Important Safety Information
GEODON is available in 20-mg, 40-mg, 60-mg, and 80-mg capsules as well as in intramuscular injection in 20-mg/mL single-use vials.
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 other QT-prolonging drugs. Hypokalemia (and/or hypomagnesemia) may increase the risk of QT prolongation and arrhythmia.
Do not use in patients with known hypersensitivity to ziprasidone.
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.
Severe Cutaneous Adverse Reactions (SCAR), such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Stevens-Johnson syndrome have been reported with ziprasidone exposure. DRESS consists of a combination of three or more of the following: cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, lymphadenopathy and one or more systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and pericarditis. SCAR, such as DRESS and Stevens-Johnson syndrome are sometimes fatal. Discontinue ziprasidone if DRESS or other types of SCAR are suspected.
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, and 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.
Antipsychotic drugs (which include GEODON) may cause somnolence, postural hypotension, and motor and sensory instability, which could lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications, that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.
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. Breastfeeding 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 was 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 a 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 co-administration 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.
GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. 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 Full Prescribing Information, including BOXED WARNING.