TARGIN

What it is

TARGIN contains oxycodone hydrochloride and naloxone hydrochloride. TARGIN is available as modified release tablets in 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. TARGIN modified release tablets are to be swallowed whole and are not to be broken, chewed or crushed. The naloxone component in a fixed combination with oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.

Approved indications

— Management of 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. — Second line symptomatic treatment of patients with 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 TARGIN tablets is 160/80 mg (12-hourly TARGIN tablets 80/40 mg). For restless legs syndrome in opioid naïve patients, the usual starting dose 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 TARGIN modified release tablets. Situations which increase the risk of respiratory depression should be identified, dosing modified in patients at risk and patients monitored closely, especially on initiation or following a dose increase. Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Dosages and durations should be limited to the minimum required and patients monitored for signs and symptoms of respiratory depression and sedation. Patients should not drink alcohol while taking TARGIN modified release tablets. TARGIN modified release tablets pose risks of hazardous and harmful use which can lead to overdose and death. The patient's risk of hazardous and harmful use should be assessed before prescribing and the patient monitored regularly during treatment. Because of the risks associated with the use of opioids, TARGIN modified release tablets should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain.

Contraindications

TARGIN 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 (due to the risk of increased intracranial pressure); uncontrolled convulsive disorders; suspected surgical abdomen; delayed gastric emptying; alcoholism; delirium tremens; concurrent administration of monoamine oxidase inhibitors (MAOIs) and for 2 weeks after their cessation. TARGIN is contraindicated in patients with a history of opioid abuse for restless legs syndrome.

PBS listing

TARGIN was recommended for listing on the Pharmaceutical Benefits Scheme in November 2015 for chronic severe disabling pain, and in November 2016 for chronic severe disabling pain unresponsive to non-opioid analgesics, as a Restricted Benefit listing. PBS pricing and item numbers are not available in the provided sources.

Regulatory history

TARGIN was first registered on the Australian Register of Therapeutic Goods on 12 May 2010, with initial ARTG registrations for the 5/2.5 mg, 10/5 mg, 20/10 mg and 40/20 mg strengths. Additional strengths (2.5/1.25 mg, 15/7.5 mg and 30/15 mg) were registered on 24 September 2014. The 60/30 mg and 80/40 mg strengths were registered on 20 July 2016. An AusPAR was approved on 14 July 2016, which extended TARGIN's indications to include second-line symptomatic treatment for severe to very severe idiopathic restless legs syndrome after dopaminergic therapy failure, approved a new maximum daily dose of 160 mg/80 mg, and authorised higher strength tablets of 60 mg/30 mg and 80 mg/40 mg.