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Azacitidine (Subcutaneous Route)


Description and Brand Names of Azacitidine (Subcutaneous Route)


Azacitidine belongs to the group of medicines known as antimetabolites. It is used to treat some kinds of cancer.

Azacitidine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by azacitidine, other effects will also occur. Some of these may be serious and must be reported to your doctor. Some effects may not occur for months or years after the medicine is used.

This medicine is available only with your doctor’s prescription.

This product is available in the following dosage forms:

  • Powder for Suspension

Before Using Azacitidine (Subcutaneous Route)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


There is no specific information comparing use of azacitidine in children with use in other age groups.


Azacitidine has been tested in elderly patients and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, older patients are more likely to have age-related kidney problems which may require monitoring



There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adenovirus Vaccine Type 4, Live
  • Adenovirus Vaccine Type 7, Live
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Influenza Virus Vaccine, Live
  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Yellow Fever Vaccine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Cancerous liver tumors – The risk of side effects that affect the liver may be increased. Azacitidine should not be used in patients with cancerous liver tumors.
  • Kidney disease or
  • Liver disease – These conditions sometimes increase the effects of medicines by causing them to be removed from the body more slowly.

Proper Use of Azacitidine (Subcutaneous Route)

Azacitidine sometimes causes nausea and vomiting. Tell your doctor if this occurs, especially if you have stomach pain


The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

Call your doctor or pharmacist for instructions.


It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests will be needed to check for unwanted effects.

Side Effects of Azacitidine (Subcutaneous Route)

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These may include certain types of cancer, such as leukemia or bladder cancer. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Black, tarry stools
  2. bladder pain
  3. bleeding gums
  4. blood in urine or stools
  5. cloudy urine
  6. body aches or pain
  7. burning or stinging of skin
  8. chest pain
  9. chills
  10. congestion
  11. cough
  12. difficult breathing
  13. difficulty swallowing
  14. dizziness
  15. ear congestion
  16. fast heartbeat
  17. fever
  18. frequent urge to urinate
  19. headache
  20. hives
  21. hoarseness
  22. itching
  23. loss of voice
  24. lower back or side pain
  25. muscle aches
  26. nasal congestion
  27. nausea
  28. pain or tenderness around eyes and cheekbones
  29. painful cold sores or blisters on lips, nose, eyes, or genitals
  30. painful or difficult urination
  31. pain, redness, swelling, tenderness, warmth on skin
  32. pale skin
  33. pinpoint red spots on skin
  34. puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
  35. rapid heartbeat
  36. runny nose
  37. shortness of breath
  38. skin rash
  39. sneezing
  40. sore throat
  41. sores, ulcers, or white spots on lips or in mouth
  42. stuffy nose
  43. swollen glands;
  44. tender, swollen glands in neck
  45. tightness in chest
  46. troubled breathing with exertion
  47. unusual bleeding or bruising
  48. unusual tiredness or weakness
  49. voice changes
  50. vomiting
  51. wheezing

Less common

  1. Change in consciousness
  2. convulsions
  3. decreased urine
  4. drowsiness
  5. dry mouth
  6. increased blood creatinine
  7. increased blood pressure
  8. increased thirst
  9. irregular heartbeat
  10. loss of appetite
  11. mood changes
  12. muscle pain or cramps
  13. numbness or tingling in hands, feet, or lips
  14. loss of consciousness

Symptoms of Overdose

  1. Diarrhea
  2. nausea
  3. vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  1. Acid or sour stomach
  2. appetite decreased
  3. belching
  4. bleeding after defecation
  5. bloody nose
  6. blurred vision
  7. bruise
  8. bumps on skin
  9. burning, crawling, itching, numbness, prickling, “pins and needles”; or tingling feelings
  10. burning while urinating
  11. confusion
  12. diarrhea
  13. difficulty having a bowel movement (stool)
  14. difficulty in moving
  15. discouragement
  16. dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  17. dry skin
  18. fainting
  19. fear
  20. feeling of discomfort or illness;
  21. feeling of sluggishness
  22. feeling sad or empty
  23. feeling unusually cold
  24. flushing
  25. full or bloated feeling or pressure in the stomach
  26. heartburn
  27. heart murmur
  28. indigestion
  29. inflamed tissue from infection at the site of injection
  30. injection site bruising
  31. irritability
  32. itching at injection site
  33. joint pain
  34. lack of appetite
  35. large, flat, blue or purplish patches in the skin
  36. loss of interest or pleasure
  37. mouth hemorrhage
  38. muscle stiffness
  39. nervousness
  40. night sweats
  41. pain in joints
  42. postnasal drip
  43. post procedural hemorrhage
  44. redness of skin
  45. shivering
  46. sleeplessness
  47. small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope
  48. small lumps under the skin
  49. small red or purple spots in mouth
  50. soreness or discomfort to touch or pressure on stomach
  51. stomach discomfort upset or pain
  52. sweating
  53. swelling of abdominal or stomach area
  54. swelling of hands, ankles, feet, or lower legs
  55. swelling or inflammation of the mouth
  56. swelling with pits or depressions visible on skin
  57. swollen joints
  58. tongue ulceration
  59. trouble concentrating
  60. trouble sleeping
  61. uncomfortable swelling around anus
  62. unusual drowsiness
  63. unusually warm skin
  64. upper abdominal pain
  65. weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.