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warnings
WARNINGS Because of the potential for symptomatic hypotension and syncope, which occurred in 3% and 0.4%, respectively, of patients during in-clinic dosing, MUSE titration should be carried out under medical supervision. During post-marketing surveillance syncope occurring within one hour of administration has been reported. Patients should be cautioned to avoid activities, such as driving or hazardous tasks, where injury could result if hypotension or syncope were to occur after MUSE administration.
ADVERSE REACTIONS In-Clinic Titration In the 2 largest double-blind, parallel, placebo-controlled trials, 1511 patients received MUSE at least 1 time in the clinic setting. The most frequently reported adverse reactions during in-clinic titration included pain in the penis (36%), urethra (13%), or testes (5%). These reactions were most commonly reported as mild and transient, but about 7% of patients withdrew at this stage because of adverse reactions. Urethral bleeding/spotting and other minor abrasions to the urethra were reported in approximately 3% of patients. Symptomatic lowering of blood pressure (hypotension) occurred in 3% of patients; in addition, some lowering of blood pressure may occur without symptoms. Dizziness was reported in 4% of patients. Syncope (fainting) was reported by 0.4% of patients. (See WARNINGS ). Home Treatment 996 patients (66% of those who began titration) were studied during the home treatment portion of 2 Phase III placebo-controlled studies. Fewer than 2% of patients discontinued from these studies primarily because of adverse reactions. The following table summarizes the frequency of adverse reactions reported by patients using MUSE or placebo. Adverse Reactions Reported by ≥ 2% of Patients Treated with MUSE, and More Common than on Placebo, at Home in Phase III Placebo-Controlled Clinical Studies for up to 3 Months Event MUSE n = 486 Placebo n = 511 UROGENITAL SYSTEM Penile Pain 32% 3% Urethral Burning 12% 4% Minor Urethral Bleeding/Spotting 5% 1% Testicular Pain 5% 1% NERVOUS SYSTEM Dizziness 2% < 1% BODY AS A WHOLE Flu Symptoms 4% 2% Headache 3% 2% Pain 3% 1% Accidental Injury 3% 2% Back Pain 2% 1% Pelvic Pain 2% < 1% RESPIRATORY Rhinitis 2% < 1% Infection 3% 2% Other drug-related side effects observed during in-clinic titration and home treatment include swelling of leg veins, leg pain, perineal pain, and rapid pulse, each occurring in < 2% of patients. Female Partner Adverse Reactions The most common adverse reactions reported by female partners during placebo-controlled clinical studies was vaginal burning/itching, reported by 5.8% of partners of patients on active vs. 0.8% of partners of patients on placebo. It is unknown whether this adverse reaction experienced by female partners was a result of the medication or a result of resuming sexual intercourse, which occurred much more frequently in partners of patients on active medication. To report suspected adverse reactions, contact Meda Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or contact FDA at 1-800-FDA-1088, fax 1-800-FDA-0178 or online at www.fda.gov/medwatch.