Pronunciation:

ay-za-SYE-ti-deen

Brand Names:

• Vidaza

Dosage Forms:

• Powder for Suspension

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Azacitidine injection is used to treat patients with French-American-British (FAB) myelodysplastic syndrome (bone marrow problem) subtypes, including refractory anemia or chronic leukemia. This medicine is also used to treat juvenile myelomonocytic leukemia (JMML).

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 to treat myelodysplastic syndrome in children and to treat juvenile myelomonocytic leukemia in children younger than 1 month of age. 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 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.

• Cedazuridine
• Levoketoconazole
• Methotrexate

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:

• Allergy to mannitol or
• Cancerous liver tumors—Should not be used in patients with these conditions.

• Anemia or
• Liver disease, severe or
• Neutropenia (low white blood cells) or
• Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. This medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use an effective form of birth control during treatment with this medicine and for at least 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 or your partner has become pregnant while using 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:

• 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.

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.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using 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 gums

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine or stools

cloudy urine

body aches or pain

burning or stinging of the skin

chest pain or tightness

chills

congestion

cough

difficult breathing

difficulty swallowing

dizziness

ear congestion

fast heartbeat

fever

frequent urge to urinate

headache

hives, itching, or skin rash

hoarseness

increased menstrual flow or vaginal bleeding

loss of voice

lower back or side pain

muscle aches

nausea

nosebleeds

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

paralysis

pinpoint red spots on the skin

prolonged bleeding from cuts

puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

rapid heartbeat

runny or stuffy nose

sneezing

sore throat

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

swollen glands

tender, swollen glands in the neck

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

voice changes

vomiting

Less common

Change in consciousness

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

seizures

Incidence not known

Chest discomfort

coughing or spitting up blood

dilated neck veins

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

red or bloodshot eye

seeing gloating spots before the eyes

stroke

swelling of the face, fingers, feet, or lower legs

thickened bronchial secretions

vomiting of blood or material that looks like coffee grounds

weight gain

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

bone pain

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 or on the skin

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.