Warnings and Precautions, Hyperglycemia (5.4), 1/2011

Warnings and Precautions, Hyperlipidemia (5.5), 1/2011

Warnings and Precautions, Weight Gain (5.6), 1/2011

Warnings and Precautions, QT Prolongation (5.12), 7/2011

Warnings and Precautions, Hypothyroidism, (5.14), 1/2011

Warnings and Precautions, Withdrawal (5.23), 05/2010

SEROQUEL XR is an atypical antipsychotic indicated for the: (1)

Treatment of schizophrenia (1.1) (1)

• Adults: Efficacy was established with SEROQUEL XR in one 6-week and one maintenance trial in patients with schizophrenia as well as in three 6-week trials with SEROQUEL in patients with schizophrenia (14.1) (1)

Acute treatment of manic or mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex (1.2) (1)

• Adults: Efficacy was established with SEROQUEL XR in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder as well as two 12-week monotherapy trials and one 3-week adjunctive trial with SEROQUEL in patients with manic episodes associated with bipolar I disorder (14.2) (1)

Acute treatment of depressive episodes associated with bipolar disorder (1.2) (1)

• Adults: Efficacy was established with SEROQUEL XR in one 8-week trial in patients with bipolar I or II disorder as well as two 8-week trials with SEROQUEL in patients with bipolar I or II disorder (14.2) (1)

Maintenance treatment of bipolar I disorder as an adjunct to lithium or divalproex (1.2) (1)

• Adults: Efficacy was established with SEROQUEL in two maintenance trials in patients with bipolar I disorder (14.2) (1)

Adjunctive treatment of major depressive disorder (MDD) (1.3) (1)

• Adults: Efficacy as an adjunct to antidepressants was established in two 6-week trials in patients with MDD who had an inadequate response to an antidepressant alone (14.3) (1)

SEROQUEL XR Tablets should be swallowed whole and not split, chewed or crushed. SEROQUEL XR should be taken without food or with a light meal (approx. 300 calories). SEROQUEL XR should be administered once daily, preferably in the evening. (2)

DOSAGE FORMS AND STRENGTHS

Extended-Release Tablets: 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg (3)
CONTRAINDICATIONS

None (4) (4)
WARNINGS AND PRECAUTIONS

• Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Antipsychotic drugs, including quetiapine, are associated with an increased risk of death; causes of death are variable. (5.1) (5)

• Suicidality and Antidepressant Drugs: Increased the risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder and other psychiatric disorders. (5.2) (5)

• Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring. (5.3) (5)

• Hyperglycemia and Diabetes Mellitus (DM): Ketoacidosis, hyperosmolar coma and death have been reported in patients treated with atypical antipsychotics, including quetiapine. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. When starting treatment, patients with diabetes or risk factors for diabetes should undergo blood glucose testing before and during treatment. (5.4) (5)

• Hyperlipidemia: Undesirable alterations in lipids have been observed. 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. (5.5) (5)

• Weight Gain: Patients should receive regular monitoring of weight. (5.6) (5)

• Tardive Dyskinesia: Discontinue if clinically appropriate. (5.7) (5)

• Orthostatic Hypotension: Associated dizziness, tachycardia and syncope may occur especially during the initial dose titration period. Use in caution in patients with known cardiovascular or cerebrovascular disease. (5.8) (5)

• Increased Blood Pressure in Children and Adolescents: Blood pressure should be measured at the beginning of, and periodically during treatment in children and adolescents. SEROQUEL XR has not been eva luated in pediatric patients. (5.9) (5)

• Leukopenia, Neutropenia and Agranulocytosis: have been reported with atypical antipsychotics including SEROQUEL XR. Patients with a pre-existing low white cell count (WBC) or a history of leukopenia/neutropenia should have complete blood count (CBC) monitored frequently during the first few months of treatment and should discontinue SEROQUEL XR at the first sign of a decline in WBC in absence of other causative factors. (5.10) (5)

• Cataracts: Lens changes have been observed in patients during long-term quetiapine treatment. Lens examination is recommended when starting treatment and at 6-month intervals during chronic treatment. (5.11) (5)

• QT Prolongation: Post-marketing cases show increases in QT interval in patients who overdosed on quetiapine, in patients with concomitant illness, and in patients taking medicines known to cause electrolyte imbalance or increase QT interval. Avoid use with drugs that increase the QT interval and in patients with risk factors for prolonged QT interval. (5.12) (5)

• Suicide: 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. (5.21) (5)

• See Full Prescribing Information for additional WARNINGS and PRECAUTIONS. (5)

Most common adverse reactions (incidence ≥5% and twice placebo) in decreasing frequency are: somnolence, dry mouth, constipation, dizziness, increased appetite, dyspepsia, weight gain, fatigue, dysarthria, and nasal congestion. (6.1) (6)

To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. (6)