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Frequently Asked Questions (FAQ)
The safety of Duodopa in patients under 18 years of age has not been established and its use in patients below the age of 18 is not recommended. There is a considerable experience in the use of levodopa/carbidopa in elderly patients. Doses for all patients including geriatric population are individually adjusted by titration.1
It is recommended that Duodopa be given initially as monotherapy1. If necessary, another medication for Parkinson's disease may be administered concomitantly1
There is no limit as to how long the tube can stay in the body.2,3 Based on clinical experience, the PEG tube can remain in place for many months without complications. In clinical trials, 82.1% of patients retained their original tubing at 24 months.2 Based on clinical experience, the J tube can remain in place for many months without complications. In clinical trials, 48.5% of patients retained their original tubing at 24 months.3
Local guidelines should be followed. A temporary NJ tube should be considered to determine if the patient responds favorably to this method of treatment before a permanent PEG-J is placed. In cases where the physician considers this assessment is not necessary, the NJ test phase may be waived and treatment initiated directly with placement of the PEG-J.1 The morning dose and continuous maintenance dose should be based on the patient’s previous morning intake of levodopa and daily intake of levodopa, respectively.1
The appropriate tubes will be provided
- For the Duodopa delivery, AbbVie PEG (15 FR or 20 FR) and AbbVie J (intestinal tube 9 FR for PEG 15 and 20 FR) are used.2,3
- For the nasojejunal test phase, AbbVie NJ 10 FR with stylet for enteral use only, are used.4
These tubes are equipped with a Luerlock connector to connect to the Duodopa cassette.
The availability of an adequate aftercare system is one of the mandatory aspects for maintaining the long-term benefits of therapy and the best possible therapeutic outcome*.
The development of most of the potential long-term complications depends solely on the quality of further care given to the tube system and can be effectively avoided if appropriate measures are taken**.
For further information, please contact your local AbbVie representative
Yes. Flush the PEG tube (via white “g” port) with at least 20 ml room temperature tap or drinking water daily. Failure to adequately flush the AbbVie PEG tube may result in occlusion or blockage.2
Duodopa should be given initially as monotherapy.1 If required, other medicinal products for Parkinson’s disease can be taken concurrently.1
Pump Guidance & Operation
The dose will be programmed, and can only be modified, by the doctor in charge. Before changing the programmed dose, the pump should be set to lock level 0 (LL0).6 Full instructions on dose adjustment are given in the Operator’s Manual.5
Instructions for changing between the different lock levels can be found in the Operator’s Manual.5 Please note that the Duodopa pump must be locked again when it is handed back to the patient (i.e., lock level 1 or 2 [LL1 or LL2]).
Lock level, LL0 permits complete access to all programming and operating functions. The Duodopa pump may only be delivered to the patient when it is locked. There are 2 lock levels for this:
- LL1 = partially locked:
– The patient can change the doses of the pump within a predetermined range.
- LL2 = fully locked:
– The patient cannot change the doses.
The dose is programmed by the doctor in charge, and only doctors are supposed to make changes. Instructions for changing between the different lock levels and the instructions for changing the dose can be found in the Operator’s Manual.5
Treatment is usually administered during the patient's awake period. If medically justified, Duodopa may be administered for up to 24 hours.1
No, the cassette can only be used for up to 24 hours once opened. The cartridges must be disposed of after use, even if they still contain residual gel. Do not reuse an opened cassette.1
This depends on the individual’s dosing needs. However, the maximum recommended daily dose is 200 ml of Duodopa (containing
4 g levodopa and 1 g carbidopa and is equivalent to two cassettes per day).1
Yes, that is possible. Duodopa is administered directly into the small intestine via the jejunal tube. As needed, enteral nutrition may be administered directly to the stomach in parallel with medication delivery to the intestine.2
Yes, the Duodopa pump must be switched off and removed.5
Non-clinical testing has demonstrated that the AbbVie J is MR-conditional. A patient with this device can be safely scanned in an MRI system meeting the following conditions:
- Static magnetic field of 1.5 Tesla and 3.0 Tesla only.
- Maximum spatial gradient magnetic field of 1900 gauss/cm (19 T/m).
- Maximum MRI system reported, whole body averaged specific absorption rate (SAR) of 4.0 W/kg (First Level Controlled Mode).
Under the scan conditions defined above, the AbbVie J tube is expected to produce a maximum temperature rise of 1.0°C after 15 minutes of continuous scanning.3
No, since the Duodopa pump is only splash-proof, it must be removed before showering or bathing.7 If necessary, an extra dose may be given beforehand to bridge the gap. The stoma should be dried well after bathing or showering.
The life of the batteries is dependent on the amount of Duodopa delivered, delivery rate, battery age, and the temperature. At the rate of 100 ml per day (one cassette), alkaline batteries will usually last about 7 days.5
No, rechargeable nickel cadmium (NiCd) or nickel metal hydride (NiMH) batteries or carbon zinc (‘heavy duty’) batteries should not be used. They do not provide sufficient power for the pump to operate properly.5 Therefore, only standard AA batteries should be used.
Complications, Warnings & Alarms
There may be a kink in the tubing or a clamp may be closed. Unkink the tubing or open the clamp and the pump will resume delivery.
Press ‘STOP/START or ‘NEXT‘ to stop the pump and silence the alarm for 2 minutes. After the cause of the high pressure has been removed, start the pump to continue delivery. If the alarm continues, the clinician responsible for the care should be contacted.
In the clinical studies, complication of device insertion was a commonly reported adverse reaction for the PEG tube. This adverse reaction was co-reported with one or more of the following adverse reactions such as:1,2
- Gastrointestinal disorders including abdominal pain, abscess, discomfort or distention, flatulence, pneumonia, pneumoperitoneum, duodenal ulcer, hemorrhage, intestinal ischemia, leakage of gastric fluid, gastritis erosive, pancreatitis, peritonitis or bleeding, intussusception, and sepsis
- Buried bumper syndrome
- Post-operative and post-procedural wound infection, incision site cellulitis or stoma infection
- Procedural and post-procedural complications including discomfort, pain, incision site erythema, implant site erosion/ulcer, discharge, haemorrhage, gastrointestinal stoma complication or postoperative ileus
- Skin and subcutaneous tissue disorders such as excessive granulation tissue
Abdominal pain may be a symptom of the above listed complications. Some events may result in serious outcomes, such as surgery and/or death. Patients should be advised to notify their physician if they experience any of the symptoms associated with the above events.6
If the upstream occlusion sensor is set to ‘ON’ and an occlusion in the Duodopa reservoir is detected, the upstream occlusion alarm will sound. Press ‘STOP/START’ or ‘NEXT‘ to stop the pump and silence the alarm for 2 minutes. You may have to detach then reattach the cassette.
Restart the pump to continue delivery.
If the alarm continues, contact your clinician.7
If you have any questions, or if the Duodopa system may be malfunctioning, please reach to the local Abbvie contact.
Everyday Life, Travelling & Carrier Systems
For some patients, Duodopa may not work well if it is taken with, or shortly after eating, protein-rich food – such as meats, fish, dairy products, seeds and nuts.8
Duodopa must be refrigerated (2-8˚C) and the cassette should be kept in the outer carton in order to protect from light.1
IMPORTANT SAFETY INFORMATION1
Duodopa is contraindicated in patients with hypersensitivity to levodopa, carbidopa, carmellose sodium, purified water or any of the excipients, narrow-angle glaucoma, severe heart failure, severe cardiac arrhythmia, acute stroke, selective type A inhibitors and nonselective MAO inhibitors, conditions contraindicated for adrenergics (e.g. pheochromocytoma, hyperthyroidism, and Cushing’s syndrome), and suspicious undiagnosed skin lesions or history of melanoma.
Some warnings and precautions include the following: Device and Procedure-related complications, sudden onset of sleep: caution should be exercised when driving and operating machines. Caution in: severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or history of peptic ulcer disease or of convulsions. Risk of symptoms resembling Neuroleptic Malignant Syndrome following abrupt dose reduction or discontinuation. Monitor all patients for the development of mental changes, depression with suicidal tendencies, and other serious mental changes. Caution in chronic wide-angle glaucoma; monitor for intra-ocular pressure changes. Patients with past or current psychosis should be treated with caution. Monitor patients regularly for the development of impulse control disorders, for example Dopamine Dysregulation Syndrome (DDS). Polyneuropathy has been reported; evaluate for history/signs
of and known risk factors before starting therapy. Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy with Duodopa. Some reported complications include, but are not limited to, abscess, pneumonia (including aspiration pneumonia), and sepsis. Patients with Parkinson’s disease have a higher risk of developing melanoma. Monitor patients for melanomas on a regular basis when using Duodopa. Duodopa is not recommended during pregnancy. Breast-feeding should be discontinued during treatment with Duodopa. The most common adverse reaction was complication of device insertion.
The very common (≥ 10%) and common (≥1% to < 10%) device and procedure -related adverse reactions reported in the clinical trials included in clinical trials included: abdominal discomfort, abdominal pain, peritonitis, pneumoperitoneum postoperative wound infection, incisional cellulitis, pneumonia/aspiration pneumonia, excessive granulation tissue, device dislocation, device occlusion, complications of device insertion, incision site erythema, post-procedural discharge, stoma complication, incision site pain, postoperative Ileus, post procedural complication, post procedural discomfort, post procedural haemorrhage.
Most of these adverse reactions were reported early in the studies, subsequent to the percutaneous endoscopic gastrostomy procedure and occurred during the first 28 days.
Drug related undesirable effects that occur frequently with the Duodopa system include nausea and dyskinesia. Device- and procedure related undesirable effects that occur frequently with the Duodopa system include abdominal pain, complications of device insertion, excessive granulation tissue, incision site erythema, postoperative wound infection, post procedural discharge, procedural pain, and procedural site reaction.
*The safety information provided is based on the Duodopa (levodopa/carbidopa intestinal gel) Summary of Product Characteristics (SmPC). Please refer to your country specific product labeling for complete product safety information
Please see Duodopa Summary of Product Characteristics for complete prescribing information
- Duodopa (levodopa/carbidopa intestinal gel) SmPC.
- AbbVie PEG information for users.
- AbbVie J information for users.
- AbbVie NJ information for users.
- Legacy Duodopa Operator’s Manual. CADD Legacy Duodopa Pump Model 1400.
- AbbVie. Duodopa PEG/J Aftercare Guideline. Risk Management Plan version 7.2. (2019).
- Legacy Duodopa Patient Information. CADD Legacy Duodopa Pump Model 1400.
- Duodopa patient information leaflet. (2017).
- Constantin, VA et al, Neuropsychiatric Disease and Treatment 2020:16 1835–1844
- Tsunemi, T et al, Mov. Dis. 2021, DOI: 10.1002/mds.28595
- Bajenaru, O et al J. Neural Transm. 2016, 123, 407–414
- Popa, LC et al Medicine 2020, 99, e23249
- Szasz, J et al Rom. J. Neurol. Rev. Romana Neurol. 2020, 19, 27–35
- Szasz, J et al Brain Sci. 2021, 11, 826
- Loser, C et al, doi: 10.1016/j.clnu.2005.06.013
- Gheorghe, C et al, J Gastrointestin Liver Dis, September 2019 Vol. 28 No 3
- Lang, AE et al, Movement Disorders, Vol. 31, No. 4, 2016
- Titova, N et al, Expert review of neurotherapeutics, 2017
- Wirdefeldt, K et al CNS Drugs (2016) 30:381–404