label":"EGFR","category":"gene"},{"label":"L01XA01","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Invasive Bladder Malignancy","category":"indication"},{"label":"Malignant tumor of ovary","category":"indication"},{"label":"Ovarian Germ Cell Tumor Carcinoma","category":"indication"},{"label":"Testicular Germ Cell Tumor","category":"indication"},{"label":"Hq Spclt Pharma","category":"company"},{"label":"Approved 1970s","category":"decade"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Cross-Linking Reagents","category":"pharmacology"},{"label":"Indicators and Reagents","category":"pharmacology"},{"label":"Radiation-Sensitizing Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":["WARNING Cisplatin 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 cisplatin 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 cisplatin have been reported. Facial edema, bronchoconstriction, tachycardia, and hypotension may occur within minutes of cisplatin administration. Epinephrine, corticosteroids, and antihistamines have been effectively employed to alleviate symptoms (see WARNINGS and ADVERSE REACTIONS ). Exercise caution to prevent inadvertent cisplatin overdose . Doses greater than 100 mg/m 2 /cycle once every 3 to 4 weeks are rarely used. Care must be taken to avoid inadvertent cisplatin overdose due to confusion with carboplatin or prescribing practices that fail to differentiate daily doses from total dose per cycle."],"safetySignals":[{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"5580 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"5291 reports"},{"date":"","signal":"NEUTROPENIA","source":"FDA FAERS","actionTaken":"4711 reports"},{"date":"","signal":"DISEASE PROGRESSION","source":"FDA FAERS","actionTaken":"4530 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"4447 reports"},{"date":"","signal":"FEBRILE NEUTROPENIA","source":"FDA FAERS","actionTaken":"4405 reports"},{"date":"","signal":"ANAEMIA","source":"FDA FAERS","actionTaken":"3878 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"3680 reports"},{"date":"","signal":"THROMBOCYTOPENIA","source":"FDA FAERS","actionTaken":"3653 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"3314 reports"}],"drugInteractions":[{"url":"/drug/darunavir","drug":"darunavir","action":"Avoid combination","effect":"May interact with Darunavir","source":"DrugCentral","drugSlug":"darunavir"}],"commonSideEffects":[{"effect":"Nephrotoxicity","drugRate":"28% to 36%","severity":"serious","_validated":true},{"effect":"Ototoxicity","drugRate":"up to 31%","severity":"serious","_validated":true},{"effect":"Myelosuppression","drugRate":"25% to 30%","severity":"serious","_validated":true},{"effect":"Hearing loss","drugRate":"40 to 60%","severity":"serious","_validated":true},{"effect":"Leukopenia","drugRate":"reported","severity":"unknown"},{"effect":"Thrombocytopenia","drugRate":"reported","severity":"unknown"},{"effect":"Anemia","drugRate":"reported","severity":"unknown"},{"effect":"Nausea","drugRate":"reported","severity":"unknown"},{"effect":"Vomiting","drugRate":"reported","severity":"unknown"},{"effect":"Diarrhea","drugRate":"reported","severity":"unknown"}],"specialPopulations":{"Lactation":"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 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":"Cisplatin Injection can cause fetal harm when administered to pregnant women. Advise pregnant women and females of reproductive potential of the potential risk to 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. 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% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.","Geriatric use":"Insufficient data are available from clinical trials of cisplatin in the treatment of metastatic testicular tumors or advanced bladder cancer to determine whether elderly patients respond differently than younger patients. In four clinical trials of combination chemotherapy for advanced ovarian carcinoma, 1484 patients received cisplatin either in combination with cyclophosphamide or paclitaxel. Of these, 426 (29%) were older than 65 years. In these trials, age was not found to be","Paediatric use":"Safety and effectiveness in pediatric patients have not been established. All children should have audiometric monitoring performed prior to initiation of therapy, prior to each subsequent dose, and for several years post therapy. Advanced testing methods may allow for earlier detection of hearing loss in an attempt to facilitate the rapid initiation of interventions that can limit the potential adverse impact of hearing impairment on child's cognitive and social development."}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=cisplatin","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:45:17.432507+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Cisplatin","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:45:28.422671+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:45:26.853511+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-19T23:45:16.548803+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=cisplatin","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:45:27.351344+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:45:10.468986+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:45:10.469017+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (boxed_warning)","rawText":"WARNING Cisplatin 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 cisplatin is severe. Other major dose-related toxicities are myelosuppression, nausea, and vomiting. Ototoxicity, which may be more pronounced in children, and is manifes","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:45:10.469023+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T23:45:28.863371+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL197201/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:45:28.072234+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA207323","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:45:10.469027+00:00"}},"allNames":"platinol-aq","offLabel":[],"synonyms":["cisplatin","platinum diamminodichloride","cis-Platinum"],"timeline":[{"date":"1978-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from HQ SPCLT PHARMA to Hq Spclt Pharma"},{"date":"1978-12-19","type":"positive","source":"DrugCentral","milestone":"FDA approval (Hq Spclt Pharma)"},{"date":"2012-04-18","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 6 manufacturers approved"}],"approvals":[{"date":"1978-12-19","orphan":false,"company":"HQ SPCLT PHARMA","regulator":"FDA"}],"brandName":"Platinol-Aq","ecosystem":[{"indication":"Invasive Bladder Malignancy","otherDrugs":[{"name":"doxorubicin","slug":"doxorubicin","company":""}],"globalPrevalence":null},{"indication":"Malignant tumor of ovary","otherDrugs":[{"name":"altretamine","slug":"altretamine","company":"Eisai Inc"},{"name":"carboplatin","slug":"carboplatin","company":""},{"name":"doxorubicin","slug":"doxorubicin","company":""},{"name":"gemcitabine","slug":"gemcitabine","company":"Lilly"}],"globalPrevalence":null},{"indication":"Ovarian Germ Cell Tumor Carcinoma","otherDrugs":[],"globalPrevalence":null},{"indication":"Testicular Germ Cell Tumor","otherDrugs":[{"name":"bleomycin","slug":"bleomycin","company":"Bristol Myers Squibb"},{"name":"ifosfamide","slug":"ifosfamide","company":"Baxter Hlthcare"},{"name":"mesna","slug":"mesna","company":"Baxter Hlthcare"}],"globalPrevalence":null}],"mechanism":{"target":"D(3) dopamine receptor","novelty":"Follow-on","targets":[{"gene":"DRD3","source":"DrugCentral","target":"D(3) dopamine receptor","protein":"D(3) dopamine receptor"},{"gene":"ADORA3","source":"DrugCentral","target":"Adenosine receptor A3","protein":"Adenosine receptor A3"},{"gene":"EGFR","source":"DrugCentral","target":"Epidermal growth factor receptor","protein":"Epidermal growth factor receptor"},{"gene":"CHRM5","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M5","protein":"Muscarinic acetylcholine receptor M5"},{"gene":"MAPK3","source":"DrugCentral","target":"Mitogen-activated protein kinase 3","protein":"Mitogen-activated protein kinase 3"},{"gene":"FYN","source":"DrugCentral","target":"Tyrosine-protein kinase Fyn","protein":"Tyrosine-protein kinase Fyn"},{"gene":"MC5R","source":"DrugCentral","target":"Melanocortin receptor 5","protein":"Melanocortin receptor 5"},{"gene":"CCR2","source":"DrugCentral","target":"C-C chemokine receptor type 2","protein":"C-C chemokine receptor type 2"},{"gene":"TBXAS1","source":"DrugCentral","target":"Thromboxane-A synthase","protein":"Thromboxane-A synthase"},{"gene":"CXCR2","source":"DrugCentral","target":"C-X-C chemokine receptor type 2","protein":"C-X-C chemokine receptor type 2"}],"modality":"Small Molecule","drugClass":"Platinum-based Drug [EPC]","explanation":"","oneSentence":"","technicalDetail":"Platinol-Aq exerts its antineoplastic effects by forming platinum-DNA adducts, which interfere with DNA replication and transcription, ultimately leading to cell death."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Cisplatin","title":"Cisplatin","extract":"Cisplatin is a chemical compound with formula cis-[Pt(NH3)2Cl2]. It is a coordination complex of platinum that is used as a chemotherapy medication used to treat a number of cancers. These include testicular cancer, ovarian cancer, cervical cancer, bladder cancer, head and neck cancer, esophageal cancer, lung cancer, mesothelioma, brain tumors and neuroblastoma. It is given by injection into a vein.","wiki_history":"== History ==\nThe compound cis-[Pt(NH3)2Cl2] was first described by Italian chemist Michele Peyrone in 1845, and known for a long time as Peyrone's salt. The structure was deduced by Alfred Werner in 1893. In 1965, Barnett Rosenberg, Van Camp et al. of Michigan State University discovered that electrolysis of platinum electrodes generated a soluble platinum complex which inhibited binary fission in Escherichia coli (E. coli) bacteria. Although bacterial cell growth continued, cell division was arrested, the bacteria growing as filaments up to 300 times their normal length. The octahedral Pt(IV) complex cis-[PtCl4(NH3)2], but not the trans isomer, was found to be effective at forcing filamentous growth of E. coli cells. The square planar Pt(II) complex, cis-[PtCl2(NH3)2] turned out to be even more effective at forcing filamentous growth. This finding led to the observation that cis-[PtCl2(NH3)2] was indeed highly effective at regressing the mass of sarcomas in rats. Confirmation of this discovery, and extension of testing to other tumour cell lines launched the medicinal applications of cisplatin. Cisplatin was approved for use in testicular and ovarian cancers by the U.S. Food and Drug Administration on 19 December 1978. and in the UK (and in several other European countries) in 1979. \nCisplatin was the first to be developed. \nIn 1983 pediatric oncologist Roger Packer began incorporating cisplatin into adjuvant chemotherapy for the treatment of childhood medulloblastoma. The new protocol that he developed led to a marked increase in disease-free survival rates for patients with medulloblastoma, up to around 85%. The Packer Protocol has since become a standard treatment for medulloblastoma. Likewise, cisplatin has been found to be particularly effective against testicular cancer, where its use improved the cure rate from 10% to 85%."},"commercial":{"launchDate":"1978","_launchSource":"DrugCentral (FDA 1978-12-19, HQ SPCLT PHARMA)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4392","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=cisplatin","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=cisplatin","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Cisplatin","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange 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