TIPS TO REMEMBER: Nexavar


Patients taking concomitant warfarin should be monitored regularly for changes in prothrombin time, INR, or clinical bleeding episodes.
Blood pressure should be monitored weekly during the first six weeks of Nexavar therapy and managed throughout treatment.
Temporary or permanent discontinuation of Nexavar therapy should be considered in those with cardiac ischemia and/or infarction.
When dose reduction is necessary, the dose may be reduced to 400 mg taken once daily. If further dose reduction is required, the dose can be reduced to a single 400-mg dose taken every other day.




For the first time in more than 10 years, the Food & Drug Administration has granted marketing approval to a drug for kidney cancer. Sorafenib (Nexavar, Bayer/ Onyx) was recently approved for the treatment of advanced renal cell carcinoma, the most common form of the disease. Sorafenib is currently available through specialty pharmacies.

Sorafenib is the first oral multi-kinase inhibitor that targets serine/ threonine and receptor tyrosine kinases in both the tumor cell and the tumor vasculature, said Ronald Bukowski, M.D., director of experimental therapeutics at the Cleveland Clinic Taussig Cancer Center in Ohio. In preclinical models, sorafenib targeted members of two classes of kinases, including RAF kinase, VEGFR-2, VEGFR-3, PDGFR-B, KIT, and FLT-3. These kinases are known to be involved in both tumor cell proliferation and tumor angiogenesis.


Nexavar

According to the manufacturer, sorafenib was approved based on data from the largest randomized, placebo-controlled clinical trial ever conducted in patients with advanced renal cell carcinoma. Compared with placebo, sorafenib was found to double the time of progression-free survival. The maker also reported that a recent interim analysis showed sorafenib reduced mortality risk by 28%.

The most common adverse events associated with sorafenib in clinical trials were diarrhea, rash/ desquamation, fatigue, blisters on the palms of the hands and soles of the feet, alopecia, nausea, pruritus, hypertension, vomiting, and anorexia. Bukowski said that in early-stage clinical trials, grades 3 and 4 adverse events were rare, occurring in probably less than 5% of patients.

Sorafenib should be used with caution when taken concomitantly with drugs eliminated primarily by the UGT1A1 pathway, such as irinotecan (Camptosar, Pfizer). In addition, the manufacturer said, exercise caution when administering sorafenib concomitantly with doxorubicin and substrates of CYP2B6 and CYP2C8. The company noted that sorafenib has not been tested in those with Child-Pugh C hepatic impairment, although no dose adjustment is necessary in those with Child-Pugh A or B hepatic impairment.

Sorafenib is classified as Pregnancy Category D, so adequate contraception during treatment and for at least two weeks after discontinuation of therapy is recommended for male and female patients. Women should be advised against breastfeeding while taking sorafenib. The recommended daily dose of sorafenib is 400 mg taken twice daily (2 x 200 mg tablets), without food, at least one hour before or two hours after eating.

Sorafenib is in phase III clinical trials for the treatment of advanced hepatocellular carcinoma and metastatic melanoma. A phase III clinical trial for non-small-cell lung cancer is planned for the first half of this year.

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发布时间：2006年09月11日