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DUODOPA is a brand name for Levodopa, supplied as a gel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: DUODOPA (levodopa/carbidopa intestinal gel) is indicated for the treatment of patients with advanced levodopa-responsive Parkinson’s disease: who do not have satisfactory control of severe, debilitating motor fluctuations and hyper- /dyskinesia despite optimized treatment with available combinations of Parkinson’s…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations General Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during dosage optimization and during extended therapy with DUODOPA. Mode of Administration DUODOPA is a gel for continuous intestinal infusion.
: 252247 Page 7 of 54 infused with a portable pump directly into the duodenum or upper jejunum by a permanent tube via percutaneous endoscopic gastrostomy (PEG) with an outer transabdominal tube and an inner intestinal tube. Alternatively, a radiological gastrojejunostomy may be considered if percutaneous endoscopic gastrostomy is not suitable for any reason.
Prior to duodenal/jejunal tube placement, it is recommended that all patients be treated short term using a nasojejunal tube (NJ). The dose should be adjusted to an optimal clinical response for the individual patient, which means maximizing the functional “On” time during the day by minimizing the number and duration of “Off” episodes (bradykinesia) and minimizing “On” time with disabling dyskinesia.
2 Recommended Dose and Dosage Adjustment). DUODOPA should be given initially as monotherapy. If required, other medicinal products for Parkinson’s disease can be taken concurrently. For administration of DUODOPA, only the CADD- Legacy® DUODOPA pump should be used.
A manual with instructions for using the portable pump is delivered together with the pump. Treatment with DUODOPA using a permanent tube can be discontinued at any time by withdrawing the tube and letting the wound heal. Treatment should then continue with oral medicinal products including levodopa/carbidopa.
2 Recommended Dose and Dosage Adjustment General Levodopa given as DUODOPA has the same bioavailability as oral levodopa and therefore conversion from one form to another should be done in approximately a 1:1 ratio. The total dose/day of DUODOPA administered over approximately 16 hours is composed of 3 individually adjusted doses: the morning bolus dose, the continuous maintenance dose and extra bolus doses.
During the nasojejunal test period the patient is supplied with and trained in the use of the portable pump, and the three DUODOPA dosing parameters are individualized for the patient. The patient can then independently control the infusion rates to suit their daily requirements, within parameters pre-set under the direction of their physician.
). Prior to insertion of PEG-J tube, a positive test of the clinical response to DUODOPA administered via a temporary nasojejunal (NJ) tube is recommended for all patients. DUODOPA should only be prescribed by neurologists who are experienced in the treatment of patients with Parkinson’s disease, and who have completed the DUODOPA education program that includes training in: the criteria for selecting suitable patients; initiation and management with DUODOPA therapy via naso-intestinal infusion and percutaneous endoscopic gastrostomy; postprocedural care; and the risks associated with the procedure and long-term use of the PEG-J.
, radiologist, gastrosurgeon) experienced in the PEG placement procedure. Dose adjustments should be carried out in association with a neurological clinic staffed with healthcare professionals trained in the use of DUODOPA. 1 Pediatrics Pediatrics (< 18 years of age): The safety and efficacy of DUODOPA in patients under 18 years of age have not been evaluated and its use in patients below the age of 18 is not recommended.
2 Geriatrics Geriatrics (≥ 65 years of age): Of the total number of patients using the DUODOPA System in the clinical studies, more than half were 65 years of age or older. No overall differences in safety or effectiveness were observed between these patients and younger patients (see 14 CLINICAL TRIALS).
2 CONTRAINDICATIONS Contraindications for Treatment with Levodopa DUODOPA is contraindicated in patients with: hypersensitivity to levodopa, carbidopa or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
narrow-angle glaucoma. : 252247 Page 5 of 54 clinical or laboratory evidence of uncompensated cardiovascular, cerebrovascular, endocrine, renal, hepatic, hematologic or pulmonary disease (including bronchial asthma). concomitant use of nonselective monoamine oxidase (MAO) inhibitors and selective MAO type A inhibitors with DUODOPA.
). : 252247 Page 10 of 54 Patients should be carefully observed when a sudden reduction of the dose is required or if it becomes necessary to discontinue treatment with DUODOPA, particularly if the patient is receiving antipsychotics (see Psychiatric and Neuroleptic Malignant Syndrome).
In case of suspected or diagnosed dementia with a decreased confusion threshold, patient’s pump should be handled by the nursing staff or a care giver and the benefit/risk of continued treatment with DUODOPA should be re-assessed. 1 Pediatrics).
Geriatrics (≥65 years of age) Doses for all patients including geriatric population are individually adjusted by titration (see 4 DOSAGE AND ADMINISTRATION). 3 Reconstitution Not applicable. 4 Administration The cassette containing DUODOPA should be attached to the portable pump and the system connected to the nasojejunal tube or the transabdominal port/jejunal tube for administration just prior to use, according to the instructions provided in the pump instruction manual.
The drug cassettes are for single use only and should not be used for longer than 1 day (up to 16 hours) even if some medicinal product remains. A cassette should not be re-used. , after 16 hours in use, or when approaching the expiration date) the gel might become slightly yellow.
This does not influence the concentration of the drug or the treatment. , small tablet or food particles) should not be administered into the PEG-J tube due to the risk intestinal tube blockage by these substances. 5 Missed Dose If the pump malfunctions, and dosing is interrupted, resume dosing as per the instructions above.
, sustained bradykinesia), will require treatment with oral levodopa/carbidopa until the problem is resolved. 5 OVERDOSAGE The most prominent symptoms of an overdose with levodopa/carbidopa are dystonia and dyskinesia. Blepharospasm can be an early sign of overdose.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Each 100 mL cassette of DUODOPA contains 2000 mg levodopa/500 mg carbidopa. Some patients may require more than 1 cassette over a 16-hour period. The drug cassettes are for single use only and should not be used for longer than 16 hours even if some medicinal product remains.
Patients should be instructed to not reuse an opened cassette. By the end of the storage time, the gel might become slightly yellow. This does not influence the concentration of the drug or the treatment. Morning Dose The Morning Dose is an individualized daily loading dose administered to achieve a therapeutic dose level within 10 to 30 minutes.
Continuous Maintenance Dose The Continuous Maintenance Dose (CMD) is administered after the Morning Dose and for the remainder of the 16-hour infusion period. The CMD is intended to provide continuous administration at a constant rate throughout the infusion period.
, patient becomes hypokinetic). The extra dose feature is programmed by the healthcare professional and can be self- administered by the patient throughout the day. The pump includes a lockout feature to prevent inadvertent adjustments.
The extra dose is customized for medication delivery to each patient. Refer to the pump manual for detailed instructions. If the need for use of the extra dose feature exceeds 5 doses/day, the physician should consider increasing the CMD.
After initial titration, additional adjustments of the dose settings may be performed over time. Table 1 - Determination of Daily Doses (Morning, Continuous and Extra) Morning Dose Continuous Maintenance Dose (CMD) Extra Doses General Usually 5 to 10 mL, corresponding to 100 to 200 mg levodopa and will normally not exceed 15 mL (300 mg levodopa).
The calculated Morning Dose should be increased by 3 mLa to compensate for the priming of the deadspace. May range from 1 to 10 mL/hour (20 to 200 mg levodopa/hour) and is usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour). In exceptional cases a higher dose may be needed.
0 mL. In rare cases, a higher dose may be needed. If the need for Extra Doses exceeds 5 doses/day, the physician should consider increasing the maintenance dose. Initiation of Treatment (Day 1) Patients should not be administered a full equivalent of their usual oral morning dose of levodopa/carbidopa.
The Morning Dose of DUODOPA is to be based on a percentage of the patient’s usual morning oral levodopa/carbidopa dose. Morning Dose of Oral Levodopa/Carbidopa vs. 1 mL/hour (2 mg/hour). 9 = D mL/hour rate of infusion May be given hourly, begin with 1 mL per dose.
: 252247 Page 9 of 54 Morning Dose Continuous […]
4 Drug-Drug Interactions). suspicious, undiagnosed skin lesions or a history of melanoma because levodopa may activate a malignant melanoma. 4 Drug-Drug Interactions). : 252247 Page 6 of 54 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Procedure- and Device-Related Complications The morbidity and mortality associated with the procedure used for placing the PEG-J and long-term use of PEG-J need to be balanced against the expected benefits of using DUODOPA.
See DUODOPA Procedure- and Device-Related Complications, Peri-Operative Considerations and Device-Related Adverse Events. Sudden Onset of Sleep Patients receiving treatment with levodopa and other dopaminergic agents have reported suddenly falling asleep while engaged in activities of daily living, including driving a car, which has sometimes resulted in accidents.
Although some of the patients reported somnolence while on levodopa, others perceived that they had no warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event. Physicians should alert patients of the reported cases of sudden onset of sleep, bearing in mind that these events were NOT limited to initiation of therapy.
Patients should also be advised that sudden onset of sleep has occurred without warning signs and should be specifically asked about factors that may increase the risk with DUODOPA such as concomitant medications or the presence of sleep disorders.
Given the reported cases of somnolence and sudden onset of sleep (not necessarily preceded by somnolence), physicians should caution patients about the risk of operating hazardous machinery, including driving motor vehicles, while taking DUODOPA.
If drowsiness or sudden onset of sleep should occur, patients should be informed to immediately contact their physician. Episodes of falling asleep while engaged in activities of daily living have also been reported in patients taking other dopaminergic agents, therefore, symptoms may not be alleviated by substituting these products.
While dose reduction clearly reduces the degree of somnolence, there is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living. Currently, the precise cause of this event is unknown.
It is known that many Parkinson’s disease patients experience alterations in sleep architecture, which results in excessive daytime sleepiness or spontaneous dozing, and that dopaminergic agents can also induce sleepiness. 1 Dosing Considerations General Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during dosage optimization and during extended therapy with DUODOPA.
Mode of Administration DUODOPA is a gel for continuous intestinal infusion. : 252247 Page 7 of 54 infused with a portable pump directly into the duodenum or upper […]
The treatment of an acute overdose of DUODOPA is in general the same as that of an acute overdose of levodopa; however, pyridoxine has no effect on the reversal of the action of DUODOPA. Electrocardiographic monitoring should be used and the patient observed carefully for the development of cardiac arrhythmias; if necessary an appropriate antiarrhythmic therapy should be given.
The possibility that the patient took other medicinal products together with DUODOPA should be taken into consideration. To date experiences with dialysis have not been reported, therefore its value in the treatment of overdose is not known.
: 252247 Page 11 of 54 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2 - Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength / Composition Non-medicinal Ingredients intestinal infusion gel/1 mL contains 20 mg levodopa and 5 mg carbidopa (monohydrate) carmellose sodium, purified water DUODOPA is a gel for continuous intestinal infusion and is supplied in hard plastic cassettes for protection.
Each cassette holds a reservoir bag containing 100 mL of gel with 2000 mg levodopa and 500 mg carbidopa monohydrate (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate). DUODOPA is available in cartons of 7 cassettes. The gel is off-white to slightly yellow in colour.
7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General Patients and/or caregivers should be thoroughly assessed for physical and cognitive ability to operate the DUODOPA system, prior to insertion of the PEG-J tube.
DUODOPA therapy should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic, or endocrine disease, or history of peptic ulcer disease or of convulsions. The dose of DUODOPA may need to be adjusted downwards in order to avoid levodopa-induced dyskinesias.
Carcinogenesis and Mutagenesis DUODOPA contains hydrazine, a degradation product of carbidopa that can be genotoxic and possibly carcinogenic (see 16 NON-CLINICAL TOXICOLOGY). 5 g carbidopa. The usual maximum daily dose is 200 mL. This includes hydrazine at up to an average exposure of 4 mg/day, with a maximum of 8 mg/day.
The clinical significance of this hydrazine exposure is not known. Cardiovascular In patients with a history of myocardial infarction or who have atrial nodal or ventricular arrhythmias, cardiac function should be monitored with particular care during the period of initial dosage adjustments.
DUODOPA may induce orthostatic hypotension and should be given cautiously to patients who are taking other medicinal products which may cause orthostatic hypotension (see Monitoring and For management of a suspected drug overdose, contact your regional Poison Control Centre.
4 Drug-Drug Interactions). Gastrointestinal Patients with a history of upper gastrointestinal problems or problems with intestinal absorption were generally excluded from DUODOPA clinical trials. Previous surgery in the upper part of the abdomen may lead to difficulty in performing gastrostomy or jejunostomy.
DUODOPA Procedure- and Device-Related Complications A commonly reported event in the clinical studies was abdominal pain associated with the PEG-J procedure. The peri-operative abdominal pain was mostly mild to moderate in severity and resolved in the first 4 weeks.
Abdominal pain may also be a symptom of other potentially serious […]