Azacitidine

What is azacitidine used for?

• Azacitidine is used to treat a health problem called myelodysplastic syndrome (MDS).
• Azacitidine may be given to you for other reasons. Talk to your doctor.

Before taking azacitidine, tell your doctor:

• If you are allergic to azacitidine; any part of this medicine; 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 azacitidine. 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 azacitidine.

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 azacitidine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take azacitidine?

• Tell all of your health care providers that you take azacitidine. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine 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 azacitidine 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.
• Very bad and sometimes deadly kidney problems have happened in people getting azacitidine along with other cancer drugs for other health problems. Talk with the doctor.
• Patients with cancer who take azacitidine 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 azacitidine with care. You could have more side effects.
• This medicine 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 azacitidine. 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 azacitidine.
• If you are a man and your sex partner gets pregnant while you take azacitidine or within several months after your last dose, call your doctor right away.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting azacitidine. Talk with your doctor.
• Use birth control to prevent pregnancy during treatment with azacitidine. 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 azacitidine.
• If you get pregnant while taking azacitidine or within several months after the last dose, call your doctor right away.

How is azacitidine best taken?

Use azacitidine 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 azacitidine to help avoid side effects.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of azacitidine that I need to call my doctor about immediately?

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.
• Chest pain or pressure.
• Shortness of breath.
• Very bad dizziness or passing out.
• Very bad headache.
• Very bad irritation where the shot was given.
• Feeling very tired or weak.
• A very bad skin problem (necrotizing fasciitis) has happened in people taking azacitidine. 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.

What are some other side effects of azacitidine?

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:

• Upset stomach or throwing up.
• Mouth irritation or mouth sores.
• Dizziness.
• Not able to sleep.
• Headache.
• Feeling tired or weak.
• Irritation where the shot is given.
• Constipation.
• Diarrhea.
• Not hungry.
• Dry skin.
• Nose and throat irritation.
• Muscle or joint pain.
• Anxiety.
• Belly pain.
• 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.

If overdose is suspected:

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.

How do I store and/or throw out azacitidine?

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

Consumer information use and disclaimer

• 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 azacitidine, 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 azacitidine 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 azacitidine. 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.