Ventoxen 100 mg (Tablet)

Indications

• Treatment of chronic lymphocytic leukemia (CLL)
• Treatment for adult patients who have received at least one prior therapy
• Suitable for patients with 17p deletion or TP53 mutation
• Suitable for patients who have failed chemoimmunotherapy
• Suitable for patients who have failed a B-cell receptor pathway inhibitor

Pharmacology

• Selective and orally bioavailable small-molecule inhibitor
• Inhibits BCL-2, an antiapoptotic protein
• Restores apoptosis process
• Demonstrated cytotoxic activity in tumor cells

Dosage & administration

• Starting dose of 20 mg once daily for 7 days
• Gradual increase of dose over 5 weeks to reach 400 mg daily
• Treatment duration of 24 months from Cycle 1 Day 1 of Rituximab

Interaction

• Contraindicated with strong CYP3A inhibitors
• Strong and moderate CYP3A inhibitors affect dose and administration
• Avoid concomitant use with P-gp and BCRP inhibitors
• Contraindicated with strong CYP3A inducers

Contraindications

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

Side effects

• Common side effects include neutropenia, diarrhea, and upper respiratory tract infection
• Serious side effects include pneumonia, febrile neutropenia, and TLS

Pregnancy & lactation

• Women of childbearing potential should use highly effective contraceptive measures
• Not recommended during pregnancy
• Breastfeeding should be discontinued
• Potential impact on male fertility

Precautions & warnings

• Risk of tumour lysis syndrome
• Monitoring for neutropenia and serious infections
• Avoid live attenuated vaccines during and after treatment
• Caution with CYP3A inducers
• Highly effective contraception for women of childbearing potential

Use in special populations

• No specific dose adjustment for elderly patients
• No dose adjustment for mild or moderate renal impairment
• Intensive prophylaxis and monitoring for reduced renal function
• No specific dose adjustment for mild or moderate hepatic impairment
• Dose reduction for severe hepatic impairment
• Safety and efficacy not established in pediatric population

Overdose effects

• No specific antidote
• Closely monitor and provide supportive treatment
• Careful monitoring for signs and symptoms of TLS

Therapeutic class

• Cytotoxic Chemotherapy

Storage conditions

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

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