Pronunciation:

dee-SYE-ta-been

Brand Names:

• Dacogen

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Antimetabolite

Uses of This Medicine:

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.

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

Older adults—

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.

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. 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 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.

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 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.

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 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 the urine or stools

bloody or cloudy urine

blue lips and fingernails

blurred vision

body aches or pain

chest pain

chills

congestion

cough

coughing that sometimes produces a pink frothy sputum

decreased urination

difficult, burning, or painful urination

difficult, fast, or noisy breathing

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position

drowsiness

dry mouth or throat

fainting

fast or irregular heartbeat

feeling unusually cold

fever

flushed, dry skin

frequent urge to urinate

fruit-like breath odor

headache

hives or welts, itching, skin rash

hoarseness

increased hunger

increased sweating

increased thirst

increased urination

lightheadedness

loss of appetite

loss of consciousness

lower back or side pain

mood or mental changes

muscle pain, cramps, spasms, or twitching

nausea

nervousness

numbness or tingling in the hands, feet, or lips

pain, redness, swelling, tenderness, or warmth on the skin

pale skin

pinpoint red spots on the skin

redness or pain at the catheter site

runny nose

seizures

shivering

small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope

small red or purple spots on the skin, lips or in the mouth

sneezing

sore mouth, tongue, or throat

sores, ulcers, or white spots on the lips or in the mouth

stomach pain and bloating

sunken eyes

swelling of the face, hands, ankles, feet, or lower legs

swollen, painful, or tender lymph glands in the neck, armpit, or groin

tightness in the chest

trembling

trouble in swallowing

troubled breathing with exertion

uncomfortable swelling around the anus

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

voice changes

vomiting

weakness or heaviness of the legs

wrinkled skin

yellow eyes or skin

Less common

Collection of blood under the skin

deep, dark purple bruise

diarrhea

pain or tenderness around the eyes and cheekbones

pain, warmth, or burning in the fingers, toes, and legs

problems with vision or hearing

skin scrape or burn

stuffy nose

swelling at the injection site

Incidence not known

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

Anxiety

back pain

belching

bumps on the skin

chest discomfort

constipation

falls

hair loss or thinning of the hair

heartburn

indigestion

loose stools

muscle stiffness

pain in the arms or legs

pain in joints

stomach discomfort or upset

swelling or inflammation of the mouth

trouble sleeping

unusual drowsiness, dullness, or feeling of sluggishness

Less common

Difficulty in moving

general feeling of discomfort or illness

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.