Treatment Name: Azacitidine (Vidaza®)
How does azacitidine work?
Azacitidine is designed to slow the production of leukemia cells and help the bone marrow produce more healthy and normal functioning cells.
Goals of therapy:
Azacitidine is given to help increase blood cell counts, reduce the risk of infection, reduce the amount of blood transfusions needed, and decrease the risk of bleeding. Azacitidine is not commonly given with the goal of cure, but may help patients live longer.
- Azacitidine subcutaneous injection (S.Q. - SubQ) or intravenous (I.V.) infusion over 10 to 40 minutes on Days 1, 2, 3, 4, 5, 6, and 7
Estimated total infusion time for this treatment:
- Up to one hour for each treatment; SubQ may only take a few minutes, but add about 30 minutes or longer wait time for drug preparation
- Infusion times are based on clinical studies, but may vary depending on doctor preference or patient tolerability. Pre-medications and 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.
Azacitidine is repeated every 28 days. This is known as one Cycle. Each cycle may be repeated until the drug no longer works or until unacceptable side effects occur. Duration of therapy depends upon response, tolerability, and number of cycles prescribed.
Some infusion centers that administer chemotherapy are not open on weekends. If azacitidine is scheduled to be given for 7 consecutive days each cycle and you need weekends off, you may receive Days 1 through 5 of azacitidine on Monday - Friday, skip Saturday and Sunday, then resume treatment on Monday and Tuesday, for Days 6 and 7.
Click here for the common azacitidine starting doses.
In clinical studies, the most commonly reported side effects of azacitidine are shown here:
- Nausea (27%)
- Low white blood cells [neutropenia] (20%)
- Low platelets (17%)
- Neutropenic fever (15%)
- Vomiting (14%)
- Decreased appetite (14%)
- Constipation (13%)
- Injection site reaction (13%)
- Fever (12%)
- Diarrhea (12%)
- Swelling and redness at the injection site (12%)
- Low red blood cells [anemia] (8%)
- Low blood potassium (2%)
- Oral cold sores (1%)
On average, 9% of patients discontinue treatment due to unacceptable side effects.
How often is monitoring needed?
Labs (blood tests) may be checked before treatment and periodically during treatment. They may be checked more often after the start of therapy until blood counts start to increase. Once blood counts return to safer levels, labs may be checked less frequently. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), plus any others your doctor may order.
How often is imaging needed?
Imaging may be checked if there is concern for an infection or internal bleeding. 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 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.
- 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 3 to 4 cycles (or 3 to 4 months) to see an improvement in the white blood cell count, red blood cell count, and platelet count
- A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
- 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 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 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 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 Azacitidine (Vidaza®)
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.
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.
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 status, 2) 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
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein
13) Serum glucose
14) Serum calcium
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.
Common Starting Doses
Azacitidine 75 mg/m2 subcutaneous injection (S.Q.), or intravenous (I.V.) infusion over 10 to 40 minutes on Days 1, 2, 3, 4, 5, 6, and 7, of a 28-day Cycle.
Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.
1. Dombret H, Seymour JF, Butrym A, et al. International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts.Blood 2015;126(3):291-9.
2. Fenaux P, Mufti GJ, Hellström-Lindberg E, et al. Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia. J Clin Oncol 2010;28(4):562-9.