Ovarian cancer

藥劑部參考美國 Johns Hopkins 大學研究團隊所建立的 NxP (Nephrotoxic Potential) 專家共識分級清單，本品具「顯著以上腎毒性風險」，被認定具中度至高度腎損傷潛勢，特別是同時合併其他腎毒性藥物、脫水、高齡或既有腎功能異常的患者族群，應更加注意。

Anticancer-Platinum Der.

Carboplatin doses of 300 to 500 mg/m2 administered to patients with creatinine clearance ?60 mL/min resulted in a biphasic decrease in plasma concentrations, with alpha and beta half-lives of 1.6 hours and 3.0 hours, respectively. Total clearance, apparent volume of distribution, and mean residence time of carboplatin were 73 mL/min, 16 L, and 3.5 hours, respectively. Maximum plasma concentration (Cmax) and area under the concentration curve (AUC) increased linearly with dose. Therefore, over the dose range studied, carboplatin exhibits linear pharmacokinetics in patients with creatinine clearance ?60 mL/min. Distribution No significant amounts of free, ultrafilterable, platinum-containing substances other than carboplatin appear in plasma; however, the platinum component of carboplatin is bound to plasma proteins and slowly eliminated with a half-life of at least 5 days. Excretion Carboplatin is primarily eliminated through the kidneys. Patients with a creatinine clearance of 60 mL/min or greater typically excrete 70% of carboplatin in the urine within 12 to 16 hours. All platinum in the 24-hour urine is present as carboplatin, with only 3 to 5% of the dose excreted between 24 and 96 hours.

A history of severe allergic reactions to carboplatin or other platinum-containing compounds, severe bone marrow suppression, bleeding tumors.Patients with severe renal insufficiency should not use this medication unless the physician and patient determine that the potential benefits outweigh the risks.

D

It is not known whether this drug is excreted in human milk. Because carboplatin may cause serious adverse reactions in breastfed infants, a decision should be made to discontinue nursing or the drug, taking into account the importance of the drug to the mother.

>10%: Endocrine & metabolic: Decreased serum calcium (22% to 31%), decreased serum magnesium (29% to 43%), decreased serum potassium (20% to 28%), decreased serum sodium (29% to 47%) Gastrointestinal: Gastrointestinal pain (17%), nausea (10% to 15%), nausea and vomiting (92%), vomiting (65% to 81%; severe vomiting: 22%) Hematologic & oncologic: Anemia (21% to 90%), leukopenia (15% to 85%), neutropenia (16% to 67%), thrombocytopenia (25% to 62%) Hepatic: Increased serum alkaline phosphatase (24% to 37%), increased serum aspartate aminotransferase (15% to 19%) Nervous system: Asthenia (11%), pain (23%) Renal: Decreased creatinine clearance (27%), increased blood urea nitrogen (14% to 22%) 1% to 10%: Dermatologic: Alopecia (2% to 3%) Gastrointestinal: Constipation (6%), diarrhea (6%), dysgeusia (1%), stomatitis (1%) Hematologic & oncologic: Hemorrhage (5%; including iatrogenic bleeding) Hepatic: Increased serum bilirubin (5%) Hypersensitivity: Hypersensitivity reaction (2%) Infection: Infection (5%) Nervous system: Neurotoxicity (5%), peripheral neuropathy (4% to 6%) Ophthalmic: Visual disturbance (1%) Otic: Ototoxicity (1%) Renal: Increased serum creatinine (6% to 10%)

Monotherapy: 360 mg/m2 intravenously on day 1, repeated every four weeks.Combination therapy with cyclophosphamide:Carboplatin: 300 mg/m2 intravenously on day 1, repeated every four weeks for six cycles.Cyclophosphamide: 600 mg/m2 intravenously on day 1, repeated every four weeks for six cycles.

Limited safety and effectiveness data available.

CrCl 41-59 mL/minute: 250mg/m2 on day 1 every cycleCrCl 16-40 mL/minute: 200mg/m2 on day 1 every cycle

There are no dosage adjustments provided in the manufacturer's labeling; however, carboplatin undergoes minimal hepatic metabolism; dosage adjustment may not be needed.

Unopened vials should be stored at 15-30°C away from light. Do not refrigerate.