Rubifen LA

What it is

Rubifen LA contains methylphenidate hydrochloride and is available in modified release capsules of 10 mg, 20 mg, 30 mg, 40 mg or 60 mg. Rubifen LA modified release capsules should be administered orally once daily in the morning. Rubifen LA may be swallowed as whole modified release capsules or alternatively may be administered by sprinkling the capsule contents on a small amount of soft food.

Approved indications

— Treatment of Attention-Deficit Hyperactivity Disorder (ADHD).

Dosing overview

The dosage of Rubifen LA should be individualised according to the patient's clinical needs and responses, with treatment initiated at a low dose with increments at weekly intervals.

Key safety warnings

Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Stimulant products, including methylphenidate, generally should not be used in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may increase the risk of sudden death due to the sympathomimetic effects of a stimulant drug. Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Before initiating Rubifen LA treatment, patients should be assessed for pre-existing cardiovascular and psychiatric disorders and a family history of sudden death, ventricular arrhythmia and psychiatric disorders. Blood pressure should be monitored at appropriate intervals in all patients taking methylphenidate, especially in those with hypertension. CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics, and worsening of Tourette's syndrome has also been reported. Serotonin syndrome has been reported following co-administration of methylphenidate with serotonergic drugs such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), and the concomitant use of methylphenidate and serotonergic drugs is not recommended as this may lead to the development of serotonin syndrome. Moderately reduced weight gain and slight growth retardation have been reported with the long-term use of stimulants, including methylphenidate, in children, and growth should be monitored as clinically necessary during treatment with methylphenidate. Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both paediatric and adult patients, and priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose or during a period of drug withdrawal. Stimulants, including methylphenidate immediate release tablets and Rubifen LA, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon, with very rare sequelae including digital ulceration and/or soft tissue breakdown.

Contraindications

Rubifen LA is contraindicated in patients with anxiety and tension states, agitation, a family history or diagnosis of Tourette's syndrome, glaucoma, hyperthyroidism, pre-existing cardiovascular disorders including uncontrolled hypertension, angina pectoris, arterial occlusive disease especially coronary arteries, heart failure, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, cardiac arrhythmia and channelopathies, treatment with monoamine oxidase (MAO) inhibitors or within a minimum of 14 days following discontinuation of a MAO inhibitor, pheochromocytoma, known drug dependence or alcohol abuse, severe depression, anorexia nervosa, psychotic symptoms or suicidal tendency, and known hypersensitivity to methylphenidate or to any component of the formulation.

PBS listing

Rubifen LA is listed on the PBS in 10 mg, 20 mg, 30 mg and 40 mg strengths, with authority required restriction. Ex-manufacturer prices are A$17.87 for the 10 mg capsule, A$25.52 for the 20 mg capsule, A$31.66 for the 30 mg capsule, and A$33.76 for the 40 mg capsule.

Regulatory history

Rubifen LA methylphenidate hydrochloride modified release capsules in 10 mg, 20 mg, 30 mg, 40 mg and 60 mg strengths were first listed on the ARTG on 26 May 2022.