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CHANTIX® (varenicline tartrate)

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX.

CHANTIX® (varenicline) tablets, for oral use
Initial U.S. Approval: 2006

RECENT MAJOR CHANGES

Warnings and Precautions, Cardiovascular Events (5.5) 6/2018

INDICATIONS AND USAGE

CHANTIX is a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment. (1 and 2.1)

DOSAGE AND ADMINISTRATION

  • Begin CHANTIX dosing one week before the date set by the patient to stop smoking. Alternatively, the patient can begin CHANTIX dosing and then quit smoking between days 8 and 35 of treatment. (2.1)
  • Starting Week: 0.5 mg once daily on days 1–3 and 0.5 mg twice daily on days 4–7. (2.1)
  • Continuing Weeks: 1 mg twice daily for a total of 12 weeks. (2.1)
  • An additional 12 weeks of treatment is recommended for successful quitters to increase likelihood of long-term abstinence. (2.1)
  • Consider a gradual approach to quitting smoking with CHANTIX for patients who are sure that they are not able or willing to quit abruptly. Patients should begin CHANTIX dosing and reduce smoking by 50% from baseline within the first four weeks, by an additional 50% in the next four weeks, and continue reducing with the goal of reaching complete abstinence by 12 weeks. Continue treatment for an additional 12 weeks, for a total of 24 weeks. (2.1)
  • Severe Renal Impairment (estimated creatinine clearance less than 30 mL/min): Begin with 0.5 mg once daily and titrate to 0.5 mg twice daily. For patients with end-stage renal disease undergoing hemodialysis, a maximum of 0.5 mg daily may be given if tolerated. (2.2)
  • Consider dose reduction for patients who cannot tolerate adverse effects. (2.1)
  • Another attempt at treatment is recommended for those who fail to stop smoking or relapse when factors contributing to the failed attempt have been addressed. (2.1)
  • Provide patients with appropriate educational materials and counseling to support the quit attempt. (2.1)

DOSAGE FORMS AND STRENGTHS

Tablets: 0.5 mg and 1 mg (3)

CONTRAINDICATIONS

History of serious hypersensitivity or skin reactions to CHANTIX. (4)

WARNINGS AND PRECAUTIONS

  • Neuropsychiatric Adverse Events: Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have 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 if they experience such adverse events. (5.1)
  • Seizures: New or worsening seizures have been observed in patients taking CHANTIX. CHANTIX should be used cautiously in patients with a history of seizures or other factors that can lower the seizure threshold. (5.2)
  • Interaction with Alcohol: Increased effects of alcohol have been reported. Instruct patients to reduce the amount of alcohol they consume until they know whether CHANTIX affects them. (5.3)
  • Accidental Injury: Accidental injuries (e.g., traffic accidents) have been reported. Instruct patients to use caution driving or operating machinery until they know how CHANTIX may affect them. (5.4)
  • Cardiovascular Events: 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. (5.5 and 6.1)
  • Somnambulism: 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. (5.6 and 6.2)
  • Angioedema and Hypersensitivity Reactions: Such reactions, including angioedema, infrequently life-threatening, have been reported. Instruct patients to discontinue CHANTIX and immediately seek medical care if symptoms occur. (5.7 and 6.2)
  • Serious Skin Reactions: Rare, potentially life-threatening skin reactions have been reported. Instruct patients to discontinue CHANTIX and contact a healthcare provider immediately at first appearance of skin rash with mucosal lesions. (5.8 and 6.2)
  • Nausea: Nausea is the most common adverse reaction (up to 30% incidence rate). Dose reduction may be helpful. (5.9)

ADVERSE REACTIONS

Most common adverse reactions (>5% and twice the rate seen in placebo-treated patients) were nausea, abnormal (e.g., vivid, unusual, or strange) dreams, constipation, flatulence, and vomiting. (6)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Other Smoking Cessation Therapies: Safety and efficacy in combination with other smoking cessation therapies has not been established. Coadministration of varenicline and transdermal nicotine resulted in a high rate of discontinuation due to adverse events. (7.1)
  • Effect of Smoking Cessation on Other Drugs: Pharmacokinetics or pharmacodynamics of certain drugs (e.g., theophylline, warfarin, insulin) may be altered, necessitating dose adjustment. (7.2)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 2/2019

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Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch