Cedazuridine (sed-az-URE-i-deen), Decitabine (dee-SYE-ta-been)

Treats myelodysplastic syndromes (MDS).

Brand Name(s):

Inqovi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Take this medicine at the same time each day.
• It is best to take this medicine on an empty stomach. Do not eat for at least 2 hours before and 2 hours after using this medicine.
• Swallow the tablet whole. Do not cut, crush, or chew it.
• You may also receive medicines to help prevent nausea and vomiting.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose and it is within 12 hours of your usual dose, take it as soon possible and go back to your regular dosing schedule. If you miss a dose and it is more than 12 hours of your usual dose, skip the missed dose and go back to your regular dosing schedule.
• If you vomit after taking a dose, do not take an additional dose. Take the next dose at the regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the medicine in its original container.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how decitabine/cedazuridine works. Tell your doctor if you are using a medicine that is metabolized by an enzyme called cytidine deaminase.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Women should use an effective form of birth control during treatment and for at least 6 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 3 months after the last dose.
• Do not breastfeed during treatment with this medicine and for at least 2 weeks after the last dose.
• Tell your doctor if you have kidney disease, liver disease, or any type of infection.
• Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, pale skin
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Lightheadedness, dizziness, fainting
• Painful or difficult urination, lower back or side pain
• Rapid weight gain, swelling in your hands, ankles, or feet
• Small red or purple spots on your skin
• Sores or white patches on your lips, mouth, or throat
• Unusual bleeding, bruising, tiredness, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, stomach pain, decreased appetite
• Headache, joint or muscle pain
• Nausea, vomiting
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088