Varenicline improves smoking abstinence at ~4 weeks, 3 months and 1 year vs combination NRT, high-dose (>22mg) nicotine patches and bupropion^3*

In a direct clinical trial comparison with a 24-hour nicotine patch, varenicline had a significantly greater continuous abstinence rate for the last 4 weeks of the treatment period.^4†

^†12 weeks of varenicline treatment versus 10 weeks of NRT patch.⁴(as per manufacturer's dosing regimens)

Varenicline has demonstrated efficacy and tolerability across a broad range of smoking cessation patients.^1,5–11

Most common adverse reactions (1 in 10) are mild/moderate nausea, insomnia, headache, abnormal dreams and nasopharyngitis.¹

This tablet option was withdrawn due to concerns over nitrosamine impurities.¹²

Nitrosamines are carcinogenic chemical compounds, formed when nitrates or nitrites react with amines.¹³ As well as in cigarette smoke, they can be found in alcoholic drinks, meat and cosmetics.¹³

To reflect evolving and highly technical evidence, the FDA renewed their recommended acceptable intake limits for nitrosamine in August 2023, stating an acceptable level of 400 ng/day for N-nitroso-varenicline.¹⁴

Laboratory tests show that 2 mg varenicline per day (highest daily dose) contains less than 400 ng of nitrosamine.^15**

Smoking continues to be the leading cause of preventable heart disease, stroke and respiratory illness.¹⁶

2 out of 3 people who continue to smoke will die due to their tobacco use.^{17, 18}

Smoking cessation in at risk patient groups is a priority health strategy

In 2019, the government set out for England to be smoke-free by 2030, with a target of only 5% of the population still smoking.¹⁹

Researchers estimate that varenicline not returning would lead to 4,200 fewer people giving up smoking long-term each year.¹²

Leading to an estimated smoking related 1,890 deaths each year.¹²

Patient Counselling Guide

Simple dosing guide for patients

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FAQs

Frequently Asked Questions

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Prescribing Information

Abbreviated Prescribing Information

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Footnotes:

COPD, Chronic Obstructive Pulmonary Disease
^*NRT, nicotine replacement therapy
^**Below the limit of quantification
^††494 people smoking ≥10 cigarettes/day with at least one prior quit attempt using varenicline, but no attempt in the last 3 months
^¶24 weeks of varenicline vs placebo in 1510 cigarette smokers not willing or able to quit within the next month, but willing to reduce smoking and attempt quitting within 3 months

References

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   Varenicline, Summary of Product Characteristics. TEVA UK Limited.

2. Back to contents.

   Coe JW, et al. J Med Chern 2005;48:3474–77.

3. Back to contents.

   Mills EJ, et al. Ann Med 2012;44:588–597.

4. Back to contents.

   Aubin H-J, et al. Thorax 2008:63:714–724.

5. Back to contents.

   Jorenby DE, et al. Jama 2006;296(1):56-63.

6. Back to contents.

   Gonzales D, et al. Clin Pharmacol Ther 2014;96(3):390–6.

7. Back to contents.

   Tashkin DP, et al. Tobacco Cessation and Prevention 2011;139(3):591-599.

8. Back to contents.

   Rigotti NA, et al. Circulation 2010; 121(2): 221–229.

9. Back to contents.

   Anthenelli RM, et al. Ann Intern Med 2013;159:390–400.

10. Back to contents.

    Gonzales D, et al. Jama 2006. 296(1):47-55.

11. Back to contents.

    Ebbert JO, et al. Jama 2015; 313(7): 687–694.

12. Back to contents.

    Jackson SE, et al. Addiction 2024; 119(7):1203-1210.

13. Back to contents.

    Robles, H. Enc Tox, 2014;3;58–5.

14. Back to contents.

    US Food and Drug Administration. Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) August 2023. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/updated-information-recommended-acceptable-intake-limits-nitrosamine-drug-substance-related. Accessed August 2024.

15. Back to contents.

    ARC Pharma 24F06584 Certificate Of Analysis. Varenicline film-coated tablets 1mg. August 2024.

16. Back to contents.

    Papadakis S, et al. Local Stop Smoking Services and support: Commissioning, delivery, and monitoring guidance. National Centre for Smoking Cessation and Training; 2024.

17. Back to contents.

    NHS England. Tobacco Dependency Programme. https://www.england.nhs.uk/ourwork/prevention/tobacco-dependency-programme. Accessed July 2024.

18. Back to contents.

    UK Health Security Agency. Smoking attributable deaths in England: When the information changes. https://ukhsa.blog.gov.uk/2021/07/06/smoking-attributable-deaths-in-england-when-the-information-changes/. Accessed July 2024.

19. Back to contents.

    Making smoking obsolete, 2022. https://www.gov.uk/government/publications/the-khan-review-making-smoking-obsolete/making-smoking-obsolete-summary. Accessed July 2024.