Dosing Information for Nexavar & Treatment of Patients With Advanced Renal Cell Carcinoma (RCC)*

Continuous twice-daily dosing recommended

Safety profile allows continuous dosing
No dose adjustments are required for
- Age (patients >65 years)
- Gender
- Body weight
- Mild to moderate hepatic impairment (Child-Pugh classes A and B)
  – No data is available on patients with Child-Pugh class C (severe) hepatic impairment
- Renal impairment
  – No dose adjustment is required in patients with mild, moderate or severe renal impairment. No data is available in patients requiring dialysis.
Nexavar is not recommended for use in adolescent (patients <18 years) due to lack of data

Administration advice

Management of suspected adverse drug reactions may require temporary interruption or dose reduction of Nexavar. When dose reduction is necessary, the Nexavar dose should be reduced to two tablets of 200 mg once daily. Discontinuations due to adverse events were comparable: Nexavar 10% vs placebo 8%.

Duration of therapy

Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.

Dose modification recommendations — skin toxicity

In the phase III study, the most common skin irritations were rash and hand-foot skin reaction, which were usually Grade 1 and 2 and generally appeared during the first 6 weeks of treatment. Management of dermatologic toxicities may include topical therapies for symptomatic relief. Temporary interruption, dose reduction, or discontinuation of Nexavar may be required. See your local Bayer Schering Pharma Medical Affairs Representative for more information regarding management of skin toxicities.

*Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha- or interleukin-2-based therapy or are considered unsuitable for such therapy.

Next: Advanced RCC Nurse Guide and FAQ

Term

Explanation for term.