OLANCOR

What it is

OLANCOR is an orally disintegrating tablet containing olanzapine, 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.

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. — Preventing recurrence of manic, mixed or depressive episodes in Bipolar I Disorder.

Dosing overview

Olanzapine may be given without regard to meals, as its absorption is not affected by food.

Key safety warnings

**Hyperglycaemia and diabetes.** 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. Epidemiological studies suggest an increased risk of treatment-emergent hyperglycaemia-related adverse events in patients treated with the atypical antipsychotics. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (for example, obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. **Lipid alterations.** Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo-controlled trials. Olanzapine-treated patients had a greater mean increase in fasting total cholesterol, Low Density Lipoprotein (LDL) cholesterol, and triglycerides compared to placebo-treated patients. **Weight gain.** Potential consequences of weight gain should be considered prior to starting olanzapine. As with all antipsychotics, patients receiving olanzapine should receive regular monitoring of weight. **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). **Seizures.** Olanzapine should be used cautiously in patients who have a history of seizures or are subject to factors which may lower the seizure threshold. Seizures have been reported to occur rarely in such patients when treated with olanzapine. **Tardive dyskinesia.** 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. **Mortality in elderly patients with dementia-related psychosis.** 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).

Contraindications

Olanzapine is contraindicated in those patients with a known hypersensitivity to any ingredient of the product. This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Regulatory history

OLANCOR olanzapine 2.5 mg, 5 mg, 7.5 mg and 10 mg film-coated tablets were first listed on the ARTG on 12 December 2014.