Prescribing Information

PRESCRIBING INFORMATION – GB, NI, ROI

ONTOZRY ▼ (cenobamate) 12.5 mg tablets and 25 mg, 50 mg, 100 mg, 150 mg and 200 mg film-coated tablets

Please refer to the full Summary of Product Characteristics (SmPC) before prescribing, particularly in relation to adverse reactions, precautions, contraindications and excipients. Please contact us for more information.

Presentations: Tablets containing 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg of cenobamate.

Indication (GB): 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 treatment with at least 2 anti-epileptic medicinal products.

Indication (NI&ROI): 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.

Dosage and administration: for oral once daily administration. The tablets cannot be split accurately as there is no break line and the accuracy of the dose cannot be ensured. The recommended starting dose of cenobamate is 12.5 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. Please refer to the full Summary of Products Characteristics for further information on the recommended titration schedule, which should not be exceeded because of the potential for serious adverse reactions.
Hepatic or renal impairment: Caution should be used for patients with renal or hepatic impairment. Cenobamate should not be used in patients with end-stage renal disease or patients undergoing haemodialysis. Cenobamate should not be used in patients with severe hepatic impairment.

Contraindications: Hypersensitivity to the active substance or to any of the excipients. Familial Short-QT syndrome.

Special warnings and precautions: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic medicinal products including cenobamate. 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. Drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, has been reported in association with cenobamate when started at higher doses and titrated rapidly (weekly or faster titration). Patients should be advised of the signs and symptoms of DRESS and monitored closely for skin reactions. 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. Clinicians should use caution when prescribing cenobamate in combination with other medicinal products that are known to shorten the QT.
This drug contains lactose and patients with rare hereditary problems such as galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Undesirable effects: Very common; Somnolence, Coordination and Gait abnormalities, Headache. Common; Confusional state, Irritability, Dysarthria, Nystagmus, Aphasia, Memory impairment, Diplopia, Vision blurred, Constipation, Diarrhoea, Nausea, Vomiting, Dry mouth, Rash, Hepatic enzyme increased. Uncommon; Suicidal ideation, Hypersensitivity. Rare; DRESS.
Prescribers should consult the SmPC in relation to all adverse events.

Legal Classification: Prescription only medicine (POM).

Package Quantity and GB&NI Price:

Ontozry 12.5 mg tablets x 14, Ontozry 25 mg film-coated tablets x 14 (total 28) £165.62
Ontozry 50 mg film-coated tablets x 14 £85.54
Ontozry 100 mg film-coated tablets x 14 £87.36
Ontozry 150 mg film-coated tablets x 14 £89.18
Ontozry 200 mg film-coated tablets x 14 £91.00
Ontozry 50 mg film-coated tablets x 28 £91.00
Ontozry 100 mg film-coated tablets x 28 £136.50
Ontozry 150 mg film-coated tablets x 28 £182.00
Ontozry 200 mg film-coated tablets x 28 £182.00

Republic of Ireland Price: Price on application

Marketing Authorization Holder (GB): Angelini Pharma UK-I Limited 6th Floor Napier House, 24 High Holborn, London, United Kingdom, WC1V 6AZ
Marketing Authorization Holder (NI&ROI): Angelini Pharma S.p.A Viale Amelia 70, 00181 Rome, Italy

Marketing Authorisation numbers (GB): PLGB 53287/0001-0007
Marketing Authorisation numbers (NI&ROI): EU/1/21/1530/001-013

UK22459P | Mar 2024

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Adverse events and product complaint should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard for the UK or www.hpra.ie for Ireland. Adverse events and product complaint should also be reported to Angelini Pharma on (UK) +44 2034889643, (IRE) +353 1 584 4671 or UKIReporting@angelinipharma.com