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.

• Eli Lilly and Company

• Lilly, Eli & Company

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.

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

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Axiron, there are no specific foods that you must exclude from your diet when receiving this medication.

Before using Axiron, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Axiron or to any of its ingredients
• have or might have prostate cancer
• have an enlarged prostate
• have or have had breast cancer
• have sleep apnea
• have heart problems
• have diabetes
• have kidney disease
• have lung disease
• have liver disease
• are pregnant or breastfeeding

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

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. 

Use testosterone exactly as prescribed.

Axiron comes as a topical solution and is applied to the armpits once daily, in the morning, at approximately the same time each day.

Apply to clean, dry intact skin of the armpit. 

• When using Axiron for the first time, make sure to prime the pump by depressing it 3 times prior to its first use. No priming is needed with subsequent uses of that pump.
• Do NOT apply Axiron to the scrotum, penis, abdomen, shoulders or upper arms.
• With testosterone doses greater than 60 mg, which require two applications of Axiron to the same armpit, make sure to let the product dry after the first application before you apply the second application.
• You may use an antiperspirant or deodorant spray before applying Axiron. If you use a stick or roll on antiperspirant or deodorant, then it should be applied prior to application of Axiron to avoid contamination of the stick or roll on product.
• Avoid swimming or washing the application site until two hours following application of Axiron.

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.

If you take too much testosterone, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If testosterone is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Store Axiron at 25°C (77°F).

Keep this and all medicines out of the reach of children.

Used pumps, packets, or storage containers for this medication should be disposed of in household trash in a manner that prevents accidental application or ingestion by children or pets.

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.