CHANTIX® (varenicline tartrate) 2 DOSAGE AND ADMINISTRATION

(varenicline tartrate)

Prescribing Information

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage for Adults

Smoking-cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided additional advice and support. Provide patients with appropriate educational materials and counseling to support the quit attempt.

The patient should set a date to stop smoking. Begin CHANTIX dosing one week before this date. Alternatively, the patient can begin CHANTIX dosing and then quit smoking between days 8 and 35 of treatment.

CHANTIX should be taken orally after eating and with a full glass of water.

The recommended dose of CHANTIX is 1 mg twice daily following a 1-week titration as follows:

Days 1 – 3:	0.5 mg once daily
Days 4 – 7:	0.5 mg twice daily
Day 8 – end of treatment:	1 mg twice daily

Patients should be treated with CHANTIX for 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with CHANTIX is recommended to further increase the likelihood of long-term abstinence.

For patients who are sure that they are not able or willing to quit abruptly, consider a gradual approach to quitting smoking with CHANTIX. 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 CHANTIX treatment for an additional 12 weeks, for a total of 24 weeks of treatment. Encourage patients to attempt quitting sooner if they feel ready [see Clinical Studies (14.5)].

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, should be encouraged to make another attempt with CHANTIX once factors contributing to the failed attempt have been identified and addressed.

Consider a temporary or permanent dose reduction in patients who cannot tolerate the adverse effects of CHANTIX.

2.2 Dosage in Special Populations

Patients with Impaired Renal Function

No dosage adjustment is necessary for patients with mild-to-moderate renal impairment. For patients with severe renal impairment (estimated creatinine clearance less than 30 mL per min), the recommended starting dose of CHANTIX is 0.5 mg once daily. The dose may then be titrated as needed to a maximum dose of 0.5 mg twice daily. For patients with end-stage renal disease undergoing hemodialysis, a maximum dose of 0.5 mg once daily may be administered if tolerated [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Elderly and Patients with Impaired Hepatic Function

No dosage adjustment is necessary for patients with hepatic impairment. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Use in Specific Populations (8.5)].

Medication Guide

MEDICATION GUIDE

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 6/2025
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: o 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 o 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 o 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	o White tablet (0.5 mg) o Take 1 tablet each day
	Day 4 to Day 7	o White tablet (0.5 mg) o Take 1 in the morning and 1 in the evening
	Day 8 to end of treatment	o Blue tablet (1 mg) o 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:
	o increased drunkenness (intoxication)	o unusual or sometimes aggressive behavior o 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: o chest discomfort (uncomfortable pressure, squeezing, fullness or pain) that lasts more than a few minutes, or that goes away and comes back o pain or discomfort in one or both arms, back, neck, jaw or stomach o 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: o swelling of the face, mouth (tongue, lips, and gums), throat or neck o trouble breathing o rash with peeling skin o 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. LAB-0328-18.0

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