Manageable safety profile

In pivotal trials across the 3 monotherapy indications at the recommended dose:

*1250 mg/m2 orally twice daily for 2 weeks followed by a 1-week rest period.
†1255 mg/m2 orally twice daily for 2 weeks followed by a 1-week rest period.

• Rates of HFS and diarrhea were similar across the 3 studies; stomatitis was infrequently observed.
• XELODA is associated with minimal neutropenia and alopecia (1.2%).1

 

In the combination therapy pivotal trial at the recommended dose:

†XELODA 1250 mg/m2 BID x14 days followed by 1 week off plus docetaxel 75 mg/m2 1-hr IV every 3 weeks.
§Docetaxel 100 mg/m2 1-hr IV every 3 weeks.
 

Grades 3 and 4 adverse events are manageable and, in most cases, reversible

In patients receiving XELODA, grades 3 and 4 adverse events can be managed using:

• Dose modification.
• Symptomatic treatment.
• Dose interruption or delay.

 
Hand-foot syndrome:

• In patients receiving XELODA monotherapy in the metastatic setting, median time to onset of HFS was 79 days (range: 11-360).
• If grade 2 or 3 HFS occurs, administration of XELODA should be interrupted until the event resolves or decreases in intensity to grade 1.

 
Diarrhea:

• In patients receiving XELODA monotherapy, median time to first occurrence of grades 2-4 diarrhea was 34 days (range: 1-369).
• The median duration of grades 3-4 diarrhea was 5 days.
• If grades 2-4 diarrhea occurs, administration of XELODA should be immediately interrupted until the diarrhea resolves or decreases in intensity to grade 1.
• Standard diarrheal treatments (eg, loperamide) are recommended.

 

REFERENCES

1. Data on file (Ref. 111-035), Hoffmann-La Roche Inc., Nutley, NJ 07110.