ARX-Oxycodone/Naloxone

What it is

ARX-Oxycodone/Naloxone contains oxycodone hydrochloride and naloxone hydrochloride. The medicine is available in modified release tablet strengths of 2.5/1.25 mg, 5/2.5 mg, 10/5 mg, 15/7.5 mg, 20/10 mg, 30/15 mg, 40/20 mg, 60/30 mg and 80/40 mg. ARX-Oxycodone/Naloxone tablets are to be swallowed whole and are not to be broken, chewed or crushed.

Approved indications

— Severe pain where other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, the pain is opioid-responsive, and requires daily, continuous, long term treatment. — Severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.

Dosing overview

The usual starting dose for opioid-naïve patients or patients presenting with severe pain uncontrolled by weaker opioids is 10/5 mg 12-hourly. Two lower strengths (2.5/1.25 mg and 5/2.5 mg) are available to facilitate dose titration when initiating opioid therapy, and individual dose adjustment. The dose should then be cautiously titrated, as frequently as every 1–2 days if necessary, to achieve pain relief. The maximum recommended daily dose of ARX-Oxycodone/Naloxone tablets is 160/80 mg (12-hourly 80/40 mg). For restless legs syndrome, the usual starting dose for an opioid naïve patient is 5 mg/2.5 mg of oxycodone hydrochloride/naloxone hydrochloride 12 hourly. Titration on a weekly basis is recommended in case higher doses are required.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of ARX-Oxycodone/Naloxone. Be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk and monitor patients closely, especially on initiation or following a dose increase. ARX-Oxycodone/Naloxone poses risks of hazardous and harmful use which can lead to overdose and death. Assess the patient's risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment. Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Limit dosages and durations to the minimum required and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patients not to drink alcohol while taking ARX-Oxycodone/Naloxone. ARX-Oxycodone/Naloxone 60/30 mg and 80/40 mg should only be used in opioid-tolerant patients. In patients not previously exposed to opioids, these tablet strengths may cause fatal respiratory depression.

Contraindications

ARX-Oxycodone/Naloxone is contraindicated in hypersensitivity to opioids, naloxone and any of the excipients or any situation where opioids are contraindicated; moderate to severe hepatic impairment; elevated carbon dioxide levels in the blood, severe respiratory disease, acute respiratory disease and respiratory depression; cor pulmonale; cardiac arrhythmias; uncontrolled bronchial asthma; severe chronic obstructive pulmonary disease; non-opioid induced paralytic ileus; pregnancy; lactation; severe CNS depression; increased cerebrospinal or intracranial pressure; brain tumour or head injury; uncontrolled convulsive disorders; suspected surgical abdomen; delayed gastric emptying; alcoholism; delirium tremens; and concurrent administration of monoamine oxidase inhibitors and for 2 weeks after their cessation. ARX-Oxycodone/Naloxone is also contraindicated in patients with a history of opioid abuse for restless legs syndrome.

Regulatory history

ARX-Oxycodone/Naloxone was first listed on the Australian Register of Therapeutic Goods on 8 October 2024 across nine strengths: 2.5/1.25 mg, 5/2.5 mg, 10/5 mg, 15/7.5 mg, 20/10 mg, 30/15 mg, 40/20 mg, 60/30 mg and 80/40 mg.