Venclexta

About Venetoclax or Venclexta

• On October 16, 2020, the Food and Drug Administration granted formal approval to venetoclax, classifying it within the category of B-Cell Lymphoma Inhibitors. Venclexta is marketed under the brand name Venclexta.
• Venetoclax is utilized for the treatment of adults diagnosed with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or acute myeloid leukemia (AML). 
• Venetoclax operates by binding to the Bcl-2 protein, abundantly present in CLL cancer cells. 
• This protein enhances the survival of cancer cells, rendering them more resilient to traditional cancer treatments. Through its interaction with Bcl-2 and inhibition of its functions, venetoclax induces the apoptosis of cancer cells, thereby impeding the progression of the disease.

Strength

Venclexta tablets are delivered in 10 mg, 50 mg, and 100 mg respectively for oral consumption with Venetoclax as the active pharmaceutical ingredient (API). 

Recommended Dosage

• Venetoclax tablets must be initiated at 20 mg once daily for 7 days, and can be increased gradually every week to the recommended daily dose of 400 mg.
• Rituximab must be given in patients receiving Venetoclax following the 5-week ramp-up period. Rituximab Cycle 1 Day 1: Continue Venetoclax for 24 months. Consult your treating doctor for assistance in administration. 
• It is recommended to take tab Venetoclax 100 mg orally with water daily after the meal. The tablet must not be chewed, broken, or crushed. 

Important: Patients must consult their treating doctor in case of any adverse reaction during the treatment. 

Warning & Precautions

• Assess the risk of Tumor Lysis Syndrome (TLS) during the treatment. Anti-hyperuricemic medication and enough hydration must be taken in advance. If there are increased risks, implement more extensive measures (intravenous hydration, frequent monitoring, hospitalization as and when necessary).
• It is necessary to monitor blood count (Neutropenia) and certain infections during the medication. Treat as medically necessary and advised. 
• Live attenuated vaccines should not be given before, during, or after Venetoclax treatment.
• Venetoclax tablets may cause fetal harm (Embryo-Fetal Toxicity). Pregnant females or women with reproductive potential must follow the necessary or prescribed contraception treatment. 

Common Venetoclax Side Effects

The most common Venclexta side effects in combination with Rituximab are:

• Neutropenia
• Diarrhea
• Upper Respiratory Tract Infection
• Fatigue
• Cough, and
• Nausea

The most common Venclexta side effects in the monotherapy studies are:

• Neutropenia
• Diarrhea
• Nausea
• Upper Respiratory Tract Infection
• Anemia
• Fatigue
• Thrombocytopenia 
• Musculoskeletal Pain
• Edema
• Cough

Use in Specific Population

• Limited data are available on the use of Venclexta in pregnant women, making it challenging to assess the drug’s potential for major birth defects and miscarriage.  
• There is also a lack of information regarding the presence of Venclexta in human milk, its impact on breastfeeding infants, and its effects on milk production. 
• Venclexta carries the risk of causing fetal harm, necessitating pregnancy testing in females of reproductive potential before initiating treatment.
• Females of reproductive potential should be advised to use effective contraception during Venclexta treatment and for at least 30 days after the last dose. 
• The safety and effectiveness of Venclexta have not been established in pediatric patients. However, no clinically significant differences in safety and effectiveness were observed between older and younger patients in both combination and monotherapy studies.
• For patients with mild or moderate renal impairment, no dose adjustment is recommended. However, a recommended dose has not been determined for patients with severe renal impairment (creatinine clearance < 30 mL/min) or patients undergoing dialysis.

Storage & Handling

• Keep the medication stored at or below 30°C (86°F). 
• Prevent freezing and shield from extreme heat exposure. 
• Ensure it remains inaccessible to pets and children.