Lacosamide has a proven safety and tolerability profile

Adverse events were generally mild to moderate in trials¹

AEs (%) with incidence ≥8% and greater than placebo in
adults in partial-onset adjunctive therapy controlled trials*

Chart

*	Patients in these clinical trials were treated with 1 to 3 concomitant AEDs.
	AE=adverse event; AED=anti-epileptic drug;
	PGTC=primary generalized tonic‑clonic.

PGTC adjunctive therapy trial

Most common adverse reactions (≥10%) reported in patients treated with lacosamide were dizziness (23%), somnolence (17%), headache (14%), and nausea (10%), vs 7%, 14%, 10%, and 6%, respectively, of placebo‑treated patients²

Myoclonic epilepsy was reported in 3% of lacosamide-treated patients vs 1% of placebo‑treated patients

*	Patients in these clinical trials were treated with 1 to 3 concomitant AEDs.
	AE=adverse event; AED=anti-epileptic drug. PGTC=primary generalized tonic‑clonic.

In the adult monotherapy clinical trial, adverse reactions were generally similar to those observed and attributed to drug in adjunctive placebo-controlled trials, with the exception of insomnia (observed at a higher rate of ≥2% in the monotherapy trial and was not reported at a similar rate in previous studies)¹
Dizziness, headache, nausea, somnolence, and fatigue were all reported at lower incidences during the AED withdrawal and monotherapy phase compared with the titration phase¹

Low risk of significant effects on cognition

Cognitive-related AEs similar to placebo³

Treatment-emergent AEs
potentially related to cognition, n (%)

Chart

AE=adverse event;

MedDRA=Medical Dictionary of Regulatory Activities.

Within the approved adult dosage range (up to 400 mg/day), the incidence of these cognition-related AEs was 6.1% and was similar to placebo³

INDICATION

MOTPOLY XR is indicated for adults and pediatric patients weighing at least 50 kg for treatment of partial-onset seizures and adjunctive therapy in the treatment of primary generalized tonic‑clonic seizures.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Antiepileptic drugs increase the risk of suicidal behavior and ideation. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behaviors.

INDICATION

MOTPOLY XR is indicated for adults and pediatric patients weighing at least 50 kg for treatment of partial-onset seizures and adjunctive therapy in the treatment of primary generalized tonic‑clonic seizures.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Antiepileptic drugs increase the risk of suicidal behavior and ideation. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behaviors.
MOTPOLY XR may cause dizziness and ataxia in patients. Advise patients not to operate machinery or motor vehicles until they know how MOTPOLY XR affects them.
Obtain ECG before beginning MOTPOLY XR, and after titration to steady-state maintenance dose in patients with underlying proarrhythmic conditions or on concomitant medications that affect cardiac conduction. Closely monitor these patients.
MOTPOLY XR may cause syncope.
Gradually withdraw MOTPOLY XR to minimize the potential of increased seizure frequency.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/multi-organ hypersensitivity has been reported and can be life-threatening or fatal. If signs or symptoms are present, immediately evaluate the patient. Discontinue MOTPOLY XR if there is no alternative etiology.

MOST COMMON ADVERSE REACTIONS

The most common adverse reactions in adults (≥10% and greater than placebo) are diplopia, headache, dizziness, nausea, and somnolence.

USE IN SPECIFIC POPULATIONS:

Dose adjustment is recommended for severe renal impairment and mild or moderate hepatic impairment. Consider dose reduction in patients with renal or hepatic impairment taking strong inhibitors of CYP3A4 and CYP2C9.
Use is not recommended in severe hepatic impairment.
Based on animal data, MOTPOLY XR may cause fetal harm if used in pregnancy.

Please refer to the full Prescribing Information and Medication Guide for MOTPOLY XR for additional important information.

References:
1. Vimpat [package insert]. Smyrna, GA: UCB, Inc.; 2021. 2. MOTPOLY XR [package insert]. Piscataway, NJ: Aucta Pharmaceuticals, Inc.; 2024. 3. Biton V, Gil-Nagel A, Isojarvi J, et al. Safety and tolerability of lacosamide as adjunctive therapy for adults with partial-onset seizures: analysis of data pooled from three randomized, double-blind, placebo-controlled clinical trials. Epilepsy Behav. 2015;52:119-127.