Vogelxo

VOGELXO- testosterone gel
VOGELXO- testosterone gel, metered
Upsher-Smith Laboratories, LLC

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.

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)].

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.

2.1 Dosing and Dose Adjustment

The recommended starting dose of Vogelxo is 50 mg of testosterone (one tube, one packet, or 4 pump actuations) applied topically once daily at approximately the same time each day to clean, dry intact skin of the shoulders and/or upper arms.

Dose Adjustment

To ensure proper dosing, serum testosterone concentrations should be measured. Morning, pre-dose serum testosterone concentrations should be measured approximately 14 days after initiation of therapy to ensure proper serum testosterone concentrations are achieved. If the serum testosterone concentration is below the normal range (300 ng/dL to 1,000 ng/dL), the daily Vogelxo dose may be increased from 50 mg testosterone (one tube, one packet, or 4 pump actuations) to 100 mg of testosterone (two tubes, two packets, or 8 pump actuations) once daily.

The maximum recommended dose of Vogelxo is 100 mg once daily.

2.2 Administration Instructions

Unit-Dose Tube or Packet

Upon opening the tube or packet the entire contents should be squeezed into the palm of the hand and immediately applied to the shoulders and/or upper arms (area of application should be limited to the area that will be covered by the patient’s short sleeve t-shirt [see figure below ]).

Table 1 has specific dosing guidelines for when the unit-dose tubes or packets are used.

Table 1: Specific Dosing Guideline for Using the Unit-Dose Tubes or Packets

Prescribed Daily Dose	Number of Unit-Dose Tubes or Packets	Application Method
50 mg testosterone	One unit-dose tube or packet (once daily)	Apply one unit-dose tube or packet to one upper arm and shoulder.
100 mg testosterone	Two unit-dose tubes or packets (once daily)	Apply one unit-dose tube or packet to one upper arm and shoulder and then apply one unit-dose tube or packet to the opposite upper arm and shoulder.

Multi-Dose Metered Pump

Patients should be instructed to prime the pump before using it for the first time by fully depressing the pump mechanism (actuation) 3 times and discard this portion of the product to assure precise dose delivery. After the priming procedure, patients should completely depress the pump one time (actuation) for every 12.5 mg of testosterone required to achieve the daily prescribed dosage. Table 2 has specific dosing guidelines for when the metered pump is used.

Table 2: Specific Dosing Guidelines for Using the Multi-Dose Pump

Prescribed Daily Dose	Number of Pump Actuations	Application Method
50 mg testosterone	4 (once daily)	Apply 4 pump actuations to one upper arm and shoulder
100 mg testosterone	8 (once daily)	Apply 4 pump actuations to one upper arm and shoulder and then apply 4 pump actuations to the opposite upper arm and shoulder

The prescribed amount of product should be delivered directly into the palm of the hand and immediately applied to the shoulders and/or upper arms (area of application should be limited to the area that will be covered by the patient’s short sleeve t-shirt [see figure below ]).

Do not apply Vogelxo to the genitals or to the abdomen.

Application sites should be allowed to dry completely prior to dressing.

Hands should be washed thoroughly with soap and water after Vogelxo has been applied.

Avoid fire, flame or smoking during the application of Vogelxo until the Vogelxo has dried [see Warnings and Precautions (5.2, 5.16)].

In order to prevent transfer to another person, clothing should be worn to cover the application site(s). If direct skin-to-skin contact of the application site(s) with another person is anticipated, the application site(s) must be washed thoroughly with soap and water [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].

The patient should avoid swimming or showering or washing the administration site for a minimum of 2 hours after application [see Clinical Pharmacology (12.3)].

Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from Vogelxo treated skin:

• Children and women should avoid contact with unwashed or unclothed application site(s) of men using Vogelxo.
• Vogelxo should only be applied to the upper arms and shoulders. The area of application should be limited to the area that will be covered by a short sleeve t-shirt.
• Patients should wash their hands with soap and water immediately after applying Vogelxo.
• Patients should cover the application site(s) with clothing (e.g., a t-shirt) after the gel has dried.
• Prior to any situation in which direct skin-to-skin contact of the application site(s) with another person is anticipated, patients should wash the application site(s) thoroughly with soap and water to remove any testosterone residue.
• In the event that unwashed or unclothed skin to which Vogelxo has been applied comes in direct contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible.

Figure