Cedazuridine and decitabine is a combination medicine that is used to treat myelodysplastic syndromes (certain types of blood or bone marrow disorders).

Cedazuridine and decitabine may also be used for purposes not listed in this medication guide.

Cedazuridine and decitabine affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, cough, mouth sores, or unusual bleeding or bruising.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Cedazuridine and decitabine is given in a 28-day treatment cycle. You may need to use the medicine only during the first 5 days of each cycle. Your doctor will determine how long to treat you with this medicine.

Take cedazuridine and decitabine on an empty stomach, at least 2 hours before or 2 hours after a meal.

Take the medicine at the same time each day.

Swallow the tablet whole and do not crush, chew, or break it.

Do not change your dose or stop using a medicine without your doctor's advice.

You may be given other medication to help prevent nausea or vomiting. Keep using that medication for as long as your doctor has prescribed.

If you vomit shortly after taking cedazuridine and decitabine, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Cedazuridine and decitabine affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Store at room temperature away from moisture and heat. Keep each tablet in the blister pack until you are ready to take a dose.

Usual Adult Dose for Myelodysplastic Syndrome:

1 tablet (containing 100 mg cedazuridine and 35 mg decitabine) orally once daily on Days 1 through 5 of each 28-day cycle for a minimum of 4 cycles until disease progression or unacceptable toxicity; a complete or partial response may take longer than 4 cycles

Comments:
-Consider administering antiemetics prior to each dose to minimize nausea and vomiting.

Use: For myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups

Tell your doctor if you have ever had:

• kidney disease; or

• liver disease.

You may need to have a negative pregnancy test before starting this treatment.

Cedazuridine and decitabine can harm an unborn baby or cause birth defects if the mother or the father is using cedazuridine and decitabine.

• If you are a woman, do not use cedazuridine and decitabine if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using this medicine.

Cedazuridine and decitabine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because the medicine can harm an unborn baby.

You should not breastfeed while using cedazuridine and decitabine and for at least 2 weeks after your last dose.

Cedazuridine and decitabine is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not take two doses at one time.

Finish taking all daily doses in the treatment cycle, even if you have to add an extra day to take the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not eat for at least 2 hours before or after taking cedazuridine and decitabine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Cedazuridine and decitabine may cause serious side effects. Call your doctor at once if you have:

• easy bruising, unusual bleeding, purple or red spots under your skin;

• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;

• low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing; or

• signs of a lung infection--fever, chills, cough with mucus, chest pain, feeling short of breath.

Your treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of cedazuridine and decitabine may include:

• fever, low blood cell counts;

• bruising or bleeding;

• abnormal liver function tests;

• headache, dizziness, feeling tired;

• swelling in your arms or legs;

• muscle or joint pain;

• painful mouth sores;

• shortness of breath, lung infection;

• nausea, loss of appetite;

• diarrhea, constipation;

• rash; or

• cold symptoms such as stuffy nose, sneezing, cough, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect cedazuridine and decitabine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.