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Decitabine (Intravenous route)

Pronunciation:

dee-SYE-ta-been

Brand Names:

  • Dacogen

Dosage Forms:

  • Powder for Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

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 .

Before Using This Medicine:

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.

Children—

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 .

Older adults—

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

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies 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.

Breast-feeding—

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.

Other medicines—

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 of This Medicine:

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 While Using This Medicine:

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 of This Medicine:

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
Black, tarry stools
bladder pain
bleeding after defecation
bleeding gums
blood in urine or stools
bloody or cloudy urine
blue lips and fingernails
blurred vision
body aches or pain
chest pain
chills
coma
congestion
convulsions
cough
coughing that sometimes produces a pink frothy sputum
decreased urination
difficult, burning, or painful urination
difficult, fast, noisy breathing, sometimes with wheezing
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
drowsiness
dry mouth
dryness of throat
facial swelling
fainting
fast or irregular heartbeat
feeling unusually cold
fever
flushed, dry skin
frequent urge to urinate
fruit-like breath odor
headache
hives or welts
hoarseness
increased hunger
increased sweating
increased thirst
increased urination
itching, pain, redness, swelling, tenderness, or warmth on skin
lightheadedness
loss of appetite
lower back or side pain
mood or mental changes
muscle pain or cramps
muscle spasms or twitching
nausea or vomiting
nervousness
numbness or tingling in hands, feet, or lips
pale skin
pinpoint red spots on skin
redness or pain at the catheter site
runny nose
seizures
shivering
shortness of breath
skin rash
small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope
small red or purple spots on skin, lips or in mouth
sneezing
sore mouth or tongue
sore throat
sores, ulcers, or white spots on lips or in mouth
stomach pain and bloating
sunken eyes
swelling of face, hands, ankles, feet, or lower legs
swollen, painful, or tender lymph glands in neck, armpit, or groin
tightness in chest
trembling
trouble in swallowing
troubled breathing with exertion
uncomfortable swelling around anus
unexplained weight loss
unusual bleeding or bruising
unusual tiredness or weakness
voice changes
weakness or heaviness of legs
wheezing
white patches in mouth and/or on tongue
wrinkled skin
yellow eyes or skin
Less common
Collection of blood under skin
deep, dark purple bruise
diarrhea
pain or tenderness around eyes and cheekbones
pain, warmth, or burning in fingers, toes, and legs
problems with vision or hearing
skin scrape or burn
stuffy nose
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
Acid or sour stomach
anxiety
back pain
belching
bumps on skin
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chest discomfort
constipation
difficulty swallowing
fall
hair loss, thinning of hair
heartburn
indigestion
loose stools
muscle stiffness
pain in arms or legs
pain in joints
sleeplessness
stomach discomfort or upset
swelling or inflammation of the mouth
trouble sleeping
unable to sleep
unusual drowsiness, dullness, or feeling of sluggishness
Less common
Difficulty in moving
general feeling of discomfort or illness
muscle aching
pain in the tongue
postnasal drip
pressure in the stomach
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.


Last Updated: 4/4/2014

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