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Important Safety Information

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. GEODON® (ziprasidone HCl) is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions].

GEODON is contraindicated in patients with a known history of QT prolongation, recent acute myocardial infarction, or uncompensated heart failure, and should not be used with certain other QT-prolonging drugs. Hypokalemia may increase the risk of QT prolongation and arrhythmia.

As with all antipsychotic medications, a rare and potentially fatal condition known as neuroleptic malignant syndrome (NMS) has been reported with GEODON. NMS can cause hyperpyrexia, muscle rigidity, diaphoresis, tachycardia, irregular pulse or blood pressure, cardiac dysrhythmia, and altered mental status. If signs and symptoms appear, immediate discontinuation, treatment, and monitoring are recommended.

Prescribing should be consistent with the need to minimize tardive dyskinesia (TD), a potentially irreversible dose- and duration-dependent syndrome. If signs and symptoms appear, discontinuation should be considered since TD may remit partially or completely.

Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain. There have been reports of hyperglycemia or diabetes mellitus in patients treated with GEODON, as well as alterations in lipids and bodily weight gain. Patients treated with an atypical antipsychotic should be monitored for symptoms of hyperglycemia, including polydipsia, polyuria, polyphagia, weakness, dyslipidemia, as well as weight gain.

Precautions include the risk of rash, orthostatic hypotension, and seizures. Other risks may include leukopenia, neutropenia, agranulocytosis, dysphagia, hyperprolactinemia, potential for cognitive and motor impairment, and difficulty with body temperature regulation. Patients should avoid alcohol while taking GEODON.

The possibility of suicide attempt is inherent in psychotic illness or bipolar disorder, and close supervision of high-risk patients should accompany drug therapy.

Neonates exposed to antipsychotic drugs during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery. GEODON should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Breast feeding is not recommended.

In short-term schizophrenia trials, the most commonly observed adverse events associated with GEODON at an incidence of ≥5% and at least twice the rate of placebo were somnolence and respiratory tract infection.

The most common adverse events associated with GEODON in bipolar mania were somnolence, extrapyramidal symptoms, dizziness, akathisia, and abnormal vision.

The most common adverse events (≥5%) associated with GEODON in the bipolar maintenance study were tremor and insomnia.

In short-term schizophrenia clinical studies, 10% of GEODON-treated patients experienced a weight gain of ≥7% of body weight vs 4% for placebo.

In short-term bipolar mania clinical studies, 4.9% of GEODON-treated patients experienced a weight gain of ≥7% of body weight vs 3.3% for placebo.

In a long-term bipolar maintenance clinical study, 5.6% of both GEODON- and placebo-treated patients experienced weight gain of ≥7%. Only patients who adequately tolerated GEODON entered the maintenance phase of this study, and there were substantial dropouts by the end of the study.

In fixed-dose, pivotal studies, the most commonly observed adverse events associated with the use of GEODON for Injection (incidence ≥5%) and observed at a rate in the higher GEODON dose groups (10 mg, 20 mg) of at least twice that of the lowest GEODON dose group (2 mg control) were somnolence (20%), headache (13%), and nausea (12%).

IM administration of GEODON for more than 3 consecutive days has not been studied.

Since there is no experience regarding the safety of administering GEODON for Injection to schizophrenic patients already taking oral GEODON, the practice of coadministration is not recommended.

GEODON for Injection has not been systematically evaluated in elderly patients or in patients with hepatic or renal impairment. As the cyclodextrin excipient is cleared by renal filtration, GEODON should be administered with caution to patients with impaired renal function.

Indications

GEODON is indicated for schizophrenia; acute treatment as monotherapy of manic or mixed episodes associated with bipolar I disorder; and maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate. GEODON (ziprasidone mesylate) for Injection is indicated for acute agitation in schizophrenia. For full symptoms and diagnostic criteria, see the DSM-IV-TR® (2000). GEODON has a greater capacity to prolong the QTc interval than several other antipsychotics. In some drugs, QT prolongation has been associated with torsade de pointes, a potentially fatal arrhythmia, and sudden death. In many cases, this would lead to the conclusion that other drugs should be tried first. Whether GEODON will cause torsade de pointes or increase the rate of sudden death is unknown.

Please see GEODON full Prescribing Information.