SMOKING CESSATION IS HARD

Transcription

1 POWER TO BREAK THE HOLD OF NICOTINE ADDICTION 1 SMOKING CESSATION IS HARD Most smokers try to quit 5-7 times before they are successful. 2 Why is it so hard to quit? Typical withdrawal symptoms from stopping smoking 3 Sleep disturbance < 4 weeks Urge to smoke > 10 weeks Depressed mood Restlessness Difficulty concentrating < 4 weeks < 4 weeks < 4 weeks Increased appetite > 10 weeks Irritability or aggression < 4 weeks Adapted from West and Shiffman Typical duration of symptoms (weeks) > Nicotine is as addictive as heroin 4 > Only 3-5% of unaided quitters remain smoke free for up to 12 months 5 > Smokers thinking about quitting fear: failure 6 weight gain 6 cravings 6 and other withdrawal symptoms 6 IT S EASIER FOR YOUR PATIENTS TO STOP SMOKING IF THEY STOP ENJOYING IT. 1

2 Reports of neuropsychiatric symptoms such as depressed mood, agitation, hallucinations, anxiety, psychosis, changes in behaviour and thinking, suicidal ideation and suicide were reported postmarketing. The role of CHAMPIX in these reports is not known. Observe patients on CHAMPIX for neuropsychiatric symptoms including changes in behaviour, or thinking, anxiety, psychosis, mood swings, agitation, aggression, depressed mood, suicidal ideation, suicidal behaviour and worsening of pre-existing psychiatric illness. Patients should be advised to stop CHAMPIX and see their doctor at the first sign of any of these symptoms. Ongoing follow-up should be provided until these symptoms resolve.(datasheet) CHAMPIX (varenicline tartrate) 0.5 mg and 1 mg tablets Indications: CHAMPIX is indicated as an aid to smoking cessation in adults over the age of 18 years. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Precautions: May alter pharmacokinetics or pharmacodynamics of some drugs (e.g. theophylline, warfarin and insulin), may increase plasma levels of CYP1A2 substrates, may exacerbate underlying or pre-existing psychiatric illnesses (e.g. depression). Care should be taken with patients with a history of psychiatric illness. Serious neuropsychiatric symptoms including changes in behaviour, thinking,* anxiety,* psychosis,* mood swings,* agitation, aggression, depressed mood, suicidal ideation and suicidal behaviour. Patients must stop taking CHAMPIX at first sign of any of these symptoms and be advised to contact a health care professional immediately. Ongoing follow up should be provided until these symptoms resolve. Post-marketing reports of rare but potentially fatal hypersensitivity reactions including angioedema, Stevens-Johnson Syndrome,* Erythema Multiforme.* Use caution when driving or operating machinery. See Data Sheet for details. Adverse effects: More common: nausea, headache, insomnia, abnormal dreams. Common: constipation, flatulence, dry mouth, dyspepsia, vomiting, abdominal distension, stomach discomfort, fatigue, increased appetite, dizziness, dysgeusia, somnolence and sleep disorder. Post-marketing reports: neuropsychiatric symptoms (e.g. depressed mood, anxiety,* psychosis,* agitation, hallucinations, changes in behaviour, thinking,* suicidal ideation and suicide) and hypersensitivity reactions (e.g. angioedema), Stevens-Johnson Syndrome,* Erythema Multiforme*). See Data Sheet for details. Dosage and Administration: Patients should set a date to quit smoking. Dosing should start 1-2 weeks before this date. Days 1-3: 0.5mg once daily. Days 4-7: 0.5mg twice daily. Day 8 - end of 12 week treatment: 1mg twice daily. Dose tapering is not required at end of treatment. For patients with severe renal impairment: Days 1-3: 0.5mg once daily. Days 4-end of 12 week treatment: 1mg once daily. CHAMPIX is being monitored on the New Zealand Intensive Medicines Monitoring Program (IMMP). Based on CHAMPIX Data Sheet dated 31 July 2009 and amended 09 September Before prescribing please review Data Sheet available from Pfizer New Zealand Limited PO Box 3998 Auckland NEW ZEALAND or the MEDSAFE website CHAMPIX is an unfunded medicine - a prescription charge will apply. Registered trademark References: 1. CHAMPIX (varenicline tartrate) Datasheet 31 July 2009 Pfizer New Zealand Limited 2. Hughes JR. CA Cancer J Clin 2000;50(3): West R and Shiffman S. Fast Facts: smoking cessation. Oxford: Health Press, Action on Smoking and Health Australia; (accessed April 2009 at 5. Hughes JR et al. Addiction 2004;99(1): Smoking Cessation Guidelines for Australian General Practice. Practice Handbook, R&A091209A.

3 POWER TO BREAK THE HOLD OF NICOTINE ADDICTION 1 HOW CHAMPIX WORKS CHAMPIX : It s easier to quit smoking if you stop enjoying it. 1 Unique dual mode of action to reduce cravings and withdrawal symptoms. 1 Why is nicotine addictive? D=Dopamine Nicotine binds to nicotine receptors in the brain 2, 3 Stimulates dopamine release, making smoking rewarding 2, 3 As nicotine levels drop after a cigarette is smoked, craving and withdrawal symptoms occur 4,5 Patient smokes again 2, 3 How does CHAMPIX reduce craving and withdrawal? CHAMPIX binds to the nicotine receptors 4,6,7 Triggers reduced dopamine release compared to nicotine Helps reduce craving and withdrawal symptoms experienced in the absence of nicotine 4,6,7 D=Dopamine What happens if a patient smokes while taking CHAMPIX? If a cigarette is smoked, CHAMPIX blocks nicotine from binding 4 Helps reduce smoking satisfaction and reward, 4,6,7 encouraging abstinence from smoking 1,8 D=Dopamine IT S EASIER FOR YOUR PATIENTS TO STOP SMOKING IF THEY STOP ENJOYING IT. 1

4 Reports of neuropsychiatric symptoms such as depressed mood, agitation, hallucinations, anxiety, psychosis, changes in behaviour and thinking, suicidal ideation and suicide were reported postmarketing. The role of CHAMPIX in these reports is not known. Observe patients on CHAMPIX for neuropsychiatric symptoms including changes in behaviour, or thinking, anxiety, psychosis, mood swings, agitation, aggression, depressed mood, suicidal ideation, suicidal behaviour and worsening of pre-existing psychiatric illness. Patients should be advised to stop CHAMPIX and see their doctor at the first sign of any of these symptoms. Ongoing follow-up should be provided until these symptoms resolve.(datasheet) CHAMPIX (varenicline tartrate) 0.5 mg and 1 mg tablets Indications: CHAMPIX is indicated as an aid to smoking cessation in adults over the age of 18 years. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Precautions: May alter pharmacokinetics or pharmacodynamics of some drugs (e.g. theophylline, warfarin and insulin), may increase plasma levels of CYP1A2 substrates, may exacerbate underlying or pre-existing psychiatric illnesses (e.g. depression). Care should be taken with patients with a history of psychiatric illness. Serious neuropsychiatric symptoms including changes in behaviour, thinking,* anxiety,* psychosis,* mood swings,* agitation, aggression, depressed mood, suicidal ideation and suicidal behaviour. Patients must stop taking CHAMPIX at first sign of any of these symptoms and be advised to contact a health care professional immediately. Ongoing follow up should be provided until these symptoms resolve. Post-marketing reports of rare but potentially fatal hypersensitivity reactions including angioedema, Stevens-Johnson Syndrome,* Erythema Multiforme.* Use caution when driving or operating machinery. See Data Sheet for details. Adverse effects: More common: nausea, headache, insomnia, abnormal dreams. Common: constipation, flatulence, dry mouth, dyspepsia, vomiting, abdominal distension, stomach discomfort, fatigue, increased appetite, dizziness, dysgeusia, somnolence and sleep disorder. Post-marketing reports: neuropsychiatric symptoms (e.g. depressed mood, anxiety,* psychosis,* agitation, hallucinations, changes in behaviour, thinking,* suicidal ideation and suicide) and hypersensitivity reactions (e.g. angioedema), Stevens-Johnson Syndrome,* Erythema Multiforme*). See Data Sheet for details. Dosage and Administration: Patients should set a date to quit smoking. Dosing should start 1-2 weeks before this date. Days 1-3: 0.5mg once daily. Days 4-7: 0.5mg twice daily. Day 8 - end of 12 week treatment: 1mg twice daily. Dose tapering is not required at end of treatment. For patients with severe renal impairment: Days 1-3: 0.5mg once daily. Days 4-end of 12 week treatment: 1mg once daily. CHAMPIX is being monitored on the New Zealand Intensive Medicines Monitoring Program (IMMP). Based on CHAMPIX Data Sheet dated 31 July 2009 and amended 09 September Before prescribing please review Data Sheet available from Pfizer New Zealand Limited PO Box 3998 Auckland NEW ZEALAND or the MEDSAFE website CHAMPIX is an unfunded medicine - a prescription charge will apply. Registered trademark References: 1. CHAMPIX (varenicline tartrate) Datasheet 31 July 2009 Pfizer New Zealand Limited 2. Dani JA and Harris RA. Nature Neuroscience 2005;8(11): Jarvis MJ. Why people smoke. BMJ 2004; 328: Coe JW et al. J Med Chem 2005;48: West R. Psychopharmacology 2008; 197: Gonzales D et al. JAMA 2006;296: Jorenby DE et al. JAMA 2006;296: European Public Assessment Report (EPAR). CHAMPIX: Scientific discussion (Available at: champix/h-699-pi-en.pdf.) R&A091209A.

5 POWER TO BREAK THE HOLD OF NICOTINE ADDICTION 1 12 WEEKS OF THERAPY Nicotine withdrawal symptoms can last more than 10 weeks weeks of CHAMPIX therapy increases your patients chances of resisting relapse. 4,5 Patients who completed 12 weeks of CHAMPIX therapy (vs. 7 weeks) demonstrated a superior quit rate in Phase II trials. 3,4,5 Study 1: CHAMPIX 1mg bd (n=127) 49.4% Study 2: CHAMPIX 1mg bd (n=259) Continuous abstinence rates (%) STOP DAY 28.8% 22.4% 14.4% ~ 52 weeks Study 1: Treatment phase Study 2: Treatment phase Adapted from Nides M et al, and Oncken C et al, This analysis included non-titrated and titrated doses of CHAMPIX 1mg bd. Only results for CHAMPIX 1mg bd are reflected in this chart. > Patients need to be advised to complete the full 12 week programme and a follow up appointment needs to be scheduled between weeks 6-8. IT S EASIER FOR YOUR PATIENTS TO STOP SMOKING IF THEY STOP ENJOYING IT. 1

6 Reports of neuropsychiatric symptoms such as depressed mood, agitation, hallucinations, anxiety, psychosis, changes in behaviour and thinking, suicidal ideation and suicide were reported postmarketing. The role of CHAMPIX in these reports is not known. Observe patients on CHAMPIX for neuropsychiatric symptoms including changes in behaviour, or thinking, anxiety, psychosis, mood swings, agitation, aggression, depressed mood, suicidal ideation, suicidal behaviour and worsening of pre-existing psychiatric illness. Patients should be advised to stop CHAMPIX and see their doctor at the first sign of any of these symptoms. Ongoing follow-up should be provided until these symptoms resolve.(datasheet) CHAMPIX (varenicline tartrate) 0.5 mg and 1 mg tablets Indications: CHAMPIX is indicated as an aid to smoking cessation in adults over the age of 18 years. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Precautions: May alter pharmacokinetics or pharmacodynamics of some drugs (e.g. theophylline, warfarin and insulin), may increase plasma levels of CYP1A2 substrates, may exacerbate underlying or pre-existing psychiatric illnesses (e.g. depression). Care should be taken with patients with a history of psychiatric illness. Serious neuropsychiatric symptoms including changes in behaviour, thinking,* anxiety,* psychosis,* mood swings,* agitation, aggression, depressed mood, suicidal ideation and suicidal behaviour. Patients must stop taking CHAMPIX at first sign of any of these symptoms and be advised to contact a health care professional immediately. Ongoing follow up should be provided until these symptoms resolve. Post-marketing reports of rare but potentially fatal hypersensitivity reactions including angioedema, Stevens-Johnson Syndrome,* Erythema Multiforme.* Use caution when driving or operating machinery. See Data Sheet for details. Adverse effects: More common: nausea, headache, insomnia, abnormal dreams. Common: constipation, flatulence, dry mouth, dyspepsia, vomiting, abdominal distension, stomach discomfort, fatigue, increased appetite, dizziness, dysgeusia, somnolence and sleep disorder. Post-marketing reports: neuropsychiatric symptoms (e.g. depressed mood, anxiety,* psychosis,* agitation, hallucinations, changes in behaviour, thinking,* suicidal ideation and suicide) and hypersensitivity reactions (e.g. angioedema), Stevens-Johnson Syndrome,* Erythema Multiforme*). See Data Sheet for details. Dosage and Administration: Patients should set a date to quit smoking. Dosing should start 1-2 weeks before this date. Days 1-3: 0.5mg once daily. Days 4-7: 0.5mg twice daily. Day 8 - end of 12 week treatment: 1mg twice daily. Dose tapering is not required at end of treatment. For patients with severe renal impairment: Days 1-3: 0.5mg once daily. Days 4-end of 12 week treatment: 1mg once daily. CHAMPIX is being monitored on the New Zealand Intensive Medicines Monitoring Program (IMMP). Based on CHAMPIX Data Sheet dated 31 July 2009 and amended 09 September Before prescribing please review Data Sheet available from Pfizer New Zealand Limited PO Box 3998 Auckland NEW ZEALAND or the MEDSAFE website CHAMPIX is an unfunded medicine - a prescription charge will apply. Registered trademark References: 1. CHAMPIX (varenicline tartrate) Datasheet 31 July 2009 Pfizer New Zealand Limited 2. West R and Shiffman S. Fast Facts: smoking cessation. Oxford: Health Press, Nides M et al. Am J Health Behav 2008;32(6): Oncken C et al. Arch Intern Med 2006;166: Fagerstrom K et al. Neuropsychiatric Disease and Treatment 2008;4(2): R&A091209A.

7 POWER TO BREAK THE HOLD OF NICOTINE ADDICTION 1 MANAGING PATIENTS EXPECTATIONS Investing time in discussing how quitting can be a challenge and what to expect with CHAMPIX helps to improve success. THINGS TO TELL PATIENTS ABOUT QUITTING SMOKING: Quitting smoking is one of the best things you can do for your health 6 TIPS TO DISCUSS WITH PATIENTS WHEN INITIATING CHAMPIX : CHAMPIX can help you quit but you need to be motivated to quit 2 Nicotine is as addictive as heroin 5 CHAMPIX can help in 2 ways: 2,7 1. It can reduce nicotine withdrawal Symptoms 2. It can reduce the satisfaction from smoking The average smoker makes 5-7 attempts to quit 3 Nausea was the most common side effect in Clinical trials 2 > recommend patients take CHAMPIX with a meal and a glass of water Nicotine withdrawal symptoms can make quitting difficult and last up to 10 weeks 4 Encourage your patient to request and read the brochure on CHAMPIX When quitting smoking, it s normal to feel common fears about weight gain and failure to succeed 6 If your patient experiences mood changes, advise them to stop taking CHAMPIX and contact you CHAMPIX is a 12 week course, it is important to follow up with patients at week 3 and 6 to enquire about progress, offer advice and reinforce importance of 12 weeks of therapy IT S EASIER FOR YOUR PATIENTS TO STOP SMOKING IF THEY STOP ENJOYING IT. 1

8 Reports of neuropsychiatric symptoms such as depressed mood, agitation, hallucinations, anxiety, psychosis, changes in behaviour and thinking, suicidal ideation and suicide were reported postmarketing. The role of CHAMPIX in these reports is not known. Observe patients on CHAMPIX for neuropsychiatric symptoms including changes in behaviour, or thinking, anxiety, psychosis, mood swings, agitation, aggression, depressed mood, suicidal ideation, suicidal behaviour and worsening of pre-existing psychiatric illness. Patients should be advised to stop CHAMPIX and see their doctor at the first sign of any of these symptoms. Ongoing follow-up should be provided until these symptoms resolve.(datasheet) CHAMPIX (varenicline tartrate) 0.5 mg and 1 mg tablets Indications: CHAMPIX is indicated as an aid to smoking cessation in adults over the age of 18 years. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Precautions: May alter pharmacokinetics or pharmacodynamics of some drugs (e.g. theophylline, warfarin and insulin), may increase plasma levels of CYP1A2 substrates, may exacerbate underlying or pre-existing psychiatric illnesses (e.g. depression). Care should be taken with patients with a history of psychiatric illness. Serious neuropsychiatric symptoms including changes in behaviour, thinking,* anxiety,* psychosis,* mood swings,* agitation, aggression, depressed mood, suicidal ideation and suicidal behaviour. Patients must stop taking CHAMPIX at first sign of any of these symptoms and be advised to contact a health care professional immediately. Ongoing follow up should be provided until these symptoms resolve. Post-marketing reports of rare but potentially fatal hypersensitivity reactions including angioedema, Stevens-Johnson Syndrome,* Erythema Multiforme.* Use caution when driving or operating machinery. See Data Sheet for details. Adverse effects: More common: nausea, headache, insomnia, abnormal dreams. Common: constipation, flatulence, dry mouth, dyspepsia, vomiting, abdominal distension, stomach discomfort, fatigue, increased appetite, dizziness, dysgeusia, somnolence and sleep disorder. Post-marketing reports: neuropsychiatric symptoms (e.g. depressed mood, anxiety,* psychosis,* agitation, hallucinations, changes in behaviour, thinking,* suicidal ideation and suicide) and hypersensitivity reactions (e.g. angioedema), Stevens-Johnson Syndrome,* Erythema Multiforme*). See Data Sheet for details. Dosage and Administration: Patients should set a date to quit smoking. Dosing should start 1-2 weeks before this date. Days 1-3: 0.5mg once daily. Days 4-7: 0.5mg twice daily. Day 8 - end of 12 week treatment: 1mg twice daily. Dose tapering is not required at end of treatment. For patients with severe renal impairment: Days 1-3: 0.5mg once daily. Days 4-end of 12 week treatment: 1mg once daily. CHAMPIX is being monitored on the New Zealand Intensive Medicines Monitoring Program (IMMP). Based on CHAMPIX Data Sheet dated 31 July 2009 and amended 09 September Before prescribing please review Data Sheet available from Pfizer New Zealand Limited PO Box 3998 Auckland NEW ZEALAND or the MEDSAFE website CHAMPIX is an unfunded medicine - a prescription charge will apply. Registered trademark References: 1. CHAMPIX (varenicline tartrate) Datasheet 31 July 2009 Pfizer New Zealand Limited 2. Hughes JR. CA Cancer J Clin 2000;50(3): West R and Shiffman S. Fast Facts: smoking cessation. Oxford: Health Press, Action on Smoking and Health Australia; (accessed April 2009 at 5. Smoking Cessation Guidelines for Australian General Practice. Practice Handbook, Coe JW et al. J Med Chem 2005;48: R&A091209A.

9 POWER TO BREAK THE HOLD OF NICOTINE ADDICTION 1 COST OF SMOKING For the average smoker the monthly cost of smoking is higher than CHAMPIX. Cost of cigarette smoking Cigarettes smoked per day Cigarettes: Monthly cost* $163 $195 $244 $325 $407 Cigarettes: Annual cost* $1,956 $2,340 $2,928 $3,900 $4,884 Cost of pouch tobacco Pouches per month (50g) Pouch Tobacco: Monthly cost* $134 $202 $269 Pouch Tobacco: Annual cost* $1,614 $2,421 $3,229 Cost of CHAMPIX Pack size Starter 2 week 4 week Cost of CHAMPIX $92 # $102 # $185 # > Is the value of your patients long term health worth $6 a day - the cost of CHAMPIX? > What is the real cost of continuing to smoke financially and on health outcomes? 12 cigarettes smoked per day is the average reported in the Ministry of Health Tobacco Facts 2005 * Consumption of cigarettes x average cost of all cigarettes or pouch tobacco # Retail cost at Radius Pharmacies nationwide IT S EASIER FOR YOUR PATIENTS TO STOP SMOKING IF THEY STOP ENJOYING IT. 1

10 Reports of neuropsychiatric symptoms such as depressed mood, agitation, hallucinations, anxiety, psychosis, changes in behaviour and thinking, suicidal ideation and suicide were reported postmarketing. The role of CHAMPIX in these reports is not known. Observe patients on CHAMPIX for neuropsychiatric symptoms including changes in behaviour, or thinking, anxiety, psychosis, mood swings, agitation, aggression, depressed mood, suicidal ideation, suicidal behaviour and worsening of pre-existing psychiatric illness. Patients should be advised to stop CHAMPIX and see their doctor at the first sign of any of these symptoms. Ongoing follow-up should be provided until these symptoms resolve.(datasheet) CHAMPIX (varenicline tartrate) 0.5 mg and 1 mg tablets Indications: CHAMPIX is indicated as an aid to smoking cessation in adults over the age of 18 years. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Precautions: May alter pharmacokinetics or pharmacodynamics of some drugs (e.g. theophylline, warfarin and insulin), may increase plasma levels of CYP1A2 substrates, may exacerbate underlying or pre-existing psychiatric illnesses (e.g. depression). Care should be taken with patients with a history of psychiatric illness. Serious neuropsychiatric symptoms including changes in behaviour, thinking,* anxiety,* psychosis,* mood swings,* agitation, aggression, depressed mood, suicidal ideation and suicidal behaviour. Patients must stop taking CHAMPIX at first sign of any of these symptoms and be advised to contact a health care professional immediately. Ongoing follow up should be provided until these symptoms resolve. Post-marketing reports of rare but potentially fatal hypersensitivity reactions including angioedema, Stevens-Johnson Syndrome,* Erythema Multiforme.* Use caution when driving or operating machinery. See Data Sheet for details. Adverse effects: More common: nausea, headache, insomnia, abnormal dreams. Common: constipation, flatulence, dry mouth, dyspepsia, vomiting, abdominal distension, stomach discomfort, fatigue, increased appetite, dizziness, dysgeusia, somnolence and sleep disorder. Post-marketing reports: neuropsychiatric symptoms (e.g. depressed mood, anxiety,* psychosis,* agitation, hallucinations, changes in behaviour, thinking,* suicidal ideation and suicide) and hypersensitivity reactions (e.g. angioedema), Stevens-Johnson Syndrome,* Erythema Multiforme*). See Data Sheet for details. Dosage and Administration: Patients should set a date to quit smoking. Dosing should start 1-2 weeks before this date. Days 1-3: 0.5mg once daily. Days 4-7: 0.5mg twice daily. Day 8 - end of 12 week treatment: 1mg twice daily. Dose tapering is not required at end of treatment. For patients with severe renal impairment: Days 1-3: 0.5mg once daily. Days 4-end of 12 week treatment: 1mg once daily. CHAMPIX is being monitored on the New Zealand Intensive Medicines Monitoring Program (IMMP). Based on CHAMPIX Data Sheet dated 31 July 2009 and amended 09 September Before prescribing please review Data Sheet available from Pfizer New Zealand Limited PO Box 3998 Auckland NEW ZEALAND or the MEDSAFE website CHAMPIX is an unfunded medicine - a prescription charge will apply. Registered trademark References: 1. CHAMPIX (varenicline tartrate) Datasheet 31 July 2009 Pfizer New Zealand Limited. R&A091209A.

11 POWER TO BREAK THE HOLD OF NICOTINE ADDICTION 1 NUMBERS NEEDED TO TREAT CHAMPIX improves outcomes vs other options 2, 3 Numbers needed to treat to achieve one successful quitter Method Number Needed to Treat (NNT) Brief advice 40 4 NRT Patches 23 5 Bupropion 18 5 CHAMPIX 10 *5 There are a number of other products on the market that may be promoted as stop smoking aids. For instance nortriptyline, that has been demonstrated to help smokers but is not routinely used because it is associated with a number of side affects McEwen A et al. Manual of Smoking Cessation p 52, 2006 Blackwell Publishing, Oxford, UK 6 If you talk to your patients about smoking cessation for more than 5 minutes you can increase their estimated quit rate over 12 months by 5-7 times. 7 NNT = Numbers Needed to Treat. NNT is an epidemiological test. It is calculated based on the absolute risk reductions for each particular treatment. No statistical comparisons are made. NRT = Nicotine Replacement Therapy (all presentations) * For a typical placebo rate of 7.5% IT S EASIER FOR YOUR PATIENTS TO STOP SMOKING IF THEY STOP ENJOYING IT. 1

12 Reports of neuropsychiatric symptoms such as depressed mood, agitation, hallucinations, anxiety, psychosis, changes in behaviour and thinking, suicidal ideation and suicide were reported postmarketing. The role of CHAMPIX in these reports is not known. Observe patients on CHAMPIX for neuropsychiatric symptoms including changes in behaviour, or thinking, anxiety, psychosis, mood swings, agitation, aggression, depressed mood, suicidal ideation, suicidal behaviour and worsening of pre-existing psychiatric illness. Patients should be advised to stop CHAMPIX and see their doctor at the first sign of any of these symptoms. Ongoing follow-up should be provided until these symptoms resolve.(datasheet) CHAMPIX (varenicline tartrate) 0.5 mg and 1 mg tablets Indications: CHAMPIX is indicated as an aid to smoking cessation in adults over the age of 18 years. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Precautions: May alter pharmacokinetics or pharmacodynamics of some drugs (e.g. theophylline, warfarin and insulin), may increase plasma levels of CYP1A2 substrates, may exacerbate underlying or pre-existing psychiatric illnesses (e.g. depression). Care should be taken with patients with a history of psychiatric illness. Serious neuropsychiatric symptoms including changes in behaviour, thinking,* anxiety,* psychosis,* mood swings,* agitation, aggression, depressed mood, suicidal ideation and suicidal behaviour. Patients must stop taking CHAMPIX at first sign of any of these symptoms and be advised to contact a health care professional immediately. Ongoing follow up should be provided until these symptoms resolve. Post-marketing reports of rare but potentially fatal hypersensitivity reactions including angioedema, Stevens-Johnson Syndrome,* Erythema Multiforme.* Use caution when driving or operating machinery. See Data Sheet for details. Adverse effects: More common: nausea, headache, insomnia, abnormal dreams. Common: constipation, flatulence, dry mouth, dyspepsia, vomiting, abdominal distension, stomach discomfort, fatigue, increased appetite, dizziness, dysgeusia, somnolence and sleep disorder. Post-marketing reports: neuropsychiatric symptoms (e.g. depressed mood, anxiety,* psychosis,* agitation, hallucinations, changes in behaviour, thinking,* suicidal ideation and suicide) and hypersensitivity reactions (e.g. angioedema), Stevens-Johnson Syndrome,* Erythema Multiforme*). See Data Sheet for details. Dosage and Administration: Patients should set a date to quit smoking. Dosing should start 1-2 weeks before this date. Days 1-3: 0.5mg once daily. Days 4-7: 0.5mg twice daily. Day 8 - end of 12 week treatment: 1mg twice daily. Dose tapering is not required at end of treatment. For patients with severe renal impairment: Days 1-3: 0.5mg once daily. Days 4-end of 12 week treatment: 1mg once daily. CHAMPIX is being monitored on the New Zealand Intensive Medicines Monitoring Program (IMMP). Based on CHAMPIX Data Sheet dated 31 July 2009 and amended 09 September Before prescribing please review Data Sheet available from Pfizer New Zealand Limited PO Box 3998 Auckland NEW ZEALAND or the MEDSAFE website CHAMPIX is an unfunded medicine - a prescription charge will apply. Registered trademark References: 1. CHAMPIX (varenicline tartrate) Datasheet 31 July 2009 Pfizer New Zealand Limited 2. Aubin HJ et al. Thorax 2008;63: Nides M et al. Am J Health Behav 2008;32(6): Lancaster T, Stead LF. Physician advice for smoking cessation (review) The Cochrane Library 2007, issue Cahill K et al. Nicotine receptor partial agonists for smoking cessation (review) The Cochrane Library 2008, issue McEwen A et al., Manual of smoking cessation. A guide for counsellors and practitioners. 2006, Addiction Press: Blackwell Publishing. 7. Schayck et al. Primary Care Respiratory Journal 2008;17(3): R&A091209A.