Onureg - Azacitidine Tablets

What is this medication?

AZACITIDINE (ay za SITE i deen) treats leukemia. It works by slowing down the growth of cancer cells.

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:

• Infection
• Low blood cell levels, such as low white cells, platelets, or red blood cells
• Myelodysplastic syndrome
• An unusual or allergic reaction to azacitidine, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Your care team may change your dose or tell you stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

This medication is taken in "cycles." There will be days you do not take it. Talk to your care team if you have questions about when to take your medication. It is very important to follow the exact schedule. Taking it more often than directed can cause serious side effects.

Handling this medication may be harmful. Wash your hands before and after touching the medication or the packaging. Wear gloves while touching the medication or packaging. Talk to your care team about how to handle this medication. Special instructions may apply.

Talk to your care team about the use of this medication 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. If you vomit after taking a dose, do not take another dose on that day. Take your next dose at your regular time.

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?

Your condition will be monitored carefully while you are receiving this medication. You may need blood work while taking this medication.

This medication 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 care team tells you to stop.

This medication can cause serious nausea. To reduce the risk, your care team may prescribe you other medications to take before this one. Follow the directions from your care team.

Other products may be available that contain the medication azacitidine. These products should not be used in place of one another. Talk to your care team if you have questions.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medication.

Talk to your care team if you or your partner may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 6 months after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication 6 months after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 3 months after the last dose.

Do not breast-feed while taking this medication and for 1 week after the last dose.

This medication may cause infertility. Talk to your care team 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 care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Unusual bruising or bleeding

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

• Constipation
• Diarrhea
• Fatigue
• Loss of appetite
• Nausea
• Stomach pain
• Vomiting

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

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

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

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.