Safety and tolerability of apomorphine SL (Uprima®)

Abstract

The side effect profile of apomorphine SL (2–6 mg) has been determined in clinical studies of over 5000 patients using over 120 000 doses. Apomorphine, 2 and 3 mg, has been shown to have an excellent safety profile. The most commonly occurring side effects (<7%), nausea, headache and dizziness, tend to be mild and not compliance limiting. Neither the incidence nor the nature of the side effects is significantly affected by common co-morbidites or by the use of many concurrent medications. Over this dose range there is little evidence of vasoactivity; there is little change in haemodynamic baseline and there is no synergistic effect with nitrates. Although syncope can occur at higher doses, it is rarely observed at approved doses (<0.2%).