In the U.S.—

• Antineoplastic

Azacitidine ( ay-za-SITE-i deen) belongs to the group of medicines known as antimetabolites. It is used to treat some kinds of cancer.

Azacitidine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by azacitidine, other effects will also occur. Some of these may be serious and must be reported to your doctor. Some effects may not occur for months or years after the medicine is used.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Parenteral
• For Injection (U.S.)

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 azacitidine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to azacitidine or mannitol. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—It is best to avoid pregnancy during treatment with this medicine. Studies in animals have found that azacitidine causes birth defects and/or death of the fetus. Be sure that you have discussed this with your doctor before starting treatment with this medicine. Also, tell your doctor right away if you think you have become pregnant while taking this medicine.

Breast-feeding—It is not known whether azacitidine passes into breast milk. However, because this medicine may cause serious side effects, breast-feeding is generally not recommended while you are receiving it.

Children—There is no specific information comparing use of azacitidine in children with use in other age groups.

Older adults—Azacitidine has been tested in elderly patients and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, older patients are more likely to have age-related kidney problems which may require monitoring

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 health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Cancerous liver tumors—The risk of side effects that affect the liver may be increased. Azacitidine should not be used in patients with cancerous liver tumors.

• Kidney disease or
• Liver disease—These conditions sometimes increase the effects of medicines by causing them to be removed from the body more slowly.

Azacitidine sometimes causes nausea and vomiting. Tell your doctor if this occurs, especially if you have stomach pain

Dosing—

The dose of azacitidine will be different for different patients. The dose that is used may depend on a number of things, including the type of cancer being treated, the patient's size, and whether or not other treatments are also being given. If you are receiving azacitidine at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of azacitidine, ask your doctor.

Missed dose—

If you miss a dose of this medicine, ask your doctor what to do.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests will be needed to check for unwanted 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.

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These may include certain types of cancer, such as leukemia or bladder cancer. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur:

• More common
  • Black, tarry stools;  bladder pain;  bleeding gums;  blood in urine or stools ;  cloudy urine;  body aches or pain;  burning or stinging of skin;  chest pain;  chills;  congestion;  cough;  difficult breathing;  difficulty swallowing;  dizziness;  ear congestion;  fast heartbeat;  fever;  frequent urge to urinate;  headache;  hives;  hoarseness;  itching;  loss of voice;  lower back or side pain;  muscle aches;  nasal congestion;  nausea;  pain or tenderness around eyes and cheekbones;  painful cold sores or blisters on lips, nose, eyes, or genitals;  painful or difficult urination;  pain, redness, swelling, tenderness, warmth on skin;  pale skin;  pinpoint red spots on skin;  puffiness or swelling of the eyelids or around the eyes, face, lips or tongue ;  rapid heartbeat;  runny nose;  shortness of breath;  skin rash;  sneezing;  sore throat;  sores, ulcers, or white spots on lips or in mouth;  stuffy nose;  swollen glands;;  tender, swollen glands in neck;  tightness in chest;  troubled breathing with exertion;  unusual bleeding or bruising;  unusual tiredness or weakness;  voice changes;  vomiting;  wheezing  
  
  

• Less common
  • Change in consciousness;  convulsions ;  decreased urine;  drowsiness ;  dry mouth;  increased blood creatinine;  increased blood pressure;  increased thirst;  irregular heartbeat ;  loss of appetite;  mood changes;  muscle pain or cramps;  numbness or tingling in hands, feet, or lips;  loss of consciousness 
  
  

• Symptoms of Overdose

  Get emergency help immediately if any of the following symptoms of overdose occur

  • Diarrhea;  nausea;  vomiting 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Acid or sour stomach;  appetite decreased ;  belching;  bleeding after defecation;  bloody nose;  blurred vision;  bruise;  bumps on skin;  burning, crawling, itching, numbness, prickling, "pins and needles"; or tingling feelings;  burning while urinating;  confusion;  diarrhea;  difficulty having a bowel movement (stool);  difficulty in moving;  discouragement;  dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly ;  dry skin;  fainting;  fear;  feeling of discomfort or illness; ;  feeling of sluggishness;  feeling sad or empty;  feeling unusually cold;  flushing;  full or bloated feeling or pressure in the stomach;  heartburn;  heart murmur;  indigestion;  inflamed tissue from infection at the site of injection;  injection site bruising;  irritability ;  itching at injection site;  joint pain;  lack of appetite;  large, flat, blue or purplish patches in the skin;  loss of interest or pleasure;  mouth hemorrhage;  muscle stiffness;  nervousness;  night sweats;  pain in joints;  postnasal drip;  post procedural hemorrhage ;  redness of skin;  shivering ;  sleeplessness;  small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope ;  small lumps under the skin;  small red or purple spots in mouth;  soreness or discomfort to touch or pressure on stomach;  stomach discomfort upset or pain;  sweating;  swelling of abdominal or stomach area;  swelling of hands, ankles, feet, or lower legs;  swelling or inflammation of the mouth;  swelling with pits or depressions visible on skin;  swollen joints;  tongue ulceration;  trouble concentrating;  trouble sleeping;  uncomfortable swelling around anus;  unusual drowsiness;  unusually warm skin;  upper abdominal pain;  weight loss 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.