Venclexta 10mg 50mg 100mg Tablets(Venetoclax)
venetoclax - Drug Summary
CLASSES
Other Antineoplastic Agents
Protein Kinase Inhibitors
DEA CLASS
Rx
DESCRIPTION
Oral, selective, small molecule inhibitor of BCL-2
Approved for use in chronic lymphocytic leukemia with 17p deletion, in patients who have received at least one prior therapy
Do not co-administer with a strong CYP3A inhibitor at initiation or during the dose titration phase and avoid concomitant use with moderate CYP3A inhibitors, strong or moderate CYP3A inducers, P-glycoprotein (P-gp) inhibitors, or narrow therapeutic index P-gp substrates
COMMON BRAND NAMES
Venclexta
HOW SUPPLIED
Venclexta/Venetoclax Oral Tab: 10mg, 50mg, 100mg, 10-50-100mg
DOSAGE & INDICATIONS
For the treatment of chronic lymphocytic leukemia (CLL).
The FDA has designated venetoclax as an orphan drug for the treatment of CLL.
For the treatment of CLL, in patients with a 17p deletion who have received at least 1 prior therapy.
Oral dosage
Adults
initial, 20 mg orally once daily for 7 days. The venetoclax dose is increased once weekly over 5 weeks as follows: week 2, 50 mg/day; week 3, 100 mg/day; week 4, 200 mg/day; and week 5 and beyond, 400 mg/day. Continue therapy until disease progression. A dose reduction and/or therapy interruption may be necessary in patients who develop toxicity. All patients must have prophylactic hydration and anti-hyperuricemics prior to first venetoclax dose to reduce the risk of tumor lysis syndrome. Do not co-administer with a strong CYP3A inhibitor at initiation or during the dose titration phase and avoid concomitant use with moderate CYP3A inhibitors, strong or moderate CYP3A inducers, P-glycoprotein (P-gp) inhibitors, or narrow therapeutic index (NTI) P-gp substrates. A venetoclax dose reduction is necessary if use with strong CYP3A inhibitor (after titration), a moderate CYP3A inhibitor, or a P-gp inhibitor cannot be avoided. Take NTI P-gp substrates at least 6 hours before venetoclax. The primary endpoint of overall response rate (ORR) was 79% in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) (n = 102) or small lymphocytic lymphoma (SLL) (n = 14) who received venetoclax in a multicenter, dose-escalation trial; 20% of patients had a complete response (CR). Additionally, the median progression-free survival (PFS) time was 22 months and the 2-year overall survival rate was 84%. In CLL patients with a known chromosome 17p deletion (n = 31), the ORR was 71% (CR, 16%) and the median PFS time was 15 months. Patients had received a median of 3 prior therapies (range, 1 to 11 therapies); patients who had received a previous allogeneic or autologous stem-cell transplantation (SCT) were excluded from this study. All patients received IV hydration and allopurinol with or without rasburicase. The ORR (assessed by an independent review committee) was 79.4% in relapsed or refractory CLL patients who had a 17p deletion in a multinational, phase II trial (M13-982 trial; n = 107); 8% of patients had a CR or a CR with incomplete recovery of blood counts. Patients in this study had received a median of 2 prior therapies (interquartile range, 1 to 4 therapies); patients who had received a previous allogeneic SCT were excluded from this study. At a median follow-up of 12.1 months, the estimated 12-month PFS and OS rates were 72% and 86.7%, respectively.
MAXIMUM DOSAGE
Adults
400 mg/day PO; 200 mg/day PO if taking a moderate CYP3A inhibitor, P-gp inhibitor, or narrow |
