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Brand Name(s): Onureg^®

WHY is this medicine prescribed?

Azacitidine is used to treat acute myeloid leukemia (AML; cancer of the white blood cells) in adults who improved after chemotherapy, but who are unable to complete intensive curative therapy. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Azacitidine comes as a tablet to take by mouth. It is usually taken with or without food once daily for the first 14 days of a 28-day cycle. Your doctor will decide how many times you should repeat this cycle depending on your response to this medication and any side effects you may experience. Take azacitidine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take azacitidine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

If your skin comes into contact with powder from the inside the tablets, wash the exposed area right away with soap and water. If your eyes or mouth come into contact with powder from inside the tablets, flush the area right away with water.

Your doctor will give you medication to prevent nausea and vomiting 30 minutes before you receive each dose of azacitidine for the first two cycles. Your doctor may continue to give you this medication for later cycles, if needed.

If you vomit after taking azacitidine, do not take another dose. Continue your regular dosing schedule.

Your doctor may decrease your dose or temporarily or permanently stop your treatment if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with azacitidine.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking azacitidine,

• tell your doctor and pharmacist if you are allergic to azacitidine, any other medications, or any of the ingredients in azacitidine tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had liver or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are taking azacitidine. If you are female, you will need to take a pregnancy test before you start treatment and use birth control to prevent pregnancy during your treatment and for at least 6 months after your final dose. If you are a male and your partner can become pregnant, you should use effective birth control during your treatment and for 3 months after your final dose. If you or your partner become pregnant while taking azacitidine, call your doctor. Azacitidine may harm the fetus.

• do not breastfeed while you are taking azacitidine and for 1 week after your final dose.

• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking azacitidine.

• you should know that azacitidine often causes diarrhea, which can be severe. Your doctor will probably tell you to take an anti-diarrhea medication to prevent dehydration (loss of too much water from your body) during your treatment with azacitidine.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss a dose or if you do not take your dose at the usual time, take it as soon as possible that day. Take your next dose at the regular time the next day. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Azacitidine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• constipation
• loss of appetite
• tiredness
• stomach pain
• joint pain
• muscle pain
• dizziness
• pain in hands or legs

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• sore throat, fever, chills, body aches, or other signs of infection
• shortness of breath or pale skin
• unusual bruising or bleeding, bloody vomit, vomit that looks like coffee grounds, or black, tarry, or bloody stools

Azacitidine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Keep the two desiccant (drying agent) canisters in the bottle of medication to keep the tablets dry. Do not eat the desiccant canisters.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to azacitidine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: November 15, 2020.