Venetoclax INN
Composition: VENEX-10: Each
tablet contains Venetoclax INN 10mg.
VENEX-50: Each tablet contains Venetoclax INN 50mg.
VENEX-100: Each tablet contains Venetoclax INN 100mg.
Indications: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Venetoclax is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Acute Myeloid Leukemia: Venetoclax is indicated in combination with Azacitidine, or Decitabine, or low-dose Cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy
In Combination with
Obinutuzumab: Start Obinutuzumab administration at 100
mg on Cycle 1 Day 1, followed by 900 mg on Cycle 1 Day 2. Administer 1000 mg on Days 8 and
15 of Cycle 1 and on Day 1 of each subsequent 28-day cycle for a total of 6 cycles. Refer
to the Obinutuzumab prescribing information for additional dosing information. On
Cycle 1 Day 22, start Venetoclax according to the 5-week ramp-up dosing schedule (see Table 1).
After completing the ramp-up phase on Cycle 2 Day 28, continue Venetoclax at a dose
of 400 mg orally once daily from Cycle 3 Day 1 until the last day of Cycle 12.
In Combination with Rituximab: Start Rituximab administration after the
patient has completed the 5-week ramp-up dosing schedule for Venetoclax (see Table 1) and
has received Venetoclax at the recommended dosage of 400 mg orally once daily for 7 days.
Administer rituximab on Day 1 of each 28-day cycle for 6 cycles, at a dose of 375 mg/m²
intravenously for Cycle 1 and 500 mg/m² intravenously for Cycles 2-6. Continue Venetoclax 400 mg
orally once daily for 24 months from Cycle 1 Day 1 of Rituximab.
Monotherapy: The recommended dosage of Venetoclax is 400 mg once daily
after completion
of the 5-week ramp-up dosing schedule (see Table 1). Continue Venetoclax until
disease
progression or unacceptable toxicity. Or, as directed by the registered
physician.
Pregnancy &
lactation: Venetoclax may cause embryo-fetal harm
when administered to a pregnant woman. There are no available data on Venetoclax use in pregnant women
to inform a drug-associated risk. Administration of Venetoclax to pregnant mice during
the period of organogenesis was fetotoxic at exposures 1.2 times the human exposure at the
recommended dose of 400 mg daily based on AUC. Advise pregnant women of the potential risk
to a fetus. The estimated background risk of major birth defects and miscarriage for the
indicated population is unknown. All pregnancies have a background risk of birth defect,
loss, or other adverse outcomes.
Packaging: VENEX-10: Each
container contains 30 tablets in a box.
VENEX-50: Each container contains 30 tablets in a box.
VENEX-100: Each container contains 30 tablets in a box.
VENEX-100: Each container contains 120 tablets in a box.