What are the contraindications for Champix (varenicline)?

Contraindications for Champix (Varenicline)

Champix (varenicline) is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to varenicline. 1

Primary Contraindications

Varenicline has very few absolute contraindications, which include:

• History of serious hypersensitivity reactions to varenicline
• History of serious skin reactions to varenicline 1

Special Populations and Precautions

While not absolute contraindications, special precautions should be taken in the following situations:

Neuropsychiatric Considerations

• Patients with brain metastases who have a history or elevated risk of seizure should avoid varenicline due to rare seizure risk 2, 3
• Although initially concerning, recent large studies including the EAGLES trial have not found significant increases in serious neuropsychiatric events compared to nicotine patch or placebo 3

Pregnancy and Breastfeeding

• Contraindicated in women who are pregnant or actively trying to conceive 2
• Not recommended for use in women who are nursing 2
• Women of reproductive potential should receive counseling regarding reliable contraception methods 2

Renal Impairment

• No dosage adjustment needed for mild to moderate renal impairment
• For severe renal impairment (creatinine clearance <30 mL/min): reduce starting dose to 0.5 mg once daily, with maximum dose of 0.5 mg twice daily
• For end-stage renal disease on hemodialysis: maximum dose of 0.5 mg once daily 1

Common Side Effects to Monitor

While not contraindications, patients should be monitored for common side effects:

• Nausea (28-29% of patients)
• Insomnia (14%)
• Abnormal dreams (10-13%) 3
• Sleep disorders (OR 1.63,95% CI 1.29-2.07) 4

Cardiovascular Safety

• Systematic reviews have not identified significant links between varenicline and increased cardiovascular risks 2, 3
• A 2015 retrospective review of 164,766 individuals found no elevated risk of cardiovascular events with varenicline compared to nicotine replacement therapy 2

Monitoring Recommendations

When prescribing varenicline, healthcare providers should:

1. Screen for history of hypersensitivity reactions to the medication
2. Assess seizure risk, especially in patients with brain metastases
3. Counsel women of reproductive potential about contraception
4. Monitor for neuropsychiatric symptoms, though recent evidence suggests minimal risk
5. Consider dose adjustments for patients with severe renal impairment

Despite initial concerns about neuropsychiatric adverse events, multiple systematic reviews and meta-analyses have found no significant increased risk of suicide, suicidal ideation, depression, or death with varenicline use 4, providing reassurance about its safety profile when used appropriately.