Venetoclax INN
Composition: Veneta-10: Each film coated tablet contains Venetoclax INN 10mg.
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.
Dosage &
administration: 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. Continue Venetoclax until disease progression
or unacceptable toxicity. Or, as directed by the
registered physicians.
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. There are no
data on the presence of Venetoclax in human milk or the effects on the
breastfed child or milk production.
Packaging: Veneta-10: Each box contains 30 tablets in a blister pack.
