Venclexta (venetoclax)
An approved treatment for Acute Myeloid Leukemia.
The same compound appears under different names depending on the context. Here is how to identify Venetoclax wherever you encounter it, plus the key facts at a glance.
- Generic name
- Venetoclax
- Brand name
- Venclexta
- Development codes
- ABT-199, GDC-0199
- Drug class
- BCL-2 inhibitor
- Manufacturer
- AbbVie (co-marketed in the United States with Genentech)
- How it's taken
- Oral tablet once daily, with azacitidine, decitabine or low-dose cytarabine
A daily pill that, combined with azacitidine, decitabine or low-dose cytarabine, is the usual first treatment for newly diagnosed AML in adults 75 or older or with health problems that rule out intensive induction chemotherapy. First approved for AML on November 21, 2018 and fully approved on October 16, 2020 after the VIALE-A trial showed longer survival. Venclexta is also approved for chronic lymphocytic leukemia, which is not covered on this page.
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Where Venetoclax fits
The backbone of first-line treatment for older or unfit adults with AML, usually with azacitidine; Tibsovo plus azacitidine is an alternative for IDH1-mutated disease and Daurismo plus low-dose cytarabine is a less used option. Menin inhibitor and other combinations with venetoclax are in Phase 3 trials.
How Venetoclax works
Leukemia cells stay alive partly by making a lot of a protein called BCL-2, which blocks the cell's built-in self-destruct program. Venetoclax binds BCL-2 and switches that block off, so the leukemia cell dies through apoptosis[1]. Azacitidine and decitabine, the hypomethylating agents it is paired with, make leukemia cells more dependent on BCL-2, which is one reason the combination works better than either drug alone[2].
Mechanism: Oral BCL-2 inhibitor that removes the survival signal leukemia cells depend on, so they die by apoptosis
Side effects and safety
- Tumor lysis syndrome. Dying leukemia cells can flood the blood with potassium, phosphate and uric acid. The dose is ramped up over 3 days with hydration and a uric acid blocker, and white cell counts are often lowered first.
- Neutropenia. Grade 3 or 4 neutropenia is expected; counts are checked through each cycle and Venclexta is paused after remission until counts recover.
- Infections. Serious infections, including sepsis and pneumonia, occurred; fever during low counts is an emergency.
- Live vaccines. No live vaccines before, during or after treatment until B cells recover.
- Embryo-fetal toxicity. May harm an unborn baby; effective contraception is needed during treatment and for 30 days after.
- Drug interactions. Strong or moderate CYP3A inhibitors, including the azole antifungals used in AML, require a Venclexta dose reduction.
- Blood chemistry for tumor lysis before the first dose and at each ramp-up step
- Complete blood counts through each cycle, with a bone marrow check after cycle 1 to confirm remission
- Review of every new medicine for CYP3A and P-gp interactions
- Pregnancy test before starting in women who could become pregnant
Venclexta has no boxed warning, but the label lists 5 warnings: tumor lysis syndrome, when dying leukemia cells release their contents faster than the kidneys can clear them, which is why the dose is ramped up over 3 days with fluids and a uric acid medicine and why VIALE-A patients were hospitalized for the ramp-up; neutropenia, with blood counts checked and doses paused; serious infections; no live vaccines; and harm to an unborn baby[1].
In VIALE-A, with azacitidine, the most common side effects were nausea (44%), diarrhea (43%), febrile neutropenia (42%, all grade 3 or 4), musculoskeletal pain (36%), fatigue (31%), vomiting (30%), swelling (27%), bleeding (27%), decreased appetite (25%), rash (25%) and sepsis (22%)[1]. Because venetoclax is cleared by CYP3A, the antifungal drugs often given during AML treatment (posaconazole, voriconazole) raise its level and require a lower dose[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Venetoclax
For AML, Venclexta is taken by mouth once a day with food. The dose ramps up over 3 days (100 mg on day 1, 200 mg on day 2, then 400 mg from day 3) when it is given with azacitidine or decitabine, and reaches 600 mg when it is given with low-dose cytarabine[1]. Azacitidine is given as an injection or IV infusion on days 1 to 7 of each 28-day cycle, decitabine as an IV infusion on days 1 to 5, and low-dose cytarabine as an injection under the skin on days 1 to 10.
Treatment continues until the leukemia progresses or side effects become unacceptable; once a bone marrow test confirms remission, Venclexta is usually paused for up to 14 days each cycle to let blood counts recover[1]. Tumor lysis prophylaxis, hydration and often a short hospital stay accompany the ramp-up, and the white cell count is brought below 25 x 10^9/L before the first dose[1].
Availability and cost
Only available as the brand-name product.
Help paying for Venclexta
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Eligible commercially insured patients pay as little as $0 per prescription for Venclexta with azacitidine, decitabine or low-dose cytarabine, up to a $25,000 yearly limit. Not for Medicare, Medicare Advantage, Medigap, Medicaid, TRICARE, VA or other government insurance; a per-fill cap may apply if your plan uses a copay accumulator or maximizer.
For: private insurance · source - Insurance and case manager help
AbbVie's nurse support line for Venclexta, (844) 926-6727, Monday to Friday, 7 AM to 7 PM Central, answers treatment questions at no cost (the nurses do not give medical advice).
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source - Free medicine program
myAbbVie Assist may provide AbbVie medicines at no cost to eligible US patients without insurance or with limited coverage; eligibility rules apply.
For: no insurance, underinsured · source
Good to know: Venclexta is co-marketed by AbbVie and Genentech in the US, which is why the copay program is Genentech's. The Venclexta.com page has a tab for people with any insurance or no insurance whose content did not render in this check; it links to medicineassistancetool.org. Status is partial until that tab is read.
Access and eligibility
Approved for newly diagnosed AML in adults who are 75 or older, or who have conditions such as poor performance status, significant heart or lung disease, moderate liver impairment or reduced kidney function that rule out intensive induction. It is not approved as a single agent in AML and is used off label in relapsed disease.
Source: Venclexta.com financial support (AbbVie)
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
VIALE-A (NCT02993523) randomized 431 adults with newly diagnosed AML who were 75 or older or unfit for intensive chemotherapy (median age 76) to venetoclax plus azacitidine or placebo plus azacitidine. Median overall survival was 14.7 months against 9.6 months (hazard ratio 0.66, 95% CI 0.52 to 0.85, p under 0.001); complete remission was reached by 37% against 18%, and complete remission with partial count recovery by 65% against 23%.
Among patients who needed red cell or platelet transfusions at the start, 49% on the combination became transfusion independent[1][2]. VIALE-C (NCT03069352) tested venetoclax with low-dose cytarabine in the same population and supports that pairing[1]. The FDA granted accelerated approval for AML on November 21, 2018 on response rates from early studies and converted it to regular approval on October 16, 2020 on the VIALE-A survival result[3].
Development history
Venetoclax was developed by AbbVie with Genentech and was first approved in April 2016 for chronic lymphocytic leukemia with a 17p deletion. The AML indication followed in November 2018 under accelerated approval and became a regular approval in October 2020. The label was revised in May 2026; the AML indication text is unchanged[1][3].
Explore Acute Myeloid Leukemia trials
Other Acute Myeloid Leukemia treatments
For people who cannot have 7+3 chemotherapy, venetoclax with a hypomethylating agent replaced hypomethylating agents alone as the standard after VIALE-A. The open questions, and the subject of most current trials, are what to add to it for specific mutations and how long to continue it.
Common questions about Venetoclax
▸What is Venetoclax (Venclexta)?
A daily pill that, combined with azacitidine, decitabine or low-dose cytarabine, is the usual first treatment for newly diagnosed AML in adults 75 or older or with health problems that rule out intensive induction chemotherapy. First approved for AML on November 21, 2018 and fully approved on October 16, 2020 after the VIALE-A trial showed longer survival. Venclexta is also approved for chronic lymphocytic leukemia, which is not covered on this page.
▸How does Venetoclax work?
Leukemia cells stay alive partly by making a lot of a protein called BCL-2, which blocks the cell's built-in self-destruct program. Venetoclax binds BCL-2 and switches that block off, so the leukemia cell dies through apoptosis[1]. Azacitidine and decitabine, the hypomethylating agents it is paired with, make leukemia cells more dependent on BCL-2, which is one reason the combination works better than either drug alone[2].
▸What are the side effects of Venetoclax?
Venclexta has no boxed warning, but the label lists 5 warnings: tumor lysis syndrome, when dying leukemia cells release their contents faster than the kidneys can clear them, which is why the dose is ramped up over 3 days with fluids and a uric acid medicine and why VIALE-A patients were hospitalized for the ramp-up; neutropenia, with blood counts checked and doses paused; serious infections; no live vaccines; and harm to an unborn baby[1]. In VIALE-A, with azacitidine, the most common side effects were nausea (44%), diarrhea (43%), febrile neutropenia (42%, all grade 3 or 4), musculoskeletal pain (36%), fatigue (31%), vomiting (30%), swelling (27%), bleeding (27%), decreased appetite (25%), rash (25%) and sepsis (22%)[1]. Because venetoclax is cleared by CYP3A, the antifungal drugs often given during AML treatment (posaconazole, voriconazole) raise its level and require a lower dose[1].
▸How is Venetoclax taken?
For AML, Venclexta is taken by mouth once a day with food. The dose ramps up over 3 days (100 mg on day 1, 200 mg on day 2, then 400 mg from day 3) when it is given with azacitidine or decitabine, and reaches 600 mg when it is given with low-dose cytarabine[1]. Azacitidine is given as an injection or IV infusion on days 1 to 7 of each 28-day cycle, decitabine as an IV infusion on days 1 to 5, and low-dose cytarabine as an injection under the skin on days 1 to 10. Treatment continues until the leukemia progresses or side effects become unacceptable; once a bone marrow test confirms remission, Venclexta is usually paused for up to 14 days each cycle to let blood counts recover[1]. Tumor lysis prophylaxis, hydration and often a short hospital stay accompany the ramp-up, and the white cell count is brought below 25 x 10^9/L before the first dose[1].
▸Is Venetoclax FDA approved?
Yes, Venetoclax (Venclexta) is FDA approved (2018) for the treatment of Acute Myeloid Leukemia.
▸Why does Venclexta start at a low dose?
To lower the risk of tumor lysis syndrome. The dose rises from 100 mg to 400 mg over 3 days while fluids and a uric acid medicine are given, and the white cell count is lowered below 25 x 10^9/L before the first dose.
▸How long do people take Venclexta for AML?
Until the leukemia progresses or side effects are unacceptable. After remission is confirmed on a marrow test, most cycles include a planned break of up to 14 days so blood counts can recover.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- AbbVie Inc. via openFDA · 2026-05-20. Venclexta (venetoclax tablets) prescribing information. https://api.fda.gov/drug/label.json?search=set_id:%22b118a40d-6b56-cee3-10f6-ded821a97018%22
- New England Journal of Medicine · 2020-08-13. Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia. https://pubmed.ncbi.nlm.nih.gov/32786187/
- FDA. Venclexta approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208573
- AbbVie. Financial assistance options for AML patients. https://www.venclexta.com/aml/resources-and-support/financial-and-treatment-support