What is the most important information I should know about Cytosar?

· Cytosar should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

· Serious side effects have been reported with the use of Cytosar including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection such as fever; chills, or sore throat); liver problems; severe nausea, vomiting, diarrhea, abdominal pain, mouth sores; and others. Talk to your doctor about the possible side effects from treatment with Cytosar.


What is Cytosar?

· Cytosar is a cancer (antineoplastic) medication. Cytosar interferes with the growth of cancer cells and slows their growth and spread in the body.

· Cytosar is used to treat blood cancers (acute non-lymphocytic leukemia, acute lymphocytic leukemia and chronic myelocytic leukemia).

· Cytosar may also be used for purposes other than those listed in this medication guide.


What should I discuss with my healthcare provider before taking Cytosar?

· Before taking Cytosar, tell your doctor if you have     ·kidney disease;     ·liver disease;     ·had recent vaccinations; or     ·bone marrow problems.

· You may not be able to take Cytosar, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

· Cytosar is in the FDA pregnancy category D. This means that Cytosar is known to cause birth defects in an unborn baby.Do not take Cytosar without first talking to your doctor if you are pregnant or could become pregnant during treatment. Contraceptive measures are recommended during treatment with Cytosar.

· It is not known whether Cytosar passes into breast milk. Do not take Cytosar without first talking to your doctor if you are breast feeding a baby.


How should I take Cytosar?

· Take Cytosar exactly as directed by your doctor. If you do not understand these instructions, ask your doctor, nurse or pharmacist to explain them to you.

· Your doctor will determine the correct amount and frequency of treatment with Cytosar depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

· Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with Cytosar to monitor progress and side effects.

· Your healthcare provider will store Cytosar as directed by the manufacturer. If you are storing Cytosar, follow the directions provided by your healthcare provider.


What happens if I miss a dose?

· Contact your doctor if you miss a dose of Cytosar.


What happens if I overdose?

· If for any reason an overdose of Cytosar is suspected, seek emergency medical attention or contact your healthcare provider immediately.

· Symptoms of a Cytosar overdose tend to be similar to side effects caused by the medication, although often more severe.


What should I avoid while taking Cytosar?

· Cytosar can lower the activity of your immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses and do not receive vaccines that contain live strains of a virus (e.g., live oral polio vaccine) during treatment with Cytosar. In addition, avoid contact with individuals who have recently been vaccinated with a live vaccine. There is a chance that the virus can be passed on to you.


What are the possible side effects of Cytosar?

· If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:     ·an allergic reaction (shortness of breath; closing of the throat; difficulty breathing; swelling of the lips, face, or tongue; or hives);     ·decreased bone marrow function and blood problems (extreme fatigue; unusual bruising or bleeding; black, bloody or tarry stools; or fever, chills, sore throat, or signs of infection);     ·shortness of breath or dry cough;     ·personality changes or severe drowsiness;     ·yellowing of the eyes or skin; or     ·eye pain or redness of the eyes.

· Other less serious side effects may be more likely to occur. Talk to your doctor if you experience     ·nausea, vomiting, diarrhea, or abdominal pain;     ·mouth sores;     ·loss of appetite;     ·temporary hair loss;     ·reddening, itching, and inflammation of the eyes (conjunctivitis);     ·rash, itching or hives;     ·dizziness; or     ·headache.

· Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other drugs will affect Cytosar?

· Do not receive "live" vaccines during treatment with Cytosar. Administration of a live vaccine may be dangerous during treatment with Cytosar.

· Many other drugs may interact with Cytosar. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with Cytosar.


Where can I get more information?

· Your pharmacist has additional information about Cytosar written for health professionals that you may read.