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Onerji is a brand name for Levodopa. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Onerji is indicated for the treatment of motor fluctuations in patients with advanced Parkinson's disease which are not sufficiently controlled by oral anti-Parkinson medicinal products.
Verbatim from this product's EMA label. Tap a section to expand.
Posology Onerji is administered with a levodopa oral morning dose. Additional oral levodopa can be prescribed as needed. If required, other classes of medicinal products for Parkinson's disease can be taken concomitantly with it and adjusted as needed.
The maximum recommended daily dose of Onerji is 720 mg of the levodopa component and 90 mg of the carbidopa component. Onerji treatment consists of an individualised daytime dose delivered over 18 hours, which starts about 3 hours before the anticipated patient’s wake up time, and a fixed nighttime dose delivered over 6 hours.
Initiation and titration instructions • Step 1:
The daily total oral levodopa equivalent dose should be calculated by utilising the appropriate levodopa conversion factors (Table 1). • Step 2: Onerji should be initiated with the full dose (720 mg of levodopa) along with a morning oral dose of levodopa.
If patients were on more than 720 mg of daily total oral levodopa equivalent dose before initiating Onerji, adjunct oral levodopa should be added throughout the day to make up the difference between their daily total oral levodopa equivalent dose minus the 720 mg of levodopa provided by Onerji and the morning oral levodopa dose.
If a catechol-O- methyltransferase (COMT) inhibitor is co-administered with Onerji, the COMT-inhibitor multiplication factor should be applied to the levodopa Onerji component. 3 • Step 3: Adjunct oral levodopa should be adjusted, if needed.
If patients need to reduce their total daily levodopa dose, adjunct oral levodopa dose should be adjusted prior to reducing Onerji dose based on Table 2. Calculating daily total oral levodopa equivalent dose The levodopa equivalent daily dose coming from oral levodopa formulations should be determined as well as COMT inhibitor therapy according to the conversion factors below (Table 1).
5 for tolcapone Optimisation and maintenance The Onerji levodopa daily dose is prescribed by the physician according to the patient’s needs, choosing from 8 regimens ranging from 370 mg to 720 mg (Table 2). 08 30 370 Interruption of therapy Sudden discontinuation or rapid dose reduction of Onerji, without administration of alternative dopaminomimetic therapy, should be generally avoided to reduce the risk of withdrawal-induced hyperpyrexia and confusion.
5%). 4 for mitigation measures. Tabulated list of adverse reactions In table 3 below, adverse reactions expected from Onerji are presented by System Organ Class (SOC) and frequency. Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100 9 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), and not known (cannot be estimated from the available data).
Table 3 Tabulated list of adverse reactions System Organ Class Very common Common Uncommon Not known3 Infections and infestations Infusion site infection1, 2 Urinary tract infection Neoplasm benign, malignant and unspecified (incl.
cysts and polyps) Malignant melanoma Blood and lymphatic system disorders Anaemia, Agranulocytosis, Thrombocytopenia, Leukopenia Immune system disorders Hypersensitivity1 Metabolism and nutrition disorders Vitamin B6 deficiency1 Hyperhomocystein aemia, Folate deficiency1, Vitamin B12 deficiency1 Decreased appetite Psychiatric disorders Anxiety, Hallucinations1, Insomnia Abnormal dreams, Confusional state, Delusion, Depression1, Impulse-control disorder1, Rapid eye movement, Sleep behaviour disorder, Sleep disorder Suicidal ideation, Psychotic disorder, Agitation, Disorientation, Dopamine dysregulation syndrome, Euphoric mood, Increased libido, Bruxism, Paranoia Nervous system disorders Dyskinesia Dizziness, Headache, Worsening of Off periods, Peripheral neuropathy1, 2, Tremor Akinesia, Dysaesthesia, Dyskinesia hyperpyrexia syndrome, Dystonia, Hypokinesia, Paraesthesia, Presyncope, Somnolence, Taste disorder Cognitive disorder, Sudden sleep onset episodes, Neuroleptic malignant syndrome, Ataxia, Horner's syndrome, Dementia Eye disorders Vision blurred, Diplopia, Mydriasis, Oculogyric crisis, Blepharospasm Cardiac disorders Palpitations, Cardiac rhythm disorders Vascular disorders Hypotension Orthostatic hypotension Hypertension, Syncope, 10 System Organ Class Very common Common Uncommon Not known3 Thrombophlebitis, Hot flushes Respiratory, thoracic and mediastinal disorders Dyspnoea, Respiration abnormal, Dysphonia, Hiccups Gastrointestinal disorders Nausea Dry mouth, Vomiting Abdominal pain, Constipation, Diarrhoea, Gastrointestinal haemorrhage, Peptic ulcer, Dysphagia, Dyspepsia, Glossodynia, Flatulence, Saliva discolouration, Salivary hypersecretion Skin and subcutaneous tissue disorders Dermatitis contact Panniculitis, Rash Angioedema, Hyperhidrosis, Pruritus, Henoch- Schonlein purpura, Urticaria, Sweat discolouration, Alopecia Musculoskeletal and connective tissue disorders Pain in extremity Muscle spasms, Trismus Renal and urinary disorders Urinary retention, Chromaturia, Urinary incontinence Reproductive system and breast disorders Priapism General disorders and administration site conditions Infusion site erythema1, 2, Infusion site eschar1, 2, Infusion site haematoma1, 2, Infusion site nodule1, 2, Infusion site pain1, 2 Infusion site discolouration, Infusion site haemorrhage, Infusion site induration, Infusion site pruritus, Infusion site reaction (unspecified), Infusion site swelling1, 2, Infusion site vesicles, Therapeutic response shortened Asthenia, Discomfort, Other infusion site reactions1, Peripheral edema1, Pyrexia Fatigue, Malaise, Gait disturbance, Chest pain 11 System Organ Class Very common Common Uncommon Not known3 Investigations Weight gain, Weight lost Injury, poisoning and procedural complications Fall Skin abrasion Product issues Leakage of medication on the skin that could cause local reaction 1 Grouped terms that include closely related preferred terms.
7). Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. 7). Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
Furthermore, a reduction of dose or termination of therapy may be considered. 2). Cardiovascular ischaemic events Levodopa should be administered with caution in patients with severe cardiovascular disease. In patients with a history of myocardial infarction who have residual atrial, nodal or ventricular arrhythmias, cardiac function should be monitored with particular care during the period of initial Onerji dose adjustments.
Hallucinations, psychosis, confusion There is an increased risk of hallucinations and psychosis in patients taking levodopa. Hallucinations may present shortly after the initiation of levodopa therapy and be responsive to levodopa dose reduction.
Hallucinations may be accompanied by confusion, insomnia, and excessive dreaming. Abnormal thinking and behaviour may present with one or more symptoms, including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behaviour, disorientation, aggressive behaviour, agitation and delirium.
Patients with a major psychotic disorder or a history of psychotic disorder must be treated cautiously with Onerji because of the risk of exacerbating psychosis. In addition, medicinal products that antagonise the effects of dopamine used to treat psychosis may exacerbate the symptoms of Parkinson’s disease and may decrease the effectiveness of Onerji.
Impulse control, compulsive behaviours Patients may experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge or compulsive eating, and/or other intense urges, as well as the inability to control these urges while taking one or more of the medicinal products used for the treatment of Parkinson’s disease that increase central dopaminergic tone.
1. • Narrow-angle glaucoma. g. phenelzine, tranylcypromine). • Patients with significant cognitive impairment. g. phaeochromocytoma, hyperthyroidism and Cushing's syndrome.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If the patient needs to discontinue Onerji, the dose should be reduced gradually, or the patient should be switched to oral levodopa. Onerji can be interrupted without further actions for brief periods of time (less than 3 hours), for example when the patient is taking a shower.
If a prolonged interruption of therapy (lasting more than 3 hours) occurs or is expected, patients should be advised to take oral levodopa, as instructed by the healthcare provider, until Onerji treatment can be resumed. Prescribing a backup oral levodopa medicinal product is recommended in the event that delivery of Onerji is interrupted.
4 Special populations Elderly Dose adjustment should be conducted with caution in patients of 85 years and older. Renal/hepatic impairment There are no studies on the pharmacokinetics of Onerji in patients with hepatic or renal impairment.
2). Paediatric population There is no relevant use of Onerji in the paediatric population in the treatment of Parkinson’s disease. Method of administration Onerji is administered as a continuous subcutaneous infusion, 24 hours per day with a medicinal product delivery pump.
Onerji should only be used with one of the following delivery systems: • Yurway Delivery System which includes a Yurway Rechargeable Pump, sterile single-use Yurway Medication Cartridge (reservoirs) with attached vial adapters. The Yurway Delivery System is used with sterile, single-use infusion sets.
For detailed instructions refer to the Yurway Delivery System user manual. • Crono Twin ND pump which uses sterile single-use syringes (reservoirs), vial adapters and infusion sets. For detailed instructions refer to Crono Twin ND Instructions for Use.
Onerji should not be administered with any other medicinal product delivery pump. Only the Yurway Delivery System and Crono Twin ND were qualified for compatibility with Onerji. Both delivery systems can be programmed to provide daytime and night-time flow rates via two infusion sites per Onerji prescribed regimens in Parkinson’s disease patients and were found to perform equivalently.
Before initiating home use, the physician must assess whether the patient can safely use the Yurway Delivery System or Crono Twin ND independently. Following training, patients who are not able to perform all critical tasks safely must use the system with the support of a trained caregiver.
Only patients and/or caregivers who have received training and have been assessed as competent may operate the Yurway Delivery System or Crono Twin ND at home. 6). The recommended infusion site locations are the abdomen, the flanks, and the outer thighs.
If needed, posterolateral […]
2 See description of selected adverse reactions. 3 These adverse reactions have not been reported with Onerji, but are expected for oral levodopa. 6 years) including nodules, haematoma, pain, infection, erythema, eschar and swelling.
The majority of the infusion site reactions were of mild severity, non- serious and were self-manageable by patients. 3% of patients, and in most cases resolved with topical or oral antibiotics, while some cases required intravenous antibiotics and/or incision and drainage.
4 for mitigation measures. 5% of the Parkinson’s disease patients treated with Onerji. The majority of dyskinesia events were of mild or moderate severity and resolved spontaneously or after levodopa dose reduction. Treatment was discontinued in 1% of patients due to dyskinesia.
4). All cases were classified as subacute or chronic, and 84% of events were of mild or moderate severity. Neuropathy was most often characterised as sensory or sensorimotor. Most cases were reported in association with low vitamin B levels (78% of cases; 61%, 39% and 17% with low vitamin B6, B9 or B12 levels, respectively) and high levodopa daily dose.
7% of patients due to neuropathy. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
6 In some cases, although not all, these urges were reported to have stopped when the dose was reduced, or the medicinal product was discontinued. Because patients may not recognise these behaviours as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while being treated with Onerji.
If a patient develops such urges reducing the dose or discontinuing Onerji should be considered. Orthostatic hypotension Levodopa can cause orthostatic hypotension. g. anti-hypertensive medicinal products. Dyskinesia Levodopa-containing products may cause dyskinesia.
A dose reduction of Onerji or other medicinal products used for the treatment of Parkinson’s disease may be required. Infusion site reactions Onerji is associated with local infusion site reactions. Patients should be instructed to rotate the infusion sites daily, avoiding returning to the same infusion site for at least 2 weeks, and to clean the infusion area with a disinfectant.
The cannulas should be placed at least 5 cm apart and at least 5 cm away from the navel. g. nodules, haematoma, infection, areas with erythema or oedema), or that are over bone, blood vessels, tattoos or scar tissue should be avoided.
Patients should be instructed to carefully monitor for any skin changes at the infusion site that could indicate a potential infection, such as redness associated with warmth, swelling and pain, particularly if associated with fever.
The majority of infusion site infection reactions can be resolved with topical or oral antibiotics and do not require interruption of Onerji. g. cellulitis or abscess) hospitalisation may be necessary for intravenous antibiotics, drainage of an abscess and/or removal of infected skin tissue.
Neuropathy Patients should be monitored clinically for neuropathy after starting Onerji treatment, especially patients with pre-existing neuropathy and patients taking other medicinal products or those having medical conditions that are associated with neuropathy.
8). Supplement in case of deficiencies, particularly if markedly low levels are observed. Depression and suicidality All patients should be observed carefully for the development of depression with suicidal tendencies. Chronic wide-angle glaucoma Patients may be treated cautiously with Onerji provided the intraocular pressure is well-controlled and the patient is monitored carefully for changes in intraocular pressure during therapy.
Peptic ulcer disease Levodopa, treatment may increase the possibility of upper gastrointestinal haemorrhage in patients with a history of peptic ulcer. 7 Laboratory monitoring Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function are recommended during extended therapy.
Interference with laboratory tests Levodopa may cause a false-positive reaction for urinary ketone bodies when a test tape […]