Testosterone (topical)

Renal Impairment No studies were conducted in patients with renal impairment.

Hepatic Impairment No studies were conducted in patients with hepatic impairment.

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. [See table below.] 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. [See table below.] 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 and Clinical Pharmacology ] .

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