Warnings and Precautions, Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis (5.3) 4/2013

SEROQUEL is an atypical antipsychotic indicated for the treatment of:

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Schizophrenia ( 1.1)

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Bipolar I disorder manic episodes (1.2)

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Bipolar disorder, depressive episodes (1.2)

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SEROQUEL can be taken with or without food (2.1)

Tablets: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg (3)
CONTRAINDICATIONS

Known hypersensitivity to SEROQUEL or any components in the formulation. (4)
WARNINGS AND PRECAUTIONS

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Cerebrovascular Adverse Reactions: Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) has been seen in elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs (5.3)

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Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring (5.4)

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Metabolic Changes: Atypical antipsychotics have been associated with metabolic changes. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain (5.5)

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Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes

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Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically, during treatment

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Weight Gain: Gain in body weight has been observed; clinical monitoring of weight is recommended

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Tardive Dyskinesia : Discontinue if clinically appropriate (5.6)

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Hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease (5.7)

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Increased Blood Pressure in Children and Adolescents: Monitor blood pressure at the beginning of, and periodically during treatment in children and adolescents (5.8)

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Leukopenia , Neutropenia and Agranulocytosis : Monitor complete blood count frequently during the first few months of treatment in patients with a pre-existing low white cell count or a history of leukopenia/neutropenia and discontinue SEROQUEL at the first sign of a decline in WBC in absence of other causative factors (5.9)

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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 (5.10)

Most common adverse reactions (incidence ≥5% and twice placebo):

Adults: somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain, postural hypotension, pharyngitis, weight gain, lethargy, ALT increased, dyspepsia (6.1)

Children and Adolescents: somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, weight increased (6.1)

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

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Concomitant use of strong CYP3A4 inhibitors: Reduce quetiapine dose to one sixth when coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) ( 2.5, 7.1, 12.3)

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Concomitant use of strong CYP3A4 inducers: Increase quetiapine dose up to 5 fold when used in combination with a chronic treatment (more than 7-14 days) of potent CYP3A4 inducers (e.g., phenytoin, rifampin, St. John’s wort) ( 2.6, 7.1, 12.3)

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Discontinuation of strong CYP3A4 inducers: Reduce quetiapine dose by 5 fold within 7-14 days of discontinuation of CYP3A4 inducers ( 2.6, 7.1, 12.3)

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Pregnancy: Limited human data. Based on animal data, may cause fetal harm. Quetiapine should be used only if the potential benefit justifies the potential risk (8.1)

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Nursing Mothers: Discontinue drug or nursing, taking into consideration importance of drug to mother’s health (8.3)