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Inbrija is a brand name for Levodopa. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Inbrija is indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor.
Verbatim from this product's EMA label. Tap a section to expand.
g. carbidopa or benserazide) regimen before starting Inbrija. Patients selected for treatment with Inbrija should be able to recognize the onset of their 'OFF' symptoms and be capable of preparing the inhaler or else have a responsible care giver able to prepare the inhaler for them when required.
Inbrija should be inhaled when symptoms, motor or non-motor, of an OFF period start to return. The recommended dose of Inbrija is 2 hard capsules up to 5 times per day each delivering 33 mg levodopa. The maximum daily dose of Inbrija should not exceed 10 capsules (330 mg).
It is not recommended to take more than 2 capsules per OFF period. Exceeding the recommended dose may lead to increased levodopa associated adverse reactions. Abrupt dose reduction or withdrawal of any levodopa medicinal product should be carefully observed, particularly in patients who are also receiving neuroleptics.
4 regarding withdrawal emergent hyperpyrexia and confusion. Elderly No dose adjustment of Inbrija is required for elderly patients (≥65 years). There is only limited data available in very elderly patients (≥75 years). Renal impairment Inbrija has not been studied in patients with renal impairment.
It is recommended to administer this medicinal product cautiously to patients with severe renal disease. 3 Hepatic impairment Inbrija has not been studied in patients with hepatic impairment. It is recommended to administer this medicinal product cautiously to patients with severe hepatic impairment.
Paediatric population The safety and efficacy of Inbrija in children under 18 years of age have not been established. No data are available. Method of administration For inhalation use only. Inbrija hard capsules must not be swallowed.
The Inbrija inhaler is to be thrown away after all the capsules have been used. The capsules must only be removed from the blister immediately before use. The physician or other healthcare professional should instruct the patient how to administer the product correctly.
A summary of how to use Inbrija is provided below. - A complete dose is 2 capsules taken one right after the other. - The patient should load 1 capsule into the Inbrija inhaler, breathe in and hold their breath for 5 seconds. The patient should hear the capsule “whirl”.
8%). Serious adverse reactions of allergic oedema have been reported with levodopa medicinal products but not in clinical studies with Inbrija. A symptom complex resembling neuroleptic malignant syndrome and rhabdomyolysis may occur with levodopa/dopa-decarboxylase inhibitor medicinal products, although no cases have been identified in clinical studies with Inbrija.
Gastrointestinal haemorrhage has been reported with levodopa medicinal products and was observed once in Inbrija clinical studies. Tabulated list of adverse reactions Adverse reactions are presented by system organ class and frequency in Table 1 below.
Frequency categories are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), not known (cannot be estimated from the available data).
Table 1:
Adverse reactions Adverse reactions with Inbrija Adverse reactions reported with oral levodopa System Organ Class Very common Common Not known Not known Neoplasm benign, malignant and unspecified (incl. 4), Dysphagia, Dyspepsia, Glossodynia, Flatulence, Saliva discolouration, Salivary hypersecretion Skin and subcutaneous tissue disorders Angioedema, Hyperhidrosis, Rash, Pruritus, Henoch-Schonlein purpura, Urticaria, Alopecia, Sweat discolouration Musculoskeletal and connective tissue disorders Muscle spasms, Trismus Renal and urinary disorders Urinary retention, Chromaturia, Urinary incontinence Reproductive system and breast disorders Priapism General disorders and administration site conditions Oedema peripheral, Asthenia, Fatigue, Malaise, Gait disturbance, Chest pain Investigations Aspartate aminotransferase increased, Alanine aminotransferase increased, Blood lactate dehydrogenase increased, 10 Adverse reactions with Inbrija Adverse reactions reported with oral levodopa System Organ Class Very common Common Not known Not known Blood bilirubin increased, Blood glucose increased, Blood creatinine increased, Blood uric acid increased, Haemoglobin decreased, Haematocrit decreased, Blood urine present, Blood urea increased, Blood alkaline phosphatase increased, Coombs test positive, White blood cells urine positive, Bacterial test positive, Weight decreased, Weight increased Injury, poisoning and procedural complications Fall a Cardiac rhythm disorder here is a combined term representing atrial fibrillation, atrial flutter, atrioventricular block, bundle branch block, sick sinus syndrome, bradycardia, and tachycardia.
Bronchospasm in patients with lung disease Because of the risk of bronchospasm, use of levodopa inhalation powder in patients with asthma, chronic obstructive pulmonary disease (COPD), or other chronic underlying lung disease is not recommended.
There is limited data regarding chronic effect of Inbrija in respiratory compromised patients. 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. Withdrawal-emergent hyperpyrexia and confusion A symptom complex that resembles neuroleptic malignant syndrome (characterised by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious aetiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in the background dopaminergic therapy.
Therefore, any abrupt dose reduction or withdrawal of any levodopa medicinal product should be carefully observed, particularly in patients who are also receiving neuroleptics. Mental disturbances Patients may experience new or worsening mental status and behavioural changes, which may be severe, including psychotic-like and suicidal behaviour during levodopa treatment or after starting or increasing the dose of levodopa.
This abnormal thinking and behaviour can consist of one or more of a variety of manifestations including anxiety, depression, 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 a levodopa/dopa-decarboxylase inhibitor because of the risk of exacerbating psychosis. In addition, certain medicinal products used to treat psychosis may exacerbate the symptoms of Parkinson’s disease and may decrease the effectiveness of levodopa.
1. - Narrow-angle glaucoma. - Phaeochromocytoma. - Co-administration with non-selective monoamine oxidase (MAO) inhibitors. 5). - A previous history of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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- The used capsule should be removed from the Inbrija inhaler and the second capsule loaded into the inhaler. The maximum time between inhalation of the powder from the first and second capsules should not exceed 10 minutes. - It is important to advise the patient that if they do not hear or feel the capsule “whirl” while inhaling they may need to take a deeper, longer breath, breathing in again using the same capsule or they may need to clean the mouthpiece.
Detailed instructions for use for the patients are included in the package leaflet.
Description of selected adverse reactions Sudden sleep onset Levodopa is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes. 4). Coughing Most cough reported in the clinical studies with Inbrija were mild to moderate in intensity, and usually reported within the first 30 days of the treatment.
Due to cough, 2% of subjects withdrew from the clinical studies with Inbrija. Sensation of choking In post-marketing experience, there have been reports of the sensation of choking associated with the drug powder impacting the back of the throat, immediately following administration.
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 11 professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
5). Impulse control disorders Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with levodopa.
Review of treatment is recommended if such symptoms develop. Dyskinesia Inbrija may cause dyskinesia. Adjustment of levodopa therapy or other medicinal products used for the treatment of Parkinson’s disease may be considered. Cardiovascular ischaemic events Inbrija should be administered with caution in patients with severe cardiovascular disease.
Care should be exercised when Inbrija is administered to patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias. Cardiac function should be monitored with particular care in such patients during the initiation of treatment with Inbrija.
Peptic ulcer disease Levodopa should be administered cautiously to patients with a history of peptic ulcer disease (because of the possibility of upper gastro-intestinal haemorrhage). Glaucoma Levodopa may cause increased intraocular pressure in patients with glaucoma.
Patients with chronic glaucoma may be treated cautiously with levodopa provided the intraocular pressure is well-controlled and the patient is monitored carefully for changes in intraocular pressure during therapy. 5 Melanoma Epidemiological studies have shown that patients with Parkinson’s disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population.
Whether the increased risk observed was due to Parkinson’s disease or other factors, such as medicinal products used to treat Parkinson’s disease, is unclear. Periodic skin examinations are recommended to monitor for melanoma in patients receiving Inbrija.
Laboratory monitoring Abnormalities in laboratory tests may include elevations of liver function tests such as alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactic dehydrogenase (LDH), and bilirubin.
Abnormalities in blood urea nitrogen (BUN) and positive Coombs test have also been reported. Interference with test Levodopa may cause a false-positive reaction for urinary ketone bodies when a test tape is used for determination of ketonuria.
This reaction will not be altered by boiling the urine specimen. False- negative tests may result with the use of glucose-oxidase methods of testing for glucosuria. Cases of falsely diagnosed pheochromocytoma in patients on levodopa/dopa-decarboxylase inhibitor therapy have been reported very rarely.
Caution should be exercised when interpreting the plasma and urine levels of catecholamines and their metabolites in patients on levodopa or levodopa/dopa- decarboxylase inhibitor therapy. Orthostatic hypotension Levodopa can cause orthostatic hypotension.
g. anti-hypertensive medicinal products. Intercurrent respiratory infection There is limited data available on the use of Inbrija during a respiratory infection. Based on individual assessments of the severity of the […]