Smoking Cessation Pharmacotherapy Varenicline Use

PREPARATION: Available by prescription only

Days 1 – 3: 0.5 mg once daily

Days 4 – 7: 0.5 mg twice daily

Day 8 – 1 mg twice daily at quit date and beyond

Varenicline (Chantix) information for Health Care Providers

CHANTIX should not be taken with other quit smoking medicines. You may need a lower dose of CHANTIX if you have kidney problems or get dialysis.

CHANTIX should not be taken with other quit smoking medicines. You may need a lower dose of CHANTIX if you have kidney problems or get dialysis.

Before starting Varenicline, tell your doctor if you are pregnant, plan to become pregnant, or if you take insulin, asthma medicines, or blood thinners. Medicines like these may work differently when you quit smoking.

You should use caution driving or operating machinery until you know how quitting smoking with Varenicline may affect you.

DOSAGE:

Days 1 – 3: 0.5 mg once daily
Days 4 – 7: 0.5 mg twice daily
Day   8 – End of treatment: 1 mg twice daily

ADMINISTRATION:

CHANTIX is supplied for oral administration in two strengths: a 0.5 mg capsular white to off-white, film-coated tablet debossed with "Pfizer" on one side and "CHX 0.5" on the other side and a 1 mg capsular biconvex, light blue film-coated tablet debossed with "Pfizer" onone side and "CHX 1.0" on the other side.

DURATION OF THERAPY:

  1. Patients should be treated with Varenicline for 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with Varenicline is recommended to further increase the likelihood of long-term abstinence.
  2. Patients who do not succeed in stopping smoking during 12 weeks of initial therapy, or who relapse after treatment, should be encouraged to make another attempt once factors contributing to the failed attempt have been identified and addressed. If making a new quit attempt, it is recommended that patients titrate up using the prescribed dosage as if using Varenicline for the first time. Use as prescribed.

ADVERSE REACTIONS:

  1. The most common adverse reactions include nausea, sleep disturbance, constipation, flatulence, and vomiting. Nausea occurred in 30% of patients; 3% discontinued due to nausea.   Nausia tends to be mild and lasts several days.  Nausea occurred in 30% of patients; 3% discontinued due to nausea.  
  2. Serious neuropsychiatric symptoms have occurred in patients being treated with Varenicline. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking; however, some of these symptoms have occurred in patients who continued to smoke.
  3. All patients being treated with Varenicline should be observed for neuropsychiatric symptoms including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.
  4. These symptoms, as well as worsening of pre-existing psychiatric illness, have been reported in patients attempting to quit smoking while taking Varenicline in the post-marketing experience.
  5. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies of CHANTIX and the safety and efficacy of Varenicline in such patients has not been established.
  6. Patients attempting to quit smoking with Varenicline and their families and caregivers should be alerted about the need to monitor for these symptoms and to report such symptoms immediately to the patient’s healthcare provider.

PRECAUTIONS AND CONSTRAINDICATIONS:

  1. Drug Interactions Based on varenicline characteristics and clinical experience to date, Varenicline has no clinically meaningful pharmacokinetic drug interactions.
  2. There are no adequate and well-controlled studies in pregnant women. Varenicline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  1. Although it is not known whether this drug is excreted in human milk, animal studies have demonstrated that varenicline can be transferred to nursing pups. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Varenicline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
  2. The potential effects of Varenicline on labor and delivery are not known.
  3. Varenicline is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

CONSIDERATIONS FOR THE ADOLESCENT POPULATION (ages 14-17):

  1. Because the safety and effectiveness of Varenicline in pediatric patients have not been established, Varenicline is not recommended for use in patients under 18 years of age.

SOURCES

Chantix Verenicline Tablets. Pfizer Labs, LAB-0327-7, January 2008