FAQ

The indication for ONTOZRY^® specifies that it can be prescribed as an adjunctive medication for adult epilepsy patients who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicinal products. While there must be unsuccessful treatment attempts with at least two anti-seizure medications (ASMs), this does not mean the patient must currently be using at least two different ASMs. ONTOZRY^® can be prescribed to a patient using only one ASM, provided that another ASM has been used at some point in their treatment history. It is important to note that ONTOZRY^® is not indicated for monotherapy in Europe.

ONTOZRY^® is not indicated to patients under 18 years old.

ONTOZRY^® has a dual mechanism of action (MoA). It has been shown to reduce repetitive neuronal firing by enhancing the inactivation of sodium channels and inhibiting the persistent component of the sodium current. In particular, ONTOZRY^® differs from many other sodium-channel blockers due to its effect on the persistent sodium current. Additionally, ONTOZRY^® acts as a positive allosteric modulator of GABAA receptors, without binding to the benzodiazepine binding site. In this way, it enhances the effect of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) in the brain.

Both mechanisms of action are central to the efficacy of cenobamate. More information on ONTOZRY^®’s MoA and the mechanisms of action of epilepsy drugs in general can be found HERE.

ONTOZRY^® is indicated for adult patients with focal-onset seizures. When selecting patients, it is important to note that cenobamate is not recommended for women of childbearing potential who are not using contraception, as insufficient data is available regarding its use in this group. In general, ONTOZRY^® can be prescribed to a wide range of patients, considering individual medications and potential comorbidities.

ONTOZRY^® is contraindicated in patients with familial short-QT syndrome or in those with hypersensitivity to the active ingredient or any excipient.

ONTOZRY^® contains lactose monohydrate.

ONTOZRY^® should be initiated at a low dose of 12.5 mg and gradually titrated to the recommended dose of 200 mg. The efficacy of ONTOZRY^® has been shown to increase with higher doses. While some patients may experience changes in seizure frequency shortly after initiation, for others, this may take longer and require higher doses.

In the ONTOZRY^® clinical trial C017, significant seizure reduction was observed as early as the first 4 weeks of treatment. Patients receiving 200 mg and 400 mg doses of CNB experienced a 50% median reduction in seizure frequency within the first 4 weeks. This early onset of action was also observed in a post-hoc analysis of the ONTOZRY^® safety study C021.

Real-world evidence suggests that, particularly in patients with more severe disease, larger doses may be needed to achieve seizure freedom. The target dose of ONTOZRY^® is 200 mg, but it can be increased to 400 mg depending on the individual response.

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Clinical trials of ONTOZRY^® included a limited number of subjects aged 65 and older. As a result, it is not possible to determine whether older adults respond differently compared to younger adults. Elderly patients taking antiepileptic medications may experience a higher incidence of adverse reactions, such as fatigue, gait disturbance, falls, ataxia, balance disorder, dizziness, and somnolence. (SmPC)

When initiating ONTOZRY^® in older adults, cautious dose selection is recommended, typically starting at the lower end of the dosing range. This approach should take into account the greater likelihood of decreased hepatic or renal function, concomitant diseases, and potential drug interactions in polymedicated patients (see SmPC section 4.4). Careful monitoring for adverse events is strongly advised. (SmPC)

Yes, ONTOZRY^® tablets can be taken whole or crushed. While ONTOZRY^® tablets are designed to be swallowed whole, the SmPC notes that they cannot be split accurately due to the absence of a break line, which may compromise dose accuracy. However, in situations where patients are unable to swallow whole tablets, crushing the tablet is an acceptable alternative. (SmPC)

To administer a crushed tablet, mix the entire crushed tablet with 25 mL of water for oral or nasogastric (NG) tube administration. When administering via an NG tube, ensure no particles remain in the container. Instill the suspension using a syringe, then follow with a 10 mL water flush to ensure complete delivery. Visually confirm that the syringe is clear of particles after the flush. (SmPC)

The most commonly reported side effects of taking ONTOZRY^® are:

Somnolence
Dizziness
Fatigue
Headache

It's important to note that these side effects were dose-dependent, and the risk may be higher with higher doses. The titration schedule (gradual dose increase) is designed to minimize the potential for these reactions. (SmPc)

ONTOZRY^® is approved as an adjunctive therapy for focal-onset seizures in adults whose epilepsy is not adequately controlled with other anti-epileptic drugs. Research has shown that ONTOZRY^® can still be effective in reducing seizures when taken alongside sodium channel blockers (SCBs) and medications that utilize other mechanisms of action, such as those affecting GABA receptors or targeting other neural pathways.²

When ONTOZRY^® is used with SCBs, there may be an increased likelihood of dizziness.² This can be managed by considering adjustments to the dosage of lacosamide, particularly if it is at a higher level (≥400 mg/day), or by reassessing the overall need for multiple SCBs.³

The most important consideration is for the prescribing doctor to carefully monitor any side effects and make necessary adjustments to medication dosages.^1,3

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Angelini is committed to supporting healthcare professionals and advancing epilepsy care. If you are interested in asking Angelini to sponsor a medical educational event, please contact your local representative. All the contact details are HERE.