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FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia
Date:7/31/2009

rved with INVEGA(R) SUSTENNA(TM) and other atypical antipsychotic medications. If you notice that you are gaining weight, please notify your doctor.

INVEGA(R) SUSTENNA(TM) and similar medicines can raise the blood levels of a hormone called prolactin and blood levels of prolactin remain high with continued use. This may result in some side effects including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection.

Some people may feel faint, dizzy, or may pass out when they stand up or sit up suddenly. Be careful not to get up too quickly. It may help if you get up slowly and sit on the edge of the bed or chair for a few minutes before you stand up. These symptoms may decrease or go away after your body becomes used to the medicine.

INVEGA(R) SUSTENNA(TM) and similar medicines have been associated with decreases in the counts of white cells in circulating blood. If you have a history of low white blood cell counts or have unexplained fever or infection, then please contact your doctor right away.

INVEGA(R) SUSTENNA(TM) can make some people feel dizzy, sleepy, or less alert. Until you know how you are going to respond to INVEGA(R) SUSTENNA(TM), be careful driving a car, operating machines, or doing things that require you to be alert.

INVEGA(R) SUSTENNA(TM) should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.

Call your doctor right away if you start thinking about suicide or wanting to hurt yourself.

In a study of people taking INVEGA(R) SUSTENNA(TM) common side effects in the treatment of schizophrenia were reactions at the injection site, sleepiness, dizziness, feeling of inner restlessness, and abnormal muscle movements, including tremor (shaking), shuffling, uncontrolle
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SOURCE Janssen
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