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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 healthcare 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.

CHANTIX is contraindicated in patients with a history of serious hypersensitivity or skin reactions to CHANTIX.

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.

In a meta-analysis of clinical trials including a trial in patients with stable cardiovascular disease, while serious cardiovascular events were infrequent overall, certain serious cardiovascular events were reported more frequently in patients treated with CHANTIX than placebo. These events occurred primarily in patients with known cardiovascular disease. Instruct patients to notify their health care providers of new or worsening cardiovascular symptoms and to seek immediate medical attention if they experience signs and symptoms of myocardial infarction or stroke.

The most common adverse reactions include nausea (30%), abnormal dreams, 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.

INDICATION

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 lapses after quit day.