Note to Affiliate: This document is based on the November 2023 Irish SmPC, the August 2020 J Tube IFU, the March 2019 NJ Tube IFU, the August 2020 PEG IFU, the 2019 CADD Duodopa Patient Information Guide, and the February 2019 CADD Duodopa Pump Operator's Manual.
Duodopa (levodopa/carbidopa intestinal gel) is for the treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results1
People in this piece are models, not actual patients.
People in this piece are models, not actual patients.
Duodopa (levodopa/carbidopa intestinal gel) is for the treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results1
People in this piece are models, not actual patients.
Because ON TIME is their time
Duodopa is a device-aided therapy for advanced Parkinson’s disease:
EFFICACY
Giving patients more ‘ON’ time2
Duodopa offers proven ‘ON’ time effectiveness1-4
See Duodopa efficacy information
Improved ‘OFF’ and ‘ON’ time without troublesome dyskinesia2
Approximately 4 hours more ‘ON’ time each day – and 4 hours less ‘OFF’ time each day with Duodopa2
Most adverse events were related to the surgical procedure or the device, were mild to moderate in severity, occurred almost exclusively within the first week, and resolved in all cases.2
Sustained improvement in ‘OFF’ and ‘ON’ time without troublesome dyskinesia3
Decreased ‘OFF’ time and increased ‘ON’ time with Duodopa sustained for more than 4 years3
Most serious adverse events were due to the surgical procedure or device.3
Patients ‘ON’ for most of the day5
Patients receiving Duodopa for 3 weeks spent 90% of the waking day in ‘ON’5
Adverse events occurred in 16 patients on conventional therapy and in 17 patients on infusion and were mostly mild. A total of 3 serious adverse events occurred.5
Real world improvement of motor symptoms4*
Two years of Duodopa treatment in routine practice resulted in significant improvements in Parkinson’s disease symptoms4
Most serious adverse events were due to the surgical procedure or device4
* Real-world evidence is collected outside of controlled clinical trials and has inherent limitations including a lesser ability for controlling factors
QUALITY OF LIFE
More time for patients to do some of the things they enjoy*1,2
* | PDQ-39 scale assessed several domains including mobility, activities of daily living, and communication. The PDQ-39 Summary Index showed a decrease from baseline of 10.9 points at week 121,2 |
See Duodopa quality of life information
Duodopa offers significant improvements in QoL and ADL1,2,4,6
Quality of life improvements after 12 weeks of Duodopa therapy2
Quality of life improvements for up to 1 year with Duodopa therapy6
One-third of patients (32.8%) experienced an adverse event; 21.9% experienced a serious adverse event; 11.1% discontinued because of an adverse event; 12.7% experienced AE possibly related to LCIG; and 3.1% died during the study (cardiac failure and sudden death)6
Consistent improvements in the first year of Duodopa treatment7
Duodopa improves quality of life as early as 4 weeks after initiation – maintained for 1 year7
* p<0.001 versus baseline, one-sample t test7
† In the pivotal study, EQ-5D Summary Index did not meet statistical significance based on the hierarchical testing procedure1
†† From screening to last visit. 7 of the 8 PDQ-39 domains (except social support) showed statistically significant mean improvement7
The most common adverse effects seen within the study were complication of device insertion, abdominal pain, and procedural pain7
Sustained improvement in patient quality of life with Duodopa4
In the real world, Parkinson’s disease-related quality of life improved for 2 years with Duodopa, and 91% of patients rate Duodopa as ‘very good’ or ‘satisfactory’4
40 (27.6%) patients experienced 49 serious adverse events which were considered related to PEG/J procedure or to device in 16.3% of the cases; 12 (8.3%) lead to discontinuations; 54 (32.7%) experienced PQCs and 13 (9%) patients died4
With Duodopa, patients can manage everyday activities better8
Activities of daily living improved with Duodopa in patients <65 years of age and in patients ≥65 years of age, and in patients with disease duration <10 years and ≥10 years8
Results from the registry confirmed the established safety profile of Duodopa8
SAFETY
Duodopa: More ‘ON’ TIME with established safety and tolerability profile1,7
- The most common adverse reaction was complication of device insertion1
See Duodopa safety information
Duodopa safety information7
Peak incidence of adverse reactions occurred in the first week after the PEG-J procedure, most were related to the surgical procedure, they resolved in most cases, and frequency reduced over time7
| • | Of 324 patients entering the PEG-J phase of a 54-week study, 8 patients discontinued due to a procedure-related or device-related adverse reaction7 |
A single event could be coded to >1 preferred term.
* Incidence of ARs peaked soon after the PEG-J procedure and reduced over time (≥10.0% during any time interval).1
NJ, nasojejunal tube test phase; n= number of patients
CONTINUOUS, INDIVIDUALIZED DOSING
Initially given as monotherapy, but other PD medicines can be taken concurrently, if required1
See Duodopa dosing information
Duodopa dosing information1
- Replaces multiple oral doses, which can reduce pill burden and dosing inconvenience
- Intra-subject variability in levodopa plasma concentrations was lower for patients treated with Duodopa (21%) compared with patients treated with oral levodopa/carbidopa (67%)1
- Total Duodopa dose/day is composed of three individually adjusted doses: the morning bolus dose, the continuous maintenance dose, and extra bolus doses administered over approximately 16 hours1*
* Treatment is usually administered during the patient's awake period. If medically justified, Duodopa may be administered for up to 24 hours1
Duodopa facilitates flexible dosing throughout the day1
I want to receive more information via a product specialist
References
- Duodopa (levodopa/carbidopa intestinal gel) SmPC; [insert current data]
- Olanow CW et al. Lancet Neurol 2014;13(2):141-149.
- Fernandez HH et al. Mov Disord 2018; 33(6):928-936.
- Lopiano L et al. J Neurol 2019; 266:2164-2176.
- Nyholm D et al. Neurology 2005; 64(2):216-223.
- Kruger R et al. Adv Ther 2017; 34(7):1741-1752.
† This study and publication were funded by AbbVie. - Fernandez HH et al. Mov Disord 2015; 30:500-509.
- Antonini A et al. Neurodegen Dis Manag 2018; 8(3):161-170.
- Slevin JT et al. J Parkinson’s Dis 2015; 5(1):165-174.
