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Azacitidine (Subcutaneous Route)

Description

Azacitidine 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.

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

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

Geriatric

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

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

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 taking 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
• 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:

• 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.

Proper Use

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

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

Call your doctor or pharmacist for instructions.

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 will be needed to check for unwanted effects.

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.

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:

• 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

• 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

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

• Diarrhea
• Nausea
• Vomiting

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:

• 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 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.

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