CHANTIX® Medication Guide
(varenicline tartrate)
| This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised Feb 2019 | |||||
MEDICATION GUIDE | ||||||
What is the most important information I should know about CHANTIX? When you try to quit smoking, with or without CHANTIX, you may have symptoms that may be due to nicotine withdrawal, including: | ||||||
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Some people have even experienced suicidal thoughts when trying to quit smoking without medication. Sometimes quitting smoking can lead to worsening of mental health problems that you already have, such as depression. Some people have had serious side effects while taking CHANTIX to help them quit smoking, including: New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depressed mood, or suicidal thoughts or actions. Some people had these symptoms when they began taking CHANTIX, and others developed them after several weeks of treatment, or after stopping CHANTIX. These symptoms happened more often in people who had a history of mental health problems before taking CHANTIX, than in people without a history of mental health problems. Stop taking CHANTIX and call your healthcare provider right away if you, your family, or caregiver notice any of these symptoms. Work with your healthcare provider to decide whether you should continue to take CHANTIX. In many people, these symptoms went away after stopping CHANTIX, but in some people symptoms continued after stopping CHANTIX. It is important for you to follow-up with your healthcare provider until your symptoms go away. Before taking CHANTIX, tell your healthcare provider if you have ever had depression or other mental health problems. You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without CHANTIX. | ||||||
What is CHANTIX? CHANTIX is a prescription medicine to help people stop smoking. Quitting smoking can lower your chances of having lung disease, heart disease or getting certain types of cancer that are related to smoking. CHANTIX has not been shown to be effective in children 16 years of age and under. CHANTIX should not be used in children 16 years of age and under. It is not known if CHANTIX is safe and effective when used with other stop smoking medicines. | ||||||
Who should not take CHANTIX? Do not take CHANTIX if you have had a serious allergic or skin reaction to CHANTIX. Symptoms may include:
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What should I tell my healthcare provider before taking CHANTIX? See "What is the most important information I should know about CHANTIX?" Before you take CHANTIX, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Your healthcare provider may need to change the dose of some of your medicines when you stop smoking. You should not use CHANTIX while using other medicines to quit smoking. Tell your healthcare provider if you use other treatments to quit smoking. Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist when you get a new medicine. | ||||||
How should I take CHANTIX?
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Weeks 1 through 4 | Reduce your smoking to reach one-half of your starting daily number of cigarettes. Example: If you usually smoke 20 cigarettes each day, reduce your smoking to 10 cigarettes each day during weeks 1 through 4. | |||||
Weeks 5 through 8 | Reduce your smoking to reach one-quarter of your starting daily number of cigarettes. Example: If you usually smoked 20 cigarettes each day, reduce your smoking to 5 cigarettes each day during weeks 5 through 8. | |||||
Weeks 9 through 12 | Keep reducing your smoking until you are no longer smoking (you reach zero cigarettes each day). | |||||
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Day 1 to Day 3 |
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Day 4 to Day 7 |
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Day 8 to end of treatment |
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What should I avoid while taking CHANTIX?
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What are the possible side effects of CHANTIX? Serious side effects of CHANTIX may include:
Stop taking CHANTIX and get medical help right away if you have any of the following symptoms:
The most common side effects of CHANTIX include:
Tell your healthcare provider about side effects that bother you or that do not go away. These are not all the side effects of CHANTIX. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | ||||||
How should I store CHANTIX?
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General information about the safe and effective use of CHANTIX Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CHANTIX for a condition for which it was not prescribed. Do not give your CHANTIX to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about CHANTIX that is written for healthcare professionals. For more information about CHANTIX and tips on how to quit smoking, go to www.CHANTIX.com or call 1-877-242-6849. If you are motivated to quit smoking and did not succeed during prior CHANTIX treatment for reasons other than side effects, or if you returned to smoking after treatment, speak with your healthcare provider about whether another course of CHANTIX therapy may be right for you. | ||||||
What are the ingredients in CHANTIX? Active ingredient: varenicline tartrate Inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry White (for 0.5 mg), Opadry Blue (for 1 mg), and Opadry Clear.
LAB-0328-17.0 | ||||||
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Medication Guide)
Initiate Treatment and Continue to Attempt to Quit if Lapse
Instruct patients to set a date to quit smoking and to initiate CHANTIX treatment one week before the quit date. Alternatively, the patient can begin CHANTIX dosing and then set a date to quit smoking between days 8 and 35 of treatment. Encourage patients to continue to attempt to quit if they have early lapses after quit day [see Dosage and Administration (2.1)].
For patients who are sure that they are not able or willing to quit abruptly, a gradual approach to quitting smoking with CHANTIX may be considered. Patients should begin CHANTIX dosing and reduce smoking during the first 12 weeks of treatment, then quit by the end of that period and continue treatment for an additional 12 weeks for a total of 24 weeks [see Dosage and Administration (2.1)].
Encourage patients who are motivated to quit and who did not succeed in stopping smoking during prior CHANTIX therapy for reasons other than intolerability due to adverse events, or who relapsed after treatment to make another attempt with CHANTIX once factors contributing to the failed attempt have been identified and addressed [see Dosage and Administration (2.1), Clinical Studies (14.6)].
How to Take
Advise patients that CHANTIX should be taken orally after eating, and with a full glass of water [see Dosage and Administration (2.1)].
Starting Week Dosage
Instruct patients on how to titrate CHANTIX, beginning at a dose of 0.5 mg/day. Explain that one 0.5 mg tablet should be taken daily for the first three days, and that for the next four days, one 0.5 mg tablet should be taken in the morning and one 0.5 mg tablet should be taken in the evening [see Dosage and Administration (2.1)].
Continuing Weeks Dosage
Advise patients that, after the first seven days, the dose should be increased to one 1 mg tablet in the morning and one 1 mg tablet in the evening [see Dosage and Administration (2.1)].
Dosage Adjustment for CHANTIX or Other Drugs
Inform patients that nausea and insomnia are side effects of CHANTIX and are usually transient; however, advise patients that if they are persistently troubled by these symptoms, they should notify the prescribing physician so that a dose reduction can be considered.
Inform patients that some drugs may require dose adjustment after quitting smoking [see Dosage and Administration (2.1)].
Counseling and Support
Provide patients with educational materials and necessary counseling to support an attempt at quitting smoking [see Dosage and Administration (2.1)].
Neuropsychiatric Adverse Events
Inform patients that some patients have experienced changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation and suicide when attempting to quit smoking while taking CHANTIX. Instruct patients to discontinue CHANTIX and contact a healthcare professional if they experience such symptoms [see Warnings and Precautions (5.1), Adverse Reactions (6.2)].
History of Psychiatric Illness
Encourage patients to reveal any history of psychiatric illness prior to initiating treatment.
Nicotine Withdrawal
Inform patients that quitting smoking, with or without CHANTIX, may be associated with nicotine withdrawal symptoms (including depression or agitation) or exacerbation of pre-existing psychiatric illness.
Seizures
Encourage patients to report any history of seizures or other factors that can lower seizure threshold. Instruct patients to discontinue CHANTIX and contact a healthcare provider immediately if they experience a seizure while on treatment [see Warnings and Precautions (5.2)].
Interaction with Alcohol
Advise patients to reduce the amount of alcohol they consume while taking CHANTIX until they know whether CHANTIX affects their tolerance for alcohol [see Warnings and Precautions (5.3), Adverse Reactions (6.2)].
Driving or Operating Machinery
Advise patients to use caution driving or operating machinery until they know how quitting smoking and/or varenicline may affect them [see Warnings and Precautions (5.4)].
Cardiovascular Events
Patients should be instructed to notify their healthcare providers of symptoms of new or worsening cardiovascular events and to seek immediate medical attention if they experience signs and symptoms of myocardial infarction or stroke [see Warnings and Precautions (5.5), Adverse Reactions (6.1)].
Somnambulism
Patients should be instructed to discontinue CHANTIX and notify their healthcare providers if they experience somnambulism [see Warnings and Precautions (5.6)].
Angioedema
Inform patients that there have been reports of angioedema, with swelling of the face, mouth (lip, gum, tongue) and neck (larynx and pharynx) that can lead to life-threatening respiratory compromise. Instruct patients to discontinue CHANTIX and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.7), Adverse Reactions (6.2)].
Serious Skin Reactions
Inform patients that serious skin reactions, such as Stevens-Johnson Syndrome and erythema multiforme, were reported by some patients taking CHANTIX. Advise patients to stop taking CHANTIX at the first sign of rash with mucosal lesions or skin reaction and contact a healthcare provider immediately [see Warnings and Precautions (5.8), Adverse Reactions (6.2)].
Vivid, Unusual, or Strange Dreams
Inform patients that they may experience vivid, unusual or strange dreams during treatment with CHANTIX.
Pregnancy and Lactation
Patients who are pregnant or breastfeeding or planning to become pregnant should be advised of: the risks of smoking to a pregnant mother and her developing baby, the potential risks of CHANTIX use during pregnancy and breastfeeding, and the benefits of smoking cessation with and without CHANTIX. Advise breastfeeding women to monitor the infant for seizures and vomiting [see Use in Specific Populations (8.1 and 8.2)].
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Health Professional Information
Medication Guide
| This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised Feb 2019 | |||||
MEDICATION GUIDE | ||||||
What is the most important information I should know about CHANTIX? When you try to quit smoking, with or without CHANTIX, you may have symptoms that may be due to nicotine withdrawal, including: | ||||||
|
|
| ||||
Some people have even experienced suicidal thoughts when trying to quit smoking without medication. Sometimes quitting smoking can lead to worsening of mental health problems that you already have, such as depression. Some people have had serious side effects while taking CHANTIX to help them quit smoking, including: New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depressed mood, or suicidal thoughts or actions. Some people had these symptoms when they began taking CHANTIX, and others developed them after several weeks of treatment, or after stopping CHANTIX. These symptoms happened more often in people who had a history of mental health problems before taking CHANTIX, than in people without a history of mental health problems. Stop taking CHANTIX and call your healthcare provider right away if you, your family, or caregiver notice any of these symptoms. Work with your healthcare provider to decide whether you should continue to take CHANTIX. In many people, these symptoms went away after stopping CHANTIX, but in some people symptoms continued after stopping CHANTIX. It is important for you to follow-up with your healthcare provider until your symptoms go away. Before taking CHANTIX, tell your healthcare provider if you have ever had depression or other mental health problems. You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without CHANTIX. | ||||||
What is CHANTIX? CHANTIX is a prescription medicine to help people stop smoking. Quitting smoking can lower your chances of having lung disease, heart disease or getting certain types of cancer that are related to smoking. CHANTIX has not been shown to be effective in children 16 years of age and under. CHANTIX should not be used in children 16 years of age and under. It is not known if CHANTIX is safe and effective when used with other stop smoking medicines. | ||||||
Who should not take CHANTIX? Do not take CHANTIX if you have had a serious allergic or skin reaction to CHANTIX. Symptoms may include:
| ||||||
|
|
| ||||
What should I tell my healthcare provider before taking CHANTIX? See "What is the most important information I should know about CHANTIX?" Before you take CHANTIX, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Your healthcare provider may need to change the dose of some of your medicines when you stop smoking. You should not use CHANTIX while using other medicines to quit smoking. Tell your healthcare provider if you use other treatments to quit smoking. Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist when you get a new medicine. | ||||||
How should I take CHANTIX?
| ||||||
Weeks 1 through 4 | Reduce your smoking to reach one-half of your starting daily number of cigarettes. Example: If you usually smoke 20 cigarettes each day, reduce your smoking to 10 cigarettes each day during weeks 1 through 4. | |||||
Weeks 5 through 8 | Reduce your smoking to reach one-quarter of your starting daily number of cigarettes. Example: If you usually smoked 20 cigarettes each day, reduce your smoking to 5 cigarettes each day during weeks 5 through 8. | |||||
Weeks 9 through 12 | Keep reducing your smoking until you are no longer smoking (you reach zero cigarettes each day). | |||||
| ||||||
| ||||||
Day 1 to Day 3 |
| |||||
Day 4 to Day 7 |
| |||||
Day 8 to end of treatment |
| |||||
| ||||||
What should I avoid while taking CHANTIX?
| ||||||
|
| |||||
What are the possible side effects of CHANTIX? Serious side effects of CHANTIX may include:
Stop taking CHANTIX and get medical help right away if you have any of the following symptoms:
The most common side effects of CHANTIX include:
Tell your healthcare provider about side effects that bother you or that do not go away. These are not all the side effects of CHANTIX. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | ||||||
How should I store CHANTIX?
| ||||||
General information about the safe and effective use of CHANTIX Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CHANTIX for a condition for which it was not prescribed. Do not give your CHANTIX to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about CHANTIX that is written for healthcare professionals. For more information about CHANTIX and tips on how to quit smoking, go to www.CHANTIX.com or call 1-877-242-6849. If you are motivated to quit smoking and did not succeed during prior CHANTIX treatment for reasons other than side effects, or if you returned to smoking after treatment, speak with your healthcare provider about whether another course of CHANTIX therapy may be right for you. | ||||||
What are the ingredients in CHANTIX? Active ingredient: varenicline tartrate Inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry White (for 0.5 mg), Opadry Blue (for 1 mg), and Opadry Clear.
LAB-0328-17.0 | ||||||
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Medication Guide)
Initiate Treatment and Continue to Attempt to Quit if Lapse
Instruct patients to set a date to quit smoking and to initiate CHANTIX treatment one week before the quit date. Alternatively, the patient can begin CHANTIX dosing and then set a date to quit smoking between days 8 and 35 of treatment. Encourage patients to continue to attempt to quit if they have early lapses after quit day [see Dosage and Administration (2.1)].
For patients who are sure that they are not able or willing to quit abruptly, a gradual approach to quitting smoking with CHANTIX may be considered. Patients should begin CHANTIX dosing and reduce smoking during the first 12 weeks of treatment, then quit by the end of that period and continue treatment for an additional 12 weeks for a total of 24 weeks [see Dosage and Administration (2.1)].
Encourage patients who are motivated to quit and who did not succeed in stopping smoking during prior CHANTIX therapy for reasons other than intolerability due to adverse events, or who relapsed after treatment to make another attempt with CHANTIX once factors contributing to the failed attempt have been identified and addressed [see Dosage and Administration (2.1), Clinical Studies (14.6)].
How to Take
Advise patients that CHANTIX should be taken orally after eating, and with a full glass of water [see Dosage and Administration (2.1)].
Starting Week Dosage
Instruct patients on how to titrate CHANTIX, beginning at a dose of 0.5 mg/day. Explain that one 0.5 mg tablet should be taken daily for the first three days, and that for the next four days, one 0.5 mg tablet should be taken in the morning and one 0.5 mg tablet should be taken in the evening [see Dosage and Administration (2.1)].
Continuing Weeks Dosage
Advise patients that, after the first seven days, the dose should be increased to one 1 mg tablet in the morning and one 1 mg tablet in the evening [see Dosage and Administration (2.1)].
Dosage Adjustment for CHANTIX or Other Drugs
Inform patients that nausea and insomnia are side effects of CHANTIX and are usually transient; however, advise patients that if they are persistently troubled by these symptoms, they should notify the prescribing physician so that a dose reduction can be considered.
Inform patients that some drugs may require dose adjustment after quitting smoking [see Dosage and Administration (2.1)].
Counseling and Support
Provide patients with educational materials and necessary counseling to support an attempt at quitting smoking [see Dosage and Administration (2.1)].
Neuropsychiatric Adverse Events
Inform patients that some patients have experienced changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation and suicide when attempting to quit smoking while taking CHANTIX. Instruct patients to discontinue CHANTIX and contact a healthcare professional if they experience such symptoms [see Warnings and Precautions (5.1), Adverse Reactions (6.2)].
History of Psychiatric Illness
Encourage patients to reveal any history of psychiatric illness prior to initiating treatment.
Nicotine Withdrawal
Inform patients that quitting smoking, with or without CHANTIX, may be associated with nicotine withdrawal symptoms (including depression or agitation) or exacerbation of pre-existing psychiatric illness.
Seizures
Encourage patients to report any history of seizures or other factors that can lower seizure threshold. Instruct patients to discontinue CHANTIX and contact a healthcare provider immediately if they experience a seizure while on treatment [see Warnings and Precautions (5.2)].
Interaction with Alcohol
Advise patients to reduce the amount of alcohol they consume while taking CHANTIX until they know whether CHANTIX affects their tolerance for alcohol [see Warnings and Precautions (5.3), Adverse Reactions (6.2)].
Driving or Operating Machinery
Advise patients to use caution driving or operating machinery until they know how quitting smoking and/or varenicline may affect them [see Warnings and Precautions (5.4)].
Cardiovascular Events
Patients should be instructed to notify their healthcare providers of symptoms of new or worsening cardiovascular events and to seek immediate medical attention if they experience signs and symptoms of myocardial infarction or stroke [see Warnings and Precautions (5.5), Adverse Reactions (6.1)].
Somnambulism
Patients should be instructed to discontinue CHANTIX and notify their healthcare providers if they experience somnambulism [see Warnings and Precautions (5.6)].
Angioedema
Inform patients that there have been reports of angioedema, with swelling of the face, mouth (lip, gum, tongue) and neck (larynx and pharynx) that can lead to life-threatening respiratory compromise. Instruct patients to discontinue CHANTIX and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.7), Adverse Reactions (6.2)].
Serious Skin Reactions
Inform patients that serious skin reactions, such as Stevens-Johnson Syndrome and erythema multiforme, were reported by some patients taking CHANTIX. Advise patients to stop taking CHANTIX at the first sign of rash with mucosal lesions or skin reaction and contact a healthcare provider immediately [see Warnings and Precautions (5.8), Adverse Reactions (6.2)].
Vivid, Unusual, or Strange Dreams
Inform patients that they may experience vivid, unusual or strange dreams during treatment with CHANTIX.
Pregnancy and Lactation
Patients who are pregnant or breastfeeding or planning to become pregnant should be advised of: the risks of smoking to a pregnant mother and her developing baby, the potential risks of CHANTIX use during pregnancy and breastfeeding, and the benefits of smoking cessation with and without CHANTIX. Advise breastfeeding women to monitor the infant for seizures and vomiting [see Use in Specific Populations (8.1 and 8.2)].
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