Drugplain

Vogelxo 12.5 mg/1

Testosterone · GEL, METERED · Upsher-Smith Laboratories, LLC

No Recall History
Plain English

Vogelxo is a gel, metered containing testosterone at 12.5 mg/1, taken topical. Manufactured by Upsher-Smith Laboratories, LLC.

Key Facts

Brand Name
Vogelxo
Generic Name
Testosterone
NDC Code (Product)
0245-0872
Manufacturer
Upsher-Smith Laboratories, LLC
Strength
12.5 mg/1
Dosage Form
GEL, METERED
Route
TOPICAL
Marketing Status
DEA Schedule
Schedule III (Controlled)
Application #
NDA204399
Drug Class
Androgen [EPC]
Marketing Start
06/09/2014

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective1,381 reports
off label use1,162 reports
fatigue1,114 reports
nausea806 reports
pain743 reports
headache739 reports
diarrhoea595 reports
anxiety594 reports
asthenia578 reports
dizziness574 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 a…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Prior to initiating Vogelxo, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range. Prior to initiating Vogelxo, confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range ( 2 ). Recommended starting dose for adult males: 50 mg of testosterone (one tube or one packet or 4 pump actuations) applied topically once daily at approximately the same time each day. ( 2.1 ) Apply to clean, dry, intact skin of the shoulders and/or upper arms. Do not apply Vogelxo to the genitals or abdomen. ( 2.1 , 2.2 ) If morning pre-dose serum testosterone concentration is below the normal range, increase dose to 100 mg. ( 2.1 ) Pre-dose serum testosterone concentration should be assessed periodically. ( 2.1 ) Patients should wash hands with soap and water immediately after applying Vogelxo and cover application site(s) with clothing after gel has dried. Wash the applicatio…

Contraindications

4 CONTRAINDICATIONS 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 Vogelxo. If a pregnant woman is exposed to Vogelxo, she should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5.2) and Use in Specific Populations (8.1 )]. Men with known carcinoma of the breast or known or suspected carcinoma of the prostate. ( 4 , 5.1 ) Women who are pregnant. Testosterone may cause fetal harm. ( 4 , 8.1 )

Drug Interactions

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 fluid retention. Use with caution, particularly in patients with cardiac, renal or hepatic disease. ( 7.3 ) 7.1 Insulin 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. 7.2 Oral Anticoagulants 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. 7.3 Corticosteroids The concurrent use of testosterone with corticosteroids may result in increased fluid retention and re…

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: Inci…

Frequently Asked Questions

What is Vogelxo used for?

Vogelxo contains Testosterone. It is a gel, metered taken topical. Consult your doctor for specific uses.

Is Vogelxo a controlled substance?

Yes, Vogelxo is classified as CIII under the DEA Controlled Substances Act.

What is the generic name for Vogelxo?

The generic name for Vogelxo is Testosterone. There are 12 other brand versions of Testosterone.

What is the NDC code for Vogelxo 12.5 mg/1?

The NDC (National Drug Code) for Vogelxo 12.5 mg/1 is 0245-0872, listed by Upsher-Smith Laboratories, LLC.

Product NDC

0245-0872

Package NDC

0245-0872-42

Other Testosterone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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