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.
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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.
A Resources for Expert Assistance and Care Helpline (REACH) program can answer questions about sorafenib treatment, reimbursement, and patient support, ensuring that patients understand how/if their insurance covers sorafenib therapy and how they may acquire the product, said Morris Lumpkin, director of operations for the REACH program. REACH can also counsel the uninsured about resources that may help them gain access to sorafenib. State programs may cover the cost of sorafenib, he said, and systems are in place to counsel Medicare patients about what coverage options are available under the Part D benefit. A low-income subsidy is available for Medicare/Medicaid dual-eligibles.
The REACH program is available at (866) NEXAVAR. Hospital pharmacists interested in ordering sorafenib should call ASD Healthcare at (800) PHON-ASD.
THE AUTHOR is a clinical writer based in New Jersey.