Rufinamide

Articles · Medicine Compliance Aid Stability · Lactation Safety Information · New Medicines ·

429802008

Articles

Medicine Compliance Aid Stability

Inovelon · Eisai Ltd

Eisai Ltd
Inovelon
Tablets f/c 100mg, 200mg, 400mg
A3 · Amber 3 · No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Airtight container
Store in airtight containers.
2nd March 2015

Lactation Safety Information

Suitable alternative antiepileptic
No published evidence of safety

New Medicines

Inovelon (EU), Banzel (US) · Adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in patients 1 years of age and older

Information

Inovelon (EU), Banzel (US)
Licence extension / variation
Eisai
Eisai

Development and Regulatory status

Launched
Launched
None
August 2018

Aug 18: Launched in the UK [3].


Jun 18: EU positive opinion for a licence change for adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in patients 1 years of age and older (previously aged 4 years and older) [2].

Category

Uncertain - possibly sodium channel antagonist
Lennox-Gastaut syndrome is characterised by multiple types of epileptic seizures, a characteristic EEG with generalised slow spike-and-wave discharges, psychomotor delay and behavioural disorders. Onset is usually before the age of 8. Prevalence is about 2 per 10,000 in Europe. The number of children affected is not known with certainty but it may account for about 3% of all childhood epilepsies. Males are affected five times more often than females [1].
Adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in patients 1 years of age and older
Oral

Evidence based evaluations