Venclexta

In combination w/ rituximab or as monotherapy for patients w/ chronic lymphocytic leukemia (CLL) who have received at least 1 prior therapy; w/ obinutuzumab for patients w/ previously untreated CLL. In combination w/ hypomethylating agent or low-dose cytarabine for adults w/ newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.

CLL Admminister 5-wk ramp-up dosing schedule. 20 mg once daily in wk 1; 50 mg once daily in wk 2; 100 mg once daily in wk 3; 200 mg once daily in wk 4; 400 mg once daily in wk 5. As monotherapy: 400 mg once daily. In combination w/ obinutuzumab: Give 6 cycles in combination w/ obinutuzumab, followed by 6 cycles of Venclexta as a single agent. On cycle 1 day 1, start obinutuzumab 100 mg, followed by 900 mg which may be administered on day 1 or day 2. Administer 1,000 mg on days 8 & 15 of cycle 1, & on day 1 of 5 subsequent cycles (total of 6 cycles, 28 days each). On cycle 1 day 22, start Venclexta according to the ramp-up schedule, continuing through cycle 2 Day 28. Continue Venclexta 400 mg once daily after completing the ramp-up schedule from cycle 3 day 1 of obinutuzumab to the end of cycle 12. In combination w/ rituximab: Start rituximab after completing ramp-up schedule w/ Venclexta & has received Venclexta 400 mg for 7 days. Administer rituximab on day 1 of each 28-day cycle for 6 cycles, w/ rituximab 375 mg/m² IV for cycle 1 & 500 mg/m² IV for cycles 2-6. Continue Venclexta 400 mg once daily for 24 mth from cycle 1 day 1 of rituximab. AML 100 mg once daily on day 1; 200 mg once daily on day 2; 400 mg once daily on day 3; 400 mg once daily on day 4 & beyond when dosing in combination w/ a hypomethylating agent; or 600 mg once daily on day 4 & beyond when dosing in combination w/ low-dose cytarabine.

Should be taken with food. Swallow whole; do not chew, crush, or break prior to swallowing.

Concomitant use w/ strong CYP3A4 inhibitors at initiation & during ramp-up phase in patients w/ CLL.

Targeted Cancer Therapy

L01XX52 - venetoclax ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.

POM