SYQUET

What it is

SYQUET contains quetiapine fumarate. SYQUET XR modified release tablets are available in five strengths containing quetiapine fumarate equivalent to 50 mg, 150 mg, 200 mg, 300 mg and 400 mg of quetiapine free base.

Approved indications —

Maintenance treatment of bipolar I disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse or 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

SYQUET XR should be administered once daily, without food. The tablets should be swallowed whole and not split, chewed or crushed. Dosing varies by indication and patient population. For prevention of relapse or recurrence of manic, depressive and mixed episodes in bipolar disorder, the usual effective dose is within the range of 300 to 800 mg per day. For bipolar depression, SYQUET XR should be titrated as 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3), 300 mg (Day 4), and can be titrated to 400 mg on Day 5 and up to 600 mg by Day 8. For acute mania, SYQUET XR should be titrated as 300 mg on Day 1, 600 mg on Day 2 and up to 800 mg after Day 2, with doses adjusted within the usual effective dose range of 400 to 800 mg per day. For schizophrenia, the daily dose at the start of therapy is 300 mg on Day 1, 600 mg on Day 2 and up to 800 mg after Day 2, with doses adjusted within the usual effective dose range of 400 to 800 mg per day. The usual effective dose in recurrent major depressive disorder is 150 mg. For generalised anxiety disorder, the recommended dose range is 50 mg to 150 mg, and doses above 150 mg per day are not recommended.

Key safety warnings

SYQUET may induce orthostatic hypotension associated with dizziness, tachycardia and, in some patients, syncope especially during the initial dose-titration period. Orthostatic hypotension, dizziness and syncope may lead to falls. In post-marketing experience there were cases reported of QT prolongation with overdose, in patients with concomitant illness, and in patients taking medicines known to cause electrolyte imbalance or increase QT interval; caution should be exercised when quetiapine is prescribed in patients with cardiovascular disease or family history of QT prolongation. Severe cutaneous 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; SYQUET should be discontinued if severe cutaneous adverse reactions occur. 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 emergence of suicidal ideation and behaviour, and this risk may persist until significant remission occurs; patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of treatment or at the time of dose changes. 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. Neuroleptic malignant syndrome has been associated with antipsychotic treatment, including quetiapine, with clinical manifestations including hyperthermia, altered mental status, muscular rigidity, autonomic instability, and increased creatine phosphokinase; in such an event, SYQUET should be discontinued and appropriate medical treatment given. There have been reports of agranulocytosis among patients treated with quetiapine during clinical trials and post-marketing reports, including fatal cases. Elderly patients with dementia-related psychosis treated with atypical antipsychotics are at an increased risk of death compared to placebo; a meta-analysis of seventeen placebo-controlled trials showed a risk of death in drug-treated patients of approximately 1.6 to 1.7 times that seen in placebo-treated patients, with a rate of death in drug-treated patients of about 4.5% compared to about 2.6% in the placebo group; most deaths appeared to be either cardiovascular or infectious in nature.

Contraindications

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

PBS listing

No source documents contain information about SYQUET's PBS listing status, item numbers, restriction type, or ex-manufacturer price.

Regulatory history

SYQUET quetiapine immediate release tablets in 25 mg, 100 mg, 200 mg and 300 mg strengths were first listed on the ARTG on 2 April 2014. SYQUET XR modified release tablets in 50 mg, 150 mg, 200 mg, 300 mg and 400 mg strengths were first listed on the ARTG on 17 September 2021.