Oncology Drug Reference Sheet: Venetoclax

August 27, 2019 by Barbara Lubejko RN, MS

Venetoclax (Venclexta®) was approved by the U.S. Food and Drug Administration (FDA) on May 15, 2019, for the treatment of adult patients with chronic lymphocytic leukemia (CLL) (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-venetoclax-cll-and-sll) or small lymphocytic lymphoma (SLL) as a single agent or in combination therapy. Previously, it had been approved in late 2018 for use in combination therapy for acute myeloid leukemia (AML) (https://www.fda.gov/drugs/fda-approves-venetoclax-combination-aml-adults) in older adults or those with significant comorbidities.

Category/Class

Targeted/small-molecule inhibitor of BCL-2    

Indication  

Dosing 

CLL/SLL Dosing Ramp-Up Schedule

week

daily dose

Week 1

20 mg

Week 2

50 mg

Week 3

100 mg

Week 4

200 mg

Week 5 and beyond

400 mg

AML Dosing Ramp-Up Schedule

Day

Daily Dose

Day 1

100 mg

Day 2

200 mg

Day 3

400 mg

Day 4 and beyond

400 mg with azacytidine; 600 mg with low-dose cytarabine 

Administration

The oral tablets should be taken with a meal and water at the same time each day.

Adverse Reactions

Patients receiving venetoclax monotherapy experienced TLS (significant, but uncommon with ramp-up dosing, prehydration and antiuricemics), neutropenia, diarrhea, nausea, upper respiratory tract infection, fatigue, musculoskeletal pain, thrombocytopenia, edema, anemia, and febrile neutropenia. Incidence rates may vary with combination therapy.

Nursing Considerations

Patient Education

Gero-Oncology Considerations

No clinically significant differences in safety and effectiveness were found between older and younger patients who received venetoclax during clinical trials.   

Safe Handling

Venetoclax is considered a hazardous drug because of its reproductive risk. Venetoclax was found to cause embryo-fetal harm in animal studies, and testicular germ cell toxicity was seen in male animals.


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