Varenicline (Page 10 of 12)

16 HOW SUPPLIED/STORAGE AND HANDLING

Varenicline tablets are supplied for oral administration in 1 mg circular, biconvex, light blue film-coated tablets, debossed with “P” on one side and “156” on other side.

Varenicline tablets are supplied in the following package configurations:
Unit dose packages of 30 (3 x 10) NDC 60687-648-21

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

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 varenicline treatment one week before the quit date. Alternatively, the patient can begin varenicline 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 varenicline may be considered. Patients should begin varenicline 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 varenicline therapy for reasons other than intolerability due to adverse events, or who relapsed after treatment to make another attempt with varenicline 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 varenicline 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 varenicline, 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 Varenicline or Other Drugs
Inform patients that nausea and insomnia are side effects of varenicline 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 varenicline. Instruct patients to discontinue varenicline 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 varenicline, 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 varenicline 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 varenicline until they know whether varenicline 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 varenicline 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 varenicline 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 varenicline. Advise patients to stop taking varenicline 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 varenicline.

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 varenicline use during pregnancy and breastfeeding, and the benefits of smoking cessation with and without varenicline. Advise breastfeeding women to monitor the infant for seizures and vomiting [see Use in Specific Populations (8.1 and 8.2)].

Chantix is a registered trade mark of Pfizer Inc.

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Par Pharmaceutical as follows:
(1 mg / 30 UD) NDC 60687-648-21 packaged from NDC 49884-156

Distributed By:
American Health Packaging
Columbus, OH 43217

8464821/1221