INOVEMED

What it is

INOVEMED contains rufinamide and is available as 200 mg and 400 mg film-coated tablets. Rufinamide is an antiepileptic carboxamide derivative. Rufinamide modulates the activity of sodium channels, prolonging their inactive state.

Approved indications

— Adjunctive therapy in the treatment of seizures associated with Lennox Gastaut syndrome in patients 4 years of age and older.

Dosing overview

INOVEMED should be taken twice daily with food in two equally divided doses, one in the morning and one in the evening. For children aged 4 years and older weighing less than 30 kg not receiving valproate, treatment should be initiated at a total daily dose of 200 mg, with increases by 200 mg/day increments up to a maximum recommended total daily dose of 1000 mg/day. For patients weighing less than 30 kg also receiving valproate, treatment should be initiated at 200 mg daily with increases by 200 mg/day to a maximum recommended total daily dose of 600 mg/day. For adults, adolescents and children aged 4 years and older weighing 30 kg or over not receiving valproate, treatment should be initiated at a total daily dose of 400 mg with increases by 400 mg/day increments, to a maximum recommended total daily dose of 1800 mg/day (for 30.0–50.0 kg), 2400 mg/day (for 50.1–70.0 kg), or 3200 mg/day (for 70.1 kg or over). For patients weighing 30 kg or over receiving valproate, treatment should be initiated at 400 mg daily with increases by 400 mg/day increments to a maximum recommended total daily dose of 1200 mg/day (for 30.0–50.0 kg), 1600 mg/day (for 50.1–70.0 kg), or 2200 mg/day (for 70.1 kg or over). When INOVEMED treatment is to be discontinued, it should be withdrawn gradually, achieved by reducing the dose by approximately 25% every two days.

Key safety warnings

Status epilepticus cases have been observed during treatment with rufinamide, whereas none were observed with placebo. If patients develop new seizure types and/or experience an increased frequency of status epilepticus that is different from their baseline condition, the benefit-risk ratio of therapy should be reassessed. Serious antiepileptic medicinal product hypersensitivity syndrome including DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) and Stevens-Johnson syndrome have occurred in association with rufinamide therapy. Patients typically presented with fever and rash associated with other organ system involvement. All patients who develop a rash while taking INOVEMED must be closely monitored. Rufinamide treatment has been associated with dizziness, somnolence, ataxia and gait disturbances, which could increase the occurrence of accidental falls. Patients and carers should exercise caution until they are familiar with the potential effects of this medicinal product. Rufinamide produced a decrease in QTc interval proportional to concentration. Clinicians should use clinical judgment when assessing whether to prescribe INOVEMED to patients at risk from further shortening their QTc duration, such as those with Congenital Short QT Syndrome or a family history of such a syndrome. Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents. A meta-analysis has shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for rufinamide. Patients should be monitored for signs of suicidal ideation and behaviours.

Contraindications

INOVEMED is contraindicated in patients with hypersensitivity to the active substance, triazole derivatives or to any of the excipients. INOVEMED should not be used in patients with severe hepatic impairment. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take INOVEMED film-coated tablets.

Regulatory history

INOVEMED rufinamide 200 mg tablets (ARTG 433232) and 400 mg tablets (ARTG 433233) were first listed on the Australian Register of Therapeutic Goods on 24 July 2025.