• Prescribing Information
  • Medication Guide
  • Patient Site
  • Dosing
    Learn about dosing and administration
    Efficacy
    Learn about CHANTIX efficacy
    Safety
    Review the full safety information for CHANTIX
    Quit Approaches
    Patients can set a quit date after 1 week, in up to 1 month, or gradually, in up to 12 weeks 1

    Safety

    Please be advised that CHANTIX is currently out of stock. For medical questions on CHANTIX and for supply updates, please contact Pfizer Medical Information at 1-800-438-1985.

    Safety and tolerability profile of CHANTIX1

    The CHANTIX label includes a contraindication in patients with a known history of serious hypersensitivity or skin reactions to CHANTIX, as well as Warnings and Precautions regarding:

    • ​​​​​​​Neuropsychiatric symptoms and suicidality
    • Seizures
    • Interaction with alcohol
    • Accidental injury
    • Cardiovascular events
    • Somnambulism
    • Angioedema and hypersensitivity reactions
    • Serious skin reactions
    • Nausea

    See the full Prescribing Information for complete Warnings and Precautions.

    Most common adverse events* in premarketing studies, ≥5% and twice the rate of placebo for CHANTIX 1 mg BID1†​​​​​​

    *Not a complete list of AEs.
    Adapted from CHANTIX USPI Table 1. AEs for CHANTIX and placebo in the 12-week, fixed-dose premarketing studies with titration in the first week.
    Including vivid, unusual, or strange dreams. Nightmare not included (1% CHANTIX vs 0% placebo).
    AE=adverse event.

    Please see Table 1 in the full Prescribing Information for the complete list of AEs.
    Consider a temporary or permanent dose reduction in patients who cannot tolerate the adverse effects of CHANTIX.
    In a clinical study, patients taking CHANTIX 1 mg BID and CHANTIX 0.5 mg BID achieved a significantly higher CAR during weeks 9 through 12 vs placebo, 51% and 45%, respectively, vs 12% (P<.0001).1,2

    Study Design: Efficacy at 0.5 mg BID

    CHANTIX was evaluated in a randomized, double-blind, placebo-controlled study of 627 patients, which compared CHANTIX 1 mg per day and 2 mg per day with placebo. Patients were treated for 12 weeks (including 1-week titration), and then were followed for 40 weeks posttreatment. CHANTIX was given in 2 divided doses daily. Each dose of CHANTIX was given in 2 different regimens, with and without initial dose titration, to explore the effect of different dosing regimens on tolerability. For the titrated groups, dosage was titrated up over the course of 1 week, with full dosage achieved starting with the second week of dosing. The titrated and nontitrated groups were pooled for efficacy analysis.1

    Discontinuation due to AEs: The discontinuation rate for any AE from patients taking CHANTIX 1 mg BID was 12% for CHANTIX compared with 10% for placebo in studies of 3 months' treatment duration.1

    Discontinuation due to the following AEs was higher for CHANTIX vs placebo: Nausea (3% vs 0.5%), insomnia (1.2% vs 1.1%), and abnormal dreams (0.3% vs 0.2%).1​​​​​​​​​​​​

    Neuropsychiatric (NPS) safety data from EAGLES1

    The NPS safety of CHANTIX and bupropion SR was evaluated in a randomized, double-blind, active-controlled (nicotine replacement therapy [NRT] patch) and placebo-controlled trial that included patients without a history of psychiatric disorder (non-psychiatric cohort, N=3912) and subjects with a history of psychiatric disorder but currently stable (psychiatric cohort, N=4003).§

    The composite endpoint of this study was intended to capture clinically significant NPS AEs, including:
    ​​​​​​​
    • Anxiety
    • Depression
    • Feeling abnormal
    • Hostility
    • Agitation
    • Aggression
    • Delusion
    • Hallucinations
    • Homicidal ideation
    • Mania
    • Panic
    • Paranoia
    • Psychosis
    • Irritability
    • Suicidal ideation
    • Suicidal behavior
    • Completed suicide
    In the non-psychiatric cohort, CHANTIX was not associated with an increased risk of clinically significant NPS AEs in a composite endpoint.

    Incidence of clinically significant or serious NPS AEs in the non-psychiatric cohort1​​​​​​

    In the psychiatric cohort, there were more clinically significant NPS AEs reported in each treatment group compared with the non-psychiatric cohort.

    In the psychiatric cohort, the incidence of events in the composite endpoint was higher for each of the active treatments compared to placebo. Risk differences (95% CI) vs placebo were: CHANTIX 2.7% (-0.05, 5.4), bupropion SR 2.2% (-0.5, 4.9), NRT patch 0.4% (-2.2, 3.0).

    Incidence of clinically significant or serious NPS AEs in the psychiatric cohort1

    *Subjects aged 18 to 75 years, smoking 10 or more cigarettes per day, were randomized 1:1:1:1 to CHANTIX 1 mg BID, bupropion SR 150 mg BID, NRT patch 21 mg/day with taper, or placebo for a treatment period of 12 weeks; they were then followed for another 12 weeks posttreatment.1

    Study Design: EAGLES

    Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) was a randomized, double-blind, active and placebo-controlled postmarketing neuropsychiatric safety outcome trial of CHANTIX. It included subjects without a history of psychiatric disorder (non-psychiatric cohort, N=3912) and with a history of psychiatric disorder (psychiatric cohort, N=4003). Subjects aged 18 to 75 years, smoking 10 or more cigarettes per day, were randomized 1:1:1:1 to CHANTIX 1 mg BID, bupropion SR 150 mg BID, nicotine replacement therapy patch (NRT) 21 mg/day with taper, or placebo for a treatment period of 12 weeks; they were then followed for another 12 weeks posttreatment. A composite safety endpoint intended to capture clinically significant neuropsychiatric (NPS) adverse events included the following NPS adverse events: anxiety, depression, feeling abnormal, hostility, agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, irritability, suicidal ideation, suicidal behavior, or completed suicide. CHANTIX was also evaluated for comparative efficacy vs bupropion SR, NRT patch, and placebo as measured by carbon monoxide confirmed abstinence during weeks 9 through 12 of treatment.1

    EAGLES Adverse Events​​​​​​​1​​​

    Common AEs reported in ≥10% of subjects treated with CHANTIX in the entire study population1
    ​​​​​​​

    In EAGLES, the most common AEs in subjects treated with CHANTIX were similar to those observed in premarketing studies.

    Psychiatric AEs were reported in ≥2% of patients in either treatment group (CHANTIX vs placebo) by cohort.1
    ​​​​​​​

    Proven Efficacy1

    View CHANTIX efficacy results


    References
    1. CHANTIX [package insert]. New York, NY: Pfizer Inc.
    2. Data on file. Pfizer Inc., New York, NY.

    INDICATION AND LIMITATIONS OF USE

    CHANTIX is indicated as an aid to smoking cessation treatment in adults.

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

    Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have been reported in patients treated with CHANTIX. These included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with CHANTIX for the occurrence of such symptoms and instruct them to discontinue CHANTIX and contact a healthcare provider immediately if they experience such adverse events.

    During clinical trials and the postmarketing experience, there have been reports of seizures in patients treated with CHANTIX, with or without a history of seizures. CHANTIX should be used cautiously in patients with a history of seizures or other factors that can lower the seizure threshold. Instruct patients to discontinue CHANTIX, and contact a healthcare provider immediately if they experience a seizure while on treatment.

    There have been postmarketing reports of patients experiencing increased intoxicating effects of alcohol while taking CHANTIX, including unusual and sometimes aggressive behavior directed to oneself or to others and often accompanied by amnesia. Advise patients to reduce the amount of alcohol they consume while taking CHANTIX until they know whether CHANTIX affects their tolerance for alcohol.

    Patients with underlying cardiovascular (CV) disease may be at increased risk of CV events; however, these concerns must be balanced with the health benefits of smoking cessation. Instruct patients to notify their healthcare providers of new or worsening CV symptoms and to seek immediate medical attention if they experience signs and symptoms of myocardial infarction (MI) or stroke.

    Cases of somnambulism have been reported in patients taking CHANTIX. Some cases described harmful behavior to self, others, or property. Instruct patients to discontinue CHANTIX and notify their healthcare provider if they experience somnambulism.

    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%), 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.

    CHANTIX is indicated as an aid to smoking cessation treatment in adults.