Updates to Chantix Prescribing Information
February 22, 2019 – The U.S. FDA has approved an update to the prescribing information for Chantix® (varenicline), manufactured by Pfizer. The drug, which is approved to aid in smoking cessation, now has a label that reflects it should not be used in patients who are 16 years of age or younger.
Originally approved in 2006 for use by adult patients, Chantix was studied in pediatric populations as a requirement of the Pediatric Research Equity Act. The study found that Chantix did not have a significant impact on abstinence in patients ages 12 to 16 years.
Recommended dosing with Chantix begins at 0.5mg once daily for the first three days, then increases to 0.5mg twice daily for the remainder of the first week. After the first week, 1mg should be taken twice daily for a total of 12 weeks. Extending treatment for another 12 weeks can help patients who successfully quit smoking maintain long-term abstinence. Chantix should be used in conjunction with appropriate educational materials and counseling to support smoking cessation.