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Drug overview for VOGELXO (testosterone):
Generic name: TESTOSTERONE (tess-TOSS-ter-own)
Drug class: Androgens/Anabolic Steroids
Therapeutic class: Endocrine
Testosterone, the principal endogenous androgen, is a naturally occurring androgenic anabolic steroid hormone.
Testosterone is used for replacement or substitution of diminished or absent endogenous testicular hormone caused by certain medical conditions. Diagnosis of hypogonadism must be confirmed by laboratory testing prior to initiation of testosterone therapy. (See Dosage and Administration.) The safety and efficacy of testosterone replacement therapy in men with low testosterone concentrations related to aging have not been established. (See Late-onset Hypogonadism under Uses: Uses in Males.)
Generic name: TESTOSTERONE (tess-TOSS-ter-own)
Drug class: Androgens/Anabolic Steroids
Therapeutic class: Endocrine
Testosterone, the principal endogenous androgen, is a naturally occurring androgenic anabolic steroid hormone.
Testosterone is used for replacement or substitution of diminished or absent endogenous testicular hormone caused by certain medical conditions. Diagnosis of hypogonadism must be confirmed by laboratory testing prior to initiation of testosterone therapy. (See Dosage and Administration.) The safety and efficacy of testosterone replacement therapy in men with low testosterone concentrations related to aging have not been established. (See Late-onset Hypogonadism under Uses: Uses in Males.)
DRUG IMAGES
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The following indications for VOGELXO (testosterone) have been approved by the FDA:
Indications:
Androgen deficiency
Bilateral anorchia
Bilateral orchiectomy
Chemotherapy-induced hypogonadism
Cryptorchidism
Gonadotropin releasing factor deficiency
Klinefelter's syndrome
Male hypogonadism
Primary hypogonadism due to bilateral torsion of testes
Primary hypogonadism due to orchitis
Professional Synonyms:
Absence of testes
Bilateral orchectomy
Bilateral orchidectomy
Bilateral testectomy
GnRH deficiency
Gonadotropin releasing hormone deficiency
LHRH Deficiency
Luliberin deficiency
Luteinizing hormone-releasing hormone deficiency
Male castration
Primary failure of testis due to orchitis
Primary gonadal failure due to testitis
Primary hypogonadism due to bilateral testicular torsion
Primary male hypogonadism due to orchiditis
Testoid deficiency
Testosterone deficiency
Undescended testis
Indications:
Androgen deficiency
Bilateral anorchia
Bilateral orchiectomy
Chemotherapy-induced hypogonadism
Cryptorchidism
Gonadotropin releasing factor deficiency
Klinefelter's syndrome
Male hypogonadism
Primary hypogonadism due to bilateral torsion of testes
Primary hypogonadism due to orchitis
Professional Synonyms:
Absence of testes
Bilateral orchectomy
Bilateral orchidectomy
Bilateral testectomy
GnRH deficiency
Gonadotropin releasing hormone deficiency
LHRH Deficiency
Luliberin deficiency
Luteinizing hormone-releasing hormone deficiency
Male castration
Primary failure of testis due to orchitis
Primary gonadal failure due to testitis
Primary hypogonadism due to bilateral testicular torsion
Primary male hypogonadism due to orchiditis
Testoid deficiency
Testosterone deficiency
Undescended testis
The following dosing information is available for VOGELXO (testosterone):
Diagnosis of hypogonadism must be confirmed by laboratory testing prior to initiation of testosterone therapy. To confirm this diagnosis, serum testosterone concentrations should be measured in the morning on at least 2 separate days and must be consistently below the normal range. Serum testosterone concentrations may be low later in the day in men with or without hypogonadism; therefore, measuring testosterone concentrations later in the day should be avoided.
Dosage of testosterone is variable and should be individualized according to the condition being treated; the severity of symptoms; the patient's age, gender, and history of prior androgenic therapy; and the specific testosterone preparation being used.
Various dosage regimens have been used to induce pubertal changes in hypogonadal males. Some clinicians recommend that lower dosages be used initially, followed by gradual increases in dosage as puberty progresses; subsequently, the dosage may be decreased to maintenance levels. Other clinicians state that higher dosages are required initially to induce pubertal changes and lower dosages can then be used for maintenance therapy after puberty.
The chronologic and skeletal ages of the patient must be considered when determining the initial dosage and subsequent dosage adjustment.
For replacement of endogenous testicular hormone in androgen-deficient males, the usual dosage of testosterone pellets is 150-450 mg implanted subcutaneously every 3-6 months. Dosage adjustment should be made according to the patient's tolerance and therapeutic response.
For delayed puberty, the dosage of testosterone pellets is generally less than the dosage used for male hypogonadism and for a limited period of time (e.g., 4-6 months).
Transdermal testosterone (Androderm(R)) is commercially available as a system delivering 2 mg/24 hours or 4 mg/24 hours. Dosage should be adjusted according to determinations of serum testosterone concentrations.
When Androderm(R) is used for the treatment of male hypogonadism, the usual initial transdermal dosage is 4 mg once daily administered nightly as one system delivering 4 mg/24 hours. Dosage should be adjusted according to morning serum testosterone concentrations approximately 2 weeks following initiation of therapy. Depending on requirements, dosage can be increased to 6 mg once daily administered nightly as one system delivering 4 mg/24 hours plus one delivering 2 mg/24 hours or can be decreased to 2 mg once daily administered nightly as one system delivering 2 mg/24 hours.
Patients currently maintained on a transdermal dosage of 2.5 mg once daily may be switched to one system delivering 2 mg/24 hours at the next scheduled dose. Patients currently maintained on a transdermal dosage of 5 mg once daily may be switched to one system delivering 4 mg/24 hours at the next scheduled dose.
Patients currently maintained on a transdermal dosage of 7.5 mg once daily may be switched to 6 mg once daily with one system delivering 4 mg/24 hours plus one delivering 2 mg/24 hours.
Approximately 2 weeks after switching therapy, the early morning serum testosterone concentrations should be measured in patients following system application the previous evening to ensure proper dosing.
Topical testosterone is commercially available as a 1% gel in unit-dose packets containing a 25-mg dose of testosterone (2.5 g of gel) (AndroGel(R)) or a 50-mg dose of testosterone (5 g of gel) (AndroGel(R), Vogelxo(R)); as a 1.62% gel in unit-dose packets (AndroGel(R)) containing a 20.25- or 40.5-mg
dose of testosterone (1.25 or 2.5 g of gel, respectively); as a nonaerosol metered-dose pump (AndroGel(R) (each actuation of the pump delivers 1.25 g of gel containing 20.25 mg of testosterone after priming), Fortesta(R) (each actuation of the pump delivers 0.5 g of gel containing 10 mg of testosterone after priming), Vogelxo(R) (each actuation of the pump delivers 1.25 g of gel containing 12.5 mg of testosterone after priming)); or in unit-dose tubes (Testim(R), Vogelxo(R)) containing a 50-mg dose (5 g of gel).
For the treatment of male hypogonadism, the usual initial dosage of testosterone gel 1% (AndroGel(R) 1%, Testim(R), Vogelxo(R)) is the entire contents of a packet or tube containing 50 mg of testosterone, the entire contents of 2 packets containing 25 mg of testosterone, or 4 actuations of the pump (5 g of gel) applied topically once daily, preferably in the morning; this dose delivers about 5 mg of testosterone systemically. The usual initial dosage of testosterone gel 1.62% (AndroGel(R) 1.62%)
is the entire contents of a packet containing 40.5 mg of testosterone or 2 actuations of the pump (2.5 g of gel) applied topically once daily in the morning. The usual initial dosage of Fortesta(R) is 40 mg of testosterone or 4 actuations of the pump (2 g of gel) applied topically once daily in the morning.
Dosage should be adjusted according to serum testosterone concentrations obtained at regular intervals following initiation of AndroGel(R) 1% therapy, approximately 14 days after initiating daily application of Testim(R) or Vogelxo(R), approximately 14 and 28 days after initiating daily application or dosage adjustment of AndroGel 1.62%, and approximately 14 and 35 days after initiating daily application or dosage adjustment of Fortesta(R).
If serum testosterone concentrations are below the normal range in a patient receiving AndroGel(R) 1%, the dosage can be increased initially to 75 mg of testosterone (7.5 g of gel) and, if necessary, subsequently to 100 mg of testosterone (10 g of gel). If serum testosterone concentrations exceed the normal range in a patient receiving AndroGel(R) 1% therapy, the daily dosage may be decreased. AndroGel(R) 1% should be discontinued if the serum testosterone concentrations consistently exceed the normal range at a daily dosage of 50 mg of testosterone (5 g of gel).
If serum testosterone concentrations are below the normal range in a patient receiving Testim(R) or Vogelxo(R), the dosage can be increased to 100 mg of testosterone (10 g of gel, 8 actuations of the pump).
If serum testosterone concentrations exceed 750 ng/dL in a patient receiving AndroGel(R) 1.62%, the dosage should be decreased to 20.25 mg of testosterone (1.25 g of gel, 1 actuation of the pump).
If serum testosterone concentrations are below 350 ng/dL in a patient receiving AndroGel(R) 1.62%, the dosage should be increased initially to 60.75 mg of testosterone (3.75 g of gel, 3 actuations of the pump) and, if necessary, subsequently to 81 mg of testosterone (5 g of gel, 4 actuations of the pump).
In patients receiving Fortesta(R), the dosage should be decreased by 20 mg of testosterone (2 actuations of the pump) if serum testosterone concentrations reach or exceed 2500 ng/dL or by 10 mg of testosterone (1 actuation of the pump) if serum testosterone concentrations are 1250 ng/dL or greater, but less than 2500 ng/dL; however, if a 10-mg dosage of testosterone requires further reduction, Fortesta(R) should be discontinued. If serum testosterone concentrations are below 500 ng/dL in a patient receiving Fortesta(R), the dosage of testosterone can be adjusted in 10-mg increments (1 actuation of the pump); however, the daily dosage should not exceed 70 mg of testosterone (7 actuations of the pump).
Topical testosterone is commercially available as a solution in a metered-dose pump (Axiron(R); each actuation of the pump delivers 1.5 mL of solution containing 30 mg of testosterone after priming). For the treatment of male hypogonadism, the recommended initial dosage of testosterone solution is 60 mg (2 actuations of the pump) applied topically once daily.
Dosage should be adjusted according to serum testosterone concentrations obtained following initiation of therapy and at least 14 days after initiating daily application or dosage adjustment of testosterone solution. If serum testosterone concentrations exceed 1050 ng/dL in a patient receiving testosterone topical solution, the dosage should be decreased from 60 mg (2 actuations of the pump) to 30 mg (1 actuation of the pump); however, if a 30-mg dosage of testosterone requires further reduction, testosterone topical solution should be discontinued. If serum testosterone concentrations are below 300 ng/dL in a patient receiving testosterone topical solution, the dosage of testosterone can be adjusted in 30-mg increments (1 actuation of the pump); however, the daily dosage should not exceed 120 mg of testosterone (4 actuations of the pump).
When testosterone buccal (transmucosal) tablets (Striant(R)) are used for the treatment of male hypogonadism, the usual dosage is 30 mg (one extended-release tablet) twice daily, morning and evening (about 12 hours apart). Serum testosterone concentrations should be obtained just prior to the morning dose 4-12 weeks after initiation of therapy with testosterone buccal tablets. If total serum testosterone concentrations are consistently outside of the normal range, testosterone buccal tablets should be discontinued.
Intranasal testosterone is commercially available as a gel in a metered-dose nasal pump (Natesto(R); each actuation of the pump delivers 0.122 g of gel containing 5.5 mg of testosterone after priming).
For the treatment of male hypogonadism, the recommended initial dosage of testosterone nasal gel is 1 actuation of the pump per nostril for a total dosage of 11 mg 3 times daily. Dosage should be adjusted according to serum testosterone concentrations obtained at least 1 month after initiating therapy and periodically thereafter. If serum testosterone concentrations consistently exceed 1050 ng/dL, testosterone nasal gel should be discontinued.
If serum testosterone concentrations are consistently below 300 ng/dL, testosterone nasal gel should be discontinued and alternative therapy considered. If severe rhinitis occurs, testosterone nasal gel should be temporarily interrupted until resolution of symptoms; however, if severe rhinitis persists, testosterone nasal gel should be discontinued and alternative therapy considered.
The manufacturers of testosterone enanthate injection, testosterone undecanoate injection, and testosterone transdermal system, topical gel, topical solution, nasal gel, and buccal tablets state that clinical studies involving patients with renal or hepatic impairment have not been conducted. Therefore, there are no special population dosage recommendations at this time.
Dosage of testosterone is variable and should be individualized according to the condition being treated; the severity of symptoms; the patient's age, gender, and history of prior androgenic therapy; and the specific testosterone preparation being used.
Various dosage regimens have been used to induce pubertal changes in hypogonadal males. Some clinicians recommend that lower dosages be used initially, followed by gradual increases in dosage as puberty progresses; subsequently, the dosage may be decreased to maintenance levels. Other clinicians state that higher dosages are required initially to induce pubertal changes and lower dosages can then be used for maintenance therapy after puberty.
The chronologic and skeletal ages of the patient must be considered when determining the initial dosage and subsequent dosage adjustment.
For replacement of endogenous testicular hormone in androgen-deficient males, the usual dosage of testosterone pellets is 150-450 mg implanted subcutaneously every 3-6 months. Dosage adjustment should be made according to the patient's tolerance and therapeutic response.
For delayed puberty, the dosage of testosterone pellets is generally less than the dosage used for male hypogonadism and for a limited period of time (e.g., 4-6 months).
Transdermal testosterone (Androderm(R)) is commercially available as a system delivering 2 mg/24 hours or 4 mg/24 hours. Dosage should be adjusted according to determinations of serum testosterone concentrations.
When Androderm(R) is used for the treatment of male hypogonadism, the usual initial transdermal dosage is 4 mg once daily administered nightly as one system delivering 4 mg/24 hours. Dosage should be adjusted according to morning serum testosterone concentrations approximately 2 weeks following initiation of therapy. Depending on requirements, dosage can be increased to 6 mg once daily administered nightly as one system delivering 4 mg/24 hours plus one delivering 2 mg/24 hours or can be decreased to 2 mg once daily administered nightly as one system delivering 2 mg/24 hours.
Patients currently maintained on a transdermal dosage of 2.5 mg once daily may be switched to one system delivering 2 mg/24 hours at the next scheduled dose. Patients currently maintained on a transdermal dosage of 5 mg once daily may be switched to one system delivering 4 mg/24 hours at the next scheduled dose.
Patients currently maintained on a transdermal dosage of 7.5 mg once daily may be switched to 6 mg once daily with one system delivering 4 mg/24 hours plus one delivering 2 mg/24 hours.
Approximately 2 weeks after switching therapy, the early morning serum testosterone concentrations should be measured in patients following system application the previous evening to ensure proper dosing.
Topical testosterone is commercially available as a 1% gel in unit-dose packets containing a 25-mg dose of testosterone (2.5 g of gel) (AndroGel(R)) or a 50-mg dose of testosterone (5 g of gel) (AndroGel(R), Vogelxo(R)); as a 1.62% gel in unit-dose packets (AndroGel(R)) containing a 20.25- or 40.5-mg
dose of testosterone (1.25 or 2.5 g of gel, respectively); as a nonaerosol metered-dose pump (AndroGel(R) (each actuation of the pump delivers 1.25 g of gel containing 20.25 mg of testosterone after priming), Fortesta(R) (each actuation of the pump delivers 0.5 g of gel containing 10 mg of testosterone after priming), Vogelxo(R) (each actuation of the pump delivers 1.25 g of gel containing 12.5 mg of testosterone after priming)); or in unit-dose tubes (Testim(R), Vogelxo(R)) containing a 50-mg dose (5 g of gel).
For the treatment of male hypogonadism, the usual initial dosage of testosterone gel 1% (AndroGel(R) 1%, Testim(R), Vogelxo(R)) is the entire contents of a packet or tube containing 50 mg of testosterone, the entire contents of 2 packets containing 25 mg of testosterone, or 4 actuations of the pump (5 g of gel) applied topically once daily, preferably in the morning; this dose delivers about 5 mg of testosterone systemically. The usual initial dosage of testosterone gel 1.62% (AndroGel(R) 1.62%)
is the entire contents of a packet containing 40.5 mg of testosterone or 2 actuations of the pump (2.5 g of gel) applied topically once daily in the morning. The usual initial dosage of Fortesta(R) is 40 mg of testosterone or 4 actuations of the pump (2 g of gel) applied topically once daily in the morning.
Dosage should be adjusted according to serum testosterone concentrations obtained at regular intervals following initiation of AndroGel(R) 1% therapy, approximately 14 days after initiating daily application of Testim(R) or Vogelxo(R), approximately 14 and 28 days after initiating daily application or dosage adjustment of AndroGel 1.62%, and approximately 14 and 35 days after initiating daily application or dosage adjustment of Fortesta(R).
If serum testosterone concentrations are below the normal range in a patient receiving AndroGel(R) 1%, the dosage can be increased initially to 75 mg of testosterone (7.5 g of gel) and, if necessary, subsequently to 100 mg of testosterone (10 g of gel). If serum testosterone concentrations exceed the normal range in a patient receiving AndroGel(R) 1% therapy, the daily dosage may be decreased. AndroGel(R) 1% should be discontinued if the serum testosterone concentrations consistently exceed the normal range at a daily dosage of 50 mg of testosterone (5 g of gel).
If serum testosterone concentrations are below the normal range in a patient receiving Testim(R) or Vogelxo(R), the dosage can be increased to 100 mg of testosterone (10 g of gel, 8 actuations of the pump).
If serum testosterone concentrations exceed 750 ng/dL in a patient receiving AndroGel(R) 1.62%, the dosage should be decreased to 20.25 mg of testosterone (1.25 g of gel, 1 actuation of the pump).
If serum testosterone concentrations are below 350 ng/dL in a patient receiving AndroGel(R) 1.62%, the dosage should be increased initially to 60.75 mg of testosterone (3.75 g of gel, 3 actuations of the pump) and, if necessary, subsequently to 81 mg of testosterone (5 g of gel, 4 actuations of the pump).
In patients receiving Fortesta(R), the dosage should be decreased by 20 mg of testosterone (2 actuations of the pump) if serum testosterone concentrations reach or exceed 2500 ng/dL or by 10 mg of testosterone (1 actuation of the pump) if serum testosterone concentrations are 1250 ng/dL or greater, but less than 2500 ng/dL; however, if a 10-mg dosage of testosterone requires further reduction, Fortesta(R) should be discontinued. If serum testosterone concentrations are below 500 ng/dL in a patient receiving Fortesta(R), the dosage of testosterone can be adjusted in 10-mg increments (1 actuation of the pump); however, the daily dosage should not exceed 70 mg of testosterone (7 actuations of the pump).
Topical testosterone is commercially available as a solution in a metered-dose pump (Axiron(R); each actuation of the pump delivers 1.5 mL of solution containing 30 mg of testosterone after priming). For the treatment of male hypogonadism, the recommended initial dosage of testosterone solution is 60 mg (2 actuations of the pump) applied topically once daily.
Dosage should be adjusted according to serum testosterone concentrations obtained following initiation of therapy and at least 14 days after initiating daily application or dosage adjustment of testosterone solution. If serum testosterone concentrations exceed 1050 ng/dL in a patient receiving testosterone topical solution, the dosage should be decreased from 60 mg (2 actuations of the pump) to 30 mg (1 actuation of the pump); however, if a 30-mg dosage of testosterone requires further reduction, testosterone topical solution should be discontinued. If serum testosterone concentrations are below 300 ng/dL in a patient receiving testosterone topical solution, the dosage of testosterone can be adjusted in 30-mg increments (1 actuation of the pump); however, the daily dosage should not exceed 120 mg of testosterone (4 actuations of the pump).
When testosterone buccal (transmucosal) tablets (Striant(R)) are used for the treatment of male hypogonadism, the usual dosage is 30 mg (one extended-release tablet) twice daily, morning and evening (about 12 hours apart). Serum testosterone concentrations should be obtained just prior to the morning dose 4-12 weeks after initiation of therapy with testosterone buccal tablets. If total serum testosterone concentrations are consistently outside of the normal range, testosterone buccal tablets should be discontinued.
Intranasal testosterone is commercially available as a gel in a metered-dose nasal pump (Natesto(R); each actuation of the pump delivers 0.122 g of gel containing 5.5 mg of testosterone after priming).
For the treatment of male hypogonadism, the recommended initial dosage of testosterone nasal gel is 1 actuation of the pump per nostril for a total dosage of 11 mg 3 times daily. Dosage should be adjusted according to serum testosterone concentrations obtained at least 1 month after initiating therapy and periodically thereafter. If serum testosterone concentrations consistently exceed 1050 ng/dL, testosterone nasal gel should be discontinued.
If serum testosterone concentrations are consistently below 300 ng/dL, testosterone nasal gel should be discontinued and alternative therapy considered. If severe rhinitis occurs, testosterone nasal gel should be temporarily interrupted until resolution of symptoms; however, if severe rhinitis persists, testosterone nasal gel should be discontinued and alternative therapy considered.
The manufacturers of testosterone enanthate injection, testosterone undecanoate injection, and testosterone transdermal system, topical gel, topical solution, nasal gel, and buccal tablets state that clinical studies involving patients with renal or hepatic impairment have not been conducted. Therefore, there are no special population dosage recommendations at this time.
Testosterone is administered by IM injection; percutaneously by topical application of a transdermal system, solution, or gel to the skin; intranasally; subcutaneously as a biodegradable implant; and intrabuccally (transmucosally) as a buccal tablet.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| VOGELXO 50 MG/5 GRAM GEL | Maintenance | Adults apply 50 mg (1 tube = 50 mg) by transdermal route once daily in the morning to shoulders and/or upper arms divided evenly between areas |
| VOGELXO 50 MG/5 GRAM GEL PACKT | Maintenance | Adults apply 1 packet (50 mg) by transdermal route once daily in the morning to shoulders/upper arms and/or abdomen divided evenly between areas |
| VOGELXO 12.5 MG/1.25 GRAM PUMP | Maintenance | Adults apply 4 pumps (50 mg) by transdermal route once daily in the morning to shoulders/upper arms and/or abdomen divided evenly between areas |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| TESTOSTERONE 12.5 MG/1.25 GRAM | Maintenance | Adults apply 4 pumps (50 mg) by transdermal route once daily in the morning to shoulders/upper arms and/or abdomen divided evenly between areas |
| TESTOSTERONE 1% (50 MG/5 G) PK | Maintenance | Adults apply 1 packet (50 mg) by transdermal route once daily in the morningto shoulders/upper arms and/or abdomen divided evenly between areas |
| TESTOSTERONE 50 MG/5 GRAM GEL | Maintenance | Adults apply 50 mg (1 tube = 50 mg) by transdermal route once daily in the morning to shoulders and/or upper arms divided evenly between areas |
| TESTOSTERONE 50 MG/5 GRAM PKT | Maintenance | Adults apply 1 packet (50 mg) by transdermal route once daily in the morningto shoulders/upper arms and/or abdomen divided evenly between areas |
The following drug interaction information is available for VOGELXO (testosterone):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for VOGELXO (testosterone):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 4 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
| Malignant tumor of male breast |
| Pregnancy |
| Prostatic carcinoma |
There are 9 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Acute myocardial infarction |
| Acutely decompensated chronic heart failure |
| Benign prostatic hyperplasia |
| Cerebrovascular accident |
| Erythrocytosis |
| Hyperlipidemia |
| Polycythemia vera |
| Pulmonary thromboembolism |
| Venous thrombosis |
There are 11 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Chronic heart failure |
| Chronic obstructive pulmonary disease |
| Diabetes mellitus |
| Disease of liver |
| Edema |
| Gynecomastia |
| Humoral hypercalcemia of malignancy |
| Hypertension |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
| Obesity |
| Sleep apnea |
The following adverse reaction information is available for VOGELXO (testosterone):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 32 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Gynecomastia Priapism Virilism |
Anemia Benign prostatic hyperplasia Dizziness Edema Epididymitis Headache disorder Hypercalcemia Mastalgia Mood changes Nausea Prostatic carcinoma Vomiting |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Acute myocardial infarction Cerebrovascular accident Cholestatic hepatitis Deep venous thrombosis Depression Drug-induced hepatitis Erythrocytosis Heart failure Hepatic necrosis Jaundice Malignant neoplasm of liver Neoplasm of liver Peliosis hepatis Pulmonary thromboembolism Venous thrombosis Vitreous detachment |
There are 51 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Increased hemoglobin Menstrual disorder Skin irritation |
Acne vulgaris Body fluid retention Contact dermatitis Dream disorder Dysgeusia Flu-like symptoms General weakness Hypertension Increased pubic hair Insomnia Libido changes Malaise Nervousness Parosmia Pruritus of skin Skin swelling Spontaneous penile erection Testicular atrophy |
| Rare/Very Rare |
|---|
|
Aggressive behavior Alopecia Anorexia Azoospermia Dry skin Dyspnea Fatigue Hair bleaching Hair discoloration Hirsutism Hostility Hyperhidrosis Hyperlipidemia Hypoglycemic disorder Increased libido Irritability Memory impairment Nocturia Oligospermia Paresthesia Peripheral edema Sleep apnea Symptoms of anxiety Testicular pain Urinary hesitancy Urinary incontinence Urinary retention Urinary urgency Vasodilation of blood vessels Weight gain |
The following precautions are available for VOGELXO (testosterone):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Testosterone may cause fetal harm when administered to pregnant women due to the potential for virilization of a female fetus. Androgenic effects including clitoral hypertrophy, labial fusion of the external genital fold to form a scrotal-like structure, abnormal vaginal development, and persistence of a urogenital sinus have occurred in the female offspring of women who were given androgens during pregnancy. The degree of masculinization is related to the amount of drug given to the woman and the age of the fetus; masculinization is most likely to occur in a female fetus when exposure to androgens occurs during the first trimester.
Since the risks clearly outweigh the possible benefits in women who are or may become pregnant, testosterone is contraindicated in such women. Women who become pregnant while receiving the drug should be informed of the potential hazard to the fetus. Pregnant women or those who may become pregnant should be aware of the possibility that testosterone could be transferred from patients treated with topical preparations of the drug such as their sexual partners or other individuals in close physical contact.
(See Cautions: Precautions and Contraindications.) Testosterone transdermal system (Androderm(R)) has an occlusive backing that prevents the partner from coming in contact with active ingredient in the system. Transdermal systems that inadvertently are transferred to a sexual partner should be removed immediately and the contacted skin washed. Pregnant women should avoid skin contact with testosterone topical gel application sites in men.
(See Cautions: Precautions and Contraindications.) If unwashed or unclothed skin to which testosterone topical gel has been applied comes in direct contact with the skin of a pregnant woman, the general area of contact by the woman should be washed with soap and water immediately. In vitro studies show that residual testosterone is removed by such washing.
Since the risks clearly outweigh the possible benefits in women who are or may become pregnant, testosterone is contraindicated in such women. Women who become pregnant while receiving the drug should be informed of the potential hazard to the fetus. Pregnant women or those who may become pregnant should be aware of the possibility that testosterone could be transferred from patients treated with topical preparations of the drug such as their sexual partners or other individuals in close physical contact.
(See Cautions: Precautions and Contraindications.) Testosterone transdermal system (Androderm(R)) has an occlusive backing that prevents the partner from coming in contact with active ingredient in the system. Transdermal systems that inadvertently are transferred to a sexual partner should be removed immediately and the contacted skin washed. Pregnant women should avoid skin contact with testosterone topical gel application sites in men.
(See Cautions: Precautions and Contraindications.) If unwashed or unclothed skin to which testosterone topical gel has been applied comes in direct contact with the skin of a pregnant woman, the general area of contact by the woman should be washed with soap and water immediately. In vitro studies show that residual testosterone is removed by such washing.
It is not known whether testosterone is distributed into milk. The manufacturers of testosterone enanthate injection (Delatestryl(R)) and testosterone pellets (Testopel(R)) state that because of the potential for serious adverse reactions to androgens in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman. The manufacturer of testosterone cypionate injection (Depo(R)-testosterone) states that use in nursing women is not recommended.
Testosterone topical gel, topical solution, nasal gel, transdermal system, and buccal tablets and testosterone undecanoate injection (Aveed(R)) are not indicated for use in women. Testosterone topical gel, topical solution, nasal gel, and buccal tablets and testosterone undecanoate injection also are contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants. Exposure of a female nursing infant to androgens may result in varying degrees of virilization. Testosterone and other androgens also may adversely affect lactation.
Testosterone topical gel, topical solution, nasal gel, transdermal system, and buccal tablets and testosterone undecanoate injection (Aveed(R)) are not indicated for use in women. Testosterone topical gel, topical solution, nasal gel, and buccal tablets and testosterone undecanoate injection also are contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants. Exposure of a female nursing infant to androgens may result in varying degrees of virilization. Testosterone and other androgens also may adversely affect lactation.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for VOGELXO (testosterone):
WARNING: Children accidentally exposed to this medication by direct contact with someone using it may absorb this drug through their skin. If this occurs, the child may have unwanted side effects due to testosterone gel. Children should avoid contact with the unwashed or unclothed area where the medication has been applied.
Tell both of your doctors right away if you notice unexpected signs of puberty in a child such as unusual increase in size of genitals (penis or clitoris), early development of pubic hair, increased erections (in boys) or sex drive, or aggressive behavior. To decrease this risk, carefully follow all directions for the proper use of this drug.
WARNING: Children accidentally exposed to this medication by direct contact with someone using it may absorb this drug through their skin. If this occurs, the child may have unwanted side effects due to testosterone gel. Children should avoid contact with the unwashed or unclothed area where the medication has been applied.
Tell both of your doctors right away if you notice unexpected signs of puberty in a child such as unusual increase in size of genitals (penis or clitoris), early development of pubic hair, increased erections (in boys) or sex drive, or aggressive behavior. To decrease this risk, carefully follow all directions for the proper use of this drug.
The following icd codes are available for VOGELXO (testosterone)'s list of indications:
| Androgen deficiency | |
| E29.1 | Testicular hypofunction |
| Bilateral anorchia | |
| Q55.0 | Absence and aplasia of testis |
| Chemotherapy-induced hypogonadism | |
| E29.1 | Testicular hypofunction |
| Cryptorchidism | |
| Q53 | Undescended and ectopic testicle |
| Q53.0 | Ectopic testis |
| Q53.00 | Ectopic testis, unspecified |
| Q53.01 | Ectopic testis, unilateral |
| Q53.02 | Ectopic testes, bilateral |
| Q53.1 | Undescended testicle, unilateral |
| Q53.10 | Unspecified undescended testicle, unilateral |
| Q53.11 | Abdominal testis, unilateral |
| Q53.111 | Unilateral intraabdominal testis |
| Q53.112 | Unilateral inguinal testis |
| Q53.12 | Ectopic perineal testis, unilateral |
| Q53.13 | Unilateral high scrotal testis |
| Q53.2 | Undescended testicle, bilateral |
| Q53.20 | Undescended testicle, unspecified, bilateral |
| Q53.21 | Abdominal testis, bilateral |
| Q53.211 | Bilateral intraabdominal testes |
| Q53.212 | Bilateral inguinal testes |
| Q53.22 | Ectopic perineal testis, bilateral |
| Q53.23 | Bilateral high scrotal testes |
| Q53.9 | Undescended testicle, unspecified |
| R39.83 | Unilateral non-palpable testicle |
| R39.84 | Bilateral non-palpable testicles |
| Gonadotropin releasing factor deficiency | |
| E23.3 | Hypothalamic dysfunction, not elsewhere classified |
| Klinefelter's syndrome | |
| Q98.0 | Klinefelter syndrome karyotype 47, XXY |
| Q98.1 | Klinefelter syndrome, male with more than two X chromosomes |
| Q98.4 | Klinefelter syndrome, unspecified |
| Male hypogonadism | |
| E29.1 | Testicular hypofunction |
| Primary hypogonadism due to bilateral torsion of testes | |
| E29.1 | Testicular hypofunction |
| Primary hypogonadism due to orchitis | |
| E29.1 | Testicular hypofunction |
Formulary Reference Tool