The safety and tolerability profile of Raxone administered at a dose of 900mg/day, has been well established in the RHODOS trial, which demonstrated that Raxone is generally well tolerated in patients with LHON.1,2
The most commonly reported adverse reactions to Raxone are nasopharyngitis, cough, mild-to-moderate diarrhea (usually not requiring discontinuation of therapy) and back pain.9
Please click here to refer to Section 4.8 of the Raxone SmPC for further safety information.
Reporting suspected adverse reactions after authorization of the medicinal product is important as this will allow quick identification of new safety information. Contact details to report any suspected adverse reactions to Raxone can be found here.
Raxone’s quality is assured by rigorous manufacturing processes and a tightly controlled supply that meet all pharmaceutical medical standards and regulatory requirements.9
EMA. EPAR summary for the public: Raxone (idebenone). 2015.
Klopstock T, et al. Brain 2011; 134:2677–2686.
Metz G, et al. ARVO 2014 poster (Abstract 6206)
Di Prospero NA, et al. Arch Neurol 2007; 64:803–808.
Lynch DR, et al. Arch Neurol 2010; 67:941–947.
Buyse GM, et al. Lancet 2015; 385:1748–1757.
Buyse GM, et al. Neuromuscul Disord 2011; 21:396–405.
EMA. Assessment report: Raxone (idebenone). 2015.
Raxone SmPC, September 2015. Available at: here. Accessed December 2015.