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Axiron® (testosterone) topical solution CIII
The U.S. Food and Drug Administration (FDA) has approved Axiron® (testosterone) topical
solution CIII for replacement therapy in men for certain conditions associated with a deficiency or
absence of endogenous testosterone, including primary hypogonadism (congenital or acquired)
and hypogonadotropic hypogonadism (congenital or acquired). Safety and efficacy of Axiron in
males younger than 18 years of age have not been established. Axiron is the first testosterone
topical solution approved for application via an armpit (underarm) applicator.
Axiron is applied to the underarm once daily using a metered dose applicator. Patients who use
antiperspirant or deodorant should apply it before using Axiron to avoid contamination of the
The data submission package for Axiron included findings from a Phase III multi-center, open
label, 120-day clinical study which demonstrated that 84 percent of men who completed the study
achieved average serum testosterone concentration within the normal range of 300-1050 ng/dL.
Additionally, after 120 days of treatment, 75 percent of responding patients finished the study on
the recommended starting dose of 60 mg.1
HOW AXIRON WORKS
Axiron is applied to the underarm once daily using a metered dose applicator. Once dry, Axiron
leaves testosterone on the skin, which acts as a reservoir from which testosterone is released to
the systemic circulation over time. This can result in testosterone concentration within the normal
range in most men.1
AXIRON AND TRANSFERENCE
Axiron can be transferred to others through skin-to-skin contact. Men who use Axiron should
apply the product using the applicator only to the underarm and always wash their hands with
soap and water immediately after use. After the solution has dried, men should cover the
application area with clothing. Women and children should avoid contact with the unwashed or
unclothed area where Axiron has been applied.1
ABOUT TESTOSTERONE DEFICIENCY
Testosterone deficiency is a clinical condition in which the testicles, hypothalamus or pituitary
gland is affected by disease or damage that results in inhibiting hormone secretion and
Although the total number of men with testosterone deficiency is unknown, it has been estimated
that up to 13 million men over 45 years of age may have symptoms associated with low
Signs/symptoms associated with male hypogonadism include erectile dysfunction and decreased
sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual
characteristics and osteoporosis.1 Men with symptoms of testosterone deficiency should consult
with their healthcare provider. Testosterone deficiency can be detected with a simple blood test. Important Safety Information about Axiron
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
• Virilization has been reported in children who were secondarily exposed to topical
• Children should avoid contact with unwashed or unclothed application sites in men using
• Healthcare providers should advise patients to strictly adhere to recommended
instructions for use
Axiron can transfer from your body to others. This can happen if other people come into contact
with the area where Axiron was applied. Signs of puberty that are not expected (for example,
pubic hair) have happened in young children who were accidentally exposed to testosterone
through skin to skin contact with men using topical testosterone products like Axiron. Women and
children should avoid contact with the unwashed or unclothed area where Axiron has been
applied. If a woman or child makes contact with the application area, the contact area on the
woman or child should be washed well with soap and water right away.
To lower the risk of transfer of Axiron from your body to others, you should follow these important
instructions. Apply Axiron only to your armpits using the applicator and wash your hands right
away with soap and water after applying Axiron. After the solution has dried, cover the application
area with clothing. Keep the area covered until you have washed the application area well or
have showered. If you expect another person to have direct skin-to-skin contact with your
underarm, first wash the application area well with soap and water.
Stop using Axiron and call your healthcare provider right away if you see any signs and
symptoms in a child or a woman that may have occurred through accidental exposure to Axiron.
Signs and symptoms in children may include enlarged penis or clitoris; early development of
pubic hair; increased erections or sex drive; aggressive behavior. Signs and symptoms in women
may include changes in body hair and a large increase in acne. Who should not use Axiron
Do not use Axiron if you have or might have prostate cancer, have breast cancer, are pregnant or
may become pregnant or are breast-feeding. Axiron may harm your unborn or breast-feeding
baby. Women who are pregnant or who may become pregnant should avoid contact with the area
of skin where Axiron has been applied. What men should tell their healthcare provider before using Axiron
Before you use Axiron, tell your healthcare provider about all your medical conditions, especially
if you have breast cancer, have or might have prostate cancer, urinary problems due to an
enlarged prostate, heart problems, kidney or liver problems or problems breathing while you
sleep (sleep apnea).
Tell your healthcare provider about all the medicines you take, including prescription and non-
prescription medicines, vitamins and herbal supplements. Using Axiron with other medicines can
affect each other. Especially, tell your healthcare provider if you take insulin, medicines that
decrease blood clotting or corticosteroids.
What are the possible side effects of Axiron
Axiron can cause serious side effects. If you already have enlargement of your prostate gland,
your signs and symptoms can get worse while using Axiron. There is a possible increased risk of
prostate cancer. Your healthcare provider should check for prostate cancer or any other prostate
problems before you start and while you use Axiron. In large doses Axiron may lower your sperm
count. You may experience swelling of your ankles, feet or body, enlarged or painful breasts,
problems breathing while you sleep (sleep apnea) or blood clots in the legs (which could include
pain, swelling or redness). Stop using Axiron and call your healthcare provider right away if you
have any of the serious side effects listed above.
The most common adverse reactions were skin redness or irritation where Axiron is applied,
increased red blood cell count, headache, diarrhea, vomiting and increase in blood level of
Prostate Specific Antigen (a test used to screen for prostate cancer). Other side effects include
more erections than are normal for you or erections that last a long time.
Axiron is flammable until dry. Let Axiron dry before smoking or going near an open flame.
For additional safety information, please see the medication guide at http://pi.lilly.com/us/axiron-
medguide.pdf or full Prescribing Information, including Boxed Warning, at
1 Axiron Prescribing Information. Last accessed on November 23, 2010.
2 Winters, S. Current Status of Testosterone Replacement in Men. Archives of Family Medicine. 1999;8:257-263. Available at http://archfami.ama-assn.org/cgi/content/full/8/3/257. Last accessed on November 14, 2010.
3 Mulligan, T., Frick, M., Zuraw, Q., Stemhagen, A. and McWhirter, C. Prevalence of Hypogonadism in Males Aged at Least 45 Years; The HIM Study. International Journal of Clinical Practice. Available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1569444/. Last accessed on November 14, 2010.
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