Treatment Name: Venetoclax (Venclexta®) + Azacitidine (Vidaza®)
Venetoclax (Venclexta®) + Azacitidine (Vidaza®) is a Chemotherapy Regimen for Acute Myeloid Leukemia (AML)
How does venetoclax + azacitidine work?
Azacitidine is designed to slow the production of leukemia cells and help the bone marrow produce more healthy and normal functioning cells. Venetoclax is designed to kill leukemia cells by binding to and inhibiting a protein in cancerous cells that prevents the cell from dying known as “BCL-2”. When azacitidine and venetoclax are given together they work together better than if either drug is given alone.
Goals of therapy:
Venetoclax + azacitidine is typically given as a first line therapy to patients who cannot tolerate intensive treatment. The goal of treatment is to help increase blood cell counts and possibly put leukemia into remission. Venetoclax + azacitidine is not commonly given with the goal of cure, but to help patients live longer.
- Azacitidine subcutaneous (SubQ) injection or intravenous (I.V.) infusion over 15 minutes on Days 1, 2, 3, 4, 5, 6, and 7
- Venetoclax 100 mg oral tablet by mouth once daily on Day 1
- Then 200 mg (two 100 mg tablets) by mouth once daily on Day 2
- Then 400 mg (four 100 mg tablets) by mouth once daily on Day 3
- Then 400 mg (four 100 mg tablets) by mouth once daily every day thereafter
Estimated total infusion time for this treatment:
- Up to 30 minutes for each day that azacitidine is given
- Infusion times are based on clinical studies, but may vary depending on doctor preference or patient tolerability. Pre-medications and intravenous (I.V.) fluids, such as hydration, may add more time
Azacitidine is usually given in an outpatient infusion center, allowing the person to go home afterwards. On occasion, it may be given in the hospital if someone is too sick. Venetoclax is usually taken at home or may be given in the hospital if someone is too sick.
Some infusion centers that administer chemotherapy are not open on weekends. If azacitidine is scheduled to be given for 7 days each cycle and you need weekends off, you may received.
Days 1 - 5 of azacitidine on Monday-Friday, skip Saturday and Sunday, then resume treatment on Monday and Tuesday, on Days 6 and 7.
Venetoclax + azacitidine is repeated every 28 days. This is known as one Cycle. Each cycle may be repeated until the regimen no longer works or until unacceptable side effects occur.
Click here for the common venetoclax + azacitidine starting doses.
In a multi-drug regimen, each medication has unique side effects. When these medicines are given together, drug-related side effects reported in clinical studies give the best estimate of what to expect. In clinical studies, the most commonly reported side effects of venetoclax + azacitidine are shown here:
- Infection (74%)
- Nausea (62%)
- Constipation (59%)
- Diarrhea (52%)
- Fatigue (39%)
- Neutropenic fever (38%)
- Swelling in arms and legs (34%)
- Low platelets [thrombocytopenia] (34%)
- Low red blood cells [anemia] (31%)
- Vomiting (31%)
- Decreased appetite (28%)
- Cough (21%)
- Low white blood cells [neutropenia] (21%)
- Low blood potassium (17%)
- Stomach bloating (7%)
- Trouble swallowing (7%)
- Tumor lysis syndrome [TLS] (0%)
How often is monitoring needed?
Labs (blood tests) may be checked before treatment then as often as every 6 to 8 hours during the first few days of treatment. After the first few days of treatment, labs are checked at your doctor’s discretion. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), uric acid, blood phosphorous levels, plus any others your doctor may order.
How often is imaging needed?
Imaging may be checked if there is concern of an infection or bleeding during treatment. Imaging may include: X-rays, magnetic resonance imaging (MRI), or computerized tomography (CT) scans.
How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue venetoclax + azacitidine as planned, reduce the dose of future treatments, delay the next dose until the side effect goes away, or switch to an alternative therapy.
- Your white blood cell count (WBC) should be less than 25 x 109/L before starting treatment. If your WBC is higher than 25 x 109/L, you may need to receive a medication such as hydroxyurea (Hydrea) to help lower your blood counts before starting therapy with venetoclax + azacitidine
- For the first few days of therapy, you may receive intravenous fluids and a medication called allopurinol to help lower your risk of experiencing tumor lysis syndrome. Once your risk of tumor lysis syndrome is determined to be very low, these medications can be stopped
- Only a certain amount of fluid can be given by subcutaneous (S.Q.) injection at one time. Because of this, the total dose of azacitidine may need to be given as multiple separate injections on the same day
- Your blood counts may initially decrease or remain very low after beginning therapy and blood transfusion may be needed or their frequency may increase. On average, it takes 1 to 2 cycles (or 1 to 2 months) to see an improvement in the white blood cell count, red blood cell count, and platelet count
- Venetoclax interacts with medications commonly taken for other reasons. Common medications that may be given that interact with ventoclax include voriconazole (Vfend®), posaconazole (Noxafil®), and fluconazole (Diflucan®)
- A pharmacist should ALWAYS review your medication list BEFORE starting venetoclax to ensure that drug interactions are prevented or managed appropriately. On occasion, medications that you were taking regularly before venetoclax may need to be switched or discontinued in order to safely take venetoclax or your dose of venetoclax may be lowered. Ask a pharmacist before starting ANY new medication if you are already taking venetoclax
- Clinical trials may exist for AML. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications
Patient Assistance & Co-payment Coverage
Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Venetoclax (Venclexta®) + Azacitidine (Vidaza®), we have provided links that may help.
Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Venetoclax (Venclexta®) + Azacitidine (Vidaza®). Depending upon your income, they may be able to help cover the cost of:
For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.
- If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.
Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Venetoclax (Venclexta®) + Azacitidine (Vidaza®) and are the best source to help you understand drug cost.
- Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.
What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.
Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.
Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.
Learn more about pursuing emotional wellness while receiving treatment with Venetoclax (Venclexta®) + Azacitidine (Vidaza®)
1) DiNardo CD, Pratz K, Pullarkat V, et al. Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. Blood. 2019;133:7-17.
2) Supplement to: DiNardo CD, Pratz K, Pullarkat V, et al. Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. Blood. 2019;133:7-17.
3) Lyons RM, Cosgriff TM, Modi SS, et al. Hematologic Response to Three Alternative Dosing Schedules of Azacitidine in Patients With Myelodysplastic Syndromes. J Clin Oncol 2009;27:1850-1856.