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Indication and Important Safety Information

INDICATION

EVOXAC is a cholinergic agonist indicated for the treatment of symptoms of dry mouth in adults with Sjögren’s disease.

Important Safety Information

CONTRAINDICATIONS

EVOXAC is contraindicated in patients:
•when miosis is undesirable, e.g., acute iritis and narrow-angle (angle-closure) glaucoma.
•with known hypersensitivity to cevimeline.
•with uncontrolled asthma.

WARNINGS AND PRECAUTIONS

Cardiovascular Adverse Reactions: EVOXAC can alter cardiac conduction and/or heart rate. Monitor patients with a history of atrial fibrillation or cardiovascular disease.

Pulmonary Adverse Reactions: EVOXAC can increase airway resistance, bronchial smooth muscle tone, and bronchial secretions. Monitor patients with controlled asthma, chronic bronchitis, or chronic obstructive pulmonary disease.

Ophthalmic Adverse Reactions: EVOXAC may cause ophthalmic adverse reactions. Muscarinic agonists may cause visual blurring, decreased visual acuity (especially at night and in patients with central lens changes) and impaired depth perception. EVOXAC is not approved for topical ophthalmic use. Advise caution while driving or performing hazardous activities.

Cholinergic Adverse Reactions: Monitor patients for adverse reactions related to EVOXAC’s cholinergic effects. Closely monitor patients with a history of nephrolithiasis or cholelithiasis.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥3%) observed with EVOXAC capsules that occurred more frequently than with placebo were excessive sweating, nausea, sinusitis, upper respiratory tract infection, rhinitis, abdominal pain, urinary tract infection, coughing, vomiting, injury, back pain, bronchitis, arthralgia, and fatigue.

DRUG INTERACTIONS

Beta-adrenergic Antagonists: Closely monitor patients who concomitantly use beta adrenergic antagonists for cardiac conduction disturbances.

Muscarinic Antagonists: Closely monitor patients who concomitantly use muscarinic antagonists. Concomitant use may interfere with antimuscarinic drugs effects.

Cholinergic Agonists: Closely monitor patients who concomitantly use cholinergic agonists. Concomitant use may increase the risk of EVOXAC-associated adverse reactions.

CYP2D6 and CYP3A3/4 Inhibitors: Closely monitor patients who concomitantly use CYP2D6 and CYP3A3/4 inhibitors. Concomitant use may increase the risk of EVOXAC-associated adverse reactions.

USE IN SPECIFIC POPULATIONS

EVOXAC is not recommended during breastfeeding and for one day after the last dose.
Closely monitor patients with known or suspected CYP2D6 deficiency.

REPORTING SUSPECTED ADVERSE REACTIONS

To report suspected adverse reactions, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see the full Prescribing Information for EVOXAC.