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warnings and cautions
5 WARNINGS AND PRECAUTIONS Urinary Retention: Use caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. ( 5.1 ) Gastrointestinal Disorders: Use caution in patients with gastrointestinal obstructive disorders or decreased intestinal motility because of the risk of gastric retention. Use caution in patients with gastroesophageal reflux and/or those taking drugs that can cause or exacerbate esophagitis. ( 5.2 ) Angioedema: Angioedema has been reported with oral oxybutynin use. If symptoms of angioedema occur, discontinue GELNIQUE and initiate appropriate therapy. ( 5.3 ) Skin Hypersensitivity: Discontinue GELNIQUE in patients with skin hypersensitivity. ( 5.4 ) Central Nervous System Effects: Somnolence has been reported with GELNIQUE. Advise patients not to drive or operate heavy machinery until they know how GELNIQUE affects them. ( 5.5 ) Skin Transference: Advise patients to cover the application site with clothing if skin-to-skin contact at the application site is anticipated. Wash hands immediately after product application. ( 5.6 ) Flammable Gel: Contains alcohol-based gel. Avoid open fire or smoking until the gel has dried. ( 5.7 ) 5.1 Urinary Retention Administer GELNIQUE with caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. 5.2 Use in Patients with Gastrointestinal Disorders Administer GELNIQUE with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention. GELNIQUE, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis or intestinal atony. GELNIQUE should be used with caution in patients who have gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis. 5.3 Angioedema Angioedema requiring hospitalization and emergency medical treatment has occurred with the first or subsequent doses of oral oxybutynin. In the event of angioedema, oxybutynin-containing product should be discontinued and appropriate therapy promptly provided. 5.4 Skin Hypersensitivity In a controlled clinical trial of skin sensitization, 1 of 200 patients (0.5%) demonstrated skin hypersensitivity to GELNIQUE. Patients who develop skin hypersensitivity to GELNIQUE should discontinue drug treatment. 5.5 Central Nervous System Effects GELNIQUE is associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported, including headache, dizziness, somnolence, confusion and hallucinations. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment. Advise patients not to drive or operate heavy machinery until they know how GELNIQUE affects them. If a patient experiences anticholinergic CNS effects, drug discontinuation should be considered. 5.6 Skin Transference Transfer of oxybutynin to another person can occur when vigorous skin-to-skin contact is made with the application site. To minimize the potential transfer of oxybutynin from GELNIQUE-treated skin to another person, patients should cover the application site with clothing after the gel has dried if direct skin-to-skin contact at the application site is anticipated [see Clinical Pharmacology (12.3) ] . Patients should wash their hands immediately after application of GELNIQUE. 5.7 Flammable Gel GELNIQUE is an alcohol-based gel and is therefore flammable. Avoid open fire or smoking until gel has dried. 5.8 Myasthenia Gravis Administer GELNIQUE with caution in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction.
6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice. The most common adverse reactions (incidence > 5% and > placebo) were dry mouth, urinary tract infection, and application site reactions. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Actavis, Inc. at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies Experience The safety of GELNIQUE was evaluated in 789 patients (389 randomized to GELNIQUE 1 g and 400 randomized to placebo) during a randomized, placebo-controlled, double-blind, 12-week clinical efficacy and safety study. A subset of these 789 patients (N = 216) participated in the 14-week open-label safety extension that followed the placebo-controlled study. Of 216 patients in the safety extension, 107 were randomized to placebo gel during the double-blind, placebo-controlled 12-week study. In the combined double-blind, placebo-controlled study and the open-label safety extension, a total of 496 patients were exposed to at least one dose of GELNIQUE. Four hundred thirty-one (431) patients received at least 12 weeks of GELNIQUE treatment and 85 patients received 26 weeks of GELNIQUE treatment. The study population primarily consisted of Caucasian women (approximately 90%) with an average age of 59 years who had overactive bladder with urge urinary incontinence. Table 1 lists adverse reactions that were reported in the randomized, double-blind, placebo-controlled 12-week study in greater than 2% of patients treated with GELNIQUE and at an incidence greater than placebo. Table 1: Common Adverse Reactions in the Randomized, Double-blind, Placebo-controlled 12-Week Study (> 2% and > placebo) Adverse Reaction GELNIQUE 1 gram N = 389 n (%) Placebo N = 400 n (%) Dry mouth 29 (7.5) 11 (2.8) Urinary tract infection 27 (6.9) 17 (4.3) Application site reactions* 21 (5.4) 4 (1.0) Upper respiratory tract infection 21 (5.4) 20 (5.0) Dizziness 11 (2.8) 4 (1.0) Nasopharyngitis 11 (2.8) 9 (2.3) Fatigue 8 (2.1) 4 (1.0) Gastroenteritis viral 8 (2.1) 7 (1.8) * Includes application site pruritus, dermatitis, papules, anesthesia, erythema, irritation, pain and papules Other common adverse reactions that were reported in ≥ 1% of GELNIQUE-treated patients were headache (1.5%), constipation (1.3%), and pruritus (1.3%). Application site pruritus (2.1%) and application site dermatitis (1.8%) were the most commonly reported application site reactions. A majority of adverse reactions were described as mild or moderate in intensity, except for two patients reporting severe headache. The most common adverse reaction leading to drug discontinuation was application site reaction (0.8% with GELNIQUE versus 0.3% with placebo). The most common adverse reactions reported during the 14-week open-label extension study were application site reactions (6.0%) and dry mouth (1.9%). The most common reason for premature discontinuation was application site reactions (9 patients or 4.2%). Two of these 9 patients experienced application site reactions of severe intensity (dermatitis, urticaria, and erythema). 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of GELNIQUE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Nervous System Disorders: dizziness, somnolence, confusion Psychiatric Disorders: hallucinations