Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Dacogen

Descriptions


Decitabine is used to treat myelodysplastic syndromes (diseases of the blood and bone marrow; MDS) and certain types of anemia. This medicine is an antineoplastic (cancer medicine) .

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

This product is available in the following dosage forms:

  • Powder for Solution

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 decitabine in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of decitabine in the elderly .

Pregnancy

Information about this decitabine-intravenous-route
Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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. When you are receiving 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:

  • Kidney disease or
  • Liver disease—Use with caution. Studies have not been done in patients with these conditions .

Proper Use

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment .

You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine .

This medicine is given through a needle placed into one of your veins .

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 may be needed to check for unwanted effects .

Using this medicine while you are pregnant can harm your unborn baby. The medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using this medicine, tell your doctor right away. Men should not father a child while receiving this medicine, and for 2 months after the treatment .

Cancer medicines can cause nausea and/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 .

Decitabine 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 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 .

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 after defecation
  4. bleeding gums
  5. blood in urine or stools
  6. bloody or cloudy urine
  7. blue lips and fingernails
  8. blurred vision
  9. body aches or pain
  10. chest pain
  11. chills
  12. coma
  13. congestion
  14. convulsions
  15. cough
  16. coughing that sometimes produces a pink frothy sputum
  17. decreased urination
  18. difficult, burning, or painful urination
  19. difficult, fast, noisy breathing, sometimes with wheezing
  20. dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
  21. drowsiness
  22. dry mouth
  23. dryness of throat
  24. facial swelling
  25. fainting
  26. fast or irregular heartbeat
  27. feeling unusually cold
  28. fever
  29. flushed, dry skin
  30. frequent urge to urinate
  31. fruit-like breath odor
  32. headache
  33. hives or welts
  34. hoarseness
  35. increased hunger
  36. increased sweating
  37. increased thirst
  38. increased urination
  39. itching, pain, redness, swelling, tenderness, or warmth on skin
  40. lightheadedness
  41. loss of appetite
  42. lower back or side pain
  43. mood or mental changes
  44. muscle pain or cramps
  45. muscle spasms or twitching
  46. nausea or vomiting
  47. nervousness
  48. numbness or tingling in hands, feet, or lips
  49. pale skin
  50. pinpoint red spots on skin
  51. redness or pain at the catheter site
  52. runny nose
  53. seizures
  54. shivering
  55. shortness of breath
  56. skin rash
  57. small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope
  58. small red or purple spots on skin, lips or in mouth
  59. sneezing
  60. sore mouth or tongue
  61. sore throat
  62. sores, ulcers, or white spots on lips or in mouth
  63. stomach pain and bloating
  64. sunken eyes
  65. swelling of face, hands, ankles, feet, or lower legs
  66. swollen, painful, or tender lymph glands in neck, armpit, or groin
  67. tightness in chest
  68. trembling
  69. trouble in swallowing
  70. troubled breathing with exertion
  71. uncomfortable swelling around anus
  72. unexplained weight loss
  73. unusual bleeding or bruising
  74. unusual tiredness or weakness
  75. voice changes
  76. weakness or heaviness of legs
  77. wheezing
  78. white patches in mouth and/or on tongue
  79. wrinkled skin
  80. yellow eyes or skin

Less common

  1. Collection of blood under skin
  2. deep, dark purple bruise
  3. diarrhea
  4. pain or tenderness around eyes and cheekbones
  5. pain, warmth, or burning in fingers, toes, and legs
  6. problems with vision or hearing
  7. skin scrape or burn
  8. stuffy nose
  9. swelling at injection site

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. anxiety
  3. back pain
  4. belching
  5. bumps on skin
  6. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  7. chest discomfort
  8. constipation
  9. difficulty swallowing
  10. fall
  11. hair loss, thinning of hair
  12. heartburn
  13. indigestion
  14. loose stools
  15. muscle stiffness
  16. pain in arms or legs
  17. pain in joints
  18. sleeplessness
  19. stomach discomfort or upset
  20. swelling or inflammation of the mouth
  21. trouble sleeping
  22. unable to sleep
  23. unusual drowsiness, dullness, or feeling of sluggishness

Less common

  1. Difficulty in moving
  2. general feeling of discomfort or illness
  3. muscle aching
  4. pain in the tongue
  5. postnasal drip
  6. pressure in the stomach
  7. swollen joints

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.