ZYPREXA

What it is

ZYPREXA contains the active ingredient olanzapine. ZYPREXA is available as olanzapine 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg tablets. ZYPREXA ZYDIS is available as olanzapine 5 mg, 10 mg, 15 mg and 20 mg wafers. Olanzapine is an atypical antipsychotic, antimanic and mood stabilising agent.

Approved indications

— Treatment of schizophrenia and related psychoses. — Short-term treatment of acute manic episodes associated with Bipolar 1 Disorder, alone or in combination with lithium or valproate. — Preventing recurrence of manic, mixed or depressive episodes in Bipolar 1 Disorder.

Dosing overview

For patients 65 and over, a low starting dose of 5 mg/day should be considered 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 ZYPREXA. Patients with an established diagnosis of diabetes mellitus should be monitored regularly for worsening of glucose control; patients with risk factors for diabetes mellitus should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Undesirable alterations in lipids have been observed in ZYPREXA-treated patients in placebo-controlled trials; ZYPREXA-treated patients had a greater mean increase in fasting total cholesterol, LDL cholesterol, and triglycerides compared to placebo-treated patients. Potential consequences of weight gain should be considered prior to starting ZYPREXA; as with all antipsychotics, patients receiving ZYPREXA should receive regular monitoring of weight. In an analysis of 13 placebo-controlled olanzapine monotherapy studies, ZYPREXA-treated patients gained an average of 2.6 kg compared to an average 0.3 kg weight loss in placebo-treated patients with a median exposure of 6 weeks; clinically significant weight gain was observed across all baseline Body Mass Index categories. Neuroleptic malignant syndrome, a potentially fatal symptom complex, is associated with antipsychotic drugs, including olanzapine; clinical manifestations include hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability with possible additional signs of elevated creatine kinase, myoglobinuria and acute renal failure; in such an event, all antipsychotic drugs including ZYPREXA should be discontinued. In elderly patients with dementia-related psychosis, the efficacy of olanzapine has not been established; in placebo-controlled clinical trials, the incidence of death in olanzapine-treated patients was significantly greater than placebo-treated patients (3.5% vs. 1.5%, respectively).

Contraindications

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

PBS listing

ZYPREXA tablets are listed on the PBS in strengths of 2.5 mg, 5 mg, 7.5 mg and 10 mg with streamlined restriction at ex-manufacturer prices ranging from A$9.34 to A$13.56. ZYPREXA ZYDIS wafers are listed in strengths of 5 mg, 10 mg, 15 mg and 20 mg with streamlined restriction at ex-manufacturer prices ranging from A$13.56 to A$23.52.

Regulatory history

ZYPREXA olanzapine tablets at 2.5 mg, 5 mg, 7.5 mg and 10 mg were first listed on the ARTG on 5 March 1997. ZYPREXA ZYDIS olanzapine wafers at 5 mg, 10 mg, 15 mg and 20 mg were first listed on the ARTG on 9 May 2000. ZYPREXA olanzapine tablets at 15 mg and 20 mg were first listed on the ARTG on 22 January 2001.