5-azacytidine

Trade Names: 5AZ, Azacytidine, Vidaza

Type of Drug: 5-azacytidine belongs to the general group of chemotherapy drugs known as antimetabolites. It is being studied for the treatment of several types of cancer including acute myelocytic leukemia.

How Drug Works: 5-azacytidine prevents cells from making DNA and RNA (our body’s genetic material). Antimetabolites look like needed chemicals in the body called metabolites. The antimetabolites fool the body into thinking they are metabolites. When the body tries to use them in place of the metabolite, the DNA and RNA cannot be made, thus stopping the growth of cancer cells.

How Drug Is Given: 5-azacytidine is given into a vein (intravenously) over a period of 20 to 60 minutes, or continuously for up to 5 days. It can also be given by an injection under the skin (subcutaneous or SQ), 1 or more times a day. The dose given will depend on your size, whether other medicines are given with it, and your blood counts.

Read the following information. If you do not understand it or if any of it causes you special concern, check with your doctor.

Before taking this drug, tell your doctor: If you are trying to become pregnant, are pregnant, or breastfeeding. This drug may cause birth defects if either the male or female is taking it at the time of conception or during pregnancy. Men and women who are taking this drug need to use some kind of birth control. However, do not use oral contraceptives (“the pill”) without checking with your doctor. If you think you may want to have children in the future. Many chemotherapy drugs can cause sterility. If you have any of the following medical problems: chickenpox or exposure to chickenpox, gout, heart disease, congestive heart failure, shingles, kidney stones, liver disease, or other forms of cancer. If you are taking any other prescription or over-the-counter drugs, including vitamins and herbals.

Should I avoid any other medicines, foods, alcohol, and/or activities? Your prescription and nonprescription medicines may interact with other drugs, causing harm. Certain foods or alcohol can also interact with drug products. Never begin taking a new medicine—prescription or nonprescription—without asking your doctor or nurse if it will interact with alcohol, food, or other medicines. Some drug products can cause drowsiness and affect activities such as driving.

Precautions: 5-azacytidine can lower your blood counts (white blood cells, red blood cells, platelets). Your doctor will check your blood counts before and after each treatment to see how it affects your blood counts. Your doctor or nurse will give you specific instructions if your blood counts are low.

5-azacytidine can cause a decrease in your white blood cell count, especially 14 to 17 days after the drug is given. This can increase your risk of getting an infection. Report fever of 100.5°F or higher, or signs of infection such as pain in passing your urine, coughing and bringing up sputum.

5-azacytidine can cause a decrease in the platelet count. This can increase your risk of bleeding. DO NOT take any aspirin or aspirin-containing medicines. Report unusual bruising, or bleeding such as nosebleeds, bleeding gums when you brush your teeth, or black, tarry stools.

While you are being treated with 5-azacytidine, and after you stop treatment, do not have any immunizations (vaccinations) without your doctor’s okay. Try to avoid contact with people who have recently taken the oral polio vaccine. Check with your doctor about this.

5-azacytidine can cause nausea and vomiting. Ask your doctor or nurse to give you medicines to prevent this or lessen it.

Tell all the doctors, dentists, and pharmacists you visit that you are taking this drug.

Most of the following side effects probably will not occur. Your doctor or nurse will want to discuss specific care instructions with you. They can help you understand these side effects and help you deal with them.

Side Effects:

More Common Side Effects Decreased white blood cell count with increased risk of infection Decreased platelet count with increased risk of bleeding Nausea Vomiting Diarrhea

Less Common Side Effects Decreased red blood cell count with increased risk of tiredness (fatigue)

Rare Side Effects Increased liver function blood tests Sores in mouth or on lips Feeling sleepy or drowsy Muscle aches Coma (very rare) Rash with itching Fever Decrease in blood pressure

Other side effects not listed above can also occur in some patients. Tell your doctor or nurse if you develop any problems.

FDA Approval: This drug is approved for the treatment of Myelodysplastic Syndrome.