What is the recommended dosing regimen for prescribing Champix (varenicline) for smoking cessation?

Recommended Dosing Regimen for Champix (Varenicline) for Smoking Cessation

The recommended dosing regimen for Champix (varenicline) is to begin with 0.5 mg once daily for days 1-3, increase to 0.5 mg twice daily for days 4-7, and then 1 mg twice daily from day 8 to the end of treatment (12 weeks). 1

Initial Dosing and Titration

• Start Champix 1 week before the patient's quit date, or alternatively, the patient can begin Champix and quit smoking between days 8 and 35 of treatment 1
• Days 1-3: 0.5 mg once daily 1
• Days 4-7: 0.5 mg twice daily 1
• Day 8 to end of treatment: 1 mg twice daily (if tolerated) 2, 1
• Champix should be taken orally after eating and with a full glass of water 1

Duration of Treatment

• Standard treatment duration is 12 weeks 2, 1
• For patients who successfully quit smoking after 12 weeks, an additional 12-week course (total 24 weeks) is recommended to increase the likelihood of long-term abstinence 1
• Therapy may be extended up to 6 months to 1 year to promote continued cessation, while attempting to avoid longer periods if possible 2

Follow-up and Monitoring

• Follow-up is recommended within 2 weeks after starting pharmacotherapy (can be extended to 3 weeks to coordinate with regularly scheduled appointments) 2
• Additional periodic follow-up during therapy at minimum 12-week intervals 2
• Monitor for neuropsychiatric adverse events (depression, suicidal ideation/behavior) and discontinue if these signs occur 2
• Nausea is a common side effect that may need to be managed, especially in patients receiving chemotherapy 2

Special Populations and Dose Adjustments

• For patients with severe renal impairment (creatinine clearance <30 mL/min): start with 0.5 mg once daily, titrate to maximum of 0.5 mg twice daily 1
• For patients with end-stage renal disease on hemodialysis: maximum dose of 0.5 mg once daily 1
• No dosage adjustment needed for patients with hepatic impairment or mild to moderate renal impairment 1
• Contraindicated in patients with brain metastases due to seizure risk 2

Alternative Approaches

• For patients unable or unwilling to quit abruptly, consider a gradual approach: begin Champix and reduce smoking by 50% within first four weeks, by another 50% in the next four weeks, with the goal of complete abstinence by 12 weeks 1
• If patients continue to smoke or experience relapse, they may continue or resume the initial pharmacotherapy, or switch to combination nicotine replacement therapy before trying subsequent therapy options 2
• Consider dose reduction in patients who cannot tolerate the adverse effects 1, 3

Common Side Effects and Precautions

• Nausea is the most common side effect (incidence peaks in weeks 1-2 and declines thereafter) 4, 5
• Monitor for neuropsychiatric issues including depression and suicidal ideation/behavior 2
• In most circumstances, side effects related to smoking cessation medications are minimal and considered an acceptable risk compared to continued smoking 2
• Serious side effects are extremely rare 2

Remember that smoking cessation therapies are more likely to succeed when patients are motivated to quit and are provided with appropriate counseling and support alongside pharmacotherapy 1, 2.