LYRILIN

What it is

LYRILIN contains pregabalin. Pregabalin is an analogue of the neurotransmitter gamma-aminobutyric acid (GABA). It has analgesic and anticonvulsant activity. LYRILIN is supplied as capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.

Approved indications

— Treatment of 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. If LYRILIN has to be discontinued, it is recommended to withdraw it gradually over a minimum of one week.

Key safety warnings

LYRILIN causes dizziness and somnolence, which generally begin shortly after initiation and occur more frequently at higher doses. Dizziness and somnolence were the adverse events most frequently leading to withdrawal from controlled studies, each at 4%. LYRILIN may cause dizziness and somnolence and therefore may have an influence on the ability to drive or use machines. Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medication affects their ability to perform these activities. Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behaviour in patients taking these drugs for any indication. Patients treated with any antiepileptic drug should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviour, and any unusual changes in mood or behaviour. Pooled analyses of 199 placebo-controlled clinical trials of 11 different antiepileptic drugs showed that patients randomised to one of the antiepileptic drugs had approximately twice the risk of suicidal thinking or behaviour compared to patients randomised to placebo. The estimated incidence rate of suicidal behaviour or ideation among antiepileptic drug-treated patients was 0.43%, compared to 0.24% among placebo-treated patients, representing an increase of approximately one case for every 530 patients treated. Weight gain occurred more frequently in patients treated with LYRILIN than in patients treated with placebo. Weight gain was related to dose and length of exposure. There have been reports of hypersensitivity reactions, including cases of angioedema. LYRILIN should be discontinued immediately if symptoms of angioedema, such as facial, perioral, or upper airway swelling occur. After discontinuation of short-term and long-term treatment with LYRILIN, withdrawal symptoms have been observed in some patients, including insomnia, headache, nausea, anxiety, hyperhidrosis and diarrhoea. There have been post-marketing reports of congestive heart failure in some patients receiving LYRILIN. LYRILIN should be used with caution in these patients.

Contraindications

LYRILIN is contraindicated in patients who have demonstrated hypersensitivity to pregabalin or to any of the excipients. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take LYRILIN.

Regulatory history

LYRILIN pregabalin was first listed on the ARTG on 18 February 2014, with eight strength formulations (25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg) registered in licence category RE.