Chantix Continuing Month Pak

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Applies to varenicline: oral tablet

Gastrointestinal

Very common (10% or more): Nausea (up to 30%)
Common (1% to 10%): Abdominal pain, flatulence, dyspepsia, vomiting, constipation, GI reflux disease, dry mouth, abdominal pain, diarrhea, abdominal distension, toothache, flatulence
Uncommon (0.1% to 1%): Hematochezia, gastritis, change of bowel habit, eructation, aphthous stomatitis, gingival pain, dysphagia, enterocolitis, esophagitis, GI hemorrhage, mouth ulceration
Rare (less than 0.1%): Hematemesis, abnormal feces, tongue coated, gastric ulcer, intestinal obstruction, acute pancreatitis
Frequency not reported: Gall bladder disease[Ref]

Psychiatric

Very common (10% or more): Abnormal dreams, insomnia
Common (1% to 10%): Sleep disorder, nightmare
Uncommon (0.1% to 1%): Panic reaction, thinking abnormal, restlessness, mood swings, depression, anxiety, hallucinations, libido increased, libido decreased, irritability, aggression, agitation, disorientation, dissociation
Rare (less than 0.1%): Dysphoria, bradyphrenia, manic episode
Frequency not reported: Suicidal ideation, psychosis, abnormal behavior, somnambulism[Ref]

Nervous system

Very common (10% or more): Headache (up to 19%)
Common (1% to 10%): Somnolence, dizziness, dysgeusia
Uncommon (0.1% to 1%): Seizure, tremor, lethargy, hypoesthesia, amnesia, parosmia, psychomotor hyperactivity, restless legs syndrome, syncope, tremor, balance disorder convulsion, facial palsy
Rare (less than 0.1%): Cerebrovascular accident, hypertonia, dysarthria, coordination abnormal, hypogeusia, circadian rhythm sleep disorder[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis
Common (1% to 10%): Bronchitis, sinusitis, dyspnea, cough
Uncommon (0.1% to 1%): Upper respiratory tract inflammation, respiratory tract congestion, dysphonia, rhinitis allergic, throat irritation, sinus congestion, upper- airway cough syndrome, rhinorrhea, hoarseness, asthma, pleurisy, postnasal drip, epistaxis
Rare (less than 0.1%): Laryngeal pain, snoring[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus
Uncommon (0.1% to 1%): Erythema, acne, hyperhidrosis, night sweats, acne, dermatitis, dry skin, eczema, psoriasis, urticaria, photosensitivity
Frequency not reported: Severe cutaneous reactions, including Stevens Johnson Syndrome and Erythema Multiforme, angioedema[Ref]

Metabolic

Common (1% to 10%): Weight increased, decreased appetite, increased appetite, anorexia
Rare (less than 0.1%): Polydipsia, C-reactive protein increased, blood calcium decreased
Frequency not reported: Diabetes mellitus, hyperglycemia, hyperlipidemia, hyperkalemia, hypoglycemia[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia, lymphadenopathy, blood calcium decreased
Rare (less than 0.1%): Platelet count decreased, leukocytosis, splenomegaly, thrombocytopenia[Ref]

Cardiovascular

Common (1% to 10%): Chest pain
Uncommon (0.1% to 1%): Angina pectoris, tachycardia, palpitations, heart rate increased, hypertension, hot flush, chest discomfort, arrhythmia, bradycardia, ventricular extrasystoles
Rare (less than 0.1%): Atrial fibrillation, electrocardiogram ST segment depression, electrocardiogram T wave amplitude decreased, acute coronary syndrome, cardiac flutter, cor pulmonale, coronary artery disease
Frequency not reported: Myocardial infarction, hypotension, peripheral ischemia[Ref]

Endocrine

Uncommon (0.1% to 1%): Thyroid gland disorders, diabetes mellitus
Very rare (less than 0.01%): Pituitary hemorrhage[Ref]

Ocular

Uncommon (0.1% to 1%): Conjunctivitis, eye pain, dry eye, eye irritation, vision blurred, visual disturbance
Rare (less than 0.1%): Scotoma, scleral discoloration, mydriasis, photophobia, myopia, lacrimation increased, acquired night blindness, blindness transient, cataract subcapsular, ocular vascular disorder, photophobia, vitreous floaters[Ref]

Hypersensitivity

Common (1% to 10%): Seasonal allergy[Ref]

Genitourinary

Uncommon (0.1% to 1%): Pollakiuria, nocturia, menorrhagia
Rare (less than 0.1%): Glycosuria, polyuria, vaginal discharge, sexual dysfunction Frequency not reported: Abnormal urine analysis, polyuria, urine abnormality, urinary retention, menstrual disorder, erectile dysfunction[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, myalgia, back pain
Uncommon (0.1% to 1%): Muscle spasms, musculoskeletal chest pain, arthritis, osteoporosis
Rare (less than 0.1%): Joint stiffness, costochondritis, asthenia[Ref]

Renal

Frequency not reported: Nephrolithiasis, urethral syndrome, acute renal failure[Ref]

Immunologic

Uncommon (0.1% to 1%): Fungal infection, viral infection, influenza like illness[Ref]

Hepatic

Common (1% to 10%): Liver function test abnormal[Ref]

Other

Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Tinnitus, pyrexia, asthenia, malaise
Rare (less than 0.1%): Feeling cold, cyst, semen analysis abnormal, deafness, Meniere's disease, thirst[Ref]

Some side effects of varenicline may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Days 1 to 3: 0.5 mg orally once a day
Days 4 to 7: 0.5 mg orally twice a day
Days 8 to end of treatment: 1 mg orally twice a day

Comments:
-The patient should set a date to stop smoking. Dosing should start 1 to 2 weeks before this date.
-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: Smoking cessation

-Mild to moderate renal impairment (CrCl 30 mL/min or greater): No adjustment recommended
-Severe renal impairment (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

No adjustment recommended

US REMS: The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for varenicline. It includes a medication guide. For additional information: www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

US BOXED WARNINGS:
SERIOUS NEUROPSYCHIATRIC EVENTS: Serious neuropsychiatric events (e.g., depression, suicidal ideation, suicide attempt, completed suicide) have been reported in patients taking this drug. Some cases may be complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking this drug who continued to smoke. These events have occurred in patients with and without preexisting psychiatric disease.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.