AXIRON Answers

Talk to your doctor and browse the topics below to help address some common questions you may have about AXIRON

ABOUT AXIRON

Important Information about AXIRON

AXIRON can transfer from your body to others. This can happen if other people come into contact with the area where the 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, follow these important instructions:

  • Apply AXIRON only to your armpits
  • Wash your hands right away with soap and water after applying AXIRON
  • After the solution has dried, cover the application area with clothing. Keep 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 armpits, 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.

AXIRON has a different application method

AXIRON is applied to the underarm with an applicator cup. Learn more >

Patients 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.

Before using AXIRON, talk to your doctor

Before you use AXIRON, tell your healthcare provider if you have:

  • Breast cancer
  • Or might have prostate cancer
  • Urinary problems due to an enlarged prostate
  • Heart problems
  • Kidney or liver problems
  • Problems breathing while you sleep (sleep apnea)
  • Any other medical conditions

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
  • Corticosteroids

How AXIRON works

You apply AXIRON to your underarm(s) once a day using an applicator. Once applied, the other ingredients of AXIRON (ethanol and isopropyl alcohol) evaporate and leave the testosterone on your skin. Over time, the testosterone is released into your bloodstream. In most men, AXIRON can restore testosterone levels to within the normal range. Learn how to apply AXIRON >

Possible side effects

AXIRON can cause serious side effects. Call your healthcare provider right away if you have any of the following:

  • If you already have enlargement of your prostate gland, your signs and symptoms can get worse while using AXIRON. This can include: increased urination at night, trouble starting your urine stream, having to pass urine many times during the day, having an urge that you have to go to the bathroom right away, having a urine accident, being unable to pass urine or weak urine flow
  • 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
  • Swelling of your ankles, feet, or body
  • Enlarged or painful breasts
  • Problems breathing while you sleep (sleep apnea)
  • Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.

The most common adverse events include: 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.

APPLYING AXIRON

No need to shave under your arms when using AXIRON

While this was not specifically studied in the AXIRON clinical trial, patients involved in the trial were instructed not to change their normal grooming routines or shave under their arms.

Using AXIRON with deodorant or antiperspirant

You should always use deodorant or antiperspirant at least 2 minutes before you apply AXIRON. This is to help avoid the transfer of AXIRON onto the deodorant or antiperspirant. If you accidentally put on antiperspirant or deodorant after applying AXIRON, safely throw away the stick or roll-on product in your household trash.

AXIRON drying time

After application, it takes approximately 3 minutes for AXIRON to dry. Individual drying time may vary. You should wait until the application site has completely dried before getting dressed.

AXIRON is flammable until dry. Let AXIRON dry before smoking or going near an open flame.

Washing or wetting underarms after applying AXIRON

You should always wait at least 2 hours after applying AXIRON before showering/bathing or swimming. Getting the area wet before this will remove most of the AXIRON you just applied.

Storing AXIRON

You should always store AXIRON in a place that is safe, out of the reach of children, and between the temperatures of 59°F and 86°F. AXIRON should also be kept away from fire since it contains alcohol.

To receive child-resistant packaging, call 1-877-9-AXIRON (1-877-929-4766).

TRAVELING WITH AXIRON

Traveling with AXIRON

Medications containing testosterone are schedule III controlled substances as defined by the Anabolic Steroid Control Act of 2004.

If you are traveling, remember to pack your AXIRON in a place that is safe and out of the reach of children.

Ideally, testosterone topical solution should be stored at 77°F with the allowable range being 59°F to 86°F. Therefore, while traveling, ensure that the medication is not stored in a location that could potentially exceed these temperatures.

Traveling with AXIRON by air domestically

When traveling by air, you may get questions about your AXIRON from security personnel.

Visit the Transportation Security Administration (TSA) Web site for specific guidelines for traveling with medications.

There are no data available that describe the effect that x-rays may have on the stability of testosterone. We recommend that you DO NOT pack AXIRON in your checked baggage as it may be subjected to temperature extremes and powerful x-rays during the handling and inspection process. Additionally, there is a risk of checked baggage being misplaced during transport.

We recommend that you carry the testosterone topical solution in your carry-on baggage with the original pharmacy label attached to the bottle or to the box. It is strongly recommended that you check with your airline or travel agent prior to traveling for any restrictions. You may also request that the security personnel visually inspect the medication by hand, thus avoiding exposing the medication to x-rays. Travelers in the United States have the right to request a hand check of x-ray sensitive materials. We suggest you contact airport security and the airline you are using prior to your departure to determine if hand inspection of your medication will be possible.

Although testosterone topical solution is considered flammable, the medication is allowed on aircraft, according to the Federal Aviation Administration guidelines for Hazardous Materials Carried by Passengers and Crewmembers.

Traveling with AXIRON by air abroad

There are instances in which you may have to travel abroad with your AXIRON. The International Air Transportation Association recommends that if a traveler will be going abroad with any preexisting medical problems, they should carry a letter from the attending physician that describes the medical condition and any prescription medications associated with the condition, including the generic name of prescribed drugs. Any medications being carried overseas should be left in their original containers and be clearly labeled. It is also recommended that travelers check with the foreign embassy of the country they are visiting to ensure that any required medications are not considered to be illegal narcotics (US Department of State Tips for Traveling Abroad).

AXIRON SAVINGS CARD

1 card, 2 ways to save*

Pay no more than $25 per month with your FIRST MONTH FREE.* After your first month free, eligible patients receive up to $75 in monthly savings. All you have to do is present the activated card along with a complete and signed prescription to your retail pharmacy. Ask your doctor or call 1‑877‑9‑AXIRON (1-877-929-4766) to learn about the AXIRON Savings Card today.

*Eligibility criteria: Offer void where prohibited by law. This offer is invalid for patients without commercial insurance coverage or those whose prescription claims for AXIRON are reimbursed, in whole or in part, by any governmental program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medigap, Champus, DOD, the VA, TriCare, or any State Patient or Pharmaceutical Assistance Program. Available only in the US and PR for residents of the US and PR. By accepting this offer, you agree that if you are required to do so under the terms of your insurance coverage for this prescription or are otherwise required to do so by law, you should notify your insurance carrier of your redemption of this AXIRON Savings Card. This offer is not valid with any other program, discount, or incentive involving AXIRON. It is illegal for any person to sell, purchase, or trade; or to offer to sell, purchase, or trade; or to counterfeit this card. This offer may be terminated, rescinded, revoked, or amended by Lilly USA, LLC at any time without notice. AXIRON® and the AXIRON logo are registered trademarks of Eli Lilly and Company. This card has no cash value.

 

Additional Resources

 

Indication & Important Safety Information

Indication: AXIRON is used to treat adult males who have low or no testosterone. AXIRON is not intended for use in women or anyone under 18 years of age. It is not known if AXIRON is safe and effective in children younger than 18 years old. Improper use of AXIRON may affect bone growth in children.

Important Safety Information for AXIRON (testosterone) topical solution

What is the most important information I should know about AXIRON?

AXIRON can transfer from your body to others. This can happen if other people come into contact with the area where the 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, follow these important instructions:

  • Apply AXIRON only to your armpits.
  • Wash your hands right away with soap and water after applying AXIRON.
  • After the solution has dried, cover the application area with clothing. Keep 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 armpits, 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 should I tell my healthcare provider before using AXIRON?

Before you use AXIRON, tell your healthcare provider if you have:

  • breast cancer
  • or might have prostate cancer
  • urinary problems due to an enlarged prostate
  • heart problems
  • kidney or liver problems
  • problems breathing while you sleep (sleep apnea)
  • any other medical conditions

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
  • corticosteroids

What are the possible side effects of AXIRON?

AXIRON can cause serious side effects. Call your healthcare provider right away if you have any of the following:

  • If you already have enlargement of your prostate gland, your signs and symptoms can get worse while using AXIRON. This can include: increased urination at night, trouble starting your urine stream, having to pass urine many times during the day, having an urge that you have to go to the bathroom right away, having a urine accident, being unable to pass urine or weak urine flow.
  • 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.
  • Swelling of your ankles, feet, or body.
  • Enlarged or painful breasts.
  • Problems breathing while you sleep (sleep apnea).
  • Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.

The most common adverse events include: 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.

Axiron is available by prescription only

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.

For more information, please see full Prescribing Information, including Boxed Warning regarding the risk of transfer to others, and Medication Guide.

TS CON ISI 10JUL2014


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*Eligibility criteria:

Offer void where prohibited by law. This offer is invalid for patients without commercial insurance coverage or those whose prescription claims for AXIRON are reimbursed, in whole or in part, by any governmental program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medigap, Champus, DOD, the VA, TriCare, or any State Patient or Pharmaceutical Assistance Program. Available only in the US and PR for residents of the US and PR. By accepting this offer, you agree that if you are required to do so under the terms of your insurance coverage for this prescription or are otherwise required to do so by law, you should notify your insurance carrier of your redemption of this AXIRON Savings Card. This offer is not valid with any other program, discount, or incentive involving AXIRON. It is illegal for any person to sell, purchase, or trade; or to offer to sell, purchase, or trade; or to counterfeit this card. This offer may be terminated, rescinded, revoked, or amended by Lilly USA, LLC at any time without notice. AXIRON® and the AXIRON logo are registered trademarks of Eli Lilly and Company. This card has no cash value.

INDICATION

AXIRON is used to treat adult males who have low or no testosterone. AXIRON is not intended for use in women or anyone under 18 years of age. It is not known if AXIRON is safe and effective in children younger than 18 years old. Improper use of AXIRON may affect bone growth in children.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about AXIRON?

AXIRON can transfer from your body to others. This can happen if other people come into contact with the area where the 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, follow these important instructions:

  • Apply AXIRON only to your armpits.
  • Wash your hands right away with soap and water after applying AXIRON.
  • After the solution has dried, cover the application area with clothing. Keep 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 armpits, 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 should I tell my healthcare provider before using AXIRON?

Before you use AXIRON, tell your healthcare provider if you have:

  • breast cancer
  • or might have prostate cancer
  • urinary problems due to an enlarged prostate
  • heart problems
  • kidney or liver problems
  • problems breathing while you sleep (sleep apnea)
  • any other medical conditions

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
  • corticosteroids

What are the possible side effects of AXIRON?

AXIRON can cause serious side effects. Call your healthcare provider right away if you have any of the following:

  • If you already have enlargement of your prostate gland, your signs and symptoms can get worse while using AXIRON. This can include: increased urination at night, trouble starting your urine stream, having to pass urine many times during the day, having an urge that you have to go to the bathroom right away, having a urine accident, being unable to pass urine or weak urine flow.
  • 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.
  • Swelling of your ankles, feet, or body.
  • Enlarged or painful breasts.
  • Problems breathing while you sleep (sleep apnea).
  • Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.

The most common adverse events include: 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.

Axiron is available by prescription only

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

See full Prescribing Information, including Boxed Warning regarding the risk of transfer to others, and Medication Guide.

TS CON ISI 10JUL2014