Axiron

Axiron is a prescription medication used to treat low testosterone levels (hypogonadism) in men who do not produce enough natural testosterone. 

Axiron is a hormone that is usually produced by the body. It controls the growth, development, and function of male sexual organs and characteristics.

This medication comes as a topical solution and is applied to the body once daily, in the morning. 

Common side effects of Axiron include irritation and redness at the site of application, headache, diarrhea, and vomiting.

Axiron is a prescription medication used to treat low testosterone levels in men who do not produce enough natural testosterone.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age
• your gender

The recommended dose range of Axiron (testosterone) for the treatment of hypogonadism in males is 60 to 120 mg daily applied to the armpits. 

The recommended starting dose of Axiron (testosterone) is 60 mg of testosterone (1 pump actuation of 30 mg of testosterone to each armpit), applied once daily, at the same time each morning.

WARNING: SECONDARY EXPOSURE TO AXIRON

• Virilization has been reported in children who were secondarily exposed to Axiron gel.
• Children should avoid contact with unwashed or unclothed application sites in men using Axiron.
• Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

Serious side effects have been reported with Axiron including the following:

• Swelling of the hands, feet, ankles, and lower legs
• Breathing problems, especially during sleep
• Excessive frequency or duration of penile erections in males
• Difficulty urinating or changes in urination habits
• Changes in skin color
• Liver dysfunction or liver cancer

Do not use Axiron if you:

• are allergic to Axiron or to any of its ingredients
• are a male with breast or prostate cancer
• are pregnant or may become pregnant
• are breastfeeding or plan to breastfeed

Serious side effects have been reported with Axiron. See the “Axiron Precautions” section.

Common side effects of Axiron include the following:

• Skin irritation at the site of application
• Diarrhea
• Vomiting
• Breast enlargement
• Decreased sexual desire
• Acne
• Hair loss
• Hot flashes
• Depression
• Changes in mood
• Nervousness
• Headache
• Weakness
• Insomnia
• Dry skin
• Changes in the ability to taste or smell
• Increase in red blood cell count
• Increase in serum Prostate Specific Antigen (PSA, a test used to screen for prostate cancer) 

This is not a complete list of Axiron side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Oral steroids such as dexamethasone (Decadron, Dexone), methylprednisone (Medrol), and prednisone (Deltasone)
• Inhaled steroids such as beclomethasone (QVAR), budesonide (Pulmicort, Rhinocort), flunisolide (AeroBid), fluticasone (Flovent, in Advair), and triamcinolone (Azmacort)
• Topical steroids such as alclometasone (Aclovate), betamethasone (Diprolene, Valisone), clobetasol (Temovate), desonide (DesOwen), Desoximetasone (Topicort), diflorasone (Psorcan, Florone), Fluocinolone (Derma-Smoother, Flurosyn, Synalar), fluocinonide (Lidex), flurandrenolide (Cordran), fluticasone (Cutivate), halcinonide (Halog), halobetasol (Ultravate), hydrocortisone (Cortizone, Westcort), mometasone (Elocon), and triamcinolone (Aristocort)
• Anticoagulants such as warfarin (Coumadin)
• Cosyntropin
• Propanolol (Inderal)
• Insulin

This is not a complete list of Axiron drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Axiron falls into category X. It has been shown that women taking Axiron during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. Axiron should never be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known how much medication in Axiron transfers into human milk. Axiron is contraindicated (not recommneded) in nursing women because of the potential for serious adverse reactions in nursing infants. Axiron and other androgens may affect lactation. 

• Testosterone may cause harmful effects to women and children who are exposed to it. Beware of contact with application sites on males.
• Testosterone will cause harm to fetuses in women who are exposed to testosterone during pregnancy.
• Follow the directions for application of topical testosterone products carefully. Each formulation of testosterone offers different instructions for use.