The concomitant use of rasagiline & fluoxetine or fluvoxamine should be avoided. At least 5 wk off fluoxetine before using rasagiline. At least 14 days off rasagiline before using fluoxetine or fluvoxamine. Impulse control disorders (ICDs) can occur in patients treated w/ dopamine agonists &/or dopaminergic treatments. Similar reports of ICDs have also been received post-marketing w/ rasagiline. Patients should be regularly monitored for the development of ICDs. Patients & carers should be made aware of the behavioural symptoms of ICDs that were observed in patients treated w/ rasagiline, including cases of compulsions, obsessive thoughts, pathological gambling, increased libido, hypersexuality, impulsive behaviour & compulsive spending or buying. Since rasagiline potentiates the effects of levodopa, the adverse effects of levodopa may be increased & pre-existing dyskinesia exacerbated. Decreasing the dose of levodopa may ameliorate this side effect. There have been reports of hypotensive effects when rasagiline is taken concomitantly w/ levodopa. Patients w/ Parkinson's disease are particularly vulnerable to the adverse effects of hypotension due to existing gait issues. The concomitant use of rasagiline & dextromethorphan or sympathomimetics such as those present in nasal & oral decongestants or cold medicinal product containing ephedrine or pseudoephedrine is not recommended. A retrospective cohort study suggested a possibly increased risk of melanoma w/ the use of rasagiline, especially in patients w/ longer duration of rasagiline exposure &/or w/ the higher cumulative dose of rasagiline. Any suspicious skin lesion should be evaluated by a specialist. Patients should therefore be advised to seek medical review if a new or changing skin lesion is identified. Caution should be used when initiating treatment w/ rasagiline in patients w/ mild hepatic impairment. Rasagiline use in patients w/ moderate hepatic impairment should be avoided. In case patients progress from mild to moderate hepatic impairment, rasagiline should be stopped. Excessive daytime sleepiness & sudden sleep onset episodes: Rasagiline may cause daytime drowsiness, somnolence, & occasionally, especially if used w/ other dopaminergic medications, falling asleep during activities of daily living. Patients must be informed of this & advised to exercise caution while driving or operating machines during treatment w/ rasagiline. Patients who have experienced somnolence &/or an episode of sudden sleep onset must refrain from driving or operating machines. There are no data from the use of rasagiline in pregnant women. Animal studies do not direct or indirect harmful effects w/ respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of rasagiline during pregnancy. Non-clinical data indicate that rasagiline inhibits prolactin secretion & thus, may inhibit lactation. It is not known whether rasagiline is excreted in human milk. Caution should be exercised when rasagiline is administered to a breast-feeding mother. No human data on the effect of rasagiline on fertility are available. Non-clinical data indicate that rasagiline has no effect on fertility. Not recommended in childn & adolescents <18 yr.
Sign Out
