Decitabine and cedazuridine (Oral)

Decitabine and cedazuridine combination is used to treat myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML), and specific types of anemia. Myelodysplastic syndromes are a group of cancers where immature blood cells in the bone marrow fail to mature and become healthy blood cells.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress during regular visits to ensure this medicine is working correctly. Blood and urine tests may be needed to look for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you can become pregnant, your doctor may give you a pregnancy test before you start using this medicine to confirm you are not pregnant. This medicine may also cause birth defects if the father is using it when his partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant or your partner has become pregnant while using this medicine, notify your doctor immediately.

Cancer medicines can cause nausea or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to manage these side effects.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the risk of getting an infection. It can also lower the number of platelets, which are important for proper blood clotting. If this happens, there are certain precautions you should take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If possible, avoid people with infections. Contact your doctor right away if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Contact your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be cautious when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may suggest other ways to clean your teeth and gums. Consult with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when using sharp objects such as a safety razor or fingernail or toenail clippers.
• Avoid contact sports or other situations where bruising or injury could occur.

If you plan to have children, discuss this with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor will weigh the risks of taking the medicine against the benefits it may provide. The following factors should be considered for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been done to determine how age affects the effects of the decitabine and cedazuridine combination in children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not found any specific problems in older adults that would limit the usefulness of the decitabine and cedazuridine combination.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together, even if an interaction might occur. In such cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions have been chosen based on their potential significance and are not necessarily a complete list.

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Azacitidine
• Capecitabine
• Cytarabine
• Cytarabine Liposome
• Gemcitabine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect how you can use this medicine. Make sure to inform your doctor about any other medical issues, especially:

• End-stage kidney disease or
• Severe kidney disease—Use has not been studied in patients with these conditions.

• Infection—May weaken your body's ability to fight an infection.

• Moderate kidney disease—Use with caution. The effects may be increased due to slower removal of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Black, tarry stools
• Bleeding gums
• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Bloody urine
• Blurred vision
• Body aches or pain
• Burning, numbness, painful, or tingling sensations
• Chest pain
• Chills
• Confusion
• Cough
• Coughing up blood
• Cracked lips
• Decreased frequency or amount of urine
• Diarrhea
• Difficult or labored breathing
• Difficulty in swallowing
• Dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
• Ear congestion
• Fainting
• Fast, slow, or irregular heartbeat
• Fever
• Headache
• Increased menstrual flow or vaginal bleeding
• Increased thirst
• Itching, pain, redness, swelling, tenderness, or warmth on the skin
• Loss of appetite
• Loss of voice
• Lower back or side pain
• Nausea
• Nosebleeds
• Painful or difficult urination
• Pale skin
• Paralysis
• Pinpoint red spots on the skin
• Prolonged bleeding from cuts
• Rapid, shallow breathing
• Runny or stuffy nose
• Sneezing
• Sore throat
• Sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• Sweating
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Unusual weight gain or loss
• Vomiting

Less common

• Fever sores on the skin
• Blue lips, fingernails, or skin

Rare

• Joint pain, stiffness, or swelling
• Stomach pain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Constipation
• Decreased appetite
• Difficulty in moving
• Falls
• Muscle pain, cramps, or stiffness
• Skin rash
• Trouble sleeping
• Unsteadiness or awkwardness
• Weakness in the arms, hands, legs, or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Inqovi

Available Dosage Forms:

• Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Antimetabolite

Medicines used to treat cancer are very strong and can have many side effects. Before using 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.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine on an empty stomach. Do not eat for at least 2 hours before and 2 hours after using this medicine. Take it at the same time each day.

Swallow the tablet whole. Do not cut, crush, or chew it.

You may receive other medicines to help prevent nausea and vomiting.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended-release tablets):For myelodysplastic syndromes: Adults—One tablet once a day on Days 1 to 5 of each 28-day cycle for at least 4 cycles. Each tablet contains 35 milligrams (mg) of decitabine and 100 mg of cedazuridine. Your doctor may adjust your dose as needed or tolerated. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the medicine in its original container.