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Product Description
COMPOSITION:
VENTOXEN Tablet: Each film coated tablet contains Venetoclax INN 100 mg.
INDICATIONS:
Venetoclax in combination with Rituximab is indicated for the treatment of adult patients with chroniclymphocytic leukaemia(CLL) who have received at least one prior therapy
Venetoclax monotherapy is indicated for the treatment of CLL:.In the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor,or
·In the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
DOSAGE&ADMINISTRATION:
The starting dose is 20 mg of Venetoclaxonce daily for 7 days.The dose must be gradually increased over a period of 5 weeks up to the daily dose of 400 mg as shown in Table 1.
Table 1:Doseincrease schedule:
Week———-Venetoclax daily dose
1 ————- 20 mg
2 —————50 mg
3—————-100 mg
4 —————-200 mg
5——————400 mg
The 5-week dose-titration schedule is designed to gradually reduce tumour burden (debulk) and decrease the risk of tumour lysis syndrome.