LAMICTAL (Page 12 of 13)

14.2 Bipolar Disorder

Adults

The effectiveness of LAMICTAL in the maintenance treatment of bipolar I disorder was established in 2 multicenter, double-blind, placebo-controlled trials in adult patients (aged 18 to 82 years) who met DSM-IV criteria for bipolar I disorder. Trial 1 enrolled patients with a current or recent (within 60 days) depressive episode as defined by DSM-IV and Trial 2 included patients with a current or recent (within 60 days) episode of mania or hypomania as defined by DSM-IV. Both trials included a cohort of patients (30% of 404 subjects in Trial 1 and 28% of 171 patients in Trial 2) with rapid cycling bipolar disorder (4 to 6 episodes per year).

In both trials, patients were titrated to a target dose of 200 mg of LAMICTAL as add-on therapy or as monotherapy with gradual withdrawal of any psychotropic medications during an 8- to 16-week open-label period. Overall 81% of 1,305 patients participating in the open-label period were receiving 1 or more other psychotropic medications, including benzodiazepines, selective serotonin reuptake inhibitors (SSRIs), atypical antipsychotics (including olanzapine), valproate, or lithium, during titration of LAMICTAL. Patients with a CGI-severity score of 3 or less maintained for at least 4 continuous weeks, including at least the final week on monotherapy with LAMICTAL, were randomized to a placebo-controlled double-blind treatment period for up to 18 months. The primary endpoint was TIME (time to intervention for a mood episode or one that was emerging, time to discontinuation for either an adverse event that was judged to be related to bipolar disorder, or for lack of efficacy). The mood episode could be depression, mania, hypomania, or a mixed episode.

In Trial 1, patients received double-blind monotherapy with LAMICTAL 50 mg/day (n = 50), LAMICTAL 200 mg/day (n = 124), LAMICTAL 400 mg/day (n = 47), or placebo (n = 121). LAMICTAL (200- and 400-mg/day treatment groups combined) was superior to placebo in delaying the time to occurrence of a mood episode (Figure 1). Separate analyses of the 200- and 400-mg/day dose groups revealed no added benefit from the higher dose.

In Trial 2, patients received double-blind monotherapy with LAMICTAL (100 to 400 mg/day, n = 59), or placebo (n = 70). LAMICTAL was superior to placebo in delaying time to occurrence of a mood episode (Figure 2). The mean dose of LAMICTAL was about 211 mg/day.

Although these trials were not designed to separately evaluate time to the occurrence of depression or mania, a combined analysis for the 2 trials revealed a statistically significant benefit for LAMICTAL over placebo in delaying the time to occurrence of both depression and mania, although the finding was more robust for depression.

Figure 1: Kaplan-Meier Estimation of Cumulative Proportion of Patients with Mood Episode (Trial 1)
(click image for full-size original)

Figure 1: Kaplan-Meier Estimation of Cumulative Proportion of Patients with Mood Episode (Trial 1)

Figure 2: Kaplan-Meier Estimation of Cumulative Proportion of Patients with Mood Episode (Trial 2)
(click image for full-size original)

Figure 2: Kaplan-Meier Estimation of Cumulative Proportion of Patients with Mood Episode (Trial 2)

16 HOW SUPPLIED/STORAGE AND HANDLING

LAMICTAL (lamotrigine) tablets

25-mg, white, scored, shield-shaped tablets debossed with “LAMICTAL” and “25”, bottles of 100 (NDC 0173-0633-02).

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place.

100-mg, peach, scored, shield-shaped tablets debossed with “LAMICTAL” and “100”, bottles of 100 (NDC 0173-0642-55).

150-mg, cream, scored, shield-shaped tablets debossed with “LAMICTAL” and “150”, bottles of 60 (NDC 0173-0643-60).

200-mg, blue, scored, shield-shaped tablets debossed with “LAMICTAL” and “200”, bottles of 60 (NDC 0173-0644-60).

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place and protect from light.

LAMICTAL (lamotrigine) Starter Kit for Patients Taking Valproate (Blue Kit)

25-mg, white, scored, shield-shaped tablets debossed with “LAMICTAL” and “25”, blister pack of 35 tablets (NDC 0173-0633-10).

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place.

LAMICTAL (lamotrigine) Starter Kit for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone and Not Taking Valproate (Green Kit)

25-mg, white, scored, shield-shaped tablets debossed with “LAMICTAL” and “25” and 100 mg, peach, scored, shield-shaped tablets debossed with “LAMICTAL” and “100”, blister pack of 98 tablets (84/25-mg tablets and 14/100-mg tablets) (NDC 0173-0817-28).

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place and protect from light.

LAMICTAL (lamotrigine) Starter Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate (Orange Kit)

25-mg, white, scored, shield-shaped tablets debossed with “LAMICTAL” and “25” and 100 mg, peach, scored, shield-shaped tablets debossed with “LAMICTAL” and “100”, blister pack of 49 tablets (42/25-mg tablets and 7/100-mg tablets) (NDC 0173-0594-02).

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place and protect from light.

LAMICTAL (lamotrigine) tablets for oral suspension

2-mg, white to off-white, round tablets debossed with “LTG” over “2”, bottles of 30 (NDC 0173-0699-00). ORDER DIRECTLY FROM GlaxoSmithKline 1-800-334-4153.

5-mg, white to off-white, caplet-shaped tablets debossed with “GX CL2”, bottles of 100 (NDC 0173-0526-00).

25-mg, white, super elliptical-shaped tablets debossed with “GX CL5”, bottles of 100 (NDC 0173-0527-00).

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place.

LAMICTAL ODT (lamotrigine) orally disintegrating tablets

25-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “25” on the other, Maintenance Packs of 30 (NDC 0173-0772-02).

50-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “50” on the other, Maintenance Packs of 30 (NDC 0173-0774-02).

100-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LAMICTAL” on one side and “100” on the other, Maintenance Packs of 30 (NDC 0173-0776-02).

200-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LAMICTAL” on one side and “200” on the other, Maintenance Packs of 30 (NDC 0173-0777-02).

Store between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F).

LAMICTAL ODT (lamotrigine) Patient Titration Kit for Patients Taking Valproate (Blue ODT Kit)

25-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “25” on the other, and 50 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “50” on the other, blister pack of 28 tablets (21/25-mg tablets and 7/50-mg tablets) (NDC 0173-0779-00).

Store between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F).

LAMICTAL ODT (lamotrigine) Patient Titration Kit for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone and Not Taking Valproate (Green ODT Kit)

50-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “50” on the other, and 100 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LAMICTAL” on one side and “100” on the other, blister pack of 56 tablets (42/50-mg tablets and 14/100-mg tablets) (NDC 0173-0780-00).

Store between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F).

LAMICTAL ODT (lamotrigine) Patient Titration Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate (Orange ODT Kit)

25-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “25” on the other, 50 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “50” on the other, and 100 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LAMICTAL” on one side and “100” on the other, blister pack of 35 (14/25-mg tablets, 14/50-mg tablets, and 7/100-mg tablets) (NDC 0173-0778-00).

Store between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F).

Blister Packs

If the product is dispensed in a blister pack, the patient should be advised to examine the blister pack before use and not use if blisters are torn, broken, or missing.

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