Venclax 10 mg (Tablet)

Indications

• Treatment of chronic lymphocytic leukemia (CLL) with prior therapy
• Treatment of CLL in presence of 17p deletion or TP53 mutation
• Treatment of CLL in absence of 17p deletion or TP53 mutation
• Indicated for adult patients

Pharmacology

• Selective small-molecule inhibitor of BCL-2
• Orally bioavailable
• Antiapoptotic protein inhibitor
• BCL-2 overexpression in CLL cells
• Mediates tumor cell survival
• Triggers mitochondrial outer membrane permeabilization
• Cytotoxic activity in tumor cells

Dosage & Administration

• Starting dose of 20 mg once daily
• Gradually increased dose over 5 weeks
• Recommended dose of 400 mg once daily
• Continued treatment until disease progression or intolerance
• 24-month treatment for Venetoclax in combination with Rituximab

Interaction

• Co-administration with CYP3A inhibitors
• Contraindicated with strong CYP3A inhibitors
• Avoidance of moderate CYP3A inhibitors during titration phase
• Concomitant use with P-gp and BCRP inhibitors
• Avoidance of CYP3A inducers
• Grapefruit and certain fruits to be avoided

Contraindications

• Hypersensitivity to active substance or excipients
• Concomitant use of strong CYP3A inhibitors
• Use of St. John's wort preparations

Side Effects

• Common side effects: neutropenia, diarrhea, upper respiratory tract infection
• Serious side effects: pneumonia, febrile neutropenia, TLS
• Serious side effects in combination study with Rituximab: anaemia, fatigue

Pregnancy & Lactation

• Contraception requirements for women of childbearing potential
• Embryo-foetal toxicity potential
• Unknown excretion in human milk

Precautions & Warnings

• Tumour lysis syndrome risk
• Neutropenia management
• Immunization recommendations
• CYP3A4 inducers interaction
• Contraception requirements for women of childbearing potential

Use in Special Populations

• No specific dose adjustment for elderly patients
• Renal impairment considerations
• Hepatic impairment considerations
• Safety and efficacy not established in pediatric population

Overdose Effects

• No specific antidote available
• Monitoring and supportive treatment required
• Interruption and careful monitoring during titration phase

Therapeutic Class

• Cytotoxic Chemotherapy

Storage Conditions

• Store below 30°C
• Protection from moisture and light
• Keep out of reach of children

Related Brands

• Ventoxen 100 mg (Tablet) - everest-pharmaceuticals-ltd