QUETIA

What it is

QUETIA contains quetiapine fumarate. QUETIA 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. QUETIA XR should be administered once daily, without food. The tablets should be swallowed whole and not split, chewed or crushed.

Approved indications

QUETIA XR is indicated for 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

For prevention of relapse/recurrence of manic, depressive and mixed episodes in bipolar disorder, the usual effective dose is within the range of 300 to 800 mg/day. For bipolar depression, QUETIA XR should be titrated as follows: 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4), with further titration to 400 mg on Day 5 and up to 600 mg by Day 8. For acute mania, QUETIA XR should be titrated to 300 mg on Day 1, 600 mg on Day 2 and up to 800 mg after Day 2, with adjustment within the usual effective dose range of 400 to 800 mg/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, adjusted within the usual effective dose range of 400 to 800 mg/day. The usual effective dose in recurrent major depressive disorder is 150 mg. For generalised anxiety disorder, doses above 150 mg/day are not recommended.

Key safety warnings

Quetiapine should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension, and caution should be observed in cardiac patients because of the risk of orthostatic hypotension. Quetiapine may induce orthostatic hypotension associated with dizziness, tachycardia and, in some patients, syncope especially during the initial dose-titration period. 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. As with other antipsychotics, caution should be exercised when quetiapine is prescribed in patients, including children and adolescents, with cardiovascular disease or family history of QT prolongation. 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 and commonly present as a combination of extensive cutaneous rash or exfoliative dermatitis, fever, lymphadenopathy and possible eosinophilia; quetiapine 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 may experience worsening of depressive symptoms and/or emergence of suicidal ideation and behaviour, whether or not taking antidepressant medications, and patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of treatment or at times of dose changes. 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; quetiapine should be discontinued and appropriate medical treatment given if this occurs. 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.

Contraindications

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

Regulatory history

QUETIA XR modified release tablets in strengths of 50 mg, 150 mg, 200 mg, 300 mg and 400 mg were first listed on the ARTG on 17 January 2014.