^aCommon adverse reactions pertaining to infusion site events included if ≥2%.

^bThese adverse reactions were identified with DUODOPA^® intestinal gel as drug-related events. However, these events were not considered adverse reactions for PRODUODOPA.

^cHallucination includes hallucination, hallucination visual, hallucination olfactory, hallucinations tactile, and hallucinations mixed..

^dPolyneuropathy includes neuropathy peripheral, polyneuropathy, decreased vibratory sense, peripheral sensory neuropathy, sensory disturbance, and sensory loss.

^eBased on post-marketing data

Description of selected adverse reactions

Infusion site ievents

In the Phase 3 studies, the most common AEs related to Produodopa were infusion site reactions 77.6% (N=294) and infusion site infections 41.4% (N=157). Infusion site events including infusion site reactions and infections, commonly seen with subcutaneous infusions were observed with Produodopa in the clinical studies. The majority of the infusion site events were non-serious, were mild or moderate in severity, and resolved spontaneously or with treatment such as antibiotics and/or incision and drainage. Three subjects with infusion site infections had a complication of sepsis resulting in hospitalisation. Monitor for any skin changes at the infusion site that could indicate a potential infection, such as redness associated with warmth, swelling, pain, and discolouration when you apply pressure to it. Aseptic techniques should be followed while using this medication and consider rotating the infusion site more frequently than every 3^rd day, using a new infusion set if you see these skin changes. It is recommended that new infusion sites be at least 2.5 cm from sites used within the previous 12 days.