Pronunciation:

dee-SYE-ta-been, sed-az-URE-i-deen

Brand Names:

• Inqovi

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Antimetabolite

Uses of This Medicine:

Decitabine and cedazuridine combination is used to treat myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML), and certain types of anemia. Myelodysplastic syndromes are a group of cancers, in which immature blood cells in the bone marrow do not mature and do not become healthy blood cells.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of decitabine and cedazuridine combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of decitabine and cedazuridine combination in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Azacitidine
• Capecitabine
• Cytarabine
• Cytarabine Liposome
• Gemcitabine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

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

• Kidney disease, moderate—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. 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. This medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use an effective form of 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, tell your doctor right away.

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 control these side effects.

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

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with 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 careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check 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 you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

If you plan to have children, talk 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 they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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.