Decitabine; Cedazuridine Oral Tablets

What is this medication?

DECITABINE; CEDAZURIDINE (dee SYE ta been; sed az ure i deen) is a chemotherapy drug. It is used to treat myelodysplastic syndromes.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): INQOVI

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• infection (especially a virus infection such as chickenpox, cold sores, or herpes)
• kidney disease
• liver disease
• an unusual or allergic reaction to decitabine, cedazuridine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Swallow tablets whole. Take this medicine on an empty stomach, at least 2 hour before or 2 hours after food. Do not take with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you take your medicine once a day, take it as soon as you can. If it is within 12 hours of your next dose, take your next dose at the normal time. If you vomit after a dose, skip it. Take your next dose at the normal time. Do not take double or extra doses. If a dose is skipped, notify your health care professional.

What may interact with this medication?

• azacitidine
• capecitabine
• cytarabine
• gemcitabine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication.

You may need blood work done while you are taking this medication.

Do not become pregnant while taking this medication or for 6 months after stopping it. Women should inform their care team if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medication and for 3 months after stopping it. There is potential for serious harm to an unborn child. Talk to your care team for more information. Do not breast-feed an infant while taking this medication or for 2 weeks after stopping it.

This medication may make it more difficult to father a child. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.
• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• constipation
• cough
• decreased appetite
• diarrhea
• dizziness
• headache
• loss of appetite
• joint pain
• muscle pain
• nausea, vomiting
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Get rid of any unused medication after the expiration date.

To get rid of medication that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, ask your care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.