Venetoclax INN

Composition: Each Veneta-100 film-coated tablet contains 100mg of Venetoclax INN.

Uses: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Venetoclax is approved for treating adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Acute Myeloid Leukemia: For adults 75 years or older, or those with certain health conditions that make intensive induction chemotherapy unsuitable, Venetoclax is used alongside Azacitidine, Decitabine, or low-dose Cytarabine to treat newly diagnosed acute myeloid leukemia (AML).

Dosage & Instructions: With Obinutuzumab: Begin with 100 mg of Obinutuzumab on the first day of the first cycle, followed by 900 mg the next day. Administer 1000 mg on the 8th and 15th days of the first cycle and the first day of each following 28-day cycle for six cycles total, as per Obinutuzumab guidelines. Start Venetoclax on the 22nd day of the first cycle, following a 5-week dose increase schedule (refer to Table 1), and after completing this phase by the 28th day of the second cycle, continue with 400 mg of Venetoclax orally once daily from the first day of the third cycle to the end of the 12th cycle. With Rituximab: After completing Venetoclax’s 5-week dose increase schedule (refer to Table 1) and taking 400 mg daily for 7 days, start Rituximab. Administer Rituximab once every 28 days for six cycles, with doses of 375 mg/m² intravenously for the first cycle and 500 mg/m² for cycles 2-6. Continue taking 400 mg of Venetoclax daily for 24 months starting from the first day of the first Rituximab cycle. As a Single Agent: After the 5-week dose escalation, the suggested dose of Venetoclax is 400 mg daily. Continue treatment until disease progression or unacceptable side effects occur, or follow the advice of a healthcare professional.

Pregnancy & Breastfeeding: Venetoclax could harm an unborn child if taken by a pregnant woman. There is no data from the use of Venetoclax in pregnant women to suggest a specific drug-related risk. Additionally, it is not known if Venetoclax passes into human milk, its effects on a breastfeeding infant, or on milk production.

Packaging: Veneta-100 comes in a box containing 30 tablets in a blister pack.