Patient Glossary

Definitions of the terms (blue) used on this site appear below:

acute myeloid leukemia (uh•KYOOT MY•eh•loid loo•KEE•mee•uh) (AML)—A type of cancer in which too many immature WBCs are found in the blood and bone marrow. "Acute" means that the leukemia develops quickly and becomes worse (See leukemia)

anemia (a•NEE•mee•a)—A condition in which the number of RBCs is below normal

antibiotic (an•tih•by•AH•tik)—A medicine that helps prevent or control infection

antibodies (AN•tee•BAH•dees)—Proteins found in the blood. They are made in response to foreign substances that invade the body. Antibodies protect the body from disease by binding to these foreign substances and destroying them

blasts—Immature blood cells that become RBCs, WBCs, or platelets

bone marrow (bone MAYR•oh)—The soft, sponge-like tissue in the center of bones that makes RBCs, WBCs, and platelets

chronic myelomonocytic leukemia (KRAH•nik MY•eh•loh•MAH•noh•SIH•tik loo•KEE•mee•uh) (CMMoL)—A slowly progressing type of cancer in which too many myelomonocytes (a type of WBC) are in the bone marrow

cytopenias (SY•toh•PEE•nee•uhs)—Reductions in the number of blood cells

FAB (FAB)—French-American-British classification system of myelodysplastic syndromes

febrile neutropenia (FEH•brile noo•troh•PEE•nee•uh)—Fever combined with a significant reduction (or decrease) in WBCs (neutropenia) needed to fight infection

hypokalemia (HI•po•ka•LEE•mee•a)—Low potassium in the blood

intravenous (IN•truh•VEE•nus)—Within a vein

leukemia (loo•KEE•mee•uh)—Cancer of the blood and bone marrow

malaise (muh•LAYZ)—A general, or overall, feeling of discomfort

monocytes (MAH•noh•sytz)—Large, circulating WBCs that are formed in the bone marrow

myalgia (my•AL•juh)—Pain in one or several muscles

myelodysplastic syndromes (MY•eh•loh•dis•PLAS•tik SIN•dromz) (MDS)—Derived from myelo, which means marrow, and dysplasia, which means abnormal growth. A group of diseases in which the bone marrow does not make enough healthy blood cells

myelosuppression (MY•eh•loh•suh•PREH•shun)—This condition prevents or slows the bone marrow’s production of blood cells

neutropenia (noo•troh•PEE•nee•uh)—A condition in which the number of neutrophils (the most numerous type of WBC that help fight infection) is below normal in the blood

platelets (PLATE•lets)—Blood cells that are essential for blood clotting

red blood cells (RBCs)—The cells that carry oxygen to the body’s tissues

refractory anemia (ree•FRAK•tuh•ree a•NEE•mee•a)—Anemia resistant to treatment

ringed sideroblasts (ringd SID•eh•ro•blasts)—RBCs that contain an iron protein complex called ferritin. The amount of ferritin in your blood helps your doctor determine how much iron is stored in your blood

subcutaneous (sub•kyoo•TAY•nee•us)—Under the skin

supportive care (suh•POR•tiv kayr)—Treatment that reduces the symptoms of the disease but does not change the course of the disease

thrombocytopenia (THROM•boh•sy•toh•PEE•nee•uh)—A condition in which the number of platelets, or thrombocytes, is below normal, resulting in the tendency to bruise and bleed more easily

transfusion (trans•FYOO•zhun)—Adds parts of blood or whole blood into the bloodstream

treatment cycle (treet•mint sie•kool)—Each 28-day period of VIDAZA treatment (the 7 days you receive VIDAZA plus the 21 days you do not)

white blood cells (WBCs)—The cells that help the body fight infection

Please see Important Safety Information and full Prescribing Information.

Indication

VIDAZA is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).

IMPORTANT SAFETY INFORMATION

VIDAZA is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol and in patients with advanced malignant hepatic tumors.
In Studies 1 and 2, the most commonly occurring adverse reactions by SC route were nausea (70.5%), anemia (69.5%), thrombocytopenia (65.5%), vomiting (54.1%), pyrexia (51.8%), leukopenia (48.2%), diarrhea (36.4%), injection site erythema (35.0%), constipation (33.6%), neutropenia (32.3%), and ecchymosis (30.5%). Other adverse reactions included dizziness (18.6%), chest pain (16.4%), febrile neutropenia (16.4%), myalgia (15.9%), injection site reaction (13.6%), and malaise (10.9%). In Study 3, the most common adverse reactions by IV route also included petechiae (45.8%), weakness (35.4%), rigors (35.4%), and hypokalemia (31.3%).
In Study 4, the most commonly occurring adverse reactions were thrombocytopenia (69.7%), neutropenia (65.7%), anemia (51.4%), constipation (50.3%), nausea (48.0%), injection site erythema (42.9%), and pyrexia (30.3%). The most commonly occurring Grade 3/4 adverse reactions were neutropenia (61.1%), thrombocytopenia (58.3%), leukopenia (14.9%), anemia (13.7%) and febrile neutropenia (12.6%).
Because treatment with VIDAZA is associated with anemia, neutropenia and thrombocytopenia, complete blood counts should be performed as needed to monitor response and toxicity, but at a minimum, prior to each dosing cycle.
Because azacitidine is potentially hepatotoxic in patients with severe preexisting hepatic impairment, caution is needed in patients with liver disease. In addition, azacitidine and its metabolites are substantially excreted by the kidneys and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.
VIDAZA may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be apprised of the potential hazard to the fetus. Men should be advised not to father a child while receiving VIDAZA.
Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother.

Please see full Prescribing Information.