PRYZEX

What it is

PRYZEX ODT contains olanzapine in orally disintegrating tablets available in strengths of 5 mg, 10 mg, 15 mg and 20 mg. Olanzapine is an atypical antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacological profile across a number of receptor systems. The orally disintegrating tablets should be placed in the mouth, where the tablet will rapidly disperse in saliva, so it can be easily swallowed. Alternatively, it may be dispersed in a full glass of water or other suitable beverage (orange juice, apple juice, milk or coffee) immediately before administration.

Approved indications

— Treatment of schizophrenia and related psychoses. — Short term treatment of acute manic episodes associated with Bipolar I Disorder, when used alone or in combination with lithium or valproate. — Prevention of recurrence of manic, mixed or depressive episodes in Bipolar I Disorder.

Dosing overview

A low starting dose of 5 mg daily should be considered for patients aged 65 and over when clinical factors warrant.

Key safety warnings

Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including olanzapine. Patients with an established diagnosis of diabetes mellitus should be monitored regularly for worsening of glucose control; those with risk factors for diabetes should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment; and any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycaemia including polydipsia, polyuria, polyphagia and weakness. Undesirable alterations in lipids have been observed in olanzapine-treated patients, with greater mean increases in fasting total cholesterol, LDL cholesterol, and triglycerides compared to placebo-treated patients. Appropriate clinical monitoring is recommended. Potential consequences of weight gain should be considered prior to starting olanzapine, patients should receive regular monitoring of weight, and significant weight gain was observed across all baseline Body Mass Index categories in olanzapine-treated patients. Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex, is associated with antipsychotic drugs including olanzapine, with clinical manifestations including hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability. In such an event or with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic drugs including olanzapine should be discontinued. In placebo-controlled clinical trials of elderly patients with dementia-related psychosis, the incidence of death in olanzapine-treated patients was significantly greater than placebo-treated patients (3.5% vs. 1.5%, respectively). Cerebrovascular adverse events including stroke and transient ischaemic attack were reported in trials of olanzapine in elderly patients with dementia-related psychosis, with a higher incidence in olanzapine-treated patients compared to placebo (1.3% vs. 0.4%, respectively).

Contraindications

Olanzapine is contraindicated in those patients with a known hypersensitivity to any ingredient of the product.

Regulatory history

PRYZEX ODT orally disintegrating tablets in strengths of 5 mg, 10 mg, 15 mg and 20 mg were first registered on the Australian Register of Therapeutic Goods on 12 August 2011 (ARTG entries 179079, 179076, 179082 and 179071 respectively).