Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

MOTPOLY XR (NDA-216185)

(LACOSAMIDE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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06/07/2024 (SUPPL-1)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

Lacosamide in Pediatric Patients

…

Primary Generalized Tonic-Clonic Seizures in Patients Adjunctive Therapy Trial (Study 5)

In the adjunctive therapy placebo-controlled trial for primary generalized tonic-clonic seizures, adverse reactions that occurred in the study were generally similar to those that occurred in partial-onset seizure placebo-controlled studies. The most common adverse reactions (greater than or equal to 10% on lacosamide) reported in patients treated with lacosamide were dizziness (23%), somnolence (17%), headache (14%), and nausea (10%), compared to 7%, 14%, 10%, and 6%, respectively, of patients who received placebo. Additionally, an adverse reaction not previously reported of myoclonic epilepsy was reported in 3% of patients treated with lacosamide compared to 1% of patients who received placebo. It is also noted that 2 patients receiving lacosamide had acute worsening of seizures shortly after drug initiation, including one episode of status epilepticus, compared to no patients receiving placebo.

8.4 Pediatric Use

Additions and/or revisions underlined:

Partial-Onset Seizures

…

Primary Generalized Tonic-Clonic Seizures

Safety and effectiveness of MOTPOLY XR as adjunctive therapy in the treatment of primary generalized tonic- clonic seizures in pediatric patients with idiopathic generalized epilepsy weighing at least 50 kg was established in a 24-week double-blind, randomized, placebo-controlled, parallel-group, multi-center study (Study 5), which included pediatric patients [see Adverse Reactions (6.1), Clinical Pharmacology (12.3) and Clinical Studies (14.1, 14.3)].

Safety and effectiveness in pediatric patients weighing less than 50 kg have not been established.

Additional pediatric use information is approved for UCB Inc.'s Vimpat (lacosamide) tablets, oral solution, and intravenous solution. However, due to UCB Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Animal Data

Lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (CRMP-2), a protein involved in neuronal differentiation and control of axonal outgrowth. Potential related adverse effects on CNS development cannot be ruled out. Administration of lacosamide to rats during the neonatal and juvenile periods of postnatal development (approximately equivalent to neonatal through adolescent development in humans) resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). The no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide exposure (AUC) less than that in humans at the maximum recommended human dose of 400 mg/day.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

Additions and/or revisions underlined:

What is MOTPOLY XR?

MOTPOLY XR is a prescription medicine used:

to treat partial-onset seizures in adults and in children weighing at least 110 pounds (50 kg).

with other medicines to treat primary generalized tonic-clonic seizures in adults and children weighing at least 110 pounds (50 kg).

It is not known if MOTPOLY XR is safe and effective for partial-onset seizures and primary generalized tonic-clonic seizures in children weighing less than 50 kg.