varenicline (Chantix, Champix)

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Introduction

Tradename: Chantix

Indications

Contraindications

  • NOT for use with nicotine replacement[2]
    • no evidence of efficacy
    • increased incidence of adverse effects
    • apparently, some specialist do combine nicotine with varenicline[12]
  • caution with renal insufficiency
  • should NOT be used by pilots, air traffic controllers, truckers, & bus drivers

Pregnancy Category C

Dosage

  • Days 1-3: 0.5 mg once daily, Days 4-7: 0.5 mg twice daily then 1 mg twice daily
  • start one week before the set stop smoking date
  • continue for 12 weeks.
  • take after eating & with a full glass of water (to decrease nausea)

Tabs: 0.5, 1 mg, bottles of 56 tablets

treatment packs

  • initial: 1 card of 11 X 0.5 mg tablets & 3 cards of 14 X 1 mg tablets
  • continuing: 4 cards of 14 X 1 mg tablets

Adverse effects

* Black box warning; potential adverse neuropsychiatric effects including suicidal ideation, seizures, alcohol interaction[25]

* FDA in votes (10-9, mixed vote) to remove Black box warning Sept 2016[30]

* risk of serious side effects on mood, behavior, or thinking lower than previously suspected[31]

Drug interactions

Mechanism of action

Clinical trials

Notes

Estimated cost (2006)

  • $112 for all strengths & packages
  • $2 per 0.5 mg or 1 mg tablet

More general terms

References

  1. ↑ Prescriber's Letter 13(5): 2006 FDA Approves Novel Medication for Smoking Cessation Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=220608&pb=PRL (subscription needed) http://www.prescribersletter.com
  2. ↑ 2.0 2.1 Prescriber's Letter 13(8): 2006 New Drug: Chantix (Varenicline) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=220814&pb=PRL (subscription needed) http://www.prescribersletter.com
  3. ↑ Prescriber's Letter 13(12): 2006 Smoking Cessation Drug Therapy Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=221212&pb=PRL (subscription needed) http://www.prescribersletter.com
  4. ↑ 4.0 4.1 4.2 Prescriber's Letter 14(11): 2007 Behavioral Side Effects with Varenicline (Chantix, Champix) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=231111&pb=PRL (subscription needed) http://www.prescribersletter.com
  5. ↑ Pfizer Inc. http://www.Chantix.com
  6. ↑ 6.0 6.1 6.2 FDA MedWatch http://www.fda.gov/medwatch/safety/2007/safety07.htm#Chantix http://www.fda.gov/medwatch/safety/2008/safety08.htm#Varenicline
    Prescriber's Letter 15(3): 2008 Behavioral Side Effects with Varenicline (Chantix, Champix) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=240313&pb=PRL (subscription needed) http://www.prescribersletter.com
  7. ↑ Prescriber's Letter 15(7): 2008 Comparison of Smoking Cessation Drug Therapy Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=240706&pb=PRL (subscription needed) http://www.prescribersletter.com
  8. ↑ 8.0 8.1 8.2 8.3 8.4 FDA Safety Alert Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics) http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170090.htm
  9. ↑ 9.0 9.1 Gunnell D et al Varenicline and suicidal behaviour: a cohort study based on data from the General Practice Research Database BMJ 2009;339:b3805 PMID: https://www.ncbi.nlm.nih.gov/pubmed/19797344 doi:10.1136/bmj.b3805 http://www.bmj.com/cgi/content/abstract/339/oct01_1/b3805
  10. ↑ 10.0 10.1 Prescriber's Letter 17(3): 2010 Varenicline (Chantix, Champix) and Cardiovascular Disease Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=260308&pb=PRL (subscription needed) http://www.prescribersletter.com
  11. ↑ 11.0 11.1 11.2 Garza D et al. A double-blind randomized placebo-controlled pilot study of neuropsychiatric adverse events in abstinent smokers treated with varenicline or placebo. Biol Psychiatry 2011 Jun 1; 69:1075. PMID: https://www.ncbi.nlm.nih.gov/pubmed/21295286
  12. ↑ 12.0 12.1 FDA MedWatch: 06/16/2011 Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259469.htm
    Prescriber's Letter 18(8): 2011 COMMENTARY: Chantix (Varenicline) and Risk of Cardiovascular Events COMMENTARY: Chantix (Varenicline): New Safety Information and Instructions For Use CHART: Smoking Cessation Therapy Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=270820&pb=PRL (subscription needed) http://www.prescribersletter.com
  13. ↑ 13.0 13.1 13.2 FDA MedWatch: 10/24/2011 Chantix (varenicline) http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm079818.htm
  14. ↑ 14.0 14.1 14.2 Moore TJ et al. Suicidal behavior and depression in smoking cessation treatments. PLoS ONE 2011 Nov 2; 6:e27016 PMID: https://www.ncbi.nlm.nih.gov/pubmed/22073240
  15. ↑ 15.0 15.1 Prochaska JJ and Hilton JF Risk of cardiovascular serious adverse events associated with varenicline use for tobacco cessation: systematic review and meta-analysis. BMJ 2012;344:e2856 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/22563098 <Internet> http://www.bmj.com/highwire/filestream/582907/field_highwire_article_pdf/0.pdf
  16. ↑ 16.0 16.1 Svanstrom H et al. Use of varenicline for smoking cessation and risk of serious cardiovascular events: Nationwide cohort study. BMJ 2012 Nov 8; 345:e7176. PMID: https://www.ncbi.nlm.nih.gov/pubmed/23138033
  17. ↑ 17.0 17.1 FDA MedWatch. 12/12/2012 Chantix (Varenicline): Safety Communication - Updated Safety Review On The Risk of Cardiovascular Adverse Events http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm331626.htm
  18. ↑ 18.0 18.1 18.2 18.3 Anthenelli RM et al. Effects of varenicline on smoking cessation in adults with stably treated current or past major depression: A randomized trial. Ann Intern Med 2013 Sep 16 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24042367 <Internet> http://annals.org/article.aspx?articleid=1738491
  19. ↑ 19.0 19.1 Thomas KH et al. Smoking cessation treatment and risk of depression, suicide, and self harm in the Clinical Practice Research Datalink: Prospective cohort study. BMJ 2013 Oct 11; 347:f5704. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24124105 <Internet> http://www.bmj.com/content/347/bmj.f5704
  20. ↑ Mills EJ et al Cardiovascular Events Associated with Smoking Cessation Pharmacotherapies: A Network Meta-Analysis. Circulation. Dex 9, 2013 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24323793 <Internet> http://circ.ahajournals.org/content/early/2013/11/25/CIRCULATIONAHA.113.003961.abstract
    Samet J Smoking Cessation: Benefits versus Risks of Using Pharmacotherapy to Quit. Circulation. Dex 9, 2013 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24323794 <Internet> http://circ.ahajournals.org/content/early/2013/11/25/CIRCULATIONAHA.113.006928.abstract
  21. ↑ 21.0 21.1 21.2 21.3 Orciari Herman A, Sadoughi S, Saitz R Chantix Label Revision Casts Doubt on Link to Suicidality. Physician's First Watch, Sept 25, 2014 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
    Young K, Fairchild DG, Di Francesco L FDA Staff: Chantix Should Keep Neuropsychiatric Warning on Label Physician's First Watch, Oct 15, 2014 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
    Orciari Herman A, Sadoughi S FDA Advisers Vote to Keep Black-Box Warning on Chantix. Physician's First Watch, Oct 20, 2014 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
  22. ↑ HIGHLIGHTS OF PRESCRIBING INFORMATION CHANTIX<TM> (varenicline) Tablets http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s032s036s038lbl.pdf
  23. ↑ 23.0 23.1 Lerman C et al Use of the nicotine metabolite ratio as a genetically informed biomarker of response to nicotine patch or varenicline for smoking cessation: a randomised, double-blind placebo- controlled trial. Lancet Respir Med. 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25588294 <Internet> http://www.thelancet.com/journals/lanres/article/PIIS2213-2600%2814%2970294-2/abstract
    Ware JJ, Davies NM, Munafo MR Importance of national context in the translation of personalised treatments for smoking cessation. Lancet Respir Med. 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25588293 <Internet> http://www.thelancet.com/journals/lanres/article/PIIS2213-2600%2814%2970319-4/abstract
  24. ↑ 24.0 24.1 Ebbert JO, Hughes JR, West RJ et al Effect of Varenicline on Smoking Cessation Through Smoking Reduction: A Randomized Clinical Trial. JAMA. 2015;313(7):687-694. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25688780 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=2110968 (industry-sponsored study)
  25. ↑ 25.0 25.1 25.2 25.3 FDA Safety Alert. March 9, 2015 Chantix (varenicline): Drug Safety Communication - FDA Updates Label to Include Potential Alcohol Interaction http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm437415.htm
  26. ↑ 26.0 26.1 26.2 26.3 26.4 Thomas KH et al. Risk of neuropsychiatric adverse events associated with varenicline: Systematic review and meta-analysis. BMJ 2015 Mar 12; 350:h1109 PMID: https://www.ncbi.nlm.nih.gov/pubmed/25767129
  27. ↑ Baker TB, Piper ME, Stein JH et al Effects of Nicotine Patch vs Varenicline vs Combination Nicotine Replacement Therapy on Smoking Cessation at 26 Weeks. A Randomized Clinical Trial. JAMA. 2016;315(4):371-379 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26813210 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=2484340
  28. ↑ 28.0 28.1 28.2 Anthenelli RM et al Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo- controlled clinical trial. The Lancet. April 22, 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27116918 <Internet> http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2816%2930272-0/abstract
  29. ↑ 29.0 29.1 Geriatric Review Syllabus, 9th edition (GRS9) Medinal-Walpole A, Pacala JT, Porter JF (eds) American Geriatrics Society, 2016
  30. ↑ 30.0 30.1 Orciari Herman J, Chavey WE FDA Advisers Recommend Removing Chantix Boxed Warning, but Vote Was Mixed. Physician's First Watch, Sept 16, 2016 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
  31. ↑ 31.0 31.1 FDA Safety Alert. Dec 16, 2016 Chantix (varenicline) and Zyban (bupropion): Drug Safety Communication - Mental Health Side Effects Revised. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm533517.htm
    FDA Safety Aommunication. Dec 16, 2016 FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings. http://www.fda.gov/Drugs/DrugSafety/ucm532221.htm
  32. ↑ 32.0 32.1 Gershon AS, Campitelli MA, Hawken S et al Cardiovascular and Neuropsychiatric Events Following Varenicline Use for Smoking Cessation. Am J Res Critical Care Med. 2018 Apr 1; 197:913. Online Dec 20, 2017. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/29260881 <Internet> http://www.atsjournals.org/doi/abs/10.1164/rccm.201706-1204OC
  33. ↑ 33.0 33.1 Windle SB, Dehghani P, Roy N, et al. Smoking abstinence 1 year after acute coronary syndrome: Follow-up from a randomized controlled trial of varenicline in patients admitted to hospital. CMAJ 2018 Mar 26; 190:E347. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/29581161 Free PMC Article <Internet> http://www.cmaj.ca/content/190/12/E347

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