SEQUASE

What it is

SEQUASE XR is a modified release tablet containing quetiapine fumarate equivalent to 50 mg, 150 mg, 200 mg, 300 mg or 400 mg of quetiapine free base. SEQUASE XR should be administered once daily, without food. The tablets should be swallowed whole and not split, chewed or crushed.

Approved indications

— Maintenance treatment of bipolar I disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes. — Treatment of depressive episodes associated with bipolar disorder. — Treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium valproate. — Treatment of schizophrenia, prevention of relapse and maintenance of clinical improvement during continuation therapy. — Treatment of recurrent major depressive disorder in patients who are intolerant of, or who have an inadequate response to alternative therapies. — Treatment of generalised anxiety disorder.

Dosing overview

Key safety warnings

Quetiapine should be used with caution in patients with known cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or other conditions predisposing to hypotension. Quetiapine may induce orthostatic hypotension associated with dizziness, tachycardia and, in some patients, syncope especially during the initial dose-titration period. Severe cutaneous adverse reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms, are potentially life threatening adverse drug reactions that have been reported during quetiapine exposure. Discontinue quetiapine if severe cutaneous adverse reactions occur. Neuroleptic malignant syndrome has been associated with antipsychotic treatment, including quetiapine. Clinical manifestations include hyperthermia, altered mental status, muscular rigidity, autonomic instability, and increased creatine phosphokinase. Concomitant administration of SEQUASE XR and other serotonergic agents such as monoamine oxidase inhibitors, selective serotonin re-uptake inhibitors, serotonin norepinephrine re-uptake inhibitors or tricyclic antidepressants may result in serotonin syndrome, a potentially life-threatening condition. Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including quetiapine. The risk of suicide attempt is inherent in depression and may persist until significant remission occurs. Patients with depression may experience worsening of their depressive symptoms and/or the emergence of suicidal ideation and behaviour, whether or not they are taking antidepressant medications. Elderly patients with dementia-related psychosis treated with atypical anti-psychotics are at an increased risk of death compared to placebo. A meta-analysis of seventeen placebo controlled trials showed a risk of death in the drug-treated patients of approximately 1.6 to 1.7 times that seen in placebo-treated patients.

Contraindications

SEQUASE XR is contraindicated in patients who are hypersensitive to any component of this product.

Regulatory history

SEQUASE XR was first registered on the Australian Register of Therapeutic Goods on 3 July 2014, with registrations for 50 mg, 150 mg, 200 mg, 300 mg and 400 mg modified release tablet strengths.