VENCLEXTA is indicated 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 therapy.

INN:

Subtype:

Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL)

License:

FDA

Class:

BCL-2 inhibitor

R/R

PIhttp://www.rxabbvie.com/pdf/venclexta.pdf 

1. Approved Labelling 

VENCLEXTA is indicated 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 therapy.

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 

2. Treatment Regimen 

Select patients for the treatment of relapsed or refractory CLL with VENCLEXTA based on the presence of 17p deletions in blood specimens. Patients without 17p deletion at diagnosis should be retested at relapse because acquisition of 17p deletion can occur.

Assess patient-specific factors for level of risk of tumor lysis syndrome (TLS) and provide prophylactic hydration and anti-hyperuricemics to patients prior to first dose of VENCLEXTA to reduce risk of TLS.

Administer the VENCLEXTA dose according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg as shown in Table 1. The 5-week ramp-up dosing schedule is designed to gradually reduce tumor burden (debulk) and decrease the risk of TLS.

VENCLEXTA tablets should be taken orally once daily with a meal and water at approximately the same time each day. Do not chew, crush, or break tablets.

 Table 1. Dosing Schedule for Ramp-Up Phase
WEEK

VENCLEXTA Daily Dose

 

1 20 mg
2 50 mg
3 100 mg
4 200 mg 
5 and beyond  400 mg 

The Starting Pack provides the first 4 weeks of VENCLEXTA according to the ramp-up schedule. Once the ramp-up phase is completed, the 400 mg dose is achieved using 100 mg tablets supplied in bottles.

VENCLEXTA should be taken orally once daily until disease progression or unacceptable toxicity is observed.

3. AE/Warnings

Please see section 5 of the PI

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