OLANZAPINE ODT-WGR

What it is

Olanzapine ODT-WGR is available in 5 mg, 10 mg, 15 mg and 20 mg orally disintegrating tablets. The tablets should be placed in the mouth, where they will rapidly disperse in saliva and can be easily swallowed. Alternatively, they 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

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, and patients with risk factors for diabetes should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. 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 in placebo-controlled trials, with olanzapine-treated patients showing a greater mean increase in fasting total cholesterol, Low Density Lipoprotein 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, and patients receiving olanzapine should receive regular monitoring of weight. In clinical trials, 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. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). In such an event or with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic drugs, including olanzapine, should be discontinued. Olanzapine should be used cautiously in patients who have a history of seizures or are subject to factors which may lower the seizure threshold, as seizures have been reported to occur rarely in such patients. In comparator studies of one year or less duration, olanzapine was associated with a statistically significantly lower incidence of treatment emergent dyskinesia. However, the risk of tardive dyskinesia increases with long-term exposure and therefore if signs or symptoms of tardive dyskinesia appear in a patient on olanzapine, a dose reduction or drug discontinuation should be considered. 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). Risk factors that may predispose this patient population to increased mortality include age greater than 80 years, sedation, concomitant use of benzodiazepines, or presence of pulmonary conditions such as pneumonia.

Contraindications

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

PBS listing

Information regarding PBS listing for Olanzapine ODT-WGR is not available in the provided source documents.

Regulatory history

Olanzapine ODT-WGR was first registered on the ARTG on 26 November 2009, with four variants registered: 5 mg, 10 mg, 15 mg and 20 mg orally disintegrating tablets, all in blister pack form.