testosterone topical solution (Axiron)

Axiron is a solution of testosterone that is administered through the skin of the armpit for treatment of low testosterone levels. It belongs to a class of drugs called androgens. Other testosterone replacement products include Androderm, Androgel, Testim, and Fortesta. Testosterone is the major male sex hormone responsible for the normal growth and development of the male sex organs and secondary sex characteristics. These effects include development of the prostate, penis and scrotum; distribution of facial, pubic, chest and axillary hair; development of a deep voice and alterations in muscle mass and fat distribution. Low production of testosterone leads to erectile dysfunction, reduced sexual desire, fatigue and loss of energy, depression, regression of secondary sexual characteristics and weakening of bones (osteoporosis). Testosterone replacement products supplement or replace natural production of testosterone and reverse symptoms of low testosterone levels. The FDA approved Axiron in November 2010.

What brand names are available for testosterone gel (Axiron)?

Axiron

Is testosterone gel (Axiron) available as a generic drug?

No

Do I need a prescription for testosterone gel (Axiron)?

Yes

The most common side effects are application site reactions such as itching, blisters, and redness.

Other side effects include:

• headache,
• diarrhea,
• vomiting,
• acne, enlarged breasts,
• high blood pressure,
• mood swings,
• nervousness,
• changes in libido,
• increased serum prostate specific antigen (PSA) levels, and
• increased volume of red blood cells.

Other important side effects include:

• Reduced sperm production,
• prolonged painful erection,
• enlarged prostate,
• depression, and
• worsening of heart failure also occur.

The recommended dose is 30 to 120 mg daily once every morning at approximately the same time. The starting dose is 30 mg (1 pump actuation) applied to each armpit (60 mg total). The total daily dose may be decreased to 30 mg or increased to 90 mg (3 pump actuations) or from 90 to 120 mg (4 pump actuations) based on blood testosterone levels. Hands should be washed thoroughly with soap and water after applying Axiron.

Axiron should not be used during pregnancy because testosterone is harmful to the fetus.

Axiron should not be used by nursing mothers because of the possibility of adverse effects in the nursing infant.

What preparations of testosterone gel (Axiron) are available?

PREPARATIONS: Solution: 2% (30 mg/1.5 ml actuation)

How should I keep testosterone gel (Axiron) stored?

Axiron should be stored at room temperature 15 C to 30 C (59 F to 86 F)