Azacitidine Oral Tablets

What is this medication?

AZACITIDINE (ay za SITE i deen) is a chemotherapy drug. This medicine reduces the growth of cancer cells and can suppress the immune system. It is used to treat acute myelogenous leukemia.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ONUREG

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• kidney disease
• liver disease
• an unusual or allergic reaction to azacitidine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Swallow the capsules whole. You can take this medicine with or without food. However, you should always take it the same way. Take your medicine at regular intervals. Do not take it more often than directed. Do not skip stop taking except on your doctor's advice.

Talk to your pediatrician about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor for checks on your progress. This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

In some cases, you may be given additional medicines to help with side effects. Follow all directions for their use.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

You may need blood work done while you are taking this medicine.

Do not become pregnant while taking this medicine and for at least 6 months after the last dose. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for at least 3 months after the last dose. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine and for 1 week after the last dose.

This medicine may interfere with the ability to have a child. Talk with your doctor or health care professional if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• fever or chills, sore throat
• signs and symptoms of infection like fever; chills; cough; sore throat; pain or trouble passing urine
• signs and symptoms of low red blood cells or anemia such as unusually weak or tired; feeling faint or lightheaded; falls; breathing problems
• unusual bruising or bleeding

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• constipation
• decreased appetite
• diarrhea
• nausea, vomiting
• stomach pain
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the original container or packaging. Keep container tightly closed. Do not throw out the packet in the container. It keeps the medicine dry. Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, take the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.