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Common Brand Name(s): Onureg
This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
This medication is used to treat a certain type of cancer (acute myeloid leukemia). Azacitidine is a chemotherapy drug that works by slowing or stopping the growth of cancer cells.
This form of azacitidine should not be used in place of the form given by injection.
Take this medication by mouth with or without food as directed by your doctor, usually once a day on days 1 through 14 of each 28-day treatment cycle. Swallow the tablets whole. Do not cut, crush, or chew the tablets. The dosage is based on your medical condition and response to treatment.
To decrease the risk of nausea and vomiting, your doctor may prescribe other medication(s) for you to take 30 minutes before each dose. If you do not have nausea and vomiting after the first 2 cycles, your doctor may direct you to not take the other medication(s). Carefully follow your doctor's directions for all your medications.
If you vomit after taking a dose, do not take another dose. Take your next dose at the regular time.
Take this medication regularly to get the most benefit from it. To help you remember, use it at the same time on days 1 through 14 of your treatment cycle.
Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.
Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.
Nausea, vomiting, diarrhea or constipation, tiredness, dizziness, muscle/joint pain, or loss of appetite may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.
Tell your doctor right away if you have any serious side effects, including:
This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).
Azacitidine sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as:
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before using azacitidine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of:
Azacitidine can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.
Tell your health care professional that you are using azacitidine before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.
This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Tell your doctor if you are pregnant or plan to become pregnant. Your doctor may order a pregnancy test before starting this medication. You should not become pregnant while using azacitidine. Azacitidine may harm an unborn baby. Men with female partners of childbearing age should use reliable forms of birth control while using this medication and for at least 3 months after the last dose. Women of childbearing age should ask about reliable forms of birth control while using this medication and for at least 6 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.
It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 1 week after the last dose is not recommended. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.
Lab and/or medical tests (such as complete blood counts, kidney function, liver function) should be done while you are taking this medication. Keep all medical and lab appointments.
If you miss a dose, take it as soon as you remember on the same day. If it is the next day when you remember, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.
Store tightly closed in the original container at room temperature away from light and moisture. Keep the desiccant (drying agent) in the bottle. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised December 2021.
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