Nexavar for Unresectable HCC

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A New Path to HCC Knowledge

RAFscience.com is an educational resource for medical professionals interested in learning more about the role of the RAF kinase cell-signaling pathway in hepatocellular carcinoma (HCC).

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Nexavar Medical Information

This medical information site provides access for health care providers to product information, congress presentations and posters, clinical trial information, and bibliography information for Nexavar.

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Nexavar — The First and Only Systemic Treatment Proven to Significantly Improve Overall Survival (OS) in Unresectable HCC7

CI=confidence interval, HR=hazard ratio.
aBased on HR of 0.69, overall survival improvement calculated as follows: (1.0/0.69-1)x100% = 44%.
bIntent-to-treat population.
cStatistically significant because the P value was below the prespecified O'Brien-Fleming stopping boundary of .0077.
dBased on 321 deaths as of the October 2006 cut-off date.

Data from SHARP, a double-blind, randomized, placebo-controlled, multicenter, phase 3 trial that compared Nexavar 400 mg bid (n=299) to placebo (n=303) in patients with unresectable HCC. For additional information about this study, click here.


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Indications and Usage


Nexavar is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC) and for the treatment of patients with advanced renal cell carcinoma (RCC)

Important Safety Considerations


Hypertension may occur early in the course of treatment. Monitor blood pressure weekly during the first 6 weeks and periodically thereafter and treat, as required.

An increased risk of bleeding may occur following Nexavar administration. If bleeding necessitates medical intervention, consider discontinuation of Nexavar.

Cardiac ischemia and/or myocardial infarction may occur. Temporary or permanent discontinuation of Nexavar should be considered in patients who develop cardiac ischemia and/or myocardial infarction.

Gastrointestinal perforation was an uncommon adverse reaction and has been reported in less than 1% of patients taking Nexavar.

Most common adverse reactions reported for Nexavar-treated patients vs placebo-treated patients in unresectable HCC, respectively, were: diarrhea (55% vs 25%), fatigue (46% vs 45%), abdominal pain (31% vs 26%), weight loss (30% vs 10%), anorexia (29% vs 18%), nausea (24% vs 20%), and hand-foot skin reaction (21% vs 3%). Grade 3/4 adverse reactions were 45% vs 32%.

Most common adverse reactions reported for Nexavar-treated patients vs placebo-treated patients in advanced RCC, respectively, were: diarrhea (43% vs 13%), rash/desquamation (40% vs 16%), fatigue (37% vs 28%), hand-foot skin reaction (30% vs 7%), alopecia (27% vs 3%),and nausea (23% vs 19%). Grade 3/4 adverse reactions were 38% vs 28%.

Hand-foot skin reaction and rash are common and management may include topical therapies for symptomatic relief. In cases of any severe or persistent adverse reactions, temporary treatment interruption, dose modification, or permanent discontinuation of Nexavar should be considered. Temporary interruption of Nexavar therapy is recommended in patients undergoing major surgical procedures.

Elevations in serum lipase and reductions in serum phosphate of unknown etiology have been associated with Nexavar. Caution is recommended when administering Nexavar with compounds that are metabolized/eliminated predominantly by the UGT1A9 pathway, UGT1A1 pathway (eg, irinotecan), doxorubicin, docetaxel, fluorouracil, and substrates of CYP2B6 and CYP2C8, and CYP3A4 inducers. Patients taking concomitant warfarin should be monitored regularly for changes in prothrombin time, INR, or clinical bleeding episodes.

Women of childbearing potential are advised to avoid becoming pregnant and against breastfeeding.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For important risk and use information, please see the full prescribing information.