TEVATIAPINE XR

What it is

TEVATIAPINE XR contains quetiapine fumarate. It is available in five strengths as modified release tablets containing quetiapine fumarate equivalent to 50 mg, 150 mg, 200 mg, 300 mg and 400 mg of quetiapine free base. TEVATIAPINE XR should be administered once daily, without food.

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 (MDD) in patients who are intolerant of, or who have an inadequate response to alternative therapies. — Treatment of generalised anxiety disorder (GAD).

Dosing overview

The safety of doses above 800 mg/day has not been evaluated.

Key safety warnings

Quetiapine should be used with caution in patients with cardiovascular disease including history of myocardial infarction, ischaemic heart disease, heart failure or conduction abnormalities. It 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. Severe cutaneous adverse reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms are potentially life-threatening and have been reported during quetiapine exposure. These commonly present as extensive cutaneous rash or exfoliative dermatitis, fever and lymphadenopathy. Discontinue quetiapine if severe cutaneous adverse reactions occur. Neuroleptic malignant syndrome has been associated with antipsychotic treatment, including quetiapine, with clinical manifestations including hyperthermia, altered mental status, muscular rigidity and autonomic instability. In such an event, quetiapine should be discontinued and appropriate medical treatment given. Concomitant administration of quetiapine 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. If concomitant treatment is clinically warranted, careful observation is advised, particularly during treatment initiation and dose increases. 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. 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. Epidemiological studies suggest an increased risk of treatment-emergent hyperglycaemia-related adverse events in patients treated with atypical antipsychotics. Agranulocytosis (severe neutropenia with infection) has been reported among patients treated with quetiapine during clinical trials and in post-marketing reports, including fatal cases. Most cases of severe neutropenia have occurred within the first two months of starting therapy.

Contraindications

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

Regulatory history

TEVATIAPINE XR was registered on the ARTG on 14 July 2016 across five strengths (50 mg, 150 mg, 200 mg, 300 mg and 400 mg modified release tablets) under licence category RE.