Onureg

Azacitidine

(ay za SYE ti deen)

Vidaza

It is used to treat a health problem called myelodysplastic syndrome (MDS). It may be given to you for other reasons. Talk with the doctor.

If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. If you have liver tumors. If you are breast-feeding. Do not breast-feed while you take this drug. You may also need to avoid breast-feeding for some time after your last dose. Talk with your doctor to see if you need to avoid breast-feeding after your last dose. This is not a list of all drugs or health problems that interact with this drug. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. This drug may lower the ability of the bone marrow to make blood cells that the body needs. If blood cell counts get very low, this can lead to bleeding problems, infections, or anemia. If you have questions, talk with the doctor. You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor. If you have upset stomach, throwing up, diarrhea, or are not hungry, talk with your doctor. There may be ways to lower these side effects. Talk with your doctor before getting any vaccines. Use of some vaccines with this drug may either raise the chance of an infection or make the vaccine not work as well. Have blood work checked as you have been told by the doctor. Talk with the doctor. This drug may cause liver problems to get worse in people who already have liver problems. Talk with your doctor if you have liver problems. Very bad and sometimes deadly kidney problems have happened in people getting this drug along with other cancer drugs for other health problems. Talk with the doctor. Patients with cancer who take this drug may be at a greater risk of getting a severe health problem called tumor lysis syndrome (TLS). This may lead to death. Call your doctor right away if you have a fast or abnormal heartbeat; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, diarrhea, or not able to eat; or feel sluggish. If you are 65 or older, use this drug with care. You could have more side effects. This drug may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child. If you are a man and have sex with a female who could get pregnant, protect her from pregnancy while you take this drug. Your sex partner may also need to avoid pregnancy for some time after your last dose. Talk with your doctor to see if your sex partner needs to avoid pregnancy after you stop this drug. If you are a man and your sex partner gets pregnant while you take this drug or within several months after your last dose, call your doctor right away. This drug may cause harm to an unborn baby. A pregnancy test will be done before you start this drug to show that you are NOT pregnant. Use birth control to prevent pregnancy during treatment with this drug. You may also need to use birth control for some time after your last dose. Talk with your doctor to see if you need to use birth control after you stop this drug. If you get pregnant while taking this drug or within several months after the last dose, call your doctor right away.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal. Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop. Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes. Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain. Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal. Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight. Chest pain or pressure. Shortness of breath. Pinpoint red spots on the skin. A very bad skin problem (necrotizing fasciitis) has happened in people taking this drug. Sometimes, this has been deadly. Call your doctor right away if your skin is warm with red or purple areas of swelling that spread quickly. Call your doctor right away if you have ulcers, blisters, black spots on the skin, or any other skin changes that concern you.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry. Mouth irritation or mouth sores. Feeling dizzy, tired, or weak. Trouble sleeping. Headache. Irritation where the shot is given. Dry skin. Nose or throat irritation. Muscle or joint pain. Anxiety. Weight loss. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. It is given as a shot into the fatty part of the skin. It is given as an infusion into a vein over a period of time. Other drugs may be given before this drug to help avoid side effects.

Call your doctor to find out what to do.

If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.

If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area. Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.