Testosteronedosage

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. 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. Apply to clean, dry, intact skin of the shoulders and/or upper arms. Do not apply Vogelxo to the genitals or abdomen. If morning pre-dose serum testosterone concentration is below the normal range, increase dose to 100 mg. Pre-dose serum testosterone concentration should be assessed periodically. 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 application sites thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated.

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 ). 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 ). 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. 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. The patient should avoid swimming or showering or washing the administration site for a minimum of 2 hours after application. 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