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CHANTIX (CHAMPIX): PRESCRIBING INFORMATION
Chantix (Champix) tablets contain varenicline (as the tartrate salt), which is a partial agonist selective for £\4£]2 nicotinic acetylcholine receptor subtypes.
Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro6,10-methano-6H-pyrazino[2,3- h]benzazepine, (2R,3R)-2,3dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3
Varenicline Tartrate (Chantix) is supplied for oral administration in two strengths: a 0.5 mg capsular biconvex, white to off-white, film-coated tablet debossed with "Pfizer" on one side and "CHX 0.5" on the other side and a 1 mg capsular biconvex, light blue film-coated tablet debossed with "Pfizer" on one side and "CHX 1.0" on the other side. Each 0.5 mg Chantix tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg Chantix tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: 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.
INDICATIONS AND USAGE
Chantix (Varenicline) is indicated for use as an aid to smoking cessation treatment.
DOSAGE AND ADMINISTRATION
Chantix (Champix) dosage and administration
Varenicline Tartrate (Chantix) is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to this medication.
WARNINGS AND PRECAUTIONS
Chantix (Champix) warnings and precautions
Chantix (Champix) adverse reactions
Based on varenicline characteristics and clinical experience to date, Chantix (Varenicline) has no clinically meaningful pharmacokinetic drug interactions.
Use with other Drugs for Smoking Cessation
Safety and efficacy of Chantix (Champix) in combination with other smoking cessation therapies have not been studied.
Bupropion: Varenicline (1 mg twice daily) did not alter the steady-state pharmacokinetics of bupropion (150 mg twice daily) in 46 smokers. The safety of the combination of bupropion and varenicline has not been established.
Nicotine replacement therapy (NRT): Although co-administration of varenicline (1 mg twice daily) and transdermal nicotine (21 mg per day) for up to 12 days did not affect nicotine pharmacokinetics, the incidence of headache, nausea, vomiting, dizziness, dyspepsia, and fatigue was greater for the combination than for NRT alone. In this study, eight of twenty-two (36%) patients treated with the combination of varenicline and NRT prematurely discontinued treatment due to adverse events, compared to 1 of 17 (6%) of patients treated with NRT and placebo.
Effect of Smoking Cessation on other Drugs
Physiological changes resulting from smoking cessation, with or without treatment with Chantix (Varenicline Tartrate), may alter the pharmacokinetics or pharmacodynamics of certain drugs (e.g., warfarin, theophylline, insulin) for which dosage adjustment may be necessary.
USE IN SPECIFIC POPULATIONS
Chantix (Champix) use in specific populations
DRUG ABUSE AND DEPENDENCE
Varenicline (Champix, Chantix) is not a controlled substance.
Humans: Fewer than 1 out of 1000 patients reported euphoria in clinical trials with this drug. At higher doses (greater than 2 mg), Chantix (Varenicline Tartrate) produced more frequent reports of gastrointestinal disturbances such as nausea and vomiting. There is no evidence of dose-escalation to maintain therapeutic effects in clinical studies, which suggests that tolerance does not develop. Abrupt discontinuation of Varenicline (Chantix) was associated with an increase in irritability and sleep disturbances in up to 3% of patients. This suggests that, in some patients, varenicline may produce mild physical dependence which is not associated with addiction.
In a human laboratory abuse liability study, a single oral dose of 1 mg varenicline did not produce any significant positive or negative subjective responses in smokers. In non-smokers, 1 mg varenicline produced an increase in some positive subjective effects, but this was accompanied by an increase in negative adverse effects, especially nausea. A single oral dose of 3 mg varenicline uniformly produced unpleasant subjective responses in both smokers and non-smokers.
Animals: Studies in rodents have shown that varenicline produces behavioral responses similar to those produced by nicotine. In rats trained to discriminate nicotine from saline, varenicline produced full generalization to the nicotine cue. In self-administration studies, the degree to which varenicline substitutes for nicotine is dependent upon the requirement of the task. Rats trained to self-administer nicotine under easy conditions continued to self-administer varenicline to a degree comparable to that of nicotine; however in a more demanding task, rats self-administered varenicline to a lesser extent than nicotine. Varenicline pretreatment also reduced nicotine self-administration.
In case of overdose, standard supportive measures should be instituted as required.
Varenicline (Champix, Chantix) has been shown to be dialyzed in patients with end stage renal disease, however, there is no experience in dialysis following overdose.
Chantix (Champix) clinical pharmacology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis: Lifetime carcinogenicity studies were performed in CD-1 mice and Sprague-Dawley rats. There was no evidence of a carcinogenic effect in mice administered varenicline by oral gavage for 2 years at doses up to 20 mg / kg per day (47 times the maximum recommended human daily exposure based on AUC). Rats were administered varenicline (1, 5, and 15 mg / kg per day) by oral gavage for 2 years. In male rats (n = 65 per sex per dose group), incidences of hibernoma (tumor of the brown fat) were increased at the mid dose (1 tumor, 5 mg / kg per day, 23 times the maximum recommended human daily exposure based on AUC) and maximum dose (2 tumors, 15 mg / kg per day, 67 times the maximum recommended human daily exposure based on AUC). The clinical relevance of this finding to humans has not been established. There was no evidence of carcinogenicity in female rats.
Mutagenesis: Varenicline Tartrate (Chantix) was not genotoxic, with or without metabolic activation, in the following assays: Ames bacterial mutation assay; mammalian CHO/HGPRT assay; and tests for cytogenetic aberrations in vivo in rat bone marrow and in vitro in human lymphocytes.
Impairment of Fertility: There was no evidence of impairment of fertility in either male or female Sprague-Dawley rats administered varenicline succinate up to 15 mg / kg per day (67 and 36 times, respectively, the maximum recommended human daily exposure based on AUC at 1 mg twice daily). However, a decrease in fertility was noted in the offspring of pregnant rats who were administered varenicline succinate at an oral dose of 15 mg / kg per day (36 times the maximum recommended human daily exposure based on AUC at 1 mg twice daily). This decrease in fertility in the offspring of treated female rats was not evident at an oral dose of 3 mg / kg per day (9 times the maximum recommended human daily exposure based on AUC at 1 mg twice daily).
Chantix (Champix) clinical studies
HOW SUPPLIED / STORAGE AND HANDLING
Chantix (Champix) is supplied for oral administration in two strengths: a 0.5 mg capsular biconvex, white to off-white, film-coated tablet debossed with "Pfizer" on one side and "CHX 0.5" on the other side and a 1 mg capsular biconvex, light blue film-coated tablet debossed with "Pfizer" on one side and "CHX 1.0" on the other side. Chantix (Varenicline Tartrate) is supplied in the following package configurations:
Starting Month PAK (First month of therapy): Pack includes 1 card of 0.5 mg x 11 tablets and 3 cards of 1 mg x 14 tablets
Continuing Month PAK (Continuing months of therapy): Pack includes 4 cards of 1 mg x 14 tablets
Starting Month Box: 0.5 mg x 11 tablets and 1 mg x 42 tablets
Continuing Month Box: 1 mg x 56 tablets
Bottles: 0.5 mg - bottle of 56
Bottles: 1 mg - bottle of 56
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) (see USP Controlled Room Temperature).
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