The combination of decitabine and cedazuridine is used to treat certain types of myelodysplastic syndrome (conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells), including chronic myelomonocytic leukemia (CMML) in adults. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It helps to increase the amount of decitabine in the body so that the medication will have a greater effect.

The combination of decitabine and cedazuridine comes as a tablet to take by mouth. It is usually taken on an empty stomach for the first 5 days of a 28-day cycle. Do not eat food for 2 hours before and 2 hours after each dose. The 28-day cycle regimen may be repeated as recommended by your doctor based on your body’s response to this medication. Treatment should usually be given for at least 4 cycles but may be continued if your doctor decides that you will benefit from additional treatment.

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

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

Your doctor will give you medication to prevent nausea and vomiting before you receive each dose of decitabine and cedazuridine.

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 decitabine and cedazuridine.

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

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

Before taking decitabine and cedazuridine,

• tell your doctor and pharmacist if you are allergic to decitabine, cedazuridine, any other medications, or any of the ingredients in decitabine and cedazuridine 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 kidney or liver disease.
• tell your doctor if you are pregnant or plan to become pregnant, or if you plan to father a child. 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 male, you and your female partner should use effective birth control while you are taking decitabine and cedazuridine and for 3 months after the final dose. If you or your partner becomes pregnant while taking this medication, call your doctor. Decitabine and cedazuridine may harm the fetus.
• tell your doctor if you are breastfeeding. Do not breastfeed while you are taking decitabine and cedazuridine and for 2 weeks after your final dose.
• you should know that this medication may decrease fertility in men. Talk to your doctor about the risks of taking decitabine and cedazuridine.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking decitabine and cedazuridine.

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

If it has been less than 12 hours since you were scheduled to take the dose, take the missed dose on an empty stomach as soon as you remember it. If it has been more than 12 hours, skip the missed dose and continue your regular dosing schedule to complete the 5 daily doses in the cycle. Do not take a double dose to make up for a missed one.

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

• excessive tiredness
• pale skin
• constipation
• diarrhea
• nausea
• vomiting
• stomach pain
• weight loss
• loss of appetite
• joint or muscle pain
• dizziness
• falling down
• headache
• difficulty falling asleep or staying asleep
• painful sores in mouth, or on tongue or lips
• swelling of the hands, feet, ankles, lower legs, or stomach
• tingling, numbness, and pain in hands or feet

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

• fever, chills, cough, body aches, or other signs of infection
• unusual bleeding or bruising, nose bleeds, or bleeding gums
• fast or pounding heartbeat
• shortness of breath
• rash

Decitabine and cedazuridine 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).

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).

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.

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.

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 decitabine and cedazuridine.

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.

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