CHANTIX® (varenicline) Tablets Dosage and Administration

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Prescribing Information

CHANTIX^® (varenicline) Tablets
Dosage and Administration


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Usual 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. Patients should be provided with appropriate educational materials and counseling to support the quit attempt.

The patient should set a date to stop smoking. CHANTIX dosing should start one week before this date.

CHANTIX should be taken 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 who cannot tolerate adverse effects of CHANTIX may have the dose lowered temporarily or permanently.

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.

Patients who do not succeed in stopping smoking during 12 weeks of initial therapy, or who relapse after treatment, should be encouraged to make another attempt once factors contributing to the failed attempt have been identified and addressed.

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, the recommended starting dose of CHANTIX is 0.5 mg once daily. Patients may then titrate as needed to a maximum dose of 0.5 mg twice a day. For patients with end-stage renal disease undergoing hemodialysis, a maximum dose of 0.5 mg once daily may be administered if tolerated well (See CLINICAL PHARMACOLOGY, Pharmacokinetics, Pharmacokinetics in Special Populations, Renal impairment).

Dosing in elderly patients 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 PRECAUTIONS, Geriatric Use).

Use in children
Safety and effectiveness of CHANTIX in pediatric patients have not been established; therefore, CHANTIX is not recommended for use in patients under 18 years of age.

PRINTER-FRIENDLY

CHANTIX Safety Information

Important Safety Information

All patients being treated with CHANTIX should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide have been reported in some patients attempting to quit smoking while taking CHANTIX in the post-marketing experience.

These events have occurred in patients with and without pre-existing psychiatric disease. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies of CHANTIX and the safety and efficacy of CHANTIX in such patients has not been established.

Advise patients and caregivers that the patient should stop taking CHANTIX and contact a health care provider immediately if agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many post-marketing cases, resolution of symptoms after discontinuation of CHANTIX was reported, although in some cases the symptoms persisted; therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

Patients should be informed that there have been reports of serious skin reactions, such as Stevens Johnson Syndrome and Erythema Multiforme and of angioedema, with swelling of the face, mouth and neck that can lead to life-threatening respiratory compromise. Patients should be instructed to discontinue CHANTIX and immediately seek medical care if they experience these symptoms or at the first sign of rash with mucosal lesions or any other signs of hypersensitivity.

The most common adverse reactions include nausea (30%), sleep disturbance, constipation, flatulence, and vomiting. Patients should be informed that they may experience vivid, unusual, or strange dreams during treatment with CHANTIX. Patients should be advised to use caution driving or operating machinery or engaging in other potentially hazardous activities until they know how CHANTIX may affect them.

Safety and efficacy of CHANTIX in combination with other smoking cessation drug therapies have not been studied. Dosage adjustment with CHANTIX is recommended in patients with severe renal impairment or in patients undergoing hemodialysis.

Smoking cessation, with or without treatment with CHANTIX, may alter the pharmacokinetics or pharmacodynamics of some drugs, such as theophylline, warfarin, and insulin. Dosage adjustment for these drugs may be necessary.

CHANTIX is indicated as an aid to smoking cessation treatment in adults 18 and over. Patients may benefit from behavioral modification and support during their quit attempt. Patients should be encouraged to continue to attempt to quit if they have early lapses after quit day.

Please see full prescribing information.

CHANTIX^® (varenicline)

Please see Medication Guide.