Other Considerations with VIDAZA

What else you need to know about treatment with VIDAZA

How long will I be on VIDAZA?

VIDAZA is not a one-time treatment. Treatment cycles are given every 28 days for as long as your doctor recommends them. It may take several cycles (about 4 to 6 months) for your doctor to notice a difference. If you stop receiving treatment, your symptoms may return. Therefore, your doctor may want to keep you on it for as long as you continue to benefit from it and side effects don’t require you to stop it.

While you’re on VIDAZA your blood cell counts may fall during your first few cycles of treatment. This may cause you to feel tired or have a fever. Always follow your doctor’s recommendations about continuing your treatment plan. By cycle 3 or 4, VIDAZA may be helping your bone marrow make healthy blood cells. As a result, your blood cell counts may begin to rise. By cycles 4-6, your need for transfusions may be decreased. That means you may feel less tired and have fewer fevers.

As you receive treatment with VIDAZA, remember:

Routine blood tests—Before each cycle of treatment, you will need to have a blood test. Blood tests help your doctor understand how you are responding to treatment. They will also help your doctor address any side effects of treatment
Pregnancy and nursing—Women should not become pregnant or breastfeed while receiving VIDAZA. Men should avoid fathering a child while receiving VIDAZA
Liver problems—Tell your doctor if you have liver problems before receiving VIDAZA
Kidney problems—Tell your doctor if you have kidney problems before receiving VIDAZA

Read answers to Frequently Asked Questions about VIDAZA

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.