Usual Adult Dose for Smoking Cessation

Days 1 to 3: 0.5 mg orally once a day
Days 4 to 7: 0.5 mg orally 2 times a day
Days 8 to end of treatment: 1 mg orally 2 times a day
Duration of therapy: 12 weeks

Comments:

• The patient should set a date to stop smoking. Dosing should start 1 to 2 weeks before this date OR the patient may begin treatment and quit smoking between Days 8 and 35.
• Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided with additional advice and support.
• In smoking cessation therapy, risk for relapse to smoking is elevated in the period immediately following the end of treatment.

Use: As an aid to smoking cessation treatment

Renal Dose Adjustments

Mild to moderate renal dysfunction (CrCl 30 mL/min or greater): No adjustment recommended.
Severe renal dysfunction (CrCl less than 30 mL/min): Recommended initial dose of 0.5 mg orally once a day; may be titrated up to a maximum dose of 0.5 mg 2 times a day
End-stage renal disease undergoing hemodialysis: A maximum dose of 0.5 mg once daily may be administered if tolerated

Liver Dose Adjustments

No adjustment recommended.

Dose Adjustments

Duration of Treatment:

• Patients should reduce smoking during the first 12 weeks of treatment and quit by the end of that treatment period.
• The likelihood of long-term abstinence increases with additional treatment.
• Some experts recommend that patients continue therapy for an additional 12 weeks for a total of 24 weeks of treatment.

Patients Unable/Unwilling to Quit Abruptly:

• A gradual approach to quitting (over 12 weeks) should be considered.
• First 4 weeks: Begin treatment and reduce smoking by 50% from baseline.
• Next 4 weeks: Continue treatment and reduce smoking by an additional 50% from baseline.
• Last 4 weeks: Continue treatment and reduce smoking, with the goal of abstinence at the end of 12 weeks.
• Continue this drug for an additional 12 weeks.
• Patients should be encouraged to stop smoking earlier if they feel ready.

Quit Attempts: Patients who are motivated to quit and who do not succeed in stopping smoking during prior 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.

Specific Populations:

• Patients Who Develop Intolerable Side Effects: A temporary or permanent dose reduction should be considered in patients who cannot tolerate the adverse effects of this drug.
• Patients with a High Risk of Relapse: Dose tapering is not required at the end of treatment; however, the dose may be tapered off at the end of treatment for patients with a high risk of relapse.

Precautions

CONTRAINDICATIONS:

• Serious hypersensitivity or skin reactions to the active component or any of the ingredients

Safety and efficacy have not been established in children.

Consult WARNINGS section for additional precautions.

Dialysis

End-stage renal disease undergoing hemodialysis: A maximum dose of 0.5 mg once daily may be administered if tolerated
Peritoneal dialysis: Data not available

Other Comments

Administration advice:

• The tablets should be swallowed whole with water.
• This drug can be taken with food.

Patient advice:

• Inform patients that this drug may cause (dizziness, loss of consciousness, and sleepiness, and they should avoid driving or operating machinery if these side effects occur.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

Frequently asked questions

• What is the mechanism of action of Tyrvaya?
• How long does a bottle of Tyrvaya last?
• Does Tyrvaya reduce inflammation?