openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
WARNINGS Testim ® should not be applied to the abdomen. Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatitis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatitis can be a life-threatening or fatal complication. Long-term therapy with testosterone enanthate, which elevates blood levels for prolonged periods has produced multiple hepatic adenomas. Transdermal testosterone is not known to produce these adverse effects. Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma. Geriatric patients and other patients with clinical or demographic characteristics that are recognized to be associated with an increased risk of prostate cancer should be evaluated for the presence of prostate cancer prior to initiation of testosterone replacement therapy. In men receiving testosterone replacement therapy, surveillance for prostate cancer should be consistent with current practices for eugonadal men (see PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility and Laboratory Tests). Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required. Gynecomastia occasionally develops and occasionally persists in patients being treated for hypogonadism. The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.
ADVERSE REACTIONS In a controlled clinical study, 304 patients were treated with Testim ® 50 mg or 100 mg or placebo gel for up to 90 days. Two hundred-five (205) patients received Testim ® 50 mg or 100 mg daily and 99 patients received placebo. Patients with adverse events that were possibly or probably related to study drug and reported by ≥1% of the Testim ® patients and greater than placebo are listed in Table 3. Table 3: Incidence of Adverse Events Judged Possibly, Probably or Definitely Related to Use of Testim® in the Controlled Clinical Trial Event Testim ® 50 mg Testim ® 100 mg Placebo Application Site Reactions 2% 4% 3% Benign Prostatic Hyperplasia 0% 1% 1% Blood Pressure Diastolic Decreased 1% 0% 0% Blood Pressure Increased 1% 1% 0% Gynecomastia 1% 0% 0% Headache 1% 1% 0% Hematocrit/hemoglobin Increased 1% 2% 0% Hot Flushes 1% 0% 0% Insomnia 1% 0% 0% Lacrimation Increased 1% 0% 0% Mood Swings 1% 0% 0% Smell Disorder 1% 0% 0% Spontaneous Penile Erection 1% 0% 0% Taste Disorder 1% 1% 0% The following adverse events possibly or probably related to Testim ® occurred in fewer than 1% of patients but were greater in Testim ® groups compared to the placebo group: activated partial thromboplastin time prolonged, blood creatinine increased, prothrombin time prolonged, appetite increased, sensitive nipples, and acne. In this clinical trial of Testim ® , six patients had adverse events that led to their discontinuation. These events included: vertigo, coronary artery disease, depression with suicidal ideation, urinary tract infection/pneumonia (none of which were considered related to Testim ® administration), mood swings and hypertension. No Testim ® patients discontinued due to skin reaction. In one foreign Phase 3 trial, one subject discontinued due to a skin-related adverse event. In the pivotal U.S. and European Phase 3 trials combined, at the 50 mg dosage strength, the percentage of subjects reporting clinically notable increases in hematocrit or hemoglobin were similar to placebo. However, in the 100 mg dose group, 2.3% and 2.8% of patients had a clinically notable increase in hemoglobin (≥ 19 gm/dL) or hematocrit (≥ 58%), respectively. In the combined ongoing U.S. and European open label extension studies, approximately 140 patients received Testim ® for at least 6 months. The preliminary results from these studies are consistent with those reported for the U.S. controlled clinical trial. DRUG ABUSE AND DEPENDENCE Testim ® contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. Oral ingestion of Testim ® will not result in clinically significant serum testosterone concentrations due to extensive first-pass metabolism.