Safety Information

Important Safety Information
Common Side Effects of Treatment
Myelosuppression
Other Things You Need to Know About Treatment With VIDAZA

Important Safety Information

• VIDAZA is not to be used in patients with advanced malignant tumors of the liver
• VIDAZA may cause harm to unborn children. While receiving treatment with VIDAZA, women of child bearing potential should avoid becoming pregnant, and men should avoid fathering a child. In addition, women treated with VIDAZA should not nurse
• Because treatment with VIDAZA is associated with low white blood cell counts (neutropenia) and low platelet counts (thrombocytopenia), your doctor will check your blood counts to monitor response and toxicity (side effects) as needed. At a minimum, your doctor will check blood counts prior to each cycle of VIDAZA treatment
• VIDAZA and its by-products (metabolites) are substantially removed from the body by the kidneys and the risk of side effects to this drug may be greater in people with decreased kidney function. Because older patients are more likely to have decreased kidney function, your doctor may closely watch kidney function during treatment with VIDAZA

Common Side Effects of Treatment

The most common side effects by subcutaneous (under the skin) injections include:

• Nausea
• Anemia (reduced red blood cell counts)
• Thrombocytopenia (reduced platelet counts)
• Vomiting
• Fever
• Leukopenia (reduced white blood cell counts)
• Diarrhea
• Fatigue
• Redness of the skin at the injection site
• Constipation
• Neutropenia (reduced white blood cell counts)
• Bruising of the skin at the injection site

The most common side effects by intravenous administration also include:

• Small reddish purple spots on the body
• Chills
• Weakness
• Low potassium in the blood

Other side effects may occur such as:

• Dizziness
• Chest pain
• Febrile neutropenia (fever with reduced white blood cell counts)
• Myalgia (muscle pain)
• Injection site reaction
• Aggravated fatigue
• Malaise (general discomfort)

Myelosuppression

In some patients, VIDAZA treatment can cause myelosuppression.¹ This common condition causes bone marrow to make fewer blood cells than normal. Myelosuppression can cause any or all of these side effects:

• Reduced red blood cell counts (also called anemia) — This may make you feel tired
• Reduced platelet counts, also called thrombocytopenia — This may cause bleeding for no reason (such as nosebleeds or bleeding gums)
• Reduced white blood cell counts, also called leukopenia or neutropenia — This may make you more likely to get an infection

The side effects of myelosuppression can usually be managed and eventually go away.

Be sure to ask your nurse or doctor about other side effects that may occur. The side effects of VIDAZA (and the effects of MDS — some of them are the same) can be unpleasant. It's important to actively treat the disease and stay on treatment for as long as your doctor recommends. This may help you to move beyond supportive care.

Other Things You Need to Know About Treatment With VIDAZA

As you receive treatment with VIDAZA, remember:

• Routine blood tests
  Before each cycle of treatment, you will need to have blood tests. They will help your doctor determine your response to VIDAZA and how well it is working. The tests will also help your doctor manage any side effects of treatment¹
• Pregnancy and nursing
  Women should not become pregnant or nurse while taking VIDAZA. Men should avoid fathering children while taking VIDAZA¹
• Liver problems
  Tell your doctor before taking VIDAZA if you have liver problems¹
• Kidney problems
  Tell you doctor before taking VIDAZA if you have kidney problems¹