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Ontozry is a brand name for Cenobamate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ontozry is indicated for the adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.
Verbatim from this product's EMA label. Tap a section to expand.
5 mg per day, titrated gradually to the recommended target dose of 200 mg per day. Based on clinical response, dose may be increased to a maximum of 400 mg per day. 8). 5 mg Weeks 1 and 2 25 mg Weeks 3 and 4 Titration 50 mg Weeks 5 and 6 100 mg Weeks 7 and 8 150 mg Weeks 9 and 10 Target dose 200 mg Weeks 11 and 12 and onwards Dose optimisation Some patients, who do not reach optimal seizure control, may benefit from doses above 200 mg (increased by increments of 50 mg/day every two weeks) up to a maximum of 400 mg daily.
Missed doses If patients miss one dose, it is recommended that they take a single dose as soon as they remember, unless it is less than 12 hours until their next regularly scheduled dose. e. over at least 2 weeks), unless safety concerns require abrupt withdrawal.
Elderly (65 years of age and above) Clinical studies of cenobamate did not include sufficient numbers of subjects aged 65 and over, to determine whether they responded differently from younger patients. It has been reported that elderly subjects on antiepileptic medicinal products have higher incidence of adverse reactions such as fatigue, gait disturbance, fall, ataxia, balance disorder, dizziness and somnolence.
4). Renal impairment Cenobamate should be used with caution and reduction of the target dose may be considered in patients with mild to moderate (creatinine clearance 30 to <90 ml/min) or severe (creatinine clearance < 30 ml/min) renal impairment.
The maximum recommended dose for patients with mild, moderate, or severe renal impairment is 300 mg/day. Cenobamate should not be used in patients with end-stage renal disease or patients undergoing haemodialysis. Hepatic impairment Exposure to cenobamate was increased in patients with chronic hepatic disease.
A change in the starting dose is not required; however, a decrease in target doses of up to 50% may need to be considered. The maximum recommended dose in patients with mild and moderate hepatic impairment is 200 mg/day. Cenobamate should not be used in patients with severe hepatic impairment.
Paediatric population The safety and efficacy of Ontozry in children aged 0 months to 18 years have not yet been established. No data are available. Method of administration Oral use. 5 Cenobamate should typically be taken once daily as single oral dose at any time.
Summary of the safety profile The most commonly reported adverse reactions were somnolence, dizziness, fatigue and headache. The discontinuation rates because of adverse reactions in clinical trials were 5%, 6% and 19% for patients randomised to receive cenobamate at doses of 100 mg/day, 200 mg/day and 400 mg/day respectively, compared to 3% in patients randomised to receive placebo.
The 400 mg dose was more associated with adverse reactions especially when taken concomitantly with clobazam. 5% vs 0 % placebo). These adverse reactions are dose dependent and the titration scheme should be strictly followed). Tabulated list of adverse reactions Adverse reactions reported in clinical studies are listed in table 2 per system organ class (SOC) and per frequency.
Within each frequency group, undesirable effects are ranked in decreasing order of severity: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000).
Table 2:
Tabulated list of adverse reactions System organ class Frequency Adverse reactions from clinical trials Immune system disorders Uncommon Hypersensitivity* 11 Psychiatric disorders Common Confusional state, Irritability Uncommon Suicidal ideation Nervous system disorders Very common Somnolence*, Coordination and Gait abnormalities*, Headache Common Dysarthria, Nystagmus, Aphasia, Memory impairment Eye disorders Common Diplopia, Vision blurred Gastrointestinal disorders Common Constipation, Diarrhoea, Nausea, Vomiting, Dry mouth Skin and subcutaneous tissue disorder Common Rash* Rare Drug reaction with eosinophilia and systemic symptoms (DRESS) Investigations Common Hepatic enzyme increased* *Grouped terms: Somnolence: Somnolence, Fatigue, Sedation and Hypersomnia; Coordination and Gait abnormalities: Dizziness, Vertigo, Balance disorder, Ataxia, Gait disturbance and abnormal coordination; Hypersensitivity: Hypersensitivity, Drug hypersensitivity, Eyelid oedema; Rash: Rash, Rash erythematous, Rash generalised, Rash macular, Rash maculo-papular, Rash morbilliform, Rash papular, Rash pruritic; Hepatic enzyme increased: Alanine aminotransferase increased, Aspartate aminotransferase increased, Hepatic enzyme increased, Hepatic function abnormal, Transaminases increased.
Suicidal ideation Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic medicinal products, including cenobamate. A meta-analysis of randomised placebo-controlled trials of anti- epileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
The mechanism of this risk is not known. Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
8). 5 mg/day and titrated every two weeks, in an open-label safety study of 1,340 epilepsy patients, no cases of DRESS were reported. At the time of prescription, patients should be advised of the signs and symptoms of DRESS and monitored closely for skin reactions.
Symptoms of DRESS include typically, although not exclusively, fever, rash associated with other organ system involvement, lymphadenopathy, liver function tests abnormalities and eosinophilia. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.
If signs and symptoms suggestive of these reactions appear, cenobamate should be withdrawn immediately and an alternative treatment considered (as appropriate). QT-shortening A dose-dependent shortening of the QTcF interval has been observed with cenobamate.
1). In clinical trials there was no 6 evidence that the combination of cenobamate with other antiepileptic medicines led to further QT- shortening. Clinicians should use caution when prescribing cenobamate in combination with other medicinal products that are known to shorten the QT.
Familial Short QT syndrome is a rare genetic syndrome, which is associated with an increased risk of sudden death and ventricular arrhythmias, particularly ventricular fibrillation. 3). Contains lactose Patients with rare hereditary problems such as galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
1. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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However, it should preferably be taken at the same time each day. 2). The tablet should be swallowed with a glass of water. The tablets cannot be split accurately as there is no break line and the accuracy of the dose cannot be ensured.
The tablet can be taken whole or can be crushed. 6). Administration of crushed tablets via nasogastric (NG) tube Ontozry crushed tablet can be mixed with water and administered also through a nasogastric feeding tube (NG tube) as follows: 1.
Crush the appropriate number of tablet(s) for the prescribed dose. 2. In an appropriate container, combine the crushed tablet(s) and 25 mL of water. 3. Shake to suspend the crushed tablet(s). 4. Ensuring no particles are left in the container, instill the suspension with a syringe into the NG tube.
5. Refill the catheter-tip syringe again with 10 mL of water, swirl gently, and administer. 6. Visually confirm that no particles are left in the syringe. If particles remain, repeat step 5.
Description of selected adverse reactions Drug reaction with eosinophilia and systemic symptoms (DRESS) Three cases of DRESS were reported within 2 to 4 weeks of starting cenobamate in studies with high starting doses (50 mg or 100 mg once daily) and weekly or faster titration.
5 mg/day and titrated every two weeks, in an open-label safety study of 1,340 epilepsy patients, no cases of DRESS were reported. At the time of prescription, patients should be advised of the signs and symptoms of DRESS and monitored closely for skin reactions.
Symptoms of DRESS include typically, although not exclusively, fever, rash associated with other organ system involvement, lymphadenopathy, liver function tests abnormalities and eosinophilia. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.
If signs and symptoms suggestive of these reactions appear, cenobamate should be withdrawn immediately and an alternative treatment considered (as appropriate). ). 5%) placebo patient experienced an event of hypersensitivity. Two patients in the cenobamate dose group experienced events of drug hypersensitivity.
One cenobamate treated patient experienced an event of hypersensitivity and 1 cenobamate treated patient experienced an event on eyelid oedema. The placebo patient experienced an event of hypersensitivity. All events were classified as mild or moderate.
Elderly Safety data from the Pooled Double-Blind and All Phase 2/3 datasets along with PK data from a Phase 1 study showed no additional safety risks in elderly subjects >65 years of age at study entry. 2). 12 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.