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warnings and cautions
5 WARNINGS AND PRECAUTIONS Urinary Retention : Caution should be exercised in patients with clinically significant bladder outflow obstruction because of urinary retention risk. ( 5.1 ) Gastrointestinal Disorders : Use with caution in patients with gastroesophageal reflux and/or those taking drugs that can cause or exacerbate esophagitis and in patients with decreased intestinal motility or gastrointestinal obstructive disorders because of the risk of gastric retention. ( 5.2 ) 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. ( 5.3 ) Flammable Gel : Contains alcohol-based gel. Avoid open fire or smoking until the gel has dried. ( 5.4 ) Central Nervous System Effects : Somnolence has been reported with drugs containing oxybutynin. Advise patients not to drive or operate heavy machinery until they know how GELNIQUE 3% affects them. ( 5.5 ) Myasthenia Gravis : Administer GELNIQUE 3% with caution in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction. ( 5.6 ) Angioedema : Angioedema has been reported with oral oxybutynin use. If symptoms of angioedema occur, discontinue GELNIQUE 3% and initiate appropriate therapy. ( 5.7 ) Controlled Narrow-Angle Glaucoma : Administer GELNIQUE 3% with caution in patients being treated for narrow-angle glaucoma. ( 5.8 ) 5.1 Urinary Retention Use GELNIQUE 3% 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 Use GELNIQUE 3% with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention. GELNIQUE 3%, 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 3% 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 Skin Transference Transfer of oxybutynin to another person can occur when vigorous bare skin-to-skin contact is made with the application site. To minimize the potential transfer of oxybutynin from 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 3%. 5.4 Flammable Gel GELNIQUE 3% is an alcohol-based gel and is therefore flammable. Avoid open fire or smoking until gel has dried. 5.5 Central Nervous System Effects Drugs containing oxybutynin are 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 3% affects them. If a patient experiences anticholinergic CNS effects, drug discontinuation should be considered. 5.6 Myasthenia Gravis Administer GELNIQUE 3% with caution in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction. 5.7 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. 5.8 Controlled Narrow-Angle Glaucoma Administer GELNIQUE 3% with caution in patients being treated for narrow-angle glaucoma.
6 ADVERSE REACTIONS Most common adverse reactions (≥ 3%) are dry mouth, and application site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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 safety of GELNIQUE 3% was evaluated in 626 patients (210 randomized to GELNIQUE 3% 56 mg/day, 214 randomized to GELNIQUE 3% 84 mg/day and 202 randomized to placebo) during a randomized, placebo-controlled, double-blind, 12-week clinical efficacy and safety study. A subset of these 626 patients (N = 77) participated in the 24-week open-label safety extension that followed the placebo-controlled study. Of the 77 patients in the safety extension, 24 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 441 patients were exposed to at least one dose of GELNIQUE 3%. 364 patients received at least 12 weeks of GELNIQUE 3% treatment and 66 patients received an additional 24 weeks of GELNIQUE 3% treatment during the open-label safety extension. The study population primarily consisted of women (87%) of Caucasian descent (87%) with an average age of 59 years who had overactive bladder with urge urinary incontinence. Table 1 lists adverse reactions (ARs), regardless of causality, that were reported in the randomized, double-blind, placebo-controlled 12-week study at an incidence greater than placebo and in greater than 3% of patients treated with GELNIQUE 3%. Overall, 672 ARs were experienced by 51.9% of patients. Majority of the ARs were mild to moderate in intensity. The AR most commonly reported was dry mouth which was experienced by a greater proportion of patients in the oxybutynin group than the placebo group (26 patients [12.1%] in the oxybutynin 84 mg group, 10 patients [5.0%] in the placebo group). Application site erythema was the next most commonly reported AR (8 patients [3.7%] in the oxybutynin 84 mg group and 2 patients [1.0%] in the placebo group). Other commonly reported ARs experienced by more patients in the oxybutynin groups compared with placebo were application site rash (7 patients [3.3%] in the oxybutynin 84 mg group and 1 patient [0.5%] in the placebo group); application site pruritus (6 patients [2.8%] in the oxybutynin 84 mg group and 1 patient [0.5%] in the placebo group). The overall rate of application site adverse reactions of any kind was 14.2% in patients receiving GELNIQUE 3% as compared to 3.7% in patients receiving placebo. Other cholinergic AEs < 2% in occurrence include dry eyes and blurred vision. There were no deaths during the study. There were no clinically meaningful changes in vital signs, laboratory values, or ECG examinations over the course of the study. Table 1: Commonly Reported Adverse Reactions that were reported in greater than 3% of patients treated with GELNIQUE 3% and at an incidence greater than placebo. Treatment Group Preferred Term * Oxybutynin 84 mg/day (N = 214) Placebo (N = 202) n (%) n (%) Dry mouth 26 (12.1) 10 (5.0) Application site erythema 8 (3.7) 2 (1.0) Application site rash 7 (3.3) 1 (0.5) * Each patient is counted only once within each treatment, body system and preferred term. All percentages are based on number of patients in the ITT population within each treatment group as denominator. During the 24-week open-label safety extension, the most commonly reported ARs were urinary tract infection and nasopharyngitis reported in 4 patients each (5.2%), followed by conjunctivitis and application site erythema (both occurred in 3 patients [3.9%]). One patient prematurely discontinued due to the application site erythema and pruritus (both considered to be of mild severity). 6. 2 Po s t m a r k e t ing E x perie n ce 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