Dosing Guide for - GSK Source

IMPORTANT SAFETY INFORMATION ON SERIOUS
SKIN RASHES AND HYPERSENSITIVITY REACTIONS
• 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
• 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).
• 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.
• 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.
• Acute multiorgan failure has resulted (some cases fatal).
• Blood dyscrasias (eg, neutropenia, thrombocytopenia,
pancytopenia) may result either with or without an
associated hypersensitivity syndrome.
IMPORTANT SAFETY INFORMATION ON
SUICIDAL BEHAVIOR AND IDEATION
• Antiepileptic drugs, including LAMICTAL ODT, increase the
risk of suicidal thoughts or behavior in patients taking these
drugs for any indication.
• 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.
• 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.
Please consult accompanying complete Prescribing Information for
LAMICTAL ODT, including Boxed Warning, and please see Important
Safety Information provided on pages 14 and 15.
IMPORTANT
SAFETY INFORMATION
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