Cisplatin package insert pdf

Patients received 20 mgm 2day of cisplatin for 5 days and 80 mgm2day of etoposide or etoposide phosphate. Alimta package insert pdf alimta pemetrexed for injection. Cisplatin gains entry into tubular cells via uptake by the oct2 system on the basolateral membrane of proximal tubular cells. Bleomycin for injection, usp is provided as a sterile lyophilized powder for reconstitution containing 15 units per vial and 30 units per vial, which are intended.

Cisplatin dosing, indications, interactions, adverse effects, and more. Cisplatin hydration for outpatients chemotherapy regimen. Cisplatin is biochemically similar to bifunctional. Please refer to the full prescribing information for pembrolizumab and for carboplatin or cisplatin. Each vial of platinol contains 50 mg cisplatin, 450 mg sodium chloride, usp, and 500 mg mannitol, usp. Cellular apoptosisnecrosis develops due to endoplasmic reticuluminduced stress, mitochondrial injury pathways, and a death receptor pathway. Package insert of accord healthcares cisplatin injection. In combination therapy, cisplatin injection and cyclophosphamide are administered sequentially. The active ingredient, cisplatin, is a yellow to orange crystalline powder with the molecular formula ptcl. Information for the user cisplatin 1mgml concentrate for solution for infusion cisplatin the name of your medicine is cisplatin 1 mgml concentrate for solution for infusion but in the rest of the leaflet it will be called cisplatin injection. The parent compound, cisplatin, is excreted in the urine and accounts for % to 17% of the dose excreted within one hour after administration of 50 mgm2. The dose of cyclophosphamide when used in combination with cisplatin is 600 mgm2 iv once every 4 weeks day 1. Cisplatin for injection is a platinumbased drug indicated for the treatment of.

Etopophos has been as a single agent in clinical studies involving 206 patients with a used variety of malignancies including one hodgkins lymphomanon and in combination with cisplatin in 60 patients with smallcell lung cancer. Patients should receive appropriate hydration prior to andor after receiving cisplatin. Package insert of accord healthcares cisplatin injection, 1 mgml, 50 ml and 100 ml is enclosed in this section. Appropriate management of therapy and complications is possible only when adequate. Navelbine plus cisplatin versus vindesine plus cisplatin versus singleagent navelbine. The ratios of cisplatin to total free ultrafilterable platni um in the plasma vary consdi erably between patients and range from 0. The recommended dose of alimta when administered with. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.

Each ml conians 1 mg cisplatin ang 9 mg sodium chloride in. Cisplatin for injection has been administered at 50 mgm. Cisplatin or cisdiamminedichloroplatinumii cddp is a platinum based chemotherapy drug used to treat various types of cancers including sarcomas, some. Cisplatin is a platinumbased agent whose nephrotoxicity is thought related to the chloride in the cis position. If symptoms of serotonin syndrome occur, discontinue aloxi and initiate supportive treatment. Withhold or discontinue imfinzi to manage adverse reactions as.

Locally advanced or metastatic nonsquamous nonsmall cell lung cancer. The drug should be administered under the supervision of an experienced. Cisplatin for injection is contraindicated in patients with severe hypersensitivity to cisplatin see warnings and precautions. In general, for severe grade 3 or 4 nonhematological toxicity, except alopecia and nauseavomiting, therapy with gemcitabine for injection plus cisplatin should be held or decreased by 50% depending on the judgment of the treating physician. As a single agent, cisplatin injection should be administered at a dose of 100 mgm 2 iv per cycle once every four weeks. Peyrone in 1844 and its chemical structure was first elucidated by. Cisplatin doses usp is a sterile white powder containing cyclophosphamide monohydrate. Cisplatin for injection has been administered at 75 mgm. Each millilitre ml of solution contains 1 milligram mg of cisplatin.

Highlights of prescribing information these highlights. Cisplatin injection contains the active ingredient cisplatin. Alimta continuation maintenance therapy is a strategy to extend overall survival os by treating patients with advanced nonsquamous nsclc who maintained stable disease or responded to alimtacisplatin initial therapy. Presentations 10 ml 25 ml 50 ml 100 ml amount of cisplatin 10 mg 25 mg 50 mg 100 mg. Platinol cisplatin for injection, usp should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Platinol cisplatin for injection, usp should be administered under the supervision.

Patients should be informed of the increased risk of serotonin syndrome, especially if aloxi is used concomitantly with other serotonergic drugs see drug interactions 7, patient counseling information 17. In combination therapy, cisplatin and cyclophosphamide are administered sequentially. In order to for patients to be treated as a day case, the regimens have been modified as follows. Higher doses of cisplatin are being given in daycare, increasing the strain on the chemotherapy suites and pharmacy. Cisplatin for injectioncan cause doserelated nephrotoxicity, including acute renal failure that becomes more prolonged and severe with repeated courses of the drug. The clinical formulation is supplied in a sterile form for intravenous use only. Cisplatin hydration guidelines for outpatients introduction there is increasing demand to treat more patients as outpatients.

It is freely soluble in water, soluble in methanol, and slightly soluble in ethanol. Cisplatin does not undergo the instantaneous and reversible binding to plasma proteins that is characteristic of normal drug. Docetaxel plus cisplatin has not been compared with cisplatin plus fluorouracil in a randomized phase iii trial. Other doses and combination regimens have been used. See full prescribing information for complete boxed warning. Cisplatin injection prescribing information getwell oncology. Cisplatin fda prescribing information, side effects and uses. The incidence of fatal vtes was similar between arms 0. Structured product labelling of accord healthcares cisplatin injection, 1 mgml, 50 ml and 100 ml is enclosed in this section.

Refer to clinical performance evaluation uc section below for kn052 study details. The mean renal clearance of cisplatin exceeds creatinine clearance and is 62 and. Dosage and administration, combination use with cisplatin 2. In a large european clinical trial, 612 patients with stage iii or iv nsclc, no prior chemotherapy, and who performance status of 0, 1, or 2 were randomized to. Cumulative renal toxicity associated with cisplatin is severe. Nonsmall cell lung cancer the recommended dose of alimta is 500 mgm. Bleomycin for injection, usp is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of streptomyces verticillus. Treatment of squamous cell carcinoma of the head and. The substitution of carboplatin for cisplatin simplifies administration and prevention and treatment of chemotherapyinduced nausea and vomiting in adults view in chinese. For directions for the administration of cyclophosphamide, refer to the cyclophosphamide package insert. Cisplatin injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. In study 1, the incidence of vte was 9% in patients receiving portrazza plus gemcitabine and cisplatin versus 5% in patients receiving gemcitabine and cisplatin alone and the incidence of grade 3 or higher vte was 5% versus 3%, respectively. This medicine is presented in amber glass containers called vials.