Health Guide
Drug Guide

Azacitidine (Injection route)

Pronunciation:

ay-za-SYE-ti-deen

Brand Names:

Dosage Forms:

Classifications:

Therapeutic

Antineoplastic Agent

Uses of This Medicine:

Azacitidine injection is used to treat patients with French-American-British (FAB) myelodysplastic syndrome subtypes, including refractory anemia or chronic leukemia.

Azacitidine belongs to the group of medicines called metabolites. It 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 to be given only by or under the direct supervision of your doctor.

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 azacitidine 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 azacitidine injection in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution in patients receiving azacitidine injection.

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.

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.

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:

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. You may also be taught how to give your medicine at home. This medicine is given as a shot under your skin or into a vein.

This medicine is given once a day, for 7 days (1 treatment cycle). Then, you may receive this medicine every 4 weeks. You may also receive medicines to help prevent nausea and vomiting.

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.

Missed dose

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

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 will be needed to check for unwanted effects.

Your unborn baby could be harmed if you use this medicine while you are pregnant. Women receiving azacitidine injection should use an effective form of birth control to keep from getting pregnant There is also a potential for this medicine to cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are receiving this medicine, tell your doctor right away.

Azacitidine 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:

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

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 gums
blood in the urine or stools
cloudy urine
body aches or pain
burning or stinging of the skin
chest pain
chills
congestion
cough
difficult breathing
difficulty swallowing
dizziness
ear congestion
fast heartbeat
fever
frequent urge to urinate
headache
hives, itching, or skin rash
hoarseness
loss of voice
lower back or side pain
muscle aches
nasal congestion
nausea
pain or tenderness around the eyes and cheekbones
painful cold sores or blisters on the lips, nose, eyes, or genitals
painful or difficult urination
pain, redness, swelling, tenderness, warmth on the skin
pale skin
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
rapid heartbeat
runny nose
sneezing
sore throat
sores, ulcers, or white spots on lips or in mouth
stuffy nose
swollen glands
tender, swollen glands in the neck
tightness in the chest
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
voice changes
vomiting
Less common
Change in consciousness
convulsions
decreased urine
drowsiness
dry mouth
increased thirst
irregular heartbeat
loss of appetite
mood changes
muscle pain or cramps
numbness or tingling in the hands, feet, or lips
loss of consciousness

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

Symptoms of overdose
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:

More common
Acid or sour stomach
appetite decreased
belching
bleeding after defecation
bloody nose
blurred vision
bruise
bumps on the skin
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
burning while urinating
diarrhea
difficulty having a bowel movement (stool)
difficulty with moving
discouragement
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
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 injection site
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 the joints
postnasal drip
post procedural hemorrhage
redness of the skin
shivering
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 the mouth
soreness or discomfort to touch or pressure on the stomach
stomach discomfort upset or pain
sweating
swelling of abdominal or stomach area
swelling of the hands, ankles, feet, or lower legs
swelling or inflammation of the mouth
swelling with pits or depressions visible on the skin
swollen joints
tongue ulceration
trouble concentrating
trouble sleeping
uncomfortable swelling around the anus
unusual drowsiness
unusually warm skin
upper abdominal or stomach 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.


Last Updated: 10/12/2016

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