Dear Healthcare Provider,

GlaxoSmithKline is very pleased to announce that:

LAMICTAL® (lamotrigine) is now FDA-approved for the adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients as young as 2 years of age through adulthood.

LAMICTAL is now approved for a broad spectrum of partial and generalized seizure types. This new indication allows you to offer the benefits of LAMICTAL to a broader range of patients.

New data in PGTC seizures
Data from a double-blind, placebo-controlled trial to assess the efficacy and tolerability of LAMICTAL in patients with PGTC seizures (with or without other idiopathic generalized seizure types) showed a reduction in PGTC seizure frequency from baseline in pediatric and adult patients.1

Biton et al. Neurology. 2005. Double-blind, placebo-controlled evaluation of adjunctive therapy with LAMICTAL for PGTC seizures (with or without other idiopathic generalized seizure types, including absence, myoclonic, clonic, tonic, and atonic) in patients 2-55 years of age. Patients with partial seizures were excluded by screening and historical EEGs. After patients were screened, the study was divided into 3 phases: baseline (8 weeks), escalation (7 or 12 weeks, depending on patient’s age), and maintenance (12 weeks). Fixed doses of LAMICTAL targeting 200-400 mg/day and 3-12 mg/kg/day based on age and concomitant AEDs (induced, non-induced, valproate).
The primary efficacy endpoint showed a significant median reduction of PGTC seizure frequency over the entire treatment period (escalation plus maintenance phases) for LAMICTAL vs placebo (67% reduction vs 34% reduction, P=0.006)
The protocol-specified secondary endpoint showed that more patients treated with LAMICTAL had a ≥50% reduction of PGTC seizure frequency during maintenance phase vs placebo (72% vs 49%, P=0.014)1
During the trial, the most common drug-related adverse events were dizziness (5% LAMICTAL, 2% placebo), somnolence (5% LAMICTAL, 2% placebo), and nausea (5% LAMICTAL, 3% placebo)
Ask your GlaxoSmithKline Clinical Specialist about the Orange Kit for epilepsy

We are now able to provide the Orange Starter Kit to help patients with epilepsy initiate with ease.The Orange Kit can be used to add LAMICTAL for patients >12 years of age taking AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate.*

Please see the "Dosage and Administration" section of the accompanying complete Prescribing Information for detailed dosing guidelines.

Important Safety Information
Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of LAMICTAL, some of which have included Stevens-Johnson syndrome. As adjunctive therapy for epilepsy, the incidence of these rashes is approximately 0.8% (8/1000) in pediatric patients and 0.3% (3/1000) in adults. In a prospectively followed cohort of 1983 pediatric patients taking adjunctive LAMICTAL for epilepsy, there was 1 rash-related death
In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate
Hypersensitivity reactions, some fatal or life-threatening, have occurred in association with the use of LAMICTAL. It is important to note that early manifestations of hypersensitivity (eg, fever, lymphadenopathy) may be present even though a rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately, and LAMICTAL should be discontinued if an alternative etiology cannot be established
Prior to initiation of treatment with LAMICTAL, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (eg, fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately
To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of LAMICTAL should not be exceeded
LAMICTAL should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related


IMPORTANT NOTE: Medication errors have occurred between LAMICTAL and other medications, most commonly Lamisil®,† lamivudine, Ludiomil®,† labetalol, and Lomotil®.† Patients who do not receive LAMICTAL would be inadequately treated and could experience serious consequences. Conversely, patients erroneously receiving LAMICTAL, especially high initial doses, would be unnecessarily subjected to a risk of serious side effects.

If you become aware of a prescription dispensing error involving these products, please contact GlaxoSmithKline at 1-888-825-5249; the USP Medication Errors Reporting Program at 1-800-233-7767; or the US Food and Drug Administration’s MedWatch program by phone at 1-800-FDA-1088. You may also contact MedWatch by fax at 1-800-FDA-0178, via the Internet at www.fda.gov/medwatch, or by mail: MedWatch, 5600 Fishers Lane, Rockville, MD 20857-9787.

LAMICTAL offers proven seizure control and tolerability benefits your patients need.We look forward to continuing to work with you to help your epilepsy patients meet their goals. If you have any questions about the new indication or about LAMICTAL in general, please contact your GlaxoSmithKline Clinical Specialist or log on to www.LAMICTAL.com.

Sincerely,


John A. Messenheimer, MD
Senior Director, Epilepsy Clinical Development
Neurosciences MDC
GlaxoSmithKline
  * Includes valproic acid and divalproex sodium.

†Lamisil (terbinafine HCl tablets) and Ludiomil (maprotiline HCl) are registered trademarks of Novartis Pharmaceuticals Corporation. Lomotil (diphenoxylate HCl, atropine sulfate) is a registered trademark of G.D. Searle LLC.

Reference: 1. Biton V, Sackellares JC,Vuong A, et al. Double-blind, placebo-controlled study of lamotrigine in primary generalized tonic-clonic seizures. Neurology.2005;65:1737-1743.
 
back