Venetoclax is an innovative BCL‑2 inhibitor that plays an important role in the treatment of hematologic malignancies.
Indications of Venetoclax Tablets
Main Indications
(1) Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma
Venetoclax is indicated for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients.
(2) Acute Myeloid Leukemia
Venetoclax, in combination with azacitidine, decitabine, or low‑dose cytarabine, is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years of age or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
Clinical Application Characteristics
(1) In the treatment of chronic lymphocytic leukemia / small lymphocytic lymphoma, venetoclax may be used as monotherapy or in combination with obinutuzumab or rituximab.
(2) In the treatment of acute myeloid leukemia, venetoclax must be used in combination with the above‑specified agents.
Description and Strengths of Venetoclax Tablets
Dosage Forms and Strengths
(1) 10 mg tablets: Round, biconvex, pale yellow film‑coated tablets, debossed with “V” on one side and “10” on the other side.
(2) 50 mg tablets: Oval, biconvex, beige film‑coated tablets, debossed with “V” on one side and “50” on the other side.
(3) 100 mg tablets: Oval, biconvex, pale yellow film‑coated tablets, debossed with “V” on one side and “100” on the other side.
Excipients
(1) Copovidone.
(2) Colloidal silicon dioxide.
(3) Polysorbate 80.
(4) Sodium stearyl fumarate.
(5) Calcium hydrogen phosphate dihydrate.
(6) The 10 mg and 100 mg film‑coated tablets also contain: yellow iron oxide, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide.
(7) The 50 mg film‑coated tablets also contain: yellow iron oxide, red iron oxide, black iron oxide, polyvinyl alcohol, talc, polyethylene glycol, and titanium dioxide.
Storage Instructions for Venetoclax Tablets
Storage Temperature
Venetoclax should be stored in the original container at a temperature not exceeding 86°F (30°C).
Precautions
(1) Keep venetoclax in its original container to protect from moisture.
(2) For CLL/SLL patients, keep tablets in the original package during the first 4 weeks of treatment.
(3) Do not transfer tablets to a different container.
(4) Keep the medicine out of the reach of children.
