VOGELXO

In a single-dose, replicate crossover clinical study evaluating 58 hypogonadal males, the serum testosterone exposures (AUC 0-24 and AUC 0-t ) and maximum testosterone concentration (C max ) following a topical administration of 100 mg testosterone administration as a 2 × 5 g Vogelxo tubes (applied to the shoulders/upper arms) were bioequivalent to those following a topical administration of an approved testosterone gel product.

AbsorptionTestosterone gel delivers physiologic amounts of testost...

14.1 Clinical Study in Hypogonadal Males Testosterone gel was evaluated in a randomized multicenter, multi-dose, active and placebo controlled 90-day study in 406 adult males with morning testosterone levels ≤300 ng/dL. The study was double-blind for the doses of testosterone gel and placebo, but open label for the non-scrotal testosterone transdermal system. During the first 60 days, patients were evenly randomized to testosterone gel 50 mg, testosterone gel 100 mg, placebo gel, or testosterone transdermal system. At Day 60, patients receiving testosterone gel were maintained at the same dose...

Most common adverse reactions (incidence ≥ 2% of the testosterone gel patients and greater than placebo) are application site reactions and increased hematocrit. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UPSHER-SMITH LABORATORIES, LLC at 1-855-899-9180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directl...

Vogelxo is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions (5.1) ] . Vogelxo is contraindicated in women who are pregnant. Vogelxo can cause virilization of the female fetus when administered to a pregnant woman. Pregnant women need to be aware of the potential for skin transfer of testosterone from men treated with ...

Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. ( 5.1 ) Avoid unintentional exposure of women or children to Vogelxo. Secondary exposure to testosterone can produce signs of virilization. Vogelxo should be discontinued until the cause of virilization is identified. ( 5.2 ) Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone products. Evaluate patients...

7 DRUG INTERACTIONS Androgens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients. ( 7.1 ) Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of International Normalized Ratio (INR) and prothrombin time is recommended in patients taking warfarin. ( 7.2 ) Use of testosterone with corticosteroids may result in increased ...