Description and Brand Names

Drug information provided by: Micromedex

Descriptions


Azacitidine injection is used to treat patients with French-American-British (FAB) myelodysplastic syndrome subtypes, including refractory anemia or chronic leukemia.

Azacitidine belongs to the group of medicines called metabolites. It 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 to be given only by or under the direct supervision of your doctor.

This product is available in the following dosage forms:

  • Powder for Suspension

Before Using

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:

Allergies

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of azacitidine injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of azacitidine injection in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution in patients receiving azacitidine injection.

Breastfeeding

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

  • Allergy to mannitol or
  • Cancerous liver tumors—Should not be used in patients with these conditions.
  • Anemia or
  • Liver disease or
  • Neutropenia (low white blood cells) or
  • Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

A nurse or other trained health professional will give you this medicine. You may also be taught how to give your medicine at home. This medicine is given as a shot under your skin or into a vein.

This medicine is given once a day, for 7 days (1 treatment cycle). Then, you may receive this medicine every 4 weeks. You may also receive medicines to help prevent nausea and vomiting.

Cancer medicines can cause nausea or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Precautions

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.

Your unborn baby could be harmed if you use this medicine while you are pregnant. Women receiving azacitidine injection should use an effective form of birth control to keep from getting pregnant There is also a potential for this medicine to cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are receiving this medicine, tell your doctor right away.

Azacitidine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

Side Effects

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.

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

More common

  1. Black, tarry stools
  2. bladder pain
  3. bleeding gums
  4. blood in the urine or stools
  5. cloudy urine
  6. body aches or pain
  7. burning or stinging of the 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, itching, or skin rash
  21. hoarseness
  22. loss of voice
  23. lower back or side pain
  24. muscle aches
  25. nasal congestion
  26. nausea
  27. pain or tenderness around the eyes and cheekbones
  28. painful cold sores or blisters on the lips, nose, eyes, or genitals
  29. painful or difficult urination
  30. pain, redness, swelling, tenderness, warmth on the skin
  31. pale skin
  32. pinpoint red spots on the skin
  33. puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
  34. rapid heartbeat
  35. runny nose
  36. sneezing
  37. sore throat
  38. sores, ulcers, or white spots on lips or in mouth
  39. stuffy nose
  40. swollen glands
  41. tender, swollen glands in the neck
  42. tightness in the chest
  43. troubled breathing with exertion
  44. unusual bleeding or bruising
  45. unusual tiredness or weakness
  46. voice changes
  47. vomiting

Less common

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

Get emergency help immediately if any of the following symptoms of overdose occur:

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