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Please refer to the PRODUODOPA SmPC and Patient Information Leaflet (PIL) for full dosing and medication preparation information.
*The dose may be adjusted to reach a clinical response that maximizes the functional “On” time and minimizes the number and duration of “Off” episodes and “On” episodes with troublesome dyskinesia.
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Please refer to the PRODUODOPA SmPC for complete Prescribing and Safety Infomation.
REFERENCE
- [DRAFT] Produodopa® (foslevodopa/foscarbidopa solution for infusion) Summary of Product Characteristics (SmPC). <insert current SmPC date>.
▼ 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.
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ALL-PRODD-220020. Date of preparation: July 2023.