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Prescribing Information
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Indications
Seroquel XR is indicated in adults for (1) adjunctive therapy to antidepressants in major depressive disorder; (2) acute depressive episodes in bipolar disorder; (3) acute manic or mixed episodes in bipolar I disorder, as either monotherapy or adjunct therapy to lithium or divalproex; (4) maintenance treatment of bipolar I disorder as an adjunct to lithium or divalproex; and (5) schizophrenia. Seroquel is indicated in adults for the treatment of (1) acute depressive episodes in bipolar disorder, (2) acute manic episodes in bipolar I disorder, as either monotherapy or adjunct therapy to lithium or divalproex; (3) maintenance treatment of bipolar I disorder as an adjunct to lithium or divalproex; and (4) schizophrenia.
Important Safety Information About Seroquel XR and Seroquel® (quetiapine fumarate) tablets
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death, compared to placebo (4.5% vs 2.6%, respectively). Seroquel XR and Seroquel are not approved for the treatment of patients with dementia-related psychosis. (See Prescribing Information for complete Boxed Warnings.)
Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies of major depressive disorder and other psychiatric disorders. Patients of all ages started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Seroquel XR is not approved for use in patients under the age of 18 years. Seroquel is not approved for use in patients under the age of 10 years. (See Prescribing Information for complete Boxed Warning and Indications.)
A potentially fatal symptom complex, sometimes referred to as neuroleptic malignant syndrome (NMS), has been reported in association with administration of antipsychotic drugs, including quetiapine. Rare cases of NMS have been reported with quetiapine. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. The management of NMS should include immediate discontinuation of antipsychotic drugs.
Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics, including quetiapine. The relationship of atypical use and glucose abnormalities is complicated by the possibility of increased risk of diabetes in the schizophrenic population and the increasing incidence of diabetes in the general population. However, epidemiological studies suggest an increased risk of treatment-emergent, hyperglycemia-related adverse reactions in patients treated with atypical antipsychotics. Patients starting treatment with atypical antipsychotics who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and periodically during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing.
Undesirable alterations in lipids have been observed with quetiapine use. Increases in total cholesterol, LDL-cholesterol and triglycerides, and decreases in HDL-cholesterol have been reported in clinical trials. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of and periodically during treatment.
Increases in weight have been observed in clinical trials. Patients receiving quetiapine should receive regular monitoring of weight.
Tardive dyskinesia (TD), a potentially irreversible syndrome of involuntary dyskinetic movements, may develop in patients treated with antipsychotic drugs. The risk of developing TD and the likelihood that it will become irreversible are believed to increase as the duration of treatment and total cumulative dose of antipsychotic drugs administered to the patient increase. TD may remit, partially or completely, if antipsychotic treatment is withdrawn. Quetiapine should be prescribed in a manner that is most likely to minimize the occurrence of TD, and discontinuation should be considered if signs and symptoms of TD occur.
Quetiapine may induce orthostatic hypotension with associated dizziness, tachycardia, and syncope, especially during the initial dose titration period and should be used with caution in patients with known cardiovascular or cerebrovascular disease.
Leukopenia, neutropenia, and agranulocytosis (including fatal cases), have been reported temporally related to atypical antipsychotics, including quetiapine. Patients with a pre-existing low white blood cell (WBC) count or a history of drug induced leukopenia/neutropenia should have their complete blood count monitored frequently during the first few months of therapy. In these patients, quetiapine should be discontinued at the first sign of a decline in WBC absent other causative factors. Patients with neutropenia should be carefully monitored, and quetiapine should be discontinued in any patient if the absolute neutrophil count is <1000/mm3.
The possibility of a suicide attempt is inherent in schizophrenia, bipolar disorder, and depression, and close supervision of high risk patients should accompany drug therapy.
Warnings and Precautions also include the risk of cataracts, seizures, hypothyroidism, hyperprolactinemia, transaminase elevations, potential for cognitive and motor impairment, priapism, body temperature dysregulation, dysphagia, and withdrawal. Examination of the lens by methods adequate to detect cataract formation, such as slit lamp exam or other appropriately sensitive methods, is recommended at initiation of treatment or shortly thereafter, and at 6-month intervals during chronic treatment.
The most commonly observed adverse reactions associated with the use of Seroquel XR versus placebo in clinical trials for all indications were somnolence (25-52% vs 9-13%), dry mouth (12-40% vs 1-8%), constipation (6-11% vs 3-6%), dizziness (10-13% vs 4-11%), increased appetite (2-12% vs 0-6%), dyspepsia (2-7% vs 1-4%), weight gain (3-7% vs 0-1%), fatigue (3-14% vs 2-4%), dysarthria (1-5% vs 0%), and nasal congestion (2-5% vs 1%).
The most commonly reported adverse reactions associated with the use of Seroquel vs placebo in adults in clinical trials for all indications were somnolence (18%- 57% vs 8%-15%), dry mouth (9%-44% vs 3%-13%), dizziness (9%-18% vs 5%-7%), constipation (8%-10% vs 3%-5%), asthenia (2%-10% vs 1%-4%), abdominal pain (4%-7% vs 1%-3%), postural hypotension (4%-7% vs 1%-2%), pharyngitis (4%-6% vs 3%), weight gain (4%-6% vs 1%-3%), lethargy (5% vs 2%), ALT increased (5% vs 1%), and dyspepsia (4%-7% vs 1%-4%).
Please see Prescribing Information for Seroquel XR and Seroquel, including Boxed Warnings.
