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Treatment Name: Azacitidine (Vidaza®)

Azacitidine (Vidaza®) is a Chemotherapy Regimen for Myelodysplastic Syndromes (MDS)

How does azacitidine work?
Azacitidine is designed to 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, decrease the risk of bleeding, and to prevent MyeloDysplastic Syndrome (MDS) from transforming to acute leukemia. Azacitidine is not commonly given with the goal of cure.

Schedule

  • Azacitidine subcutaneous injection (S.Q.) or intravenous (I.V.) infusion over 30 minutes on days 1, 2, 3, 4, 5, 6, and 7
    OR
  • Azacitidine S.Q. injection or I.V. infusion over 30 minutes on days 1, 2, 3, 4, and 5 (no day 6 or day 7)

Azacitidine is usually given in an outpatient infusion center, allowing the person to go home afterwards. On occasion, azacitidine 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 receive days 1 - 5 of azacitidine on Monday-Friday, skip Saturday and Sunday, then resume treatment on Monday and Tuesday, on days 6 and 7.

Azacitidine is repeated every 28 days. This is known as one cycle. Treatment is continued until azacitidine is no longer working or it is stopped because of unacceptable side effects.

Estimated total infusion time for this treatment: 30 minutes

  • 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

Click here for common starting doses

Side Effects

In clinical studies, the most commonly reported side effects with azacitidine are shown here. Side effects sometimes have percentage ranges [example 38 – 45%] because they differed between in clinical studies:

  • Injection site redness (55%)
  • Low white blood cells (38 - 94%)
  • Injection site pain (34%)
  • Anemia [low red blood cells] (29 - 64%)
  • Fatigue (23 - 56%)
  • Increased bleeding risk [low platelets] (18 - 93%)
  • Nausea (4 - 9%)

On average, 3 - 9% of patients discontinue azacitidine due to unacceptable side effects.

Side effect videos Side Effect Videos
AnemiaAnemiaFatigue Fatigue BleedingBleedingNausea and VomitingNausea and Vomiting

Monitoring

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: computerized tomography (CT) scans and x-rays.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue azacitidine as planned, reduce the dose, delay, or switch therapy

ChemoExperts Tips

  • 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 - 4 cycles (= 3 - 4 months) to see an improvement in the White Blood Cell count, Red Blood Cell count/Hemoglobin, or 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 MDS. 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:

  • 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 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 Azacitidine (Vidaza®)

Individual Drug Label Information

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. Silverman LR, Demakos EP, Peterson BL, et al. Randomized Controlled Trial of Azacitidine in Patients With the Myelodysplastic Syndrome: A Study of the Cancer and Leukemia Group B. J Clin Oncol. 2002;20:2429-2440.

2. Fenaux P, Mufti GJ, Hellstrom-Lindberg E, et al. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study. Lancet Oncol 2009;10:223-232.

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.

4. Martin MG, Walgren RA, Procknow E, et al. A phase II study of 5-day intravenous azacitidine in patients with myelodysplastic syndromes. Am J Hematol. 2009;84:560-564.

Created: October 1, 2015 Updated: September 10, 2018

What is Myelodysplastic Syndromes (MDS)?

Myelodysplastic Syndromes (MDS) are a group of blood disorders where the bone marrow either fails to make mature blood cells, or immature cells build up and crowd out normal cells preventing them from developing normally.

This often results in the bone marrow producing too few blood cells leading to: 1) A low white blood cell count (neutropenia), which can increase the risk of infection; 2) A low red blood cell count (anemia), which may contribute to weakness, fatigue, or shortness of breath; or 3) A low platelet count (thrombocytopenia), which can increase the risk of bleeding. Depending upon the type of MDS, some patients have neutropenia, AND anemia, AND thrombocytopenia.

In newly diagnosed cases of MDS, the causes are not always known. This is sometimes referred to as “de novo” MDS. However, exposure to certain chemicals, radiation, and chemotherapy are known to increase the risk of MDS. When causes are known, this is referred to as "secondary MDS." There are various subtypes of MDS and treatment depends on the specific subtype and risk level. High risk patients may be treated more aggressively than low risk patients. The effectiveness of treatment often depends upon the type of MDS as not all types respond the same way to treatment.

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.

Clinical Studies

If you are interested in reading the clinical trials results, please click on references below:

1. Silverman LR, Demakos EP, Peterson BL, et al. Randomized Controlled Trial of Azacitidine in Patients With the Myelodysplastic Syndrome: A Study of the Cancer and Leukemia Group B. J Clin Oncol. 2002;20:2429-2440.

2. Fenaux P, Mufti GJ, Hellstrom-Lindberg E, et al. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study. Lancet Oncol 2009;10:223-232.

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.

4. Martin MG, Walgren RA, Procknow E, et al. A phase II study of 5-day intravenous azacitidine in patients with myelodysplastic syndromes. Am J Hematol. 2009;84:560-564.

Common Starting doses

  • Azacitidine 75 mg/m2 subcutaneous (S.Q.) injection or I.V. infusion over 30 minutes on Days 1, 2, 3, 4, 5, 6, and 7

OR

  • Azacitidine 75 mg/m2 S.Q. injection or I.V. infusion over 30 minutes on Days 1, 2, 3, 4, and 5 (NO day 6 or day 7)

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

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 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.