LAMICTAL - LAMICTAL ODT - Pediatric Dosing of LAMICTAL

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Pediatric Dosing of LAMICTAL

We are proud of the 19-year reputation for proven efficacy and tolerability in adults and children that LAMICTAL has established over the course of more than 5 million patient exposures worldwide.1 These benefits are demonstrated in patients as young as 2 years and throughout adulthood.

LAMICTAL ODT is another form of LAMICTAL. LAMICTAL ODT is pleasant-tasting and easy-to-swallow.

LAMICTAL and LAMICTAL ODT are indicated as adjunctive therapy for partial seizures, primary generalized tonic-clonic seizures, and the generalized seizures of Lennox-Gastaut syndrome (LGS) in pediatric patients (>2 years of age).

Safety and effectiveness of LAMICTAL and LAMICTAL ODT 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.

Dosing advantages for younger patients:

2-mg dosage of LAMICTAL Tablets available to healthcare professionals only from your representative or through the GlaxoSmithKline Response Center (1-888-825-5249); 5-mg and 25-mg tablets available from your representative and through retail pharmacies
Sample Kits of LAMICTAL and LAMICTAL ODT for appropriate patients are available from your GSK representative
No blood monitoring required—an important benefit for younger patients and their parents

Dosing guidelines for patients 2 to 12 years of age

Escalation Regimen for LAMICTAL in Patients 2 to 12 Years of Age With Epilepsy
	For Patients Taking Valproate* (see Table 10 of Prescribing Information for weight-based dosing guide)	For Patients Taking AEDs Other Than Carbamazepine, Phenytoin, Phenobarbital, or Primidone,^† and Not Taking Valproate	For Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone^† and Not Taking Valproate
Weeks 1 and 2	0.15mg/kg/day in 1 or 2 divided doses, rounded down to the nearest whole tablet (see table below for weight-based dosing guide).	0.3 mg/kg/day in 1 or 2 divided doses, rounded down to the nearest whole tablet.	0.6 mg/kg/day in 2 divided doses, rounded down to the nearest whole tablet.
Weeks 3 and 4	0.3 mg/kg/day in 1 or 2 divided doses, rounded down to the nearest whole tablet (see table below for weight-based dosing guide).	0.6 mg/kg/day in 2 divided doses, rounded down to the nearest whole tablet.	1.2 mg/kg/day in 2 divided doses, rounded down to the nearest whole tablet.
Weeks 5 onwards to maintenance	The dose should be increased every 1 to 2 weeks as follows: calculate 0.3 mg/kg/day, round this amount down to the nearest whole tablet, and add this amount to the previously administered daily dose.	The dose should be increased every 1 to 2 weeks as follows: calculate 0.6 mg/kg/day, round this amount down to the nearest whole tablet, and add this amount to the previously administered daily dose	The dose should be increased every 1 to 2 weeks as follows: calculate 1.2 mg/kg/day, round this amount down to the nearest whole tablet, and add this amount to the previously administered daily dose
Usual Maintenance Dose	1 to 5 mg/kg/day (maximum 200 mg/day in 1 or 2 divided doses). 1 to 3 mg/kg/day with valproate alone	4.5 to 7.5 mg/kg/day (maximum 300 mg/day in 2 divided doses)	5 to 15 mg/kg/day (maximum 400 mg/day in 2 divided doses)
Maintenance dose in patients less than 30 kg	May need to be increased by as much as 50%, based on clinical response	May need to be increased by as much as 50%, based on clinical response	May need to be increased by as much as 50%, based on clinical response

Note: Only whole tablets should be used for dosing
^*Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of lamotrigine
^† These drugs induce glucuronidation and increase clearance. Other drugs which have similar effects include estrogen-containing oral contraceptives and rifampin. Dosing recommendations for oral contraceptives can be found in General Dosing Considerations in the Prescribing Information . Patients on rifampin should follow the same dosing titration/maintenance regimen used with drugs that induce glucuronidation and increase clearance.

The Initial Weight-Based Dosing Guide for Patients 2 to 12 Years Taking Valproate (Weeks 1 to 4) With Epilepsy
If the patient’s weight is		Give this daily dose, using the most appropriate combination of LAMICTAL 2-mg and 5-mg tablets
Greater than	And less than	Weeks 1 and 2	Weeks 3 and 4
6.7 kg	14 kg	2 mg every other day	2 mg every day
14.1 kg	27 kg	2 mg every day	4 mg every day
27.1 kg	34 kg	4 mg every day	8 mg every day
34.1 kg	40 kg	5 mg every day	10 mg every day

Other dosing considerations

For women starting estrogen-containing oral contraceptives and not taking carbamazepine, phenytoin, phenobarbital, primidone, or rifampin, the maintenance dose of LAMICTAL and LAMICTAL ODT will in most cases need to be increased, by as much as two-fold over the recommended target maintenance dose, in order to maintain a consistent lamotrigine plasma level.

Conversely, the maintenance dose of LAMICTAL and LAMICTAL ODT will in most cases need to be decreased by as much as 50% if estrogen-containing oral contraceptives are stopped in these patients.

Adverse events consistent with elevated levels of lamotrigine (such as dizziness, ataxia, and diplopia) may occur during the week of inactive hormone preparation (pill-free week). (See DOSAGE AND ADMINISTRATION section of the Prescribing Information for additional recommendations.)

Adjustments to maintenance doses also may be necessary during pregnancy and following delivery.

Dose adjustments are recommended for patients with hepatic or renal functional impairment.

If you have any questions about the pediatric indications or the pediatric dosing guidelines for LAMICTAL and LAMICTAL ODT, please call the GlaxoSmithKline Response Center at 1-888-825-5249.

THE 2004 AAN/AES TREATMENT GUIDELINES

Evidence-based treatment guidelines support the use of LAMICTAL. These guidelines preceded publication of the study supporting the FDA approval of the PGTC seizure indication for LAMICTAL. For more information, click here.

Important Safety Information About LAMICTAL and LAMICTAL ODT

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LAMICTAL ODT is another form of LAMICTAL.

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Cases of life-threatening serious rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and/or rash-related death, have been caused by LAMICTAL. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include:

– coadministration with valproate

– exceeding recommended initial dose of LAMICTAL

– exceeding recommended dose escalation of LAMICTAL

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Benign rashes are also caused by LAMICTAL; however, it is not possible to predict which rashes will prove to be serious or life-threatening. LAMICTAL should be discontinued at the first sign of rash, unless the rash is clearly not drug-related (see Boxed Warning in Prescribing Information).

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Hypersensitivity reaction may be fatal or life-threatening. Early signs of hypersensitivity (eg, fever, lymphadenopathy) may present without rash; if signs present, patient should be evaluated immediately. LAMICTAL should be discontinued if alternate etiology for hypersensitivity signs is not found.

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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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Acute multiorgan failure has resulted (some cases fatal).

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Blood dyscrasias (eg, neutropenia, thrombocytopenia, pancytopenia) may result either with or without an associated hypersensitivity syndrome.

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Antiepileptic drugs, including LAMICTAL ODT, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.

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Patients treated with any antiepileptic drug for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

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Patients, their caregivers, and families should be informed that antiepileptic drugs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Medication Guide for LAMICTAL^® (lamotrigine) Tablets and LAMICTAL^® ODT™ (lamotrigine) Orally Disintegrating Tablets

Complete Prescribing Information and Medication Guide for LAMICTAL^® (lamotrigine) Tablets and LAMICTAL^® ODT™ (lamotrigine) Orally Disintegrating Tablets including Boxed Warning

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