Vogelxo
Generic: TESTOSTERONE
Basic Information
Manufacturer
Upsher-Smith Laboratories, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
2dd150f6-cdfd-4d51-8888-12b288f26262
Indications & Usage
1 INDICATIONS AND USAGE Vogelxo is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.
These men usually have low serum testosterone levels and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.
These men have low testosterone serum levels but have gonadotropins in the normal or low range.
Vogelxo is an androgen indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired).
( 1 ) Hypogonadotropic hypogonadism (congenital or acquired).
( 1 ) Limitations of Use: Safety and efficacy of Vogelxo in men with age-related hypogonadism have not been established ( 1 ) Safety and efficacy of Vogelxo in males less than 18 years old have not been established ( 8.4 ) Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure ( 1 , 12.3 ) Limitations of Use: Safety and efficacy of Vogelxo in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.
Safety and efficacy of Vogelxo in males less than 18 years old have not been established [see Use in Specific Populations (8.4) ] .
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure [see Dosage and Administration (2) and Clinical Pharmacology (12.3) ] .
These men usually have low serum testosterone levels and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.
These men have low testosterone serum levels but have gonadotropins in the normal or low range.
Vogelxo is an androgen indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired).
( 1 ) Hypogonadotropic hypogonadism (congenital or acquired).
( 1 ) Limitations of Use: Safety and efficacy of Vogelxo in men with age-related hypogonadism have not been established ( 1 ) Safety and efficacy of Vogelxo in males less than 18 years old have not been established ( 8.4 ) Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure ( 1 , 12.3 ) Limitations of Use: Safety and efficacy of Vogelxo in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.
Safety and efficacy of Vogelxo in males less than 18 years old have not been established [see Use in Specific Populations (8.4) ] .
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure [see Dosage and Administration (2) and Clinical Pharmacology (12.3) ] .
Adverse Reactions
6 ADVERSE REACTIONS 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 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 Testosterone Gel 50 mg Testosterone Gel 100 mg Placebo Event (n=103) (n=149) (n=99) 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.
6.2 Postmarketing Experience 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) ].
( 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 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 Testosterone Gel 50 mg Testosterone Gel 100 mg Placebo Event (n=103) (n=149) (n=99) 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.
6.2 Postmarketing Experience 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) ].