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androgel.com - Dosing Information for AndroGel (testosterone gel) 1.62% CIII

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The maintenance of normal testosterone levels

With AndroGel 1.62%, the total dose of testosterone can be adjusted between 20.25 mg and 81 mg in 20.25 mg increments based on the patient's response to therapy. Dosing for Daily Application of AndroGel 1.62%1 20.25 mg PUMP: One pump actuation (once daily) in the morning PACKETS: One 20.25 mg packet (once daily) in the morning 40.5 mg (Recommended Starting Dose) PUMP: Two pump actuations (once daily) in the morning PACKETS: One 40.5 mg packet (once daily) in the morning 60.75 mg PUMP: Three pump actuations (once daily) in the morning PACKETS: One 40.5 mg packet and one 20.25 mg packet (once daily) in the morning 81 mg PUMP: Four pump actuations (once daily) in the morning PACKETS: Two 40.5 mg packets (once daily) in the morning Testosterone levels should be checked at 14 and 28 days after starting treatment and periodically thereafter.1

Applying AndroGel 1.62%

AndroGel 1.62% is a daily therapy. This means that patients with hypogonadism due to associated medical conditions need to commit to applying it every morning. Remind them that applying daily helps keep testosterone levels in a normal range. If therapy is stopped, testosterone levels could return to baseline in 48-72 hours.1 1 APPLY1 AndroGel 1.62% should be applied at the same time each morning to clean, dry, intact skin

Patients should apply AndroGel 1.62% only to the upper arm(s) and shoulder(s)

Instruct patients not to apply AndroGel 1.62% to any other parts of the body, including the abdomen, genitals, chest, armpits (axillae), or knees The application area should be limited to the area that will be covered by a short-sleeve T-shirt 2 WASH1 Patients should wash their hands with soap and water immediately after application Patients should wash the application site(s) thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated 3 COVER1 Patients should cover the application site(s) with clothing after the gel has dried Children and women should avoid contact with unwashed or unclothed application site(s) of men using AndroGel 1.62% In the event that AndroGel 1.62% 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 Safety Considerations1 When you prescribe AndroGel 1.62% to your patients, it’s important to remind them of these steps for daily application to avoid unintentional exposure of women or children to AndroGel 1.62% . Secondary exposure to testosterone can produce signs of virilization. Exposure of a pregnant woman to AndroGel may result in potential hazard to the fetus. AndroGel 1.62% should be promptly discontinued until the cause of virilization is identified.

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Titration guidelines for AndroGel 1.62% Pre-dose morning serum total testosterone concentration Dose titration >750 ng/dL Decrease daily dose by 20.25 mg 350-750 ng/dL Continue on current dose <350 ng/dL Increase daily dose by 20.25 mg Clinical trial titration rates: In the 182-day clinical study, 74% of patients had their dose titrated based on treatment response. Patients’ total serum testosterone levels were assessed on Days 14, 28, and 42, and dosing adjustments were made when indicated.3 Additional considerations for titration1 Increase in hematocrit: Monitor hematocrit prior to and periodically during treatment. Monitor hemoglobin periodically. Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone replacement therapy. An increase in red blood cell mass may increase the risk of thromboembolic events Changes in serum lipid profile: Monitor lipid concentrations periodically. Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy AndroGel 1.62% and 1%: understanding the differences1,2 There are differences between AndroGel 1.62% and AndroGel 1%. AndroGel 1.62% offers patients a more concentrated formulation of testosterone than AndroGel 1%.1,2 The chart below shows other key differences, including application areas and dose adjustment.

AndroGel 1.62%1 AndroGel 1%2 Packaging options

(products are self-applied) PUMP AND PACKETS: Pump (20.25 mg per pump press) AND Packets (20.25 mg or 40.5 mg testosterone gel) PACKETS ONLY: (25 mg and 50 mg testosterone gel) Amount of daily gel at starting dose1,2,4 2.5 g of gel (40.5 mg) 5 g of gel (50 mg) Application sites 2 application sites (shoulders and upper arms) Instruct patients not to apply AndroGel 1.62% to any other parts of the body, including the abdomen, genitals, chest, armpits (axillae), or knees. The application sites and dosage of AndroGel 1% and 1.62% are not interchangeable.

4 application sites (shoulders and upper arms, and/or stomach area)

Instruct patients not to apply AndroGel 1% to any other part of the body including the genitals, chest, armpits (axillae), knees, or back. The application sites and dosage of AndroGel 1% and 1.62% are not interchangeable.

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Dosing and application AndroGel 1.62%

AndroGel 1.62% recommended starting dose: 40.5 mg (2 pumps) applied to the shoulders and upper arms once daily in the morning AndroGel 1.62% should not be applied to any other areas of the body, including the abdomen or genitals AndroGel 1.62% is supplied in a single package including 1 metered-dose pump. AndroGel 1.62% is also supplied in 20.25 mg and 40.5 mg packets is also supplied in 20.25 mg and 40.5 mg packets Dose adjustment: Titrate based on pre-dose morning serum testosterone levels from a single blood draw at approximately 14 days and 28 days after starting treatment or following dose adjustment, and assess serum testosterone levels periodically thereafter

Dosing can be adjusted between a minimum of 20.25 mg of testosterone

(1 pump actuation) and a maximum of 81 mg of testosterone (4 pump actuations) (1 pump actuation) and a maximum of 81 mg of testosterone (4 pump actuations) Each 1.25 g pump actuation contains 20.25 mg of testosterone gel AndroGel 1% AndroGel 1% recommended starting dose: 50 mg (5 grams of gel) applied to the shoulders and upper arms and/or stomach area once daily in the morning AndroGel 1% should not be applied to any other areas of the body, including the genitals

AndroGel 1% is available in 25 mg and 50 mg testosterone packets

Dose adjustment: Monitor serum testosterone levels initially and periodically during treatment and adjust dosing as needed Dosing can be adjusted between 50 mg (5 grams of gel) and 100 mg (10 grams of gel) of testosterone. If serum testosterone levels consistently exceed the normal range at a daily dose of 50 mg (5 grams of gel), AndroGel 1% therapy should be discontinued therapy should be discontinued Each 1.25 g of gel contains 12.5 mg of testosterone AbbVie has stopped manufacturing the AndroGel 1% pump for the US market (effective 12/1/13) due to low demand compared to other formulations of AndroGel.

For more information call 1-800-633-9110 or visit abbviemedinfo.com

androgel.com - Dosing Information for AndroGel (testosterone gel) 1.62% CIII

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