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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.

Schedule

  • 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.

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Side Effects

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%)

Side effect videos Side Effect Videos
Nausea and VomitingNausea and VomitingConstipationConstipationDiarrheaDiarrheaFatigue Fatigue Neutropenic FeverNeutropenic FeverAnemiaAnemia

Monitoring

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.

ChemoExperts Tips

  • 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:

  • Venetoclax
  • Azacitidine

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.

Emotional Wellness

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®)

Individual Drug Label Information

Venetoclax (Venclexta®)

  • Venetoclax is an oral tablet, available in the following doses: 10 mg, 50 mg, 100 mg 
  • Tumor Lysis Syndrome is expected. Patients at high risk for tumor lysis may need to be hospitalized for the first several doses to receive adequate IV fluids, plus electrolyte and kidney function monitoring 
  • Neutropenia is common. Antibiotics may be needed to prevent or treat infections 
  • Live attenuated vaccines should not be administered before, during, or after treatment with venetoclax as they have not been studied and it is unknown if they are safe to use. Ask your pharmacist if you are not sure which vaccines are safe to use 
  • Venetoclax may make certain vaccines less effective. Repeat vaccination may be required at a later time 
  • Take with food and a large glass of water around the same time of day, each day. Do NOT crush, break, or chew tablets. If your dose is 200 mg or 400 mg, multiple tablets will need to be taken at the same time. Do NOT split up dosing during a day as this may change how the medication works or the incidence of certain side effects 
  • Drug interactions may be severe. Certain medications should NOT be taken together with venetoclax. Ask a pharmacist if your home medications are safe to use 
  • It is recommended to take with food to help with absorption 
  • Avoid grapefruit, grapefruit juice, Seville oranges, marmalade and star fruit as these may increase the amount of venetoclax that is in your body leading to unwanted side effects 
  • If you miss a dose, take venetoclax within 8 hours of the normal time you take it, and resume the normal schedule the next day. If a dose is missed and more than 8 hours has past since you usually take it, skip the dose and resume the next day at your usual time 
  • If vomiting occurs, no dose should be taken until the next scheduled dose on the following day. Do NOT make up for missed doses. 
  • Stored at or below 86 degrees Fahrenheit  
  • Dosage adjustments may be required kidney or liver problems 
  • May interact with antifungal medications ending in “azole,” such as voriconazole or posaconazole. These medications MUST NOT be used during the first 5 weeks of venetoclax therapy 
  • May interact with common medications such as ciprofloxacin, fluconazole, diltiazem, verapamil, amiodarone, St. John’s wort, digoxin, warfarin, vitamins, herbal supplements, and many others. Alternative medications should be considered, or the doses greatly reduced (for example, by 50% or more) 
  • Drug interactions with venetoclax may lead to severe side effects. Certain medications should NOT be taken together. Ask a pharmacist if your home medications are safe with this drug
  • May cause fetal harm, avoid this drug during pregnancy and breastfeeding. Females of child-bearing potential should take a pregnancy test before starting venetoclax and use effective contraceptive during therapy and for at least 30 days after the last dose
  • Males may consider sperm banking as venetoclax may cause infertility 
General Venetoclax (Venclexta) Side Effects 
  • Neutropenia [increased infection risk] 
  • Neutropenic fever [medical emergency requiring IV antibiotics immediately] 
  • Diarrhea 
  • Nausea 
  • Anemia [low red blood cells] 
  • Upper respiratory tract infections such as sinus infection, or sore throat 
  • Low platelet count [increased risk of bleeding] 
  • Fatigue 
  • Vomiting 
  • Constipation 
  • Swelling or water retention 
  • Back pain 
  • Headache 
  • Cough 
  • Venetoclax is NOT expected to cause hair loss 
  • Click on the venetoclax (Venclexta) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue BleedingBleedingPainPainAnemiaAnemiaNeutropenic FeverNeutropenic Fever

See DailyMed package insert.

Azacitidine (Vidaza®)

  • Azacitidine is an intravenous infusion or a subcutaneous (SubQ) injection 
  • Depending upon your dose, you may receive 2 to 3 separate injections if given subcutaneously. This is because only a small amount of fluid can be administered with each subcutaneous injection. In other words, the total dose may be divided into 2 or more injections under the skin
  • Azacitidine is very unstable when given as an intravenous infusion and must finish infusing within 1 hour after it is made.
  • Dosage adjustments may be required for low white blood cells or low platelets 
General Azacitidine (Vidaza) Side Effects 
  • Commonly causes low red blood cells, white blood cells, and platelets. Good blood cells often start to increase after 3 - 4 cycles
  • Click on the azacitidine (Vidaza) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Fatigue Fatigue AnemiaAnemia

See DailyMed package insert.

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References

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.

Created: March 3, 2019 Updated: April 28, 2019

What is Acute Myeloid Leukemia (AML)?

A disease of the myeloid cells found in the bone marrow. Myeloid cells are responsible for developing into mature white blood cells, red blood cells, and platelets. In AML, immature myeloid cells know as “blasts” replicate at a very fast rate. Sometimes blasts crowd out the normal cells in the bone marrow so that red blood cells or platelets are unable to develop. Common symptoms of this include fatigue, difficulty exercising, or easy bruising or bleeding.

Most cases of AML are considered “de novo” meaning that the cause is unknown. However, there are a few known risk factors for AML, such as exposure to radiation, various environmental toxins, and certain chemotherapy agents. There is no staging system for AML. Chromosomes (strands of DNA) are often analyzed to determine which mutations in the chromosomes exist. The effectiveness of the treatment may depend upon the specific chromosome mutations that are present.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

Common Venetoclax (Venclexta®) + Azacitidine (Vidaza®) starting doses

  • Azacitidine 75 mg/m2 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

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

What is Tumor Lysis Syndrome (TLS)?

Tumor lysis syndrome, or TLS, occurs when many cancer cells die quickly and release their contents into the bloodstream. Many times the body has the ability to flush these substances out through the kidneys or metabolize them via the liver. However, sometimes the body needs medicines to help eliminate these substances and to prevent organ damage.