Cedazuridine and decitabine

Cedazuridine and decitabine is a combination medicine used to treat myelodysplastic syndromes, which are certain types of blood or bone marrow disorders.

Cedazuridine and decitabine is also used together with venetoclax to treat adults who are newly diagnosed with acute myeloid leukemia (AML) and are 75 years old or older, or have other medical conditions that make it unsafe to use standard chemotherapy.

The brand name is Inqovi.

Cedazuridine and decitabine may also be used for other reasons not mentioned in this medication guide.

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

Cedazuridine and decitabine is given in a 28-day treatment cycle. You may need to take the medicine only during the first 5 days of each cycle. Your doctor will decide how long you will be treated 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 the medicine without your doctor's advice.

You may be given other medication to help prevent nausea or vomiting. Continue 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, including serious or fatal infections. Your doctor will need to check on you regularly.

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

Important safety information and serious side effects

Cedazuridine and decitabine may cause serious side effects, including:

• Low blood cell counts (myelosuppression). Low blood counts (white blood cells, platelets, and red blood cells) are common with cedazuridine and decitabine but can also be serious and lead to infections that may be life-threatening. If your blood cell counts are too low, your healthcare provider may need to delay treatment with cedazuridine and decitabine, lower your dose of cedazuridine and decitabine, or, in some cases, give you a medicine to help treat low blood cell counts. Your healthcare provider may need to give you antibiotic medicines to prevent or treat infections or fever while your blood cell counts are low. Your healthcare provider will check your blood cell counts before you start treatment and regularly during treatment with cedazuridine and decitabine.

Tell your healthcare provider right away if you get any of the following signs and symptoms during treatment with cedazuridine and decitabine:

• fever chills body aches tiredness bruising more easily than usual.
• Harm to an unborn baby. Cedazuridine and decitabine can harm your unborn baby if you take it while you are pregnant. You should not be pregnant when starting cedazuridine and decitabine. See pregnancy information below.

Cedazuridine and decitabine may affect fertility in men. Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of cedazuridine and decitabine. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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.

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

Cedazuridine and decitabine can cause serious side effects. Call your doctor right away if you experience:

• 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 treatment may be delayed or stopped completely if you have certain side effects.

Common side effects

The most common side effects of cedazuridine and decitabine in adults with MDS or CMML include:

• low white blood cell count (leukopenia, neutropenia)
• low platelets in your blood (thrombocytopenia)
• low red blood cell count (anemia)
• tiredness
• constipation
• bleeding
• muscle pain
• pain or sores in your mouth or throat
• joint pain
• nausea
• shortness of breath
• diarrhea
• rash
• dizziness
• fever with low white blood cell count (febrile neutropenia)
• swelling of arms or legs
• headache
• cough
• decreased appetite
• upper respiratory tract infection
• pneumonia
• changes in liver function tests.

The most common side effects of cedazuridine and decitabine in adults with AML in combination with venetoclax include:

• low white blood cell counts (leukopenia, lymphocytopenia, neutropenia)
• low platelets in your blood (thrombocytopenia)
• fever with low white blood cell count (febrile neutropenia)
• bleeding
• low red blood cell count (anemia)
• infection
• diarrhea
• tiredness
• pain or sores in your mouth or throat
• constipation
• joint pain
• decreased appetite
• swelling of arms or legs
• nausea
• shortness of breath
• sepsis
• pneumonia
• rash
• changes in liver function tests
• muscle pain
• abnormal heart rhythm
• stomach-area (abdomen) pain
• dizziness or feeling lightheaded
• decreased kidney function.

To report suspected side effects, contact Taiho Oncology, Inc. at 1-844-878-2446 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dose of cedazuridine and decitabine for MDS or AML

• 1 tablet (containing 100 mg cedazuridine and 35 mg decitabine) orally once daily on Days 1 through 5 of each 28-day cycle.
• Take on an empty stomach.

Comments:

• Consider administering antiemetics before each dose to minimize nausea and vomiting.
• For MDS or CMML, cedazuridine and decitabine should be taken for a minimum of 4 cycles until disease progression or unacceptable toxicity occurs. A complete or partial response may take longer than 4 cycles.
• For AML, cedazuridine and decitabine should be taken until disease progression or unacceptable toxicity occurs. Match Day 1 cedazuridine and decitabine dosing with Day 1 of venetoclax dosing for each 28-day cycle.

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.

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.