Pfizer Corporation Hong Kong Limited 美國輝瑞科研製藥

Indications¹

Aid to smoking cessation in adults >18 years

Clinical Evidence

Effective and well-tolerated pharmacotherapy for smoking cessation in Asian smokers^2,3

Smoking cessation rates superior to bupropion SR for weeks 9 through 12 (4-week continuous abstinence rate)^4,5

Approximately 44% of smokers who received varenicline were able to quit smoking by the end of 12 weeks of treatment^4,5
Significantly more efficacious than placebo for smoking cessation at all time points and significantly more efficacious than bupropion SR at the end of 12 weeks of drug treatment and at 24 weeks⁴

An additional 12 weeks of varenicline provided significantly greater continuous abstinence versus placebo (p<0.001)⁶

Safety Profile¹

ADVERSE REACTIONS: Changes in behaviour, agitation, aggression, depressed mood; nausea, constipation, flatulence, dry mouth, dyspepsia, vomiting, abdominal distension, stomach discomfort, fatigue, increased appetite; headache, dizziness, dysgeusia, somnolence, insomnia, abnormal dreams, sleep disorder

INTERACTIONS: Smoking cessation may result in an increase of plasma levels of CYP1A2 substrates including theophylline, warfarin and insulin.

Dosages¹

Days 1–3 0.5 mg od Days 4–7 0.5 mg bid Day 8–end of treatment (week 12) 1 mg bid.  In patients with severe renal impairment, reduced dosing frequency of 1 mg od is recommended. Dosing should begin at 0.5 mg od for the first 3 days, and then increased to 1 mg od. Not recommended for use in children below 18 years of age.

Strengths¹

0.5 mg, 1 mg

Packing¹

Film-coated tablets (starter pack): 0.5 mg x 11's plus 1 mg x 14's; 1 mg x 28's; 1 mg x 56's.

Important Safety Information¹

CONTRAINDICATIONS: Champix® is contraindicated in individuals with hypersensitivity to the active substance or to any of the excipients.

SPECIAL PRECAUTIONS: Pregnancy and lactation, concurrent nicotine replacement therapy, renal impairment, known underlying psychiatric illness; there have been reports of serious neuropsychiatric adverse events in people trying to quit smoking with Champix®. It is not known whether these are related to the drug, but patients should be advised to report any neuropsychiatric symptoms.

ADVERSE REACTIONS: Changes in behaviour, agitation, aggression, depressed mood; nausea, constipation, flatulence, dry mouth, dyspepsia, vomiting, abdominal distension, stomach discomfort, fatigue, increased appetite; headache, dizziness, dysgeusia, somnolence, insomnia, abnormal dreams, sleep disorder

PREGNANCY and LACTATION: Champix® should not be used during pregnancy.

Please refer to the full prescribing information for more safety information.

References

1. Champix® (varenicline) Prescribing Information. Pfizer Corporation Hong Kong Limited: 14 January 2011

2. Tsai ST, Cho HJ, Cheng HS, et al. A randomized, placebo-controlled trial of varenicline, a selective alpha4beta2 nicotinic acetylcholine receptor partial agonist, as a new therapy for smoking cessation in Asian smokers. Clin Ther. 2007;29(6):1027-1039.

3. Nakamura M, Oshima A, Fujimoto Y, et al. Efficacy and tolerability of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, in a 12-week, randomized, placebo-controlled, dose-response study with 40-week follow-up for smoking cessation in Japanese smokers. Clin Ther. 2007;29(6):1040-1056.

4. Gonzales D, Rennard SI, Nides M, et al. Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006;296(1):47-55.

5. Jorenby DE, Hays JT, Rigotti NA, et al. Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006;296(1):56-63.

6. Tonstad S, Tonnesen P, Hajek P, et al. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA. 2006;296(1):64-71.

Please review the full product information or package insert before prescribing.

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