CHANTIX® Full Patient Information

(varenicline tartrate)

Full Patient Information

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)].

This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised Feb 2019    

MEDICATION GUIDE
CHANTIX (CHANT-iks)
(varenicline)
Tablets

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:

  • urge to smoke
  • depressed mood
  • trouble sleeping
  • irritability
  • frustration
  • anger
  • feeling anxious
  • difficulty concentrating
  • restlessness
  • decreased heart rate
  • increased appetite
  • weight gain

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:

  • swelling of the face, mouth (tongue, lips, gums), throat or neck
  • trouble breathing
  • rash, with peeling skin
  • blisters in your mouth

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:

  • use other treatments to quit smoking. Using CHANTIX with a nicotine patch may cause nausea, vomiting, headache, dizziness, upset stomach, and tiredness to happen more often than if you just use a nicotine patch alone.
  • have kidney problems or get kidney dialysis. Your healthcare provider may prescribe a lower dose of CHANTIX for you.
  • have a history of seizures
  • drink alcohol
  • have heart or blood vessel problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant.
  • are breastfeeding. It is not known if CHANTIX passes into breast milk. If you breastfeed and take CHANTIX, monitor your baby for seizures as well as spitting up or vomiting more than normal.

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?

  • There are 3 ways that you can use CHANTIX to help you quit smoking. Talk to your healthcare provider about the following 3 ways to use CHANTIX:
    • Choose a quit date when you will stop smoking. Start taking CHANTIX 1 week (7 days) before your quit date. Take CHANTIX for 12 weeks.
      OR
    • Start taking CHANTIX before you choose a quit date. Pick a date to quit smoking that is between days 8 and 35 of treatment. Take CHANTIX for 12 weeks.
      OR
    • If you are sure that you are not able or willing to quit smoking right away, start taking CHANTIX and reduce smoking during the first 12 weeks of treatment, as follows:

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).

 
Aim to quit by the end of the 12th week of treatment, or sooner if you feel ready. Continue to take CHANTIX for another 12 weeks, for a total of 24 weeks of treatment.
Starting CHANTIX before your quit date gives CHANTIX time to build up in your body. You can keep smoking during this time. Take CHANTIX exactly as prescribed by your healthcare provider.
  • CHANTIX comes as a white tablet (0.5 mg) and a blue tablet (1 mg). You start with the white tablet and then usually go to the blue tablet. See the chart below for dosing instructions for adults.

Day 1 to Day 3

  • White tablet (0.5 mg)
  • Take 1 tablet each day

Day 4 to Day 7

  • White tablet (0.5 mg)
  • Take 1 in the morning and 1 in the evening

Day 8 to end of treatment

  • Blue tablet (1 mg)
  • Take 1 in the morning and 1 in the evening
  • Make sure that you try to stop smoking on your quit date. If you slip-up and smoke, try again. Some people need to take CHANTIX for a few weeks for CHANTIX to work best.
  • Most people will take CHANTIX for up to 12 weeks. If you have completely quit smoking by 12 weeks, your healthcare provider may prescribe CHANTIX for another 12 weeks to help you stay cigarette-free.
  • Take CHANTIX after eating and with a full glass (8 ounces) of water.
  • This dosing schedule may not be right for everyone. Talk to your healthcare provider if you are having side effects such as nausea, strange dreams, or sleep problems. Your healthcare provider may want to reduce your dose.
  • If you miss a dose of CHANTIX, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Just take your next dose at your regular time.

What should I avoid while taking CHANTIX?

  • Use caution when driving or operating machinery until you know how CHANTIX affects you. CHANTIX may make you feel sleepy, dizzy, or have trouble concentrating, making it hard to drive or perform other activities safely.
  • Decrease the amount of alcoholic beverages that you drink during treatment with CHANTIX until you know if CHANTIX affects your ability to tolerate alcohol. Some people have experienced the following when drinking alcohol during treatment with CHANTIX:
  • increased drunkenness (intoxication)
  • unusual or sometimes aggressive behavior
  • no memory of things that have happened

What are the possible side effects of CHANTIX?

Serious side effects of CHANTIX may include:

  • See "What is the most important information I should know about CHANTIX?"
  • Seizures. Some people have had seizures during treatment with CHANTIX. In most cases, the seizures have happened during the first month of treatment with CHANTIX. If you have a seizure during treatment with CHANTIX, stop taking CHANTIX and contact your healthcare provider right away.
  • New or worse heart or blood vessel (cardiovascular) problems, mostly in people, who already have cardiovascular problems. Tell your healthcare provider if you have any changes in symptoms during treatment with CHANTIX.
    Get emergency medical help right away if you have any of the following symptoms of a heart attack, including:
    • chest discomfort (uncomfortable pressure, squeezing, fullness or pain) that lasts more than a few minutes, or that goes away and comes back
    • pain or discomfort in one or both arms, back, neck, jaw or stomach
    • shortness of breath, sweating, nausea, vomiting, or feeling lightheaded associated with chest discomfort
  • Sleepwalking can happen with CHANTIX, and can sometimes lead to behavior that is harmful to you or other people, or to property. Stop taking CHANTIX and tell your healthcare provider if you start sleepwalking.
  • Allergic reactions can happen with CHANTIX. Some of these allergic reactions can be life-threatening.
  • Serious skin reactions, including rash, swelling, redness, and peeling of the skin. Some of these skin reactions can become life-threatening.

Stop taking CHANTIX and get medical help right away if you have any of the following symptoms:

  • swelling of the face, mouth (tongue, lips, and gums), throat or neck
  • trouble breathing
  • rash with peeling skin
  • blisters in your mouth

The most common side effects of CHANTIX include:

  • nausea
  • sleep problems (trouble sleeping or vivid, unusual, or strange dreams)
  • constipation
  • gas
  • vomiting

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?

  • Store CHANTIX at room temperature, between 68°F to 77°F (20°C to 25°C).
  • Keep CHANTIX and all medicines out of the reach of children.

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.

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Full Patient Information

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)].

This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised Feb 2019    

MEDICATION GUIDE
CHANTIX (CHANT-iks)
(varenicline)
Tablets

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:

  • urge to smoke
  • depressed mood
  • trouble sleeping
  • irritability
  • frustration
  • anger
  • feeling anxious
  • difficulty concentrating
  • restlessness
  • decreased heart rate
  • increased appetite
  • weight gain

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:

  • swelling of the face, mouth (tongue, lips, gums), throat or neck
  • trouble breathing
  • rash, with peeling skin
  • blisters in your mouth

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:

  • use other treatments to quit smoking. Using CHANTIX with a nicotine patch may cause nausea, vomiting, headache, dizziness, upset stomach, and tiredness to happen more often than if you just use a nicotine patch alone.
  • have kidney problems or get kidney dialysis. Your healthcare provider may prescribe a lower dose of CHANTIX for you.
  • have a history of seizures
  • drink alcohol
  • have heart or blood vessel problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant.
  • are breastfeeding. It is not known if CHANTIX passes into breast milk. If you breastfeed and take CHANTIX, monitor your baby for seizures as well as spitting up or vomiting more than normal.

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?

  • There are 3 ways that you can use CHANTIX to help you quit smoking. Talk to your healthcare provider about the following 3 ways to use CHANTIX:
    • Choose a quit date when you will stop smoking. Start taking CHANTIX 1 week (7 days) before your quit date. Take CHANTIX for 12 weeks.
      OR
    • Start taking CHANTIX before you choose a quit date. Pick a date to quit smoking that is between days 8 and 35 of treatment. Take CHANTIX for 12 weeks.
      OR
    • If you are sure that you are not able or willing to quit smoking right away, start taking CHANTIX and reduce smoking during the first 12 weeks of treatment, as follows:

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).

 
Aim to quit by the end of the 12th week of treatment, or sooner if you feel ready. Continue to take CHANTIX for another 12 weeks, for a total of 24 weeks of treatment.
Starting CHANTIX before your quit date gives CHANTIX time to build up in your body. You can keep smoking during this time. Take CHANTIX exactly as prescribed by your healthcare provider.
  • CHANTIX comes as a white tablet (0.5 mg) and a blue tablet (1 mg). You start with the white tablet and then usually go to the blue tablet. See the chart below for dosing instructions for adults.

Day 1 to Day 3

  • White tablet (0.5 mg)
  • Take 1 tablet each day

Day 4 to Day 7

  • White tablet (0.5 mg)
  • Take 1 in the morning and 1 in the evening

Day 8 to end of treatment

  • Blue tablet (1 mg)
  • Take 1 in the morning and 1 in the evening
  • Make sure that you try to stop smoking on your quit date. If you slip-up and smoke, try again. Some people need to take CHANTIX for a few weeks for CHANTIX to work best.
  • Most people will take CHANTIX for up to 12 weeks. If you have completely quit smoking by 12 weeks, your healthcare provider may prescribe CHANTIX for another 12 weeks to help you stay cigarette-free.
  • Take CHANTIX after eating and with a full glass (8 ounces) of water.
  • This dosing schedule may not be right for everyone. Talk to your healthcare provider if you are having side effects such as nausea, strange dreams, or sleep problems. Your healthcare provider may want to reduce your dose.
  • If you miss a dose of CHANTIX, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Just take your next dose at your regular time.

What should I avoid while taking CHANTIX?

  • Use caution when driving or operating machinery until you know how CHANTIX affects you. CHANTIX may make you feel sleepy, dizzy, or have trouble concentrating, making it hard to drive or perform other activities safely.
  • Decrease the amount of alcoholic beverages that you drink during treatment with CHANTIX until you know if CHANTIX affects your ability to tolerate alcohol. Some people have experienced the following when drinking alcohol during treatment with CHANTIX:
  • increased drunkenness (intoxication)
  • unusual or sometimes aggressive behavior
  • no memory of things that have happened

What are the possible side effects of CHANTIX?

Serious side effects of CHANTIX may include:

  • See "What is the most important information I should know about CHANTIX?"
  • Seizures. Some people have had seizures during treatment with CHANTIX. In most cases, the seizures have happened during the first month of treatment with CHANTIX. If you have a seizure during treatment with CHANTIX, stop taking CHANTIX and contact your healthcare provider right away.
  • New or worse heart or blood vessel (cardiovascular) problems, mostly in people, who already have cardiovascular problems. Tell your healthcare provider if you have any changes in symptoms during treatment with CHANTIX.
    Get emergency medical help right away if you have any of the following symptoms of a heart attack, including:
    • chest discomfort (uncomfortable pressure, squeezing, fullness or pain) that lasts more than a few minutes, or that goes away and comes back
    • pain or discomfort in one or both arms, back, neck, jaw or stomach
    • shortness of breath, sweating, nausea, vomiting, or feeling lightheaded associated with chest discomfort
  • Sleepwalking can happen with CHANTIX, and can sometimes lead to behavior that is harmful to you or other people, or to property. Stop taking CHANTIX and tell your healthcare provider if you start sleepwalking.
  • Allergic reactions can happen with CHANTIX. Some of these allergic reactions can be life-threatening.
  • Serious skin reactions, including rash, swelling, redness, and peeling of the skin. Some of these skin reactions can become life-threatening.

Stop taking CHANTIX and get medical help right away if you have any of the following symptoms:

  • swelling of the face, mouth (tongue, lips, and gums), throat or neck
  • trouble breathing
  • rash with peeling skin
  • blisters in your mouth

The most common side effects of CHANTIX include:

  • nausea
  • sleep problems (trouble sleeping or vivid, unusual, or strange dreams)
  • constipation
  • gas
  • vomiting

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?

  • Store CHANTIX at room temperature, between 68°F to 77°F (20°C to 25°C).
  • Keep CHANTIX and all medicines out of the reach of children.

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.

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Prescribing Information
Download Prescribing Information

Health Professional Information

Full Patient Information

Full Patient Information

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)].

This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised Feb 2019    

MEDICATION GUIDE
CHANTIX (CHANT-iks)
(varenicline)
Tablets

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:

  • urge to smoke
  • depressed mood
  • trouble sleeping
  • irritability
  • frustration
  • anger
  • feeling anxious
  • difficulty concentrating
  • restlessness
  • decreased heart rate
  • increased appetite
  • weight gain

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:

  • swelling of the face, mouth (tongue, lips, gums), throat or neck
  • trouble breathing
  • rash, with peeling skin
  • blisters in your mouth

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:

  • use other treatments to quit smoking. Using CHANTIX with a nicotine patch may cause nausea, vomiting, headache, dizziness, upset stomach, and tiredness to happen more often than if you just use a nicotine patch alone.
  • have kidney problems or get kidney dialysis. Your healthcare provider may prescribe a lower dose of CHANTIX for you.
  • have a history of seizures
  • drink alcohol
  • have heart or blood vessel problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant.
  • are breastfeeding. It is not known if CHANTIX passes into breast milk. If you breastfeed and take CHANTIX, monitor your baby for seizures as well as spitting up or vomiting more than normal.

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?

  • There are 3 ways that you can use CHANTIX to help you quit smoking. Talk to your healthcare provider about the following 3 ways to use CHANTIX:
    • Choose a quit date when you will stop smoking. Start taking CHANTIX 1 week (7 days) before your quit date. Take CHANTIX for 12 weeks.
      OR
    • Start taking CHANTIX before you choose a quit date. Pick a date to quit smoking that is between days 8 and 35 of treatment. Take CHANTIX for 12 weeks.
      OR
    • If you are sure that you are not able or willing to quit smoking right away, start taking CHANTIX and reduce smoking during the first 12 weeks of treatment, as follows:

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).

 
Aim to quit by the end of the 12th week of treatment, or sooner if you feel ready. Continue to take CHANTIX for another 12 weeks, for a total of 24 weeks of treatment.
Starting CHANTIX before your quit date gives CHANTIX time to build up in your body. You can keep smoking during this time. Take CHANTIX exactly as prescribed by your healthcare provider.
  • CHANTIX comes as a white tablet (0.5 mg) and a blue tablet (1 mg). You start with the white tablet and then usually go to the blue tablet. See the chart below for dosing instructions for adults.

Day 1 to Day 3

  • White tablet (0.5 mg)
  • Take 1 tablet each day

Day 4 to Day 7

  • White tablet (0.5 mg)
  • Take 1 in the morning and 1 in the evening

Day 8 to end of treatment

  • Blue tablet (1 mg)
  • Take 1 in the morning and 1 in the evening
  • Make sure that you try to stop smoking on your quit date. If you slip-up and smoke, try again. Some people need to take CHANTIX for a few weeks for CHANTIX to work best.
  • Most people will take CHANTIX for up to 12 weeks. If you have completely quit smoking by 12 weeks, your healthcare provider may prescribe CHANTIX for another 12 weeks to help you stay cigarette-free.
  • Take CHANTIX after eating and with a full glass (8 ounces) of water.
  • This dosing schedule may not be right for everyone. Talk to your healthcare provider if you are having side effects such as nausea, strange dreams, or sleep problems. Your healthcare provider may want to reduce your dose.
  • If you miss a dose of CHANTIX, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Just take your next dose at your regular time.

What should I avoid while taking CHANTIX?

  • Use caution when driving or operating machinery until you know how CHANTIX affects you. CHANTIX may make you feel sleepy, dizzy, or have trouble concentrating, making it hard to drive or perform other activities safely.
  • Decrease the amount of alcoholic beverages that you drink during treatment with CHANTIX until you know if CHANTIX affects your ability to tolerate alcohol. Some people have experienced the following when drinking alcohol during treatment with CHANTIX:
  • increased drunkenness (intoxication)
  • unusual or sometimes aggressive behavior
  • no memory of things that have happened

What are the possible side effects of CHANTIX?

Serious side effects of CHANTIX may include:

  • See "What is the most important information I should know about CHANTIX?"
  • Seizures. Some people have had seizures during treatment with CHANTIX. In most cases, the seizures have happened during the first month of treatment with CHANTIX. If you have a seizure during treatment with CHANTIX, stop taking CHANTIX and contact your healthcare provider right away.
  • New or worse heart or blood vessel (cardiovascular) problems, mostly in people, who already have cardiovascular problems. Tell your healthcare provider if you have any changes in symptoms during treatment with CHANTIX.
    Get emergency medical help right away if you have any of the following symptoms of a heart attack, including:
    • chest discomfort (uncomfortable pressure, squeezing, fullness or pain) that lasts more than a few minutes, or that goes away and comes back
    • pain or discomfort in one or both arms, back, neck, jaw or stomach
    • shortness of breath, sweating, nausea, vomiting, or feeling lightheaded associated with chest discomfort
  • Sleepwalking can happen with CHANTIX, and can sometimes lead to behavior that is harmful to you or other people, or to property. Stop taking CHANTIX and tell your healthcare provider if you start sleepwalking.
  • Allergic reactions can happen with CHANTIX. Some of these allergic reactions can be life-threatening.
  • Serious skin reactions, including rash, swelling, redness, and peeling of the skin. Some of these skin reactions can become life-threatening.

Stop taking CHANTIX and get medical help right away if you have any of the following symptoms:

  • swelling of the face, mouth (tongue, lips, and gums), throat or neck
  • trouble breathing
  • rash with peeling skin
  • blisters in your mouth

The most common side effects of CHANTIX include:

  • nausea
  • sleep problems (trouble sleeping or vivid, unusual, or strange dreams)
  • constipation
  • gas
  • vomiting

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?

  • Store CHANTIX at room temperature, between 68°F to 77°F (20°C to 25°C).
  • Keep CHANTIX and all medicines out of the reach of children.

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.

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