Health Care Professionals

OUR MEDICINES

Santhera is passionate about developing new treatments for patients with mitochondrial diseases. Our focus is on the development of treatments for neuromuscular and neuro-ophthalmological diseases that currently lack treatment options.

Raxone in LHON: Safety

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

Additionally, longer-term tolerability of Raxone has been established in the Expanded Access Program (EAP) for up to 3 years.3

In addition to the Raxone safety and tolerability data from clinical trials in patients with LHON, supporting data is provided by multiple clinical studies that have investigated the safety and tolerability profile of Raxone in other indications.4–8 Doses of up to 2250 mg/day have been administered in clinical studies in other indications, demonstrating a safety profile consistent with the pivotal trial in LHON.4–6

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. Healthcare professionals are asked to report any suspected adverse reactions to Raxone by telephone or email:

Phone: +44 1423 850 750
Email: aereporting@santhera.com

Quality assurance

Raxone’s quality is assured by rigorous manufacturing processes and a tightly controlled supply that meet all pharmaceutical medical standards and regulatory requirements.9

References

1.

EMA. EPAR summary for the public: Raxone (idebenone). 2015.

2.

Klopstock T, et al. Brain 2011; 134:2677–2686.

3.

Metz G, et al. ARVO 2014 poster (Abstract 6206)

4.

Di Prospero NA, et al. Arch Neurol 2007; 64:803–808.

5.

Lynch DR, et al. Arch Neurol 2010; 67:941–947.

6.

Buyse GM, et al. Lancet 2015; 385:1748–1757.

7.

Buyse GM, et al. Neuromuscul Disord 2011; 21:396–405.

8.

EMA. Assessment report: Raxone (idebenone). 2015.

9.

Raxone SmPC, September 2015. Available at: here. Accessed December 2015.

This section of the website is intended
to provide healthcare professionals with
information about Raxone® and other
products in Santhera’s pipeline.

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