ABYRAZ

What it is

ABYRAZ contains aripiprazole and is available as tablets in strengths of 10 mg, 15 mg, 20 mg or 30 mg.

Approved indications

— Schizophrenia, including maintenance of clinical improvement during continuation therapy.

Dosing overview

The recommended starting dose for schizophrenia in adults is 10 or 15 mg daily, administered as a once-daily schedule without regard to meals. Doses in the range of 10 to 30 mg daily have been effective in clinical trials, and daily dosage may be adjusted on the basis of individual clinical status within this range. Dosage increases should not be made before 2 weeks, the time needed to achieve steady state. The maintenance dose is 15 mg daily.

Key safety warnings

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at increased risk of death compared to placebo, with analyses of seventeen placebo-controlled trials revealing a risk of death between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week trial, the death rate in drug-treated patients was about 4.5%, compared to about 2.6% in the placebo group. ABYRAZ is not approved for the treatment of patients with dementia-related psychosis. The possibility of suicide attempt is inherent in psychotic illness and close supervision of high-risk patients should accompany drug therapy. Prescriptions should be written for the smallest quantity consistent with good patient management, in order to reduce the risk of overdose. Sleep apnoea and related disorders have been reported in patients treated with ABYRAZ, with or without prior history of sleep apnoea. ABYRAZ should be used with caution in patients who have sleep apnoea or risk factors for developing it, including overweight or obesity, males, and concomitant use of central nervous system depressants. A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome has been reported in association with administration of antipsychotic drugs including ABYRAZ, with rare cases occurring during treatment. If a patient develops signs and symptoms indicative of this syndrome or presents with unexplained high fever without additional clinical manifestations, all antipsychotic drugs including ABYRAZ must be discontinued. The risk of tardive dyskinesia increases with long-term exposure to antipsychotic treatment. If signs and symptoms of tardive dyskinesia appear in a patient on ABYRAZ, a dose reduction or drug discontinuation should be considered. Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotic agents including ABYRAZ. Epidemiological studies suggest an increased risk of treatment-emergent hyperglycaemia-related adverse events in patients treated with atypical antipsychotics.

Contraindications

ABYRAZ is contraindicated in patients who are hypersensitive to aripiprazole or any of the excipients.

Regulatory history

ABYRAZ aripiprazole tablets in 10 mg, 15 mg, 20 mg and 30 mg strengths were first listed on the ARTG on 16 July 2010.