Product Details
!: , : ) Patients with hepatic impairment: No dose adjustment is required in patients with mild to moderate hepatic impairment (C and B). Nexavar (sorafenib) has not been studied in patients with severe hepatic impairment.
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!: , : ) Patients with renal impairment: No dose adjustment is required in patients with mild to moderate renal impairment. Sorafenib has not been studied in patients with severe renal impairment or on dialysis.
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!: , : ) [Adverse reactions] Safety data from key European and American clinical studies supporting the marketing of this product: from Nexavar (sorafenib) as a single drug treatment patients (mainly Caucasian, including a small number of African Americans, Asians, Hispanics and other races). The most common drug-related adverse events were diarrhea, rash, alopecia, and hand-foot syndrome. Laboratory Abnormalities Elevated lipase and amylase are commonly seen after taking Nexavar (sorafenib). In the study, % of patients in the Nexavar (sorafenib) group had or increased lipase, and % of patients in the placebo group had elevated lipase levels. % of patients in the Nexavar (sorafenib) group experienced or graded amylase elevations, compared with % of patients in the placebo group. Pancreatitis (Grade) occurred in 3 patients taking Nexavar (sorafenib) and 9 patients in the placebo group (Grade).
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!: , : ) Safety data results in Asians: The trial was a non-randomized, non-controlled, open-label trial of Nexavar (sorafenib) in advanced kidney cancer conducted in Japan Compared with the phase II clinical studies in Europe and the United States, the drug-related adverse events reported in the trials are similar. The most common ones are: increased lipase, hand-foot syndrome, alopecia, and increased amylase. , rash/scaling and diarrhea. The trial is a multi-center, non-randomized Phase III clinical study of Nexavar (sorafenib) in the treatment of advanced renal cancer conducted in Asia, including mainland China and Taiwan, and the study is ongoing.
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!: , : ) Currently, among all patients who have received at least one treatment with Nexavar (sorafenib), patients (.%) have experienced drug-related Common adverse events include hand-foot syndrome (.%), rash (.%), hypertension (.%), diarrhea (.%), fatigue (.%), etc. In trials, Nexavar (sorafenib) demonstrated good safety, with most adverse events occurring being mild and tolerable.
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!: , : ) [Notes] There is still a lack of sufficient clinical research data on the Chinese population, so it must be used under the guidance of a doctor who has experience in using this product.
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!: , : ) Skin toxicity: Hand-foot skin reactions and rash are the most common adverse reactions of taking Nexavar (sorafenib). Rashes and hand-foot skin reactions are usually C (International Common Toxicity Criteria for Oncology) grade to grade, and most often occur within a few weeks after starting to take Nexavar (sorafenib). Management of cutaneous toxic reactions includes topical application to reduce symptoms, temporary discontinuation of the drug, and/or dose adjustment of Nexavar (sorafenib). Permanent discontinuation of Nexavar (sorafenib) may be required in patients with severe skin toxicity and prolonged reactions. In severe cases, the drug should be discontinued permanently.
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!: , : ) Hypertension: The incidence of hypertension is increased in patients taking Nexavar (sorafenib). Drug-related hypertension is mostly mild to moderate, often appears in the early stages after starting to take medication, and can be controlled with conventional antihypertensive drugs. Blood pressure should be monitored routinely and treated according to standard treatment regimens if necessary. Permanent discontinuation of Nexavar (sorafenib) should be considered in patients with severe or persistent hypertension or hypertensive crisis despite the use of antihypertensive drugs.
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!: , : ) Bleeding: The chance of bleeding may increase after treatment with Nexavar (sorafenib). Severe bleeding disorders are uncommon. Once treatment is required, it is recommended to consider permanently discontinuing Nexavar (sorafenib).
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!: , : ) Warfarin: Some patients taking Nexavar (sorafenib) and warfarin concurrently have occasional bleeding or increased international normalized ratio of coagulation time. For patients taking warfarin together, prothrombin time and R value should be measured routinely and clinical signs of bleeding should be noted.
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!: , : ) Wound healing complications: The effects of taking Nexavar (sorafenib) on wound healing have not been specifically studied. Patients who require major surgery are advised to suspend Nexavar (sorafenib). There is limited clinical experience in when patients should use Nexavar (sorafenib) again after surgery. Therefore, clinical considerations should be made before deciding to take it again. wound healing. Myocardial ischemia and/or myocardial infarction: In the trial, treatment-related myocardial ischemia/myocardial infarction occurred more frequently in the NEXAVAR (sorafenib) group (.%) than in the placebo group (.%). Patients with unstable coronary artery disease and patients with recent myocardial infarction were not enrolled in the trial. Temporary or long-term discontinuation of Nexavar (sorafenib) therapy should be considered in patients who develop myocardial ischemia and/or myocardial infarction.
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!: , : ) Gastrointestinal perforation: Gastrointestinal perforation is rare. Gastrointestinal perforation has been reported in less than % of patients taking Nexavar (sorafenib). In some cases, gastrointestinal perforation is not accompanied by the development of overt intra-abdominal tumors, and treatment with this product should be discontinued.
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!: , : ) Liver damage: There are no study data on patients with liver damage levels. Because Nexavar (sorafenib) is primarily eliminated by the liver, exposure may be elevated in patients with severely impaired hepatic function.
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!: , : ) Drug-drug interactions: Route: It is recommended that caution be used when Nexavar (sorafenib) is combined with drugs metabolized through the route (such as irinotecan).
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!: , : ) Docetaxel: docetaxel (/or/) combined with this product (.or. administered twice daily), this product and polyene There was a three-day dosing interval between paclitaxel, and the C of docetaxel increased by ∼%. Caution is recommended when using this product in combination with docetaxel (see
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