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WARNING
SECONDARY EXPOSURE TO TESTOSTERONE
Vogelxo (testosterone) gel, for topical use is a clear to translucent hydroalcoholic topical gel containing testosterone, an androgen. Vogelxo provides continuous transdermal delivery of testosterone for 24 hours, following a single application to intact, clean, dry skin of the shoulders and/or upper arms.
Vogelxo is available in unit-dose tubes, unit-dose packets, and a metered-dose pump. One 5-g or two 5-g tubes/packets of Vogelxo contains 50 mg or 100 mg of testosterone, respectively. One pump actuation dispenses 1.25 g of gel, which contains 12.5 mg of testosterone. Four pump actuations or eight pump actuations contain 50 mg or 100 mg of testosterone, respectively. Each metered-dose pump container is capable of dispensing 60 pump actuations.
The active pharmacological ingredient in Vogelxo is testosterone. Testosterone USP is a white to practically white crystalline powder chemically described as 17-β hydroxyandrost-4-en-3-one. The structural formula is shown in the following figure:
 |
Inactive ingredients in Vogelxo are carbomer copolymer Type B, carbomer homopolymer Type C, diisopropyl adipate, ethyl alcohol, glycerin, methyl laurate, oleyl alcohol, polyethylene glycol, propylene glycol, purified water, and tromethamine.
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 trials of another drug and may not reflect the rates observed in practice.
In a controlled clinical study, 304 patients were treated with testosterone gel 50 mg or 100 mg or placebo gel for up to 90 days. Two hundred-five (205) patients received testosterone gel 50 mg or 100 mg daily and 99 patients received placebo. Subjects could be counted in both testosterone gel treatment groups if they received both 50 mg and 100 mg at different points in the study and experienced an adverse reaction at both dose levels. Adverse reactions reported by ≥1% of the testosterone gel patients and greater than placebo are listed in Table 3.
Table 3: Incidence of Adverse Reactions (Reported by ≥1% of the Testosterone Gel Patients and Greater than Placebo) in the Controlled Clinical Trial Through 90 Days
|
Event |
Testosterone Gel 50 mg (n=103) |
Testosterone Gel 100 mg (n=149) |
Placebo |
|
Application Site Reactions |
2% |
4% |
3% |
|
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% |
|
Mood Swings |
1% |
0% |
0% |
|
Smell Disorder |
1% |
0% |
0% |
|
Spontaneous Penile Erection |
1% |
0% |
0% |
|
Taste Disorder |
1% |
1% |
0% |
The following adverse reactions occurred in fewer than 1% of patients but were greater in testosterone gel 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 testosterone gel, six patients had adverse events that led to their discontinuation. These events included: depression with suicidal ideation, urinary tract infection, mood swings and hypertension. No testosterone gel 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 g/dL) or hematocrit (≥ 58%), respectively, compared to 1.0% and 1.5% of patients in the placebo group, respectively.
In the combined U.S. and European open label extension studies, approximately 140 patients received testosterone gel for at least 6 months. The results from these studies are consistent with those reported for the U.S. controlled clinical trial.
In a 16-week clinical study, 24-hour ambulatory blood pressure monitoring (ABPM) was conducted in 122 male patients, 108 of whom completed the study. ABPM was conducted at baseline and at Week 16 of Vogelxo treatment. A total of 99 patients had acceptable 24-hour ABPM recordings at both baseline and Week 16, and were at least 85% compliant with study drug. In that group, the mean change in systolic BP from Baseline to Week 16 was 2.4 mm Hg (95% CI: 0.6, 4.1) and the mean change in diastolic BP was 0.9 mm Hg (95% CI: -0.2, 1.9). In normotensive patients with no history of hypertension (n=45), the mean ABPM systolic and diastolic blood pressures increased by 3.6 mm Hg (95% CI: 1.7, 5.5) and 1 mm Hg (95% CI: - 0.2, 2.3), respectively. In normotensive patients who were receiving antihypertensive medications (n=22), the mean ABPM systolic and diastolic blood pressures increased by 4.6 mm Hg (95% CI: -4.5, 13.7) and 3.6 mm Hg (95% CI: -0.5, 7.8), respectively.
Five patients (4.1%) on Vogelxo either started new antihypertensive medications (n=3) or had their antihypertensive medication regimen adjusted (n=2) during the ABPM study.
Of the 122 patients in the ABPM study who used Vogelxo, 5 patients (4.1%) were reported to have an adverse reaction of hypertension.
TRAVERSE was a randomized, double-blind, cardiovascular outcomes study to assess the cardiovascular (CV) safety of topical testosterone replacement therapy compared to placebo in 5,198 hypogonadal men aged 45 to 80 years with a history of CV disease or with multiple CV risk factors. The primary outcome was the incidence of the composite endpoint of major adverse cardiovascular events (MACE), consisting of CV death, non-fatal myocardial infarction (MI), and non-fatal stroke.
The mean duration of therapy was approximately 22 months. The mean duration of follow-up was 33 months. Approximately 61% of all patients discontinued topical testosterone gel or placebo therapy.
The mean patient age (±SD) was 63.3 (7.9) years, with 2,452 patients aged 65 years or more (47%); 2,847 (about 55%) patients had pre-existing cardiovascular disease, whereas 2,357 patients (about 45%) had an elevated cardiovascular risk at baseline, and mean BMI was 35 kg/m2. Approximately 80% of patients were White, 17% were Black, and 3% were of other races or ethnic groups. Approximately 69%, 84%, and 93% had diabetes mellitus, hyperlipidemia, and hypertension, respectively.
The mean serum testosterone concentration at baseline in patients receiving topical testosterone gel was 220.4 ng/dL (n=2,596). The mean serum testosterone concentrations at 12 months, 24 months, 36 months, and 48 months in patients receiving topical testosterone gel were 440.5 ng/dL (n=1,683), 420.9 ng/dl (n=1,125), 428.7 ng/dL (n=731), and 365.2 ng/dL (n=220), respectively.
For patients treated with topical testosterone gel, the incidence of MACE was 7.0% (n=182 events) and for those receiving placebo, the incidence of MACE was 7.3% (n=190 events). The study demonstrated non-inferiority of topical testosterone gel versus placebo because the upper bound of 95% CI was less than the pre-specified risk margin, of 1.5 for MACE (Hazard Ratio 0.96 [95% CI: 0.78, 1.17]).
Additional adverse reactions reported in TRAVERSE at an incidence rate >2% in either treatment group and greater in topical testosterone gel versus placebo included: nonfatal arrythmias warranting intervention (5.2% vs 3.3%), atrial fibrillation (3.5% vs 2.4%), acute kidney injury (2.3% vs 1.5%) and bone fracture (3.5% vs 2.5%). For the adverse reaction of bone fracture, each event was adjudicated by clinical review.
The following adverse reactions have been identified during post-approval use of testosterone gel products. Because the 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.
Secondary Exposure to Testosterone in Children
Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarketing surveillance of testosterone gel products. Signs and symptoms of these reported cases have included enlargement of the clitoris (with surgical intervention) or of the penis, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases with a reported outcome, these signs and symptoms were reported to have regressed with removal of the testosterone gel exposure. In a few cases, however, enlarged genitalia did not fully return to age-appropriate normal size, and bone age remained modestly greater than chronological age. In some of the cases, direct contact with the sites of application on the skin of men using testosterone gel was reported. In at least one reported case, the reporter considered the possibility of secondary exposure from items such as the testosterone gel user’s shirts and/or other fabrics, such as towels and sheets [see Warnings and Precautions (5.2)].
Cardiovascular Disorders:
Myocardial infarction, stroke [see Warnings and Precautions (5.5)].
Vascular Disorders:
Venous thromboembolism [see Warnings and Precautions (5.4)].
Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of anti-diabetic medication.
Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking warfarin, especially at the initiation and termination of androgen therapy.
The concurrent use of testosterone with corticosteroids may result in increased fluid retention and requires careful monitoring particularly in patients with cardiac, renal or hepatic disease.
Vogelxo contains testosterone, a Schedule III controlled substance in the Controlled Substances Act.
Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice.
Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression.
The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility.
The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities.
The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty.
Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors:
Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism.
Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.
Included as part of the PRECAUTIONS section.
Cases of secondary exposure resulting in virilization of children have been reported in postmarketing surveillance. Signs and symptoms have included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases, these signs and symptoms regressed with removal of the exposure to testosterone gel. In a few cases, however, enlarged genitalia did not fully return to age-appropriate normal size, and bone age remained modestly greater than chronological age. The risk of transfer was increased in some of these cases by not adhering to precautions for the appropriate use of the topical testosterone product. Children and women should avoid contact with unwashed or unclothed application sites in men using Vogelxo [see Dosage and Administration (2.2), Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)].
Inappropriate changes in genital size or development of pubic hair or libido in children, or changes in body hair distribution, significant increase in acne, or other signs of virilization in adult women should be brought to the attention of a physician and the possibility of secondary exposure to testosterone gel should also be brought to the attention of a physician. Testosterone gel should be promptly discontinued until the cause of virilization has been identified.
Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. Check hematocrit prior to initiating treatment. It would also be appropriate to re-evaluate the hematocrit 3 to 6 months after starting treatment, and then annually. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable concentration. An increase in red blood cell mass may increase the risk of thromboembolic events.
There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as Vogelxo.
In the Testosterone Replacement therapy for Assessment of long-term Vascular Events and efficacy Response in hypogonadal men (TRAVERSE) Study, a randomized, double-blind, placebo-controlled, cardiovascular (CV) outcomes study, compared to placebo, topical testosterone gel was associated with a numerically higher incidence of VTE (1.7% vs 1.2%) which included DVT (0.6% vs 0.5%) and PE events (0.9% vs 0.5%) [see Adverse Reactions (6.1)].
Evaluate patients who report signs and symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with Vogelxo and initiate appropriate workup and management [see Adverse Reactions (6.2)].
Vogelxo can increase blood pressure. In an ambulatory blood pressure monitoring (ABPM) study, Vogelxo increased the mean systolic/diastolic blood pressure by 2.4/0.9 mm Hg from baseline after 16 weeks of treatment. In patients with hypertension on antihypertensive therapy, Vogelxo increased the mean systolic/diastolic BP by 4.4/3.4 mm Hg from baseline. Blood pressure increases can increase cardiovascular (CV) risk over time.
The CV risk associated with testosterone replacement therapy was evaluated in TRAVERSE, a randomized, double-blind, placebo-controlled, CV outcomes study in men with a history of CV disease or multiple CV risk factors. In TRAVERSE, topical testosterone gel increased mean systolic blood pressure by 1.0 mm Hg from baseline to 36 months, whereas a mean decrease from baseline of 0.5 mm Hg was observed in the placebo group at this timepoint, for a mean between-group difference of 1.5 mm Hg. However, the incidences of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction [MI] and non-fatal stroke, were similar between treatment groups (7% for topical testosterone gel vs 7.3% for placebo) [see Adverse Reactions (6.1)].
Monitor blood pressure periodically in men using Vogelxo, especially men with hypertension. Vogelxo is not recommended for use in patients with uncontrolled hypertension.
Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions [see Drug Abuse and Dependence (9)].
If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids.
Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.
Due to lack of controlled evaluations in women and potential virilizing effects, Vogelxo is not indicated for use in women [see Contraindications (4) and Use in Specific Populations (8.1, 8.2)].
With large doses of exogenous androgens, including Vogelxo, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) which could possibly lead to adverse effects on semen parameters including sperm count.
Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular testosterone enanthate, which elevate blood levels for prolonged periods, has produced multiple hepatic adenomas. Vogelxo is not known to produce these adverse effects. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). If these occur, promptly discontinue Vogelxo while the cause is evaluated.
Androgens, including Vogelxo, may promote retention of sodium and water. 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 [see Adverse Reactions (6.1)].
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.
Changes in the serum lipid profile may occur. Monitor the lipid profile periodically, particularly after starting testosterone therapy and after any dose increases.
Androgens, including Vogelxo, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.
Androgens, including Vogelxo, may decrease concentrations of thyroxine-binding globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Alcohol-based products, including Vogelxo, are flammable; therefore, patients should be advised to avoid fire, flame or smoking until the Vogelxo has dried.
Testosterone has been tested by subcutaneous injection and implantation in mice and rats. In mice, the implant induced cervical-uterine tumors, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.
Testosterone was negative in the in vitro Ames and in the in vivo mouse micronucleus assays.
The administration of exogenous testosterone has been reported to suppress spermatogenesis in the rat, dog and non-human primates, which was reversible on cessation of the treatment.
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Men with known or suspected prostate or breast cancer should not use Vogelxo [see Contraindications (4) and Warnings and Precautions (5.1)].
Secondary exposure to testosterone in children and women can occur with the use of testosterone gel products in men. Cases of secondary exposure to testosterone have been reported in children.
Physicians should advise patients of the reported signs and symptoms of secondary exposure which may include the following:
Strict adherence to the following precautions is advised to minimize the potential for secondary exposure to testosterone from Vogelxo in men [see Medication Guide]
Patients using Vogelxo should apply the product as directed and strictly adhere to the following:
Inform patients that Vogelxo can cause venous thromboembolism. Advise patients of the signs and symptoms of venous thromboembolism, which may include the following: lower limb pain, edema, or erythema; and dyspnea or chest pain. Advise patients to promptly report the signs and symptoms of venous thromboembolism, discontinue use of Vogelxo, and seek urgent medical care.
Inform patients that Vogelxo may increase BP which can increase cardiovascular risk over time. Instruct patients about the importance of monitoring BP periodically while on Vogelxo. If BP increases while on Vogelxo, antihypertensive medications may need to be started, added, or adjusted to control BP, or Vogelxo may need to be discontinued.
Patients should be informed that treatment with androgens may lead to adverse reactions which include:
Distributed by:
UPSHER-SMITH LABORATORIES, LLC
Maple Grove, MN 55369 Made in Canada
Vogelxo is a registered trademark of Upsher-Smith Laboratories, LLC. All trademarks are property of their respective owners.
Revised: 7/2025
There were no reports of overdose in the testosterone gel clinical trials. There is a single report in the literature of acute overdosage after injection of testosterone enanthate. This subject had serum testosterone concentrations of up to 11,400 ng/dL, which were implicated in a cerebrovascular accident.
Treatment of overdosage would consist of discontinuation of Vogelxo, washing the application site with soap and water, and appropriate symptomatic and supportive care.
Endogenous androgens, including testosterone and dihydrotestosterone (DHT) are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of the prostate, seminal vesicles, penis, and scrotum; the development of male hair distribution, such as facial, pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, and alterations in body musculature and fat distribution.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter’s syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).
No specific pharmacodynamic studies were conducted using Vogelxo.
In a single-dose, replicate crossover clinical study evaluating 58 hypogonadal males, the serum testosterone exposures (AUC0-24 and AUC0-t) and maximum testosterone concentration (Cmax) following a topical administration of 100 mg testosterone administration as a 2 X 5 g Vogelxo tubes (applied to the shoulders/upper arms) were bioequivalent to those following a topical administration of an approved testosterone gel product.
Testosterone gel delivers physiologic amounts of testosterone, producing circulating testosterone concentrations that approximate normal levels (e.g., 300 – 1000 ng/dL) seen in healthy men.
The skin serves as a reservoir for the sustained release of testosterone into the systemic circulation. Approximately 10% of the testosterone applied on the skin surface is absorbed into the systemic circulation during a 24-hour period.
Single Dose
In a single dose, replicate crossover study, when Vogelxo 100 mg was applied, absorption of testosterone into the blood continued for the entire 24 hour dosing period. The average (± SD) AUC0-24 and AUC0-t and Cmax were 6625 (±3671) ng·hr/dL, 10425 (±5521) ng·hr/dL, and 573 (±284) ng/dL, respectively.
Multiple Dose
With single daily applications of testosterone gel 50 mg and 100 mg, follow-up measurements at 30 and 90 days after starting treatment have confirmed that serum testosterone and DHT concentrations are generally maintained within the normal range.
Figure 1 summarizes the 24-hour pharmacokinetic profile of testosterone for patients maintained on testosterone gel 50 mg or testosterone gel 100 mg for 30 days.
Figure 1: Mean Steady-State Serum Testosterone (±SD) (ng/dL) Concentrations on Day 30 in Patients Applying Testosterone Once Daily
 |
The average daily testosterone concentration produced by testosterone gel 100 mg at Day 30 was 612 (± 286) ng/dL and by testosterone gel 50 mg at Day 30 was 365 (± 187) ng/dL.
Circulating testosterone is primarily bound in the serum to sex hormone-binding globulin (SHBG) and albumin. Approximately 40% of testosterone in plasma is bound to SHBG, 2% remains unbound (free) and the rest is loosely bound to albumin and other proteins.
Testosterone is metabolized to various 17-keto steroids through two different pathways. The major active metabolites of testosterone are estradiol and DHT. The average daily DHT concentration produced by testosterone gel 100 mg at Day 30 was 555 (± 293) pg/mL and by testosterone gel 50 mg at Day 30 was 346 (± 212) pg/mL.
Figure 2 summarizes the 24-hour pharmacokinetic profile of DHT for patients maintained on testosterone gel 50 mg or testosterone gel 100 mg for 30 days.
Figure 2: Mean Steady-State Serum Dihydrotestosterone (±SD) (pg/mL) Concentrations on Day 30 in Patients Applying Testosterone Once Daily
 |
There is considerable variation in the half-life of testosterone concentration as reported in the literature, ranging from 10 to 100 minutes. About 90% of a dose of testosterone given intramuscularly is excreted in the urine as glucuronic acid and sulfuric acid conjugates of testosterone and its metabolites. About 6% of a dose is excreted in the feces, mostly in the unconjugated form. Inactivation of testosterone occurs primarily in the liver.
The potential for dermal testosterone transfer following Vogelxo use was evaluated in a clinical study between males dosed with Vogelxo and their untreated female partners. Two (2) hours after application of 50 mg of testosterone from 5 g of Vogelxo to upper arm and shoulder of one side by the male subjects, the couples (N = 48 couples) engaged in a 15 minute session of skin- to-skin contact. Serum concentrations of testosterone were monitored in the female subjects for 24 hours after the transfer procedure. Under these study conditions, unprotected female partners had a mean testosterone AUC0-24 and Cmax that were 2.8 and 4 times greater than their mean baseline values, respectively. When a shirt covered the application site or the application site was washed, study results showed less than 10% increase in testosterone AUC0-24 and Cmax, compared to baseline in these females.
In a clinical study conducted to evaluate the effect of hand washing on the residual amount of testosterone, 36 healthy male subjects received 50 mg of testosterone from 5 g of Vogelxo on a hand and applied testosterone gel to the upper arm and shoulder of one side. Subjects washed their hands with liquid soap and warm water immediately after drug application. Then the hand was allowed to air dry or patted dry with a cloth towel. A skin swab sample was collected and analyzed for testosterone content. A mean (SD) of 0.16 (0.46) to 0.65(1.03) µg of residual testosterone (i.e., 99% reduction compared to when hands were not washed) was recovered after washing hands with liquid soap and warm water.
The effect of showering (with mild soap) at 1, 2 and 6 hours post application of testosterone gel 100 mg was evaluated in a clinical trial in 12 men. The study demonstrated that the overall effect of washing was to decrease testosterone concentrations; however, when washing occurred two or more hours post drug application, serum testosterone concentrations remained within the normal range.
MEDICATION GUIDE
VOGELXO® (voh-JELKS-oh) CIII
(testosterone) gel, for topical use
What is the most important information I should know about Vogelxo?
1. Vogelxo can transfer from your body to others including, children and women. Children and women should avoid contact with the unwashed or not covered (unclothed areas) where Vogelxo has been applied to your skin. Early signs and symptoms of puberty have occurred in young children who have come in direct contact with testosterone by touching areas where men have used Vogelxo.
Children
Signs and symptoms of early puberty in a child when they come in direct contact with Vogelxo may include:
Abnormal sexual changes:
Behavior problems:
Women
Signs and symptoms in women when they come in direct contact with Vogelxo may include:
Stop using Vogelxo and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have happened through accidental touching of the area where you have applied Vogelxo.
2. To lower the risk of transfer of Vogelxo from your body to others, follow these important instructions:
What is Vogelxo?
Vogelxo is a prescription medicine that contains testosterone. Vogelxo is used to treat adult males who have low or no testosterone due to certain medical conditions.
Vogelxo is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your Vogelxo in a safe place to protect it. Never give your Vogelxo to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and it is against the law.
Vogelxo is not meant for use in women.
Do not use Vogelxo if you:
Women who are pregnant or who may become pregnant should avoid contact with the area of skin where Vogelxo has been applied.
Before using Vogelxo, tell your healthcare provider about all of your medical conditions including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using Vogelxo with certain other medicines you take can affect each other.
Especially, tell your healthcare provider if you take:
How should I use Vogelxo?
What are the possible side effects of Vogelxo? Vogelxo can cause serious side effects including:
See “What is the most important information I should know about Vogelxo?”
Call your healthcare provider right away if you have any of the serious side effects listed above.
The most common side effects of Vogelxo include:
Other side effects include more erections than are normal for you or erections that last a long time.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Vogelxo. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of Vogelxo.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Vogelxo for a condition for which it was not prescribed. Do not give Vogelxo to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about Vogelxo that is written for health professionals.
What are the ingredients in Vogelxo?
Active ingredient: testosterone
Inactive ingredients: carbomer copolymer Type B, carbomer homopolymer Type C, diisopropyl adipate, ethyl alcohol, glycerin, methyl laurate, oleyl alcohol, polyethylene glycol, propylene glycol, purified water, and tromethamine
Distributed by:
UPSHER-SMITH LABORATORIES, LLC
Maple Grove, MN 55369 Made in Canada
For more information about Vogelxo, call 1-888-650-3789 or go to www.upsher-smith.com.
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 7/2025
INSTRUCTIONS FOR USE
VOGELXO® (voh-JELKS-oh) CIII
(testosterone) gel, for topical use
Read this Instructions for Use for Vogelxo before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.
Applying Vogelxo:
Vogelxo comes in tubes, packets, or in a pump.
 |
(Figure A)
If you are using Vogelxo tubes:
If you are using Vogelxo packets:
If you are using the Vogelxo pump:
How should I store Vogelxo?
Keep Vogelxo and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 7/2025
