Objective: To explore the utilization and tolerability of Rytary in the clinical setting.

Background: Rytary is a novel extended-release carbidopa-levodopa (CD-LD) formulation that was approved in US in January 2015 for the treatment of all stages of PD. There is still limited post marketing experience with the drug.

Methods: A single-center, retrospective study of PD patients followed in the Movement Disorders Clinics at Northwestern University who were prescribed Rytary between February and November 2015. Data were extracted from the electronic medical records.

Results: Of 81 patients who were started on Rytary, all of them were previously treated with immediate-release CD-LD, and all were converted based on the suggested initial dosing conversion table in the package insert. The indications for starting Rytary were the following: motor fluctuations/dyskinesia (n=72, 89%), frequent dosing of IR CD-LD (n=7, 8.5%), and non-motor fluctuation (n=2, 2.5%). 43 patients (53%) remained on Rytary at the time of the review. The reasons for stopping Rytary were the following: less potent ON time or peak effect (n=18, 48.6%), fatigue and drowsiness (n=6, 16.2%), unpredictable OFFs (n=5, 13.5%), severe dyskinesia (n=3, 8.1%), anxiety/depression (n=2, 5.4%), cost of medication (n=2, 5.4%) and nausea (n=1, 2.7%). Of 18 patients who stopped Rytary due to less potency, Rytary was up titrated in 8 (44.5%). 9 patients (50%) refused to try higher doses and requested IR CD-LD. One patient decreased the Rytary dose due to severe dyskinesia but eventually stopped it due to less potency at lower doses. Of 43 patients who remained on Rytary, 21 (49%) remained on the initially suggested dosage as per the conversion table, 18 (42%) required dose up-titration, and 3 (7%) required dose reduction due to dyskinesia. The mean frequency of Rytary administration was 3.5 times a day, compared with IR CD-LD, with mean frequency of 5.1 times per day.

Conclusions: Rytary was utilized exclusively for patients with advanced PD. There was an unexpectedly high rate of Rytary discontinuation due to adverse events and suboptimal control of motor fluctuations despite utilization of the recommended dose conversion. Rytary allowed significant reduction of the LD dosing frequency, as previously reported. Long term efficacy and tolerability of Rytary in the clinical setting will need to be assessed with longer observation.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/experience-with-utilization-of-rytary-in-the-clinical-setting/