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Okedi is a brand name for Risperidone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: OKEDI is indicated for the treatment of schizophrenia in adults for whom tolerability and effectiveness have been established with oral risperidone.
Verbatim from this product's EMA label. Tap a section to expand.
Posology OKEDI should be administered every 28 days by intramuscular (IM) injection.
OKEDI should be initiated according to the patient’s clinical context:
Patients with history of previous response to Risperidone who are currently stabilised with oral antipsychotics (mild to moderate psychotic symptoms) Patients stabilised with oral risperidone can be switched to OKEDI without previous titration.
Patients stabilised on other oral antipsychotics (different from risperidone) should be titrated with oral risperidone before initiating treatment with OKEDI. The duration of the titration period should be sufficiently long (at least 6 days) to confirm the tolerability and responsiveness to risperidone.
Patients never treated before with oral Risperidone Patients who are candidates to receive OKEDI and have NOT been previously treated with risperidone, the tolerability and responsiveness to risperidone must be confirmed with a period of oral risperidone treatment before initiating treatment with OKEDI.
The duration of the titration period is recommended to be at least 14 days. Switching from oral risperidone to OKEDI 3 The recommended doses of oral risperidone and OKEDI needed to maintain a similar active moiety steady-state exposure are as follows: Previous oral risperidone dose of 3 mg/day to OKEDI injection 75 mg every 28 days Previous oral risperidone dose of 4 mg/day or higher to OKEDI injection 100 mg every 28 days OKEDI must be initiated approximately 24 hours after the last oral risperidone dose.
Dose adjustments of OKEDI may be made every 28 days. A maintenance dose of OKEDI 75 mg every 28 days is generally recommended. However, some patients may benefit from OKEDI 100 mg every 28 days, according to the patient’s clinical response and tolerability.
Neither a loading dose nor any supplemental oral risperidone is recommended when using OKEDI. , two weeks after the last risperidone bi-weekly long-acting injection). OKEDI should then be continued at 28-day intervals. No oral concomitant risperidone is recommended.
5 mg to OKEDI injection 75 mg every 28 days Risperidone bi-weekly long-acting 50 mg to OKEDI injection 100 mg every 28 days Switching from OKEDI to oral risperidone When switching patients from OKEDI injection back to oral risperidone therapy, the prolonged release characteristics of the OKEDI formulation must be considered.
1%). Tabulated list of adverse reactions The following are all the ADRs that were reported in clinical trials and post-marketing experience with risperidone by frequency category estimated from risperidone clinical trials. The following terms and frequencies are applied: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. System Organ Class Adverse Drug Reaction Frequency Very Common Common Uncommon Rare Very Rare Not known Infections and infestations pneumonia, bronchitis, upper respiratory tract infection, respiratory tract infection, cystitis, eye infection, tonsillitis, infection 13 System Organ Class Adverse Drug Reaction Frequency Very Common Common Uncommon Rare Very Rare Not known sinusitis, urinary tract infection, ear infection, influenza onychomycosis, cellulitis localised infection, viral infection, acarodermatitis Blood and lymphatic system disorders neutropenia, white blood cell count decreased, thrombocytopenia , anaemia, haematocrit decreased, eosinophil count increased agranulocytosis c Immune system disorders hypersensitivity anaphylactic reactionc Endocrine disorders hyperprolactinae miaa inappropriate antidiuretic hormone secretion, glycosuria Metabolism and nutrition disorders weight increased, increased appetite, decreased appetite diabetes mellitusb, hyperglycaemia, polydipsia, weight decreased, anorexia, blood cholesterol increased, blood triglycerides increased water intoxicationc, hypoglycaemia, hyperinsulinae miac diabetic ketoacido sis Psychiatric disorders insomniad sleep disorder, agitation, depression, anxiety mania, confusional state, libido decreased, nervousness, nightmare catatonia, somnambulism, sleep-related eating disorder, blunted affect, anorgasmia Nervous system disorders parkinsonismd, headache sedation/ somnolence, akathisiad, dystoniad, dizziness, dyskinesiad, tremor tardive dyskinesia, cerebral ischaemia, loss of consciousness, convulsiond, syncope, psychomotor hyperactivity, balance disorder, coordination abnormal, dizziness postural, disturbance in neuroleptic malignant syndrome, cerebrovascular disorder, diabetic coma, head titubation, unresponsive to stimuli, depressed level of consciousness 14 System Organ Class Adverse Drug Reaction Frequency Very Common Common Uncommon Rare Very Rare Not known attention, dysarthria, dysgeusia, hypoaesthesia, paraesthesia Eye disorders vision blurred, conjunctivitis photophobia, dry eye, lacrimation increased, ocular hyperaemia glaucoma, eye movement disorder, eye rolling, eyelid margin crusting, floppy iris syndrome (intraoperative) c Ear and labyrinth disorders vertigo, tinnitus, ear pain Cardiac disorders tachycardia atrial fibrillation, atrioventricular block, conduction disorder, electrocardiogram QT prolonged, bradycardia, electrocardiogram abnormal, palpitations sinus arrhythmia Vascular disorders hypertension hypotension, orthostatic hypotension, flushing pulmonary embolism, venous thrombosis Respiratory, thoracic and mediastinal disorders dyspnoea, pharyngolaryngea l pain, cough, nasal congestion respiratory tract congestion, wheezing, epistaxis sleep apnoea syndrome, hyperventilatio n, rales, pneumonia aspiration, pulmonary congestion, dysphonia, respiratory disorder Gastrointesti nal disorders abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhoea, dyspepsia, dry mouth, toothache faecal incontinence, faecaloma, gastroenteritis, dysphagia, flatulence pancreatitis, intestinal obstruction, swollen tongue, cheilitis ileus 15 System Organ Class Adverse Drug Reaction Frequency Very Common Common Uncommon Rare Very Rare Not known Hepatobiliar y disorders transaminases increased, gamma- glutamyltransferas e increased, hepatic enzyme increased jaundice Skin and subcutaneou s tissue disorders rash, erythema urticaria, pruritus, alopecia, hyperkeratosis, eczema, dry skin, skin discolouration, acne, seborrhoeicc dermatitis, skin disorder, skin lesion drug eruption, dandruff angioede ma Stevens- Johnson syndrome /toxic epidermal necrolysis c Musculoskel etal and connective tissue disorders muscle spasms, musculoskeletal pain, back pain, arthralgia blood creatine phosphokinase increased, posture abnormal, joint stiffness, joint swelling muscular weakness, neck pain rhabdomyolysis Renal and urinary disorders urinary incontinence pollakiuria, urinary retention, dysuria Pregnancy, puerperium, and perinatal conditions drug withdrawal syndrome neonatalc Reproductiv e system and breast disorders erectile dysfunction, ejaculation disorder, amenorrhoea, menstrual disorderd, gynaecomastia, galactorrhoea, sexual dysfunction, breast pain, breast discomfort, vaginal discharge priapismc, menstruation delayed, breast engorgement, breast enlargement, breast discharge General disorders and oedemad, pyrexia, chest pain, face oedema, chills, body temperature hypothermia, body temperature 16 System Organ Class Adverse Drug Reaction Frequency Very Common Common Uncommon Rare Very Rare Not known administrati on site conditions asthenia, fatigue, pain increased, gait abnormal, thirst, chest discomfort, malaise, feeling abnormal, discomfort decreased, peripheral coldness, drug withdrawal syndrome, indurationc Injury, poisoning and procedural complication s Fall, injection site pain, injection site swelling procedural pain, injection site discomfort, injection site erythema a Hyperprolactinaemia can in some cases lead to gynaecomastia, menstrual disturbances, amenorrhoea, anovulation, […]
2). Consideration should be given to the prolonged release nature of the medicinal product and the long elimination half-life of risperidone when assessing treatment needs and the potential need to be able to discontinue treatment. 5 Elderly patients with dementia Increased mortality in elderly people with dementia OKEDI has not been studied in elderly patients with dementia, hence it should not be used in this group of patients.
In a meta-analysis of 17 controlled trials of atypical antipsychotics, including risperidone, elderly patients with dementia treated with atypical antipsychotics have an increased mortality compared to placebo. 1% for placebo-treated patients.
1). The mean age (range) of patients who died was 86 years (range 67-100). Data from two large observational studies showed that elderly people with dementia who are treated with conventional antipsychotics are also at a small increased risk of death compared with those who are not treated.
There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic active substance as opposed to some characteristic(s) of the patients is not clear.
1%; mean age 80 years, range 67-90). The increase in mortality in patients treated with furosemide plus risperidone was observed in two of the four clinical trials. Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings.
No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death observed. Nevertheless, caution should be exercised and the risks and benefits of this combination or co-treatment with other potent diuretics should be considered prior to the decision to use.
1.
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In general, it is recommended to start oral risperidone treatment 28 days after the last OKEDI administration. Missed doses Avoiding missed doses To avoid a missed 28-day dose, patients may be given the injection up to 3 days before the 28- day time point.
If a dose is delayed by 1 week, the median trough concentration decreases by approximately 50% during that week. The clinical relevance of this is unknown. If the dose is delayed, the next 28-day interval injection should be scheduled according to the last injection date.
Special populations Elderly Efficacy and safety of OKEDI in elderly > 65 years have not been established for the OKEDI prolonged-release suspension for injection. OKEDI should be used with caution in elderly. Tolerability to ≥ 3 mg daily oral risperidone should be reliably established prior to administration of OKEDI.
In general, recommended dosing of risperidone for elderly patients with normal renal function is the same as for adult patients with normal renal function. However, if it is considered clinically appropriate, starting with 75 mg OKEDI should be considered (see Renal impairment below for dosing recommendations in patients with renal impairment).
4 Renal impairment OKEDI has not been systematically studied in patients with renal impairment. For patients with mild renal impairment (creatinine clearance 60 to 89 mL/min) no dose adjustment is required for OKEDI. OKEDI is not recommended in patients with moderate to severe renal impairment (creatinine clearance < 60 mL/min).
Hepatic impairment OKEDI has not been systematically studied in patients with hepatic impairment. Patients with impaired hepatic function have increases in plasma concentration of the free fraction of risperidone. OKEDI should be used with caution in these groups of patients.
A careful titration with oral risperidone (halving starting doses and slowing titration) before initiating treatment with OKEDI at a dose of 75 mg is recommended, if tolerability of an oral dose of at least 3 mg is confirmed. Paediatric population The safety and efficacy of OKEDI in children and adolescents less than 18 years have not been established.
No data are available. 6) or by any other route. It should be administered by a healthcare professional. OKEDI should be administered by deep intramuscular deltoid or gluteal injection using the appropriate sterile needle. For deltoid administration, the 1-inch needle should be used alternating injections between the two deltoid muscles.
For gluteal administration, the 2-inch needle should be used alternating injections between the two gluteal muscles. The pre-filled syringe of OKEDI powder should be reconstituted with the pre-filled syringe of accompanying solvent immediately prior to administration by injection.
6. An incorrect reconstitution could affect the correct dissolution of the powder and in […]
There was no increased incidence of mortality among patients taking other diuretics as concomitant treatment with risperidone. Irrespective of treatment, dehydration was an overall risk factor for mortality and should, therefore, be carefully avoided in elderly patients with dementia.
Cerebrovascular adverse reactions An approximately 3-fold increased risk of cerebrovascular adverse reactions (CVAEs) have been seen in randomised placebo-controlled clinical trials in the dementia population with some atypical antipsychotics.
2% (8/712) of patients treated with placebo. 50). The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations. OKEDI should be used with caution in patients with risk factors for stroke.
6 Orthostatic hypotension Due to the alpha-blocking activity of risperidone, (orthostatic) hypotension can occur. Some cases of hypotension or orthostatic hypotension have been reported during the clinical development program of OKEDI at doses that ranged from 50 mg to 100 mg.
Clinically significant hypotension has been observed post-marketing with concomitant use of risperidone and antihypertensive treatment. , heart failure, myocardial infarction, conduction abnormalities, dehydration, hypovolaemia, or cerebrovascular disease).
The risk/benefit of further treatment with OKEDI should be assessed if clinically relevant orthostatic hypotension persists. Leukopenia, neutropenia, and agranulocytosis Events of leukopenia, neutropenia and agranulocytosis have been reported with risperidone.
Agranulocytosis has been reported very rarely (< 1/10,000 patients) during post-marketing surveillance. Patients with a history of a clinically significant low white blood cell count (WBC) or a drug- induced leukopenia/neutropenia should be monitored during the first few months of therapy and discontinuation of OKEDI should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
Patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count < 1 × 109/L) should discontinue OKEDI and have their WBC followed until recovery.
Tardive dyskinesia/extrapyramidal symptoms (TD/EPS) Medicines with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia (TD) characterised by rhythmical involuntary movements, predominantly of the tongue and/or face.
The onset of extrapyramidal symptoms (EPS) is a risk factor for TD. If signs and symptoms of TD appear, the discontinuation of all antipsychotics should be considered. g. methylphenidate) and risperidone concomitantly, as […]