Cisplatin 1 mgml sterile concentrate summary of product. Cisplatin for injection is a sterile, lyophilized mixture of cisplatin, mannitol, and sodium chloride. In the absence of compatibility studies, this medicinal product must not be. Search the australian register of therapeutic goods.
Early breast cancer ebc the safety of the various combination chemotherapy regimens prior to herceptin therapy was not separately analyzed in the hera trial. Your dosage will be based on your medical condition, weight, and response to the. Cisplatin drug monograph pediatric care online aap. The balversa product monograph describes safety results for the 87 patients previously treated with chemotherapy, therefore rates may differ.
Alimta in combination with cisplatin is indicated for the first line treatment of patients with locally. One of the limiting side effects of cisplatin use is nephrotoxicity. Cisplatin investigated as a drug, mutagen, natural product, reproductive effector, and tumorigen. Purpose this standard operating procedure sop describes the guidelines for the use of cisplatin in rodents. Generic drug manufacturers must update their pm to ensure it aligns with the canadian reference product. To minimize cisplatin resistance, combinatorial therapies were. Discovery cisplatin and the treatment of testicular and. 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. The recommended dose of alimta when administered with cisplatin in patients with a creatinine clearance calculated by cockcroftgault equation of 45mlmin or greateris 500mgm2 as an intravenous infusion over 10minutes on day 1 of each 21day cycle until disease progression or unacceptable toxicity. The recommendations in this online publication do not indicate an exclusive course of treatment or serve as a standard of medical care. Mechanism of action cisplatin is believed to kill cancer cells by binding to dna and interfering with its repair mechanism, eventually leading to cell death. Hci andor sodium hydroxide added to adjust ph to 3.
Treatment of patients with stage iv locally advanced or metastatic transitional cell carcinoma tcc of the bladder in combination with cisplatin. Product monograph paclitaxel for injection paclitaxel 6 mg. A multicentre, randomised, open label phase 3 study of alimta versus. Eye disorders individual cases and clusters of serious ocular adverse events affecting multiple patients have been reported from unauthorized intravitreal use of avastin following variable and non. Pemetrexed in combination with cisplatin versus cisplatin monotherapy in patients with recurrent or metastatic head and neck cancer final results of a randomized. Cisplatin is a chemotherapy medication used to treat a number of cancers. Due to the fact that the information originated with an organization that is not subject to the official languages act, the document may only appear in the language in which it was written. Batch specific molecular weights may vary from batch to batch due to the degree of hydration, which will affect the solvent volumes required to prepare stock solutions. For treatment of disseminated disease, a regimen of cisplatin, bleomycin, and. These complexes are slowly eliminated with a halflife of 5 days or more.
In a phase 1 trial in which paclitaxel was administered as a 24hour infusion and cisplatin was administered as a 1mgmin infusion, myelosuppression was more profound when paclitaxel. For one of the suppliers, the active substance master file asmf procedure is. Higher doses of cisplatin are being given in daycare, increasing the strain on the chemotherapy suites and pharmacy. Cisplatin, the active ingredient in cisplatin injection, is a yellow to orange crystalline powder with the molecular formula cl 2 h 6 n 2 pt and a molecular weight of 300. Prior to use of cisplatin may also result in a decrease of etoposide total body clearance in children. Several payment sources exist for cancer drugs in ontario, depending on the drug, disease indication, and how and where it is delivered. The product monograph brand safety updates table provides updates on safety information in pms of brand name pharmaceutical drug products. Each vial of platinol contains 50 mg cisplatin, 450 mg sodium chloride, usp, and.
Cisplatin hydration for outpatients chemotherapy regimen. Platinol cisplatin for injection, usp should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. If you have questions regarding any taj pharmaceuticals ltd product or are experiencing a medical emergency, please consult your health care provider. Variations, taking into account individual circumstances, may. Cisplatin supplier cas 15663271 cddp tocris bioscience. Ondansetron oral solution product monograph page 1 of 29 product monograph ondansetron 4 mg5 ml ondansetron oral solution, usp as ondansetron hydrochloride dihydrate antiemetic 5ht 3 receptor antagonist aa pharma inc. Cisplatin injection description clinical pharmacology fda. Prcisplatin injection bp page 3of 26 cisplatin does not undergo instantaneous and reversible binding to plasma proteins characteristic of normal drugprotein binding. Twenty patients with epithelial ovarian carcinoma were treated with highdose cisplatin 200mg m2. The active substance is cisplatin, an established active substance described in the european, united states and british pharmacopoeia. Health canada is requesting that product monographs be provided in pdf format for webposting purposes. The following data is based on the product molecular weight 300. If cisplatin is used in combination therapy, the dose of cisplatin must be reduced.
Ototoxicity may be more pronounced in younger children. A typical dose is 20 mgm 2 or more once every 3 to 4 weeks for treatment of cervical cancer cisplatin is used in combination with radiotherapy. Pemetrexed in combination with cisplatin versus cisplatin. Ogivri in combination with capecitabine or intravenous 5fluorouracil and cisplatin is indicated. Cisplatin and other similar platinumbased drugs were developed with national cancer institute nci support. Cisplatin is a major antineo plastic drug for the treatment of solid tumors, but it has dosedependent renal toxicity.
It is given by injection into a vein common side effects include bone marrow suppression, hearing problems, kidney problems. Product monographs posted to the health canada website. The first step in the process after the cisplatin molecule penetrates the cell membrane intact is for a molecule of water to. Etopophos is indicated, in combination with cisplatin, for firstline treatment of patients with small cell lung cancer. Canada drug product database site for current product monograph information. Cisplatin cas no 15663271,manufacturers,distributors. Numerous mechanisms of cisplatin resistance were described including changes in cellular uptake, drug efflux, increased detoxification, inhibition of apoptosis and increased dna repair. For instructions for dilution of the product before administration see section 6. Considerations cisplatin is a platinum based chemotherapy drug, an antineoplastic ag ent.
Product monograph pr paclitaxel injection usp paclitaxel injection, 6 mgml therapeutic classification. Pricing, sizing, legal catgories and other medicinal forms information for cisplatin. Adjunct to other antineoplastic agents for the treatment of metastatic testicular tumors including nonseminomatous testicular carcinoma, seminoma testis, and extragonadal germcell tumors in patients who have already received appropriate surgery andor radiation therapy. Cisplatin injection cisplatin injection cisplatin cisplatin injection injection is a sterile aqueous solution, available in 50, 100 and 200 ml multiple dose vials, each ml containing 1 mg of cisplatin cisplatin injection and 9 mg sodium chloride in water for injection. Cisplatin comes as a liquid that is injected into a vein over six to eight hours in a hospital or medical facility. Overall, eight 40% of patients responded with a complete response in five 25%. Cisplatin 1 mgml concentrate for solution for infusion. Lc test for related substances and assay of the ph. For solution and drug compatibility information, see compatibility under stability.
Appropriate management of therapy and complications is. In order to for patients to be treated as a day case, the regimens have been modified as follows. Cisplatin for injection is a highly emetogenic antineoplastic agent. Patients were to receive three cycles at 21 day intervals. Delayed onset hearing loss has been reported in pediatric patients. The name of your medicine is cisplatin 1 mgml concentrate for solution for. Using a clean magnetic stir bar, alternately stir at a high speed for 5 minutes and sonicate for 10 seconds until complete solution is effected, inverting the flask frequently to remove particles that may cling to the neck. Cisplatin is also used in the treatment of a wide range of other cancers, including lung, bladder, cervical, and ovarian cancers. Cisplatin dosing, indications, interactions, adverse. Cisplatin medicinal forms bnfc content published by nice. Pdf cisplatin is currently one of the most widely used anticancer drugs in the world. Cisplatin is a widely used and highly effective cancer chemotherapeutic agent. Translations of the document are the responsibility of. Cisplatin hydration guidelines for outpatients introduction there is increasing demand to treat more patients as outpatients.
Cisplatin injection is a clear, lightyellow, sterile aqueous solution available in amber vials containing 1 mgml of cisplatin. Like cisplatin, carboplatin interferes with dna intrastrand and interstrand crosslinks in cells. These include testicular cancer, ovarian cancer, cervical cancer, breast cancer, bladder cancer, head and neck cancer, esophageal cancer, lung cancer, mesothelioma, brain tumors and neuroblastoma. Drug name mechanism of action and pharmacokinetics indications and status adverse effects dosing administration.
Only select registry of toxic effects of chemical substances rtecs data is presented here. Cisplatin ebewe 1 mgml, concentrate for solution for. Cisplatin 1 mgml sterile concentrate is to be diluted before administration. Product monograph prpaclitaxel injection usp paclitaxel for injection paclitaxel 6 mgml sterile therapeutic classification. Alimta pemetrexed disodium in combination with cisplatin is indicated for the firstline treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. Treatment was stopped if severe myelosuppression or any neurotoxicity occurred. Research over the past 10 years has uncovered many of the cellular mechanisms which underlie cisplatininduced renal cell death. Cisplatin, concentrate for solution for infusion 7220341. However, the platinum from cisplatin becomes bound to plasma proteins. The risk of ototoxicity may be increased by concomitant administration of other ototoxic drugs e. Single agent highdose cisplatin 200 mg m2 treatment in. Summary of product characteristics for specific dosing advice.
296 921 1248 755 360 538 949 775 1480 166 128 865 1127 253 650 415 1099 1640 1537 1132 1256 776 682 884 584 1081 481 1081