Important Safety Information and Indications
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 Important Safety Information and Indications
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 (eg, heart failure, sudden death) or infectious (eg, 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.
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.
Terms and Conditions
By using the GEODON Savings Card, you acknowledge that you currently meet the eligibility criteria and will comply with the following terms and conditions.
- Offer is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, or other federal or state health care programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico formerly known as “La Reforma de Salud”)
- Offer is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs that reimburse you for the entire cost of your prescription drugs
- By using the Card, patients may receive savings of up to $250 per fill and pay a minimum of $4 per fill. The Card is good for a maximum of $3,000 per year. After a maximum of $3,000, patient will pay monthly out-of-pocket costs
- The Card may be used once per month for the life of the program
- You must deduct the value of the Card from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf
- Card is not valid for Massachusetts residents whose prescriptions are covered in whole or in part by third-party insurance, or where otherwise prohibited by law
- Card cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription
- Card will be accepted only at participating pharmacies
- Card is not health insurance
- Offer good only in the US and Puerto Rico
- Card is limited to 1 per person during this offering period and is not transferable
- Pfizer reserves the right to rescind, revoke, or amend this offer without notice
- No membership fee
- Offer expires 12/31/2019
- For further information, call 1-800-725-9655, visit www.GEODON.com, or write: Attn: GEODON Savings Card: 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560
Dosing and Administration
ORAL DOSING (BID with meals)
Acute treatment of manic/mixed episodes of bipolar I disorder
- Initiate at 40 mg twice daily (80 mg daily). The dose may then be increased to 60 mg or 80 mg twice daily on the second day of treatment and then adjusted on the basis of tolerance and efficacy within the range of
40 mg - 80 mgtwice daily
- Give oral doses with food
Maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate
- Continue treatment at the same dose on which the patient was initially stabilized, within the range of
40 mg - 80 mgtwice daily
- Give oral doses with food
- Initiate at 20 mg twice daily (40 mg daily). Daily dosage may be adjusted up to 80 mg twice daily (160 mg daily)
- Dose adjustments should occur at intervals of not less than 2 days
- Lowest effective dose should be used
- Give oral doses with food