Healthcare Professionals - Frequently Asked Questions

How long do the effects of RenehaVis™ last?

The pivotal clinical trial has already shown that RenehaVis™ effects last for up to and sometimes beyond 52 weeks after a full treatment although the SPC approval is for 12 months. This confirms data from the 2 year monitored study, originally unveiled at EULAR 2010 and now published in Rheumatology Reports;3:e4 (March 2011) (see studies) with an effect up to 2 years in approximately 20% of patients, and also accompanied by stronger VAS reduction than comparators, despite greater concurrent analgesic used with those comparators as allowed in the study design. This data is currently being incorporated into the SPC/PIL.

What grades of knee OA is RenehaVis™ approved for?

RenehaVis™ can be used for grades 1, 2A and 2B. RenehaVis™ has not yet been approved for grade 3 knee OA.

Can I inject more than once in a week?

RenehaVis™ has been approved for use in a treatment course of up to 3 injections, subject to disease and pain severity, the recommendation being that 2 injections will enable optimal onset of effect, as shown by VAS measurements in the 2 year comparator study, each injection administered at weekly intervals. Any usage outside this recommendation is at the physician’s discretion.

Can the patient be administered other therapies concurrently with RenehaVis™

There have been no fully documented studies concerning the safety and efficacy of concomitant administration of HA with other intra-articular products. However, other systemic therapies such as pain relief medication do not interfere with the administration of HA although it was noted in the 2 year study that the need for concurrent analgesic use was significantly reduced with RenehaVis™?

What is the molecular weight and concentration of the two HAs in RenehaVis™?

seringue The first chamber of RenehaVis™ contains 0.7ml of 2.2% HA with an average molecular weight of 1 million Daltons.

The second chamber of RenehaVis™ contains 0.7ml of 1.0% HA with an average molecular weight of 2 million Daltons.

What is the source of your HA?

RenehaVis™ originates from bacterial fermentation while the manufacturing process itself is the subject of a patent as it has been developed to ensure the highest degree of purification.

Can I use RenehaVis™ for OA at other joints?

The specific use of RenehaVis™ at other joints is not yet approved.

Is RenehaVis™ registered?

RenehaVis™ was granted a CE certificate (class 3) in Feb 2009 and is approved to be marketed in the EU as well as several countries outside the EU as separate registration or notification processes are being conducted. An updated efficacy guideline of 1 year per treatment (formerly 16 weeks) was added in April 2012 to reflect findings of a unique and ongoing long term study assessing duration and replication of efficacy.