CHANTIX Safety Information
Important Safety Information
All patients being treated with CHANTIX should be observed for neuropsychiatric symptoms
including changes in behavior, hostility, agitation, depressed mood, and suicide-related
events, including ideation, behavior, and attempted suicide. These symptoms, as well as
worsening of pre-existing psychiatric illness and completed suicide have been reported in
some patients attempting to quit smoking while taking CHANTIX in the post-marketing experience.
These events have occurred in patients with and without pre-existing psychiatric disease.
Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major
depressive disorder did not participate in the pre-marketing studies of CHANTIX and the safety
and efficacy of CHANTIX in such patients has not been established.
Advise patients and caregivers that the patient should stop taking CHANTIX and contact a
health care provider immediately if agitation, hostility, depressed mood, or changes in
behavior or thinking that are not typical for the patient are observed, or if the patient
develops suicidal ideation or suicidal behavior. In many post-marketing cases, resolution
of symptoms after discontinuation of CHANTIX was reported, although in some cases the symptoms
persisted; therefore, ongoing monitoring and supportive care should be provided until
symptoms resolve.
Patients should be informed that there have been reports of serious skin reactions,
such as Stevens Johnson Syndrome and Erythema Multiforme and of angioedema, with
swelling of the face, mouth and neck that can lead to life-threatening respiratory
compromise. Patients should be instructed to discontinue CHANTIX and immediately seek
medical care if they experience these symptoms or at the first sign of rash with mucosal
lesions or any other signs of hypersensitivity.
The most common adverse reactions include nausea (30%), sleep disturbance, constipation,
flatulence, and vomiting. Patients should be informed that they may experience vivid,
unusual, or strange dreams during treatment with CHANTIX. Patients should be advised
to use caution driving or operating machinery or engaging in other potentially hazardous
activities until they know how CHANTIX may affect them.
Safety and efficacy of CHANTIX in combination with other smoking cessation drug
therapies have not been studied. Dosage adjustment with CHANTIX is recommended
in patients with severe renal impairment or in patients undergoing hemodialysis.
Smoking cessation, with or without treatment with CHANTIX, may alter the pharmacokinetics
or pharmacodynamics of some drugs, such as theophylline, warfarin, and insulin.
Dosage adjustment for these drugs may be necessary.
CHANTIX is indicated as an aid to smoking cessation treatment in adults 18 and over.
Patients may benefit from behavioral modification and support during their quit attempt.
Patients should be encouraged to continue to attempt to quit if they have early lapses
after quit day.