What is Venclexta / Venclyxto (venetoclax) for?
Venclexta / Venclyxto (venetoclax) is a BCL-2 inhibitor (chemotherapy) indicated for the treatment of people with chronic lymphocytic leukemia (CLL) with 17p deletion who have received at least one prior therapy1,8, 9. Venetoclax is marketed in the USA and in Australia under the name Venclexta1,9, and in the European Union under the name Venclyxto8. The presence of 17p deletion can be assessed through the use of specifically designed diagnostic tools3.
How does Venclexta / Venclyxto (venetoclax) work?
CLL is a slow-growing disease in which too many immature lymphocytes (white blood cells) accumulate in the blood and bone marrow2. About 10% of patients with untreated CLL and approximately 20% of patients with relapsed CLL have a particular chromosomal abnormality (17p deletion)3 that is related to a specific type of CLL named B-Cell lymphoma 2 (BCL-2).
Patients with CLL who have a 17p deletion lack a portion of the 17th chromosome where resides a gene involved with the identification and elimination of faulty cells4. This gene acts to suppress cancer growth. In the presence of a 17p deletion, healthy cells are unable to use this identification/elimination pathway to prevent and control malignant cells5.
Venetoclax is a selective inhibitor of a protein, named B-Cell lymphoma 2 (BCL-2 protein), that inhibits cell death (anti-apoptotic protein). Over-expression of BCL-2 protein has been demonstrated in BCL-2 cells where it mediates tumour cell survival and has been associated with resistance to chemotherapeutics. Patients with 17p deletion usually have poor outcomes with conventional chemo-immunotherapy6. Venetoclax is the first approved treatment that helps restore the process of apoptosis (cell death) by binding directly to the BCL-2 protein and preventing the inhibition of cell death1.
Where has Venclexta / Venclyxto (venetoclax) been approved?
Venclexta / Venclyxto (venetoclax) was approved by:
Food and Drug Administration (FDA), USA: April 11th, 2016, for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy1.
European Medical Agency (EMA), European Union, December 5, 20168
for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion or patients with relapsed or refractory CLL when other medicines are unsuitable or have failed8,9.
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
How is Venclexta / Venclyxto (venetoclax) taken?
The standard dosage consists of a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg:
- Week 1: 20 mg daily.
- Week 2: 50 mg daily.
- Week 3: 100 mg daily.
- Week 4: 200 mg daily
- Week 5+: 400 mg daily.
- The starter pack covers the treatment up to week 4. For week 5 and beyond venetoclax is dispensed as a one month supply in a bottle containing 120 100 mg tablets.
Concomitant use with strong inhibitors of CYP3A at initiation and during ramp-up phase is contraindicated1,8,9.
Complete information about Venclexta / Venclyxto (venetoclax) dosage and administration can be found in the official prescribing information listed in our resources section1,8,9.
Note: Please consult with your treating doctor for personalised dosing.
Are there any known side effects of Venclexta / Venclyxto (venetoclax)?
Common side effects
The most common side effects (≥20%) listed in the prescribing information include1,8,9:
- neutropenia (neutrophil count decreased)
- upper respiratory tract infection
- Serious adverse reactions
The serious side effects (≥2%) listed in the prescribing information include:
- febrile neutropenia
- tumour lysis syndrome (TLS).
Use in specific populations
Venclexta / Venclyxto (venetoclax) can be fatal for a fetus, it is advised to avoid pregnancies and breast-feeding.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,8,9.