Dacogen

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

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

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.

• Bacillus of Calmette and Guerin Vaccine, Live


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Poliovirus Vaccine, Live


• Rotavirus 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 diseasea€”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

• 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.