LUMIN

What it is

LUMIN is a tablet containing mianserin hydrochloride, available in strengths of 10 mg or 20 mg. Mianserin belongs to the tetracyclic series of antidepressant compounds, the piperazinoazepines, which are chemically different from the common tricyclic antidepressants. It increases central noradrenergic neurotransmission by α2-autoreceptor blockade and noradrenaline reuptake inhibition, and has interactions with serotonin receptors in the central nervous system.

Approved indications

— Treatment of major depression.

Dosing overview

Treatment should begin with a daily dose of 30 mg given in three divided doses or as a single bedtime dose and be adjusted weekly in light of clinical response. The effective daily dose for adult patients usually lies between 30 mg and 90 mg (average 60 mg) in divided doses or as a single bedtime dose. A maximum daily dose of 120 mg should not be exceeded. In elderly patients, initially not more than 30 mg daily and increased slowly under close supervision, with a reduced dose often required for maintenance, and a single night-time dose preferred to divided doses. LUMIN should not be used in children and adolescents under the age of 18 years.

Key safety warnings

The risk of suicidality is inherent in depression and may persist until significant remission occurs, with patients at greater risk including those with a history of suicide-related events or significant suicidal ideation prior to treatment commencement. Patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of a course of treatment or at the time of dose changes. Pooled analysis of short-term placebo-controlled trials showed that antidepressants increased the risk of suicidal ideation and behaviours in children, adolescents, and young adults aged 18–24 years during initial treatment. Bone marrow depression, usually presenting as neutropenia, agranulocytosis and thrombocytopenia, have been reported during treatment with mianserin, occurring most commonly after 4 to 6 weeks of treatment. Patients complaining of sore throat, stomatitis, fever, malaise, flu-like symptoms or other signs of infection should discontinue treatment and have a full blood count obtained. QT prolongation and ventricular arrhythmias including Torsades de Pointes have been reported, and mianserin should be used with caution in patients with risk factors including congenital long QT syndrome, age over 65 years, female sex, structural heart disease, renal or hepatic disease, and use of medicines affecting mianserin metabolism or QT-prolonging medicines. Hypokalaemia and hypomagnesaemia should be corrected prior to treatment. Mianserin, especially in the first days of treatment, may impair concentration and psychomotor skills, with this risk increased if alcohol is taken concurrently. Mianserin may lower the convulsive threshold in patients with epilepsy, and mianserin products including LUMIN should be avoided if possible in patients with epilepsy.

Contraindications

LUMIN is contraindicated in patients with hypersensitivity to mianserin or any excipients, mania, severe liver disease, and in patients receiving concomitant monoamine oxidase inhibitor therapy.

PBS listing

The 10 mg tablet strength is listed on the PBS with 2 items, restricted access, and an ex-manufacturer price of A$7.25. The 20 mg tablet strength is listed on the PBS with 2 items, restricted access, and an ex-manufacturer price of A$15.30.

Regulatory history

LUMIN 10 mg and LUMIN 20 mg tablets were first registered on the ARTG on 20 May 1996.