1.2.2.2 Tolerability


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Proven tolerability patients need

In a double-blind, active-control* study of 156 adult patients with partial seizures inadequately controlled on carbamazepine (CBZ) or phenytoin (PHT) (> 4 seizures/month)¹

Rates of many common adverse events reduced ~50% following conversion to monotherapy with LAMICTAL^† from carbamazepine or phenytoin

* This study employed a low-dose active control for ethical reasons, to provide some seizure protection. The study is not intended to imply the superiority of LAMICTAL to the active control, which was low-dose valproate.

^† Adverse events occurring in >10% of patients in either the group receiving LAMICTAL or the low-dose VPA control group. If a patient's adverse event was reported during both the transition period and the monotherapy period, it is reported in both columns.

LAMICTAL or active control was titrated to 250 mg BID and 500 mg BID, respectively. CBZ or PHT was withdrawn over the next 4 weeks. LAMICTAL or control was maintained for 12 weeks at target doses.

Safety and effectiveness of LAMICTAL have not been established 1) as initial monotherapy, 2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate, or 3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs

More than 5 million patient exposures worldwide and growing²

More than 13 years of worldwide postmarketing experience

Learn more about enrolling appropriate patients in the pregnancy registry.

References: 1. Gilliam F, Vazquez B, Sackellares JC, et al. An active-control trial of lamotrigine monotherapy for partial seizures. Neurology. 1998;51:1018-1025. 2. Data on file, GlaxoSmithKline. Based on kg of lamotrigine sold.

Important Safety Information

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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

Epilepsy clinical trials: The incidence of these rashes is approximately 0.8% (8/1000) in pediatric patients (age <16 years) receiving LAMICTAL as adjunctive therapy and 0.3% (3/1000) in adults on adjunctive therapy. In a prospectively followed cohort of 1983 pediatric patients taking adjunctive LAMICTAL, there was 1 rash-related death

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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

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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 patients should be evaluated immediately. LAMICTAL should be discontinued if an alternative etiology cannot be established

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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

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To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of LAMICTAL should not be exceeded

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LAMICTAL should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related

Complete Prescribing Information for LAMICTAL^® (lamotrigine) Tablets

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