|
|
|
First and Only
PRODUODOPA is the first‑and‑only subcutaneous 24‑hour infusion that provides continuous stable levodopa plasma levels.1,13
More Motor Control*
With PRODUODOPA, patients can achieve more motor control* continuously morning, day, and night,†‡ without surgery.1,3
Continuous and Personalized
PRODUODOPA provides a wide range of customizable dosing, delivered via a single infusion site and canula that can remain in place for up to 3 days, to accommodate individual patient needs.1§
PRODUODOPA can be taken alone or, if necessary, with other concurrent medicinal products for PD, based on the judgment of the HCP.1
*More refers to improvement from baseline compared with oral IR levodopa/carbidopa in “On” and “Off” time at Week 12.1 Tap the underlined link to see data.
†Patients made an entry in a PD diary upon waking and every 30 minutes during their normal waking time, and upon awakening from time asleep.1,3
‡PRODUODOPA is a levodopa-based therapy delivered subcutaneously as a 24-hour infusion.1,3
§Rotate the infusion set and use a new infusion set at least every 3 days.1 PRODUODOPA allows for dosing up to 4260 mg levodopa/day with 3 programmable flow rates (base, high, and low) and an extra-dose capability. Infusion rates may be adjusted in increments as small as 0.01 mL/hour (~1.7 mg of levodopa/hour).1
HCP=healthcare professional; IR=immediate release; PD=Parkinson's disease; PK=pharmacokinetics.
Safety
The most frequent adverse reactions (≥10%) were infusion site events (infusion site erythema, infusion site cellulitis, infusion site nodule, infusion site pain, infusion site oedema, infusion site reaction, and infusion site infection), hallucination, fall, and anxiety.1
Safety
The most frequent adverse reactions (≥10%) were infusion site events (infusion site erythema, infusion site cellulitis, infusion site nodule, infusion site pain, infusion site oedema, infusion site reaction, and infusion site infection), hallucination, fall, and anxiety.1
Levodopa exposure following PRODUODOPA infusion in PD patients compared to oral levodopa/carbidopa dosing
Formulation
Foslevodopa/Foscarbidopa
Oral LD/CDII
IITo assess PK fluctuation differences, the average levodopa and carbidopa exposures following PRODUODOPA infusion were compared to simulated exposure of daily doses of 400/100 mg levodopa/carbidopa TID.
IR=immediate release; LC/CD=levodopa/carbidopa; TID=three times a day.
Adapted from Rosebraugh, 2021.2
Note to affiliate: The graph presented here based on the published Rosebraugh 2021 study, however the colors have been adjusted to match the project. Please update as per your local rules and regulations.
*In the PK comparability study, PRODUODOPA was administered as a continuous subcutaneous infusion, 24 hours per day. In healthy volunteers, steady state was achieved within 2 hours when PRODUODOPA was delivered as a loading dose followed by continuous infusion. Steady state was maintained during the infusion period.1
Note to affiliate: Click through this button to review primary and secondary endpoints from DUODOPA data.
When treated with PRODUODOPA, patients experienced more “On” time and less “Off” time.1*†
Continue to Clinical Profile page
*In the PRODUODOPA pivotal study at Week 12, “On” time without troublesome dyskinesia for patients on PRODUODOPA increased 2.72 hours from baseline compared with an increase from baseline of 0.97 hours for patients taking oral IR levodopa/carbidopa.1
†In the PRODUODOPA safety study, at Week 52 compared to baseline, “On” time without troublesome dyskinesia improved by an average of 3.8 hours (N=104); “Off” time decreased by an average of 3.5 hours (N=104).1,5
Please refer to the PRODUODOPA SmPC for complete Prescribing and Safety Information.
REFERENCES:
- [DRAFT] Produodopa® (foslevodopa/foscarbidopa solution for infusion) Summary of Product Characteristics (SmPC). <insert current SmPC date>.
- Rosebraugh M, Liu W, Neenan M, Facheris MF. Foslevodopa/foscarbidopa is well tolerated and maintains stable levodopa and carbidopa exposure following subcutaneous infusion. J Parkinsons Dis. 2021;11(4):1695-1702. doi:10.3233/JPD-212813
- Soileau MJ, Aldred J, Budur K, et al. Safety and efficacy of continuous subcutaneous foslevodopa-foscarbidopa in patients with advanced Parkinson’s disease: a randomised, double-blind, active-controlled, phase 3 trial. Lancet Neurol. 2022;21(12):1099-1109. doi:10.1016/S1474-4422(22)00400-8. Erratum in: Lancet Neurol. 2023;22(3):e5.
- Rosebraugh M, Stodtmann S, Liu W, Facheris MF. Foslevodopa/foscarbidopa subcutaneous infusion maintains equivalent levodopa exposure to levodopa-carbidopa intestinal gel delivered to the jejunum. Parkinsonism Relat Disord. 2022;97:68-72.
- Aldred J, Freire-Alvarez E, Amelin AV, et al. Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinson's Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study. Neurol Ther. 2023. doi:10.1007/s40120-023-00533-1. Epub ahead of print. PMID: 37632656.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
PRODUODOPA® Indication and Summary of Important Treatment Considerations1
Indication:
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 results.
Contraindications:
PRODUODOPA is contraindicated in patients with hypersensitivity to the active substances or to any of the excipients, narrow-angle glaucoma, severe heart failure, acute stroke, severe cardiac arrhythmia, co-medication with selective type A inhibitors and nonselective MAO inhibitors, conditions contraindicated for adrenergics (e.g. pheochromocytoma, hyperthyroidism, and Cushing’s syndrome), and suspicious skin lesions or history of melanoma.
Some special warnings and precautions for PRODUODOPA:
• Not recommended for the treatment of drug-induced extrapyramidal reactions.
• Caution use in patients with: severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or history of peptic ulcer disease or of convulsions, history of myocardial infarction with residual atrial nodal or ventricular arrhythmias, cardiac function should be monitored during the initial dosage adjustments. Monitor all patients for the development of mental changes, depression with suicidal tendencies, and other serious mental changes. Caution with past or current psychosis and antipsychotics. Higher frequency of hallucinations may occur with dopamine agonists and/or other dopaminergic treatments including PRODUODOPA. Monitor patients regularly for the development of impulse control disorders, for example Dopamine Dysregulation Syndrome (DDS). Caution in chronic wide-angle glaucoma; monitor for intra-ocular pressure changes. Levodopa may induce hypotension, somonolence and sudden sleep: caution should be exercised when driving and operating machines. Risk of symptoms resembling Neuroleptic Malignant Syndrome following abrupt dose reduction or discontinuation.
• Patients with Parkinson’s disease have a higher risk of developing melanoma. Monitor patients for melanomas on a regular basis when using PRODUODOPA.
• Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy with PRODUODOPA.
• PRODUODOPA contains hydrazine (foscarbidopa degradation product), that can be genotoxic and probably carcinogenic. The approximately median exposure of hydrazine is 0.2 mg/day, with a maximum of 0.5 mg/day. The clinical significance of this hydrazine exposure is not known.
• Polyneuropathy has been reported; evaluate for history/signs of and known risk factors before starting therapy.
• PRODUODOPA is high in sodium; considered especially in patients on a low salt diet.
• Caution is needed in concomitant administration of PRODUODOPA with the following medicinal products: Antihypertensive, antidepressants, COMT inhibitors, dopamine agonists, MAO inhibitors, amantadine. Foscarbidopa is a potential inducer of CYP1A2 in vitro. Care should be taken when prescribing PRODUODOPA in combination with sensitive CYP1A2 substrates (e.g. caffeine).
• PRODUODOPA is not recommended during pregnancy. Breast-feeding should be discontinued during treatment with PRODUODOPA.
• The most frequent adverse reactions (≥10%) were infusion site events (infusion site erythema, infusion site nodule, infusion site cellulitis, infusion site oedema, infusion site pain, infusion site infection, and infusion site reaction), hallucination, fall, anxiety, and dizziness.
• Infusion site events were reported with Produodopa in the clinical studies. Following aseptic techniques and frequent rotation of the infusion site are recommended to reduce the risk. Few patients who reported infusion site reactions also experienced infusion site infections. Therefore, careful monitoring of serious infusion site reactions and infusion site infections is recommended.
Please refer to the Produodopa SmPC for complete Prescribing and Safety Information.
<placeholder link for local PRODUODOPA SmPC>
ALL-PRODD-220020. Date of preparation: July 2023.
Levodopa exposure following 24-hour PRODUODOPA infusion and 16-hour DUODOPA infusion followed by nighttime oral LD/CD doses4
Formulation
PRODUODOPA
DUODOPA + Nighttime Oral LD/CD
Note to affiliate: the graph presented here is based on the published Rosebraugh reference, however the colors have been adjusted to match the project. Please update per your local rules and regulations.