Patient Handout: Varenicline (Chantix®)

Description: 
See FDA package insert for more complete information.

Warnings and side effects of Varenicline (Chantix) are included in the table below. For more information, you can refer to the FDA package insert.

 

Description

Varenicline is a quit-smoking medication approved by the Food and Drug Administration. It does not contain any nicotine. It is available as Chantix® and only by prescription. You can use it for up to 12 weeks. An additional 12 weeks may be recommended by your physician after successful cessation to help maintain abstinence.

How Well Does It Work?

Studies have shown that Chantix increases short and long-term quit rates when compared to a placebo. Some evidence suggests varenicline is the most effective monotherapy available for smoking (Fiore 2010).

Warnings


Precautions
  • Suicidal thoughts, aggressive and erratic behavior, drowsiness: The Food and Drug Administration revised the warnings and precautions for varenicline (Chantix®) on February 1, 2008. Because there may be an association between Chantix and serious neuropsychiatric symptoms, they recommend that healthcare professionals monitor patients for behavior or mood changes. Patients should also be asked about history of psychiatric illness. Patients on the medication who experience these symptoms should contact their doctors. On this date the FDA requested that Pfizer, the manufacturer of Chantix, revise the warnings and precautions section of the Chantix prescribing information, labelling, and the patient medication guide to reflect this information. Patients also should use caution when driving or operating machinery until they know how smoking cessation using varenicline might affect them. As of July 1, 2009, the FDA requires new, stronger "boxed warnings" on all Chantix and varenicline labels due to symptoms of serious mental illness that could lead to depression or suicide. The manufacturers of these drugs must also describe these risks in the medication guide of each product. See the FDA Patient Information Sheet.

  • Cardiovascular: "Increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease" has been reported and so physicians will consider this in deciding whether to prescribe varenicline; also patients on varenicline "should contact their healthcare professional if they experience new or worsening symptoms of cardiovascular disease" (FDA, 2011).
  • Diabetes, asthma, and blood thinners: Consult with your doctor about whether you need to change the dosage of the drugs you take for these conditions, once you quit smoking.

  • Pregnancy, breast feeding: Your doctor will compare the risks of taking any medications during pregnancy or breast-feeding versus the benefits.

  • Kidney problems: This medication may not be right for you if you have kidney problems or your doctor may approach its use cautiously.









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Side Effects

Possibly suicidal thoughts, aggressive and erratic behavior, drowsiness (See Warnings above.)

Nausea, headache, vomiting, flatulence, insomnia, abnormal dreams, dysgeusia (altered taste) (USFDA 2006)

How Do I Take
This Medication?

  • As always, talk to your doctor about this and any medication and how you should take it.

  • Start taking the medication 1 week prior to your quit date.

  • Take one of the lower dose tablets (0.5 mg) in the morning for 3 days

  • Then take a lower dose tablet in the morning and evening for 4 days

  • Then take a full dose tablet (1 mg) morning and evening

  • Stay on medication for a total of 12 weeks. See your doctor regarding extending beyond the 12 weeks after successful cessation.









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References: Fiore, M. Smoking Cessation. The Merck Manual. 2010. Available at: https://www.fda.gov/Drugs/DrugSafety/ucm259161.htm
FDA. FDA Drug Safety Communication: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm259161.htm Retrieved July 5, 2011.

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