Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Dacogen

Descriptions


Decitabine injection is used to treat myelodysplastic syndromes (MDS), a group of cancers in which immature blood cells in the bone marrow do not mature and do not become healthy blood cells. It also treats certain types of anemia. Decitabine 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 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 decitabine in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

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:

  • Infection—May decrease your body's ability to fight an infection.

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.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. You may receive this medicine either as a 3-day or 5-day regimen.

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.

Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

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.

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 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.

If you plan to have children, talk with your doctor before receiving this medicine. Some men receiving this medicine have become infertile (unable to have children).

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

Less common

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

Incidence not known

  1. Fever sores on the skin

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. Anxiety
  2. back pain
  3. belching
  4. bumps on the skin
  5. chest discomfort
  6. constipation
  7. falls
  8. hair loss or thinning of the hair
  9. heartburn
  10. indigestion
  11. loose stools
  12. muscle stiffness
  13. pain in the arms or legs
  14. pain in joints
  15. stomach discomfort or upset
  16. swelling or inflammation of the mouth
  17. trouble sleeping
  18. unusual drowsiness, dullness, or feeling of sluggishness

Less common

  1. Difficulty in moving
  2. general feeling of discomfort or illness
  3. postnasal drip
  4. pressure in the stomach
  5. 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.