Product Dossier

LYRICA

Product Dossier for LYRICA (pregabalin, Viatris). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

LYRICA contains the active ingredient pregabalin, available in capsule strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg.

Approved indications

— Neuropathic pain in adults. — Adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Dosing overview

The dose range is 150 to 600 mg per day given in two divided doses. For neuropathic pain, treatment can be started at a dose of 150 mg per day given as two divided doses, and based on individual patient response and tolerability, the dosage may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval. For epilepsy, treatment can be started with a dose of 150 mg per day given as two divided doses, the dosage may be increased to 300 mg per day given as two divided doses after 1 week, and the maximum dosage of 600 mg per day given as two divided doses may be achieved after an additional week. If LYRICA has to be discontinued, it is recommended to withdraw it gradually over a minimum of one week.

Key safety warnings

Pregabalin is a potential drug of misuse, abuse, and dependence, and poses risks of misuse, abuse and dependence which can lead to overdose and death especially when used concomitantly with opioids and other CNS depressants. The patient's risk of misuse, abuse or dependence should be assessed before prescribing and the patient monitored regularly during treatment, particularly amongst patients with current or past misuse, abuse or dependence of opioids and/or benzodiazepines.

Regulatory history

LYRICA pregabalin 25 mg, 75 mg, 150 mg and 300 mg capsules were first listed on the ARTG on 13 April 2005. LYRICA CR (modified release tablets) in strengths of 82.5 mg, 165 mg and 330 mg were first listed on 10 March 2021.