Applying AXIRON

AXIRON should be applied to the underarm without rubbing into the skin with fingers or hands


AXIRON Application Video

  • Intro
  • Pump
  • Swipe
  • Wash
  • Dress

Before you get started

  • The first time you use a new bottle, prime it by pumping 3 times into the sink or toilet. Do not use any of the liquid that came out when you primed, and rinse or flush away to avoid exposure to others
  • Apply deodorant or antiperspirant at least 2 minutes before applying AXIRON to keep it from getting on your deodorant
  • Apply AXIRON at about the same time each morning
  • Apply only to the underarms and make sure they are clean and dry with no broken skin. Do not apply AXIRON to other parts of your body like your stomach, penis, scrotum, shoulders, or upper arms
PUMP image

PUMP the right dose

  • Hold the applicator cup level to keep AXIRON from spilling
  • Press the pump only once into the applicator cup and raise it straight up to your underarm
SWIPE image

SWIPE it on

  • Starting a little above your underarm and ending a little below your underarm, swipe down and up. Your doctor will determine how many applications are right for you
  • If AXIRON drips or runs, wipe it back up with the applicator cup
  • Do not apply AXIRON with your fingers or hand, and do not rub in the solution with your fingers or hand once it has been applied
WASH image

WASH up

  • Rinse the applicator cup with warm running water, pat it dry with a tissue, and discard the tissue safely. Clean up any spilled solution from sink or floor to prevent others from coming into contact with AXIRON
  • Wash hands right away with soap and water. Store AXIRON safely out of the reach of children
DRESS to cover image

DRESS to cover

  • Let underarms dry completely before dressing (this takes about 3 minutes)
  • Always cover your underarms with clothing and keep covered to avoid skin-to-skin contact with others until you’ve washed the application area or showered

Grooming considerations

Use deodorant or antiperspirant at least 2 minutes before applying 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 into your household trash
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 not instructed to change their normal grooming routines or shave under their arms
  • You should apply AXIRON to clean, dry, and unbroken skin
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

Other important things to remember

Controlled substance

AXIRON is a controlled substance (CIII) because it contains testosterone, which can be a target for people who abuse prescription medicines. Keep your AXIRON in a safe place to protect it and never give it to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law.

Contact with eyes

Throughout the application process, be careful to avoid splashing AXIRON in the eyes. In case of contact with eyes, flush thoroughly with water. If irritation persists, seek medical advice.

Flammability

Since AXIRON contains alcohol, it is flammable until dry. Always let it dry before smoking or going near an open flame.

Know your testosterone (T) levels

It’s important to apply AXIRON daily as prescribed by your doctor
  • Applying AXIRON daily can help keep your testosterone levels in the normal range
  • Without treatment, T levels can drop
A blood test will let you and your doctor know if AXIRON is working for you
  • Ask your doctor when to schedule a follow-up appointment to help monitor your results
  • After starting AXIRON, your doctor may recommend a blood test in 2 to 3 months, and then annually

Questions?

Call the AXIRON patient support line at 1-877-9-AXIRON (1-877-929-4766).

Risk of Transfer

Patient steering boat

Important Safety Information or considerations regarding the risk of transfer to others

AXIRON can transfer from your body to others. Women and children should avoid contact where AXIRON is applied as unexpected signs of puberty in children or changes in body hair or increased acne in women may occur. If contact is made, the contact area on the woman or child should be washed well with soap and water right away. To lower the risk of transfer, always 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 and keep 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 of puberty in a child, or changes in body hair or increased acne in a woman, that may have occurred through accidental exposure to AXIRON.

Dosing

Your doctor will prescribe the right dose for you

Use the chart below to make sure you’re properly applying your dose.

Daily DoseNumber of Pumps*Putting it on
30 mg1 each daySwipe once on one underarm only (right OR left).
60 mg2 each daySwipe once on the left AND once on the right underarm.
90 mg3 each daySwipe once on the left AND once on the right underarm. Wait for AXIRON to dry. Then swipe again once on EITHER the right OR the left underarm.
120 mg4 each daySwipe once on the left AND once on the right underarm. Wait for AXIRON to dry. Then apply once again on the left AND once again on the right underarm.

*Pumps = applications.

Indication and Important Safety InformationIndication, Important Safety Info & Boxed Warning

Indication and Important Safety Information Indication, Important Safety Info & Boxed Warning

Indication: AXIRON is used to treat adult males who have low or no testosterone due to certain medical conditions. It is not known if AXIRON is safe or effective to treat men who have low testosterone due to aging. 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.
  • 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.
  • Possible increased risk of heart attack or stroke.
  • 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).

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.

TS CON ISI 15MAY2015

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

Indication

AXIRON is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

  • Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above the normal range
  • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range

Limitations of use

  • Safety and efficacy of AXIRON in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.
  • Safety and efficacy of AXIRON in males <18 years old have not been established.

Important Safety Information for AXIRON (testosterone) topical solution

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE

  • Virilization has been reported in children who were secondarily exposed to topical testosterone products.
  • 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.

CONTRAINDICATIONS

AXIRON is contraindicated in:
  • men with breast cancer or known or suspected prostate cancer
  • women that are or may become pregnant, or are breastfeeding. AXIRON may cause fetal harm if administered to a pregnant woman and may cause serious adverse reactions in nursing infants. If a pregnant woman is exposed to AXIRON, she should be apprised of the potential hazard to the fetus.

WARNINGS AND PRECAUTIONS

  • Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer: Monitor patients with BPH for worsening of signs and symptoms. Patients treated with androgens may be at increased risk for prostate cancer. Evaluate for prostate cancer before initiating treatment, re-evaluate 3 to 6 months after initiation of treatment, then in accordance with prostate cancer screening practices.
  • Secondary Exposure to Testosterone: Cases of secondary exposure in children and women have been reported with topical testosterone products, including cases resulting in virilization of children. Signs and symptoms included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases, these regressed with removal of testosterone exposure. In a few cases, enlarged genitalia did not fully return to age-appropriate size, and bone age remained modestly greater than chronological age. Risk of transfer was increased in some cases by not adhering to precautions for appropriate use of the product. Children and women should avoid contact with unwashed or unclothed application sites in men using AXIRON. Inappropriate changes in genital size or development of pubic hair or libido in children; or changes in body hair distribution, significant increase in acne, or other signs of virilization in adult women and the possibility of secondary exposure should be brought to the attention of a physician. Therapy should be promptly discontinued at least until the cause of virilization is identified.
  • Strict adherence to the following precautions is advised to minimize the potential for secondary exposure to testosterone from the skin:
  • Children and women should avoid contact with the unclothed or unwashed application sites on the skin of men using AXIRON.
  • Patients should wash their hands immediately with soap and water after AXIRON application.
  • Patients should cover the application site(s) with clothing (e.g., a T-shirt) after the solution has dried.
  • Prior to any situation in which direct skin-to-skin contact is anticipated, patients should wash the application site thoroughly with soap and water to remove any testosterone residue. In the event that unwashed or unclothed skin to which AXIRON has been applied comes in contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible.

    While interpersonal testosterone transfer can occur with a T-shirt on, it has been shown that it can be substantially reduced by wearing a T-shirt and the majority of residual testosterone is removed from the skin surface by washing with soap and water.
  • Polycythemia: Increases in hematocrit may require lowering or discontinuation of testosterone treatment. Check hematocrit prior to initiating treatment; re-evaluate 3 to 6 months after starting treatment, then annually. If hematocrit becomes elevated, stop therapy until it decreases to an acceptable level. An increase in hematocrit may increase the risk of thromboembolic events.
  • Venous Thromboembolism: There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as AXIRON. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with AXIRON and initiate appropriate workup and management.
  • Cardiovascular Risk: Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use AXIRON.
  • Spermatogenesis: At large doses, spermatogenesis may be suppressed which could possibly lead to adverse effects on semen parameters including, sperm count.
  • Edema: Androgens, including AXIRON, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease.
  • Gynecomastia: Gynecomastia may develop and may persist in patients being treated with androgens, including AXIRON.
  • Sleep Apnea: Testosterone treatment may potentiate sleep apnea in some patients, especially those with risk factors (e.g. obesity, chronic lung disease).
  • Lipids: Changes in serum lipid profile may require dose adjustment or discontinuation of therapy.
  • Hypercalcemia: Use androgens, including AXIRON with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.
  • Decreased Thyroxine-binding Globulin: Androgens, including AXIRON, may decrease thyroxin-binding globulin concentrations resulting in decreased total T4 serum concentration and increased resin uptake of T3 and T4. Free thyroid hormone concentration remain unchanged, however there is no clinical evidence of thyroid dysfunction.
  • Flammability: Patients should be advised to avoid smoking, fire, or flame until the AXIRON dose applied has dried.

DRUG INTERACTIONS

  • Insulin: Changes in insulin sensitivity or glycemic control may occur. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.
  • Oral anti-coagulants: Changes in anticoagulant activity may occur. More frequent monitoring of INR and prothrombin time is recommended in patients taking anticoagulants, especially at initiation and termination of androgen therapy.
  • Corticosteroids: Use of testosterone with ACTH or corticosteroids may result in increased fluid retention and should be monitored cautiously, particularly in patients with cardiac, renal, or hepatic disease.

USE IN SPECIFIC POPULATIONS

  • Geriatric Use: There were insufficient numbers of geriatric patients in AXIRON studies to determine if efficacy in those >65 years of age differs from younger patients. 21 of 155 patients in the pivotal clinical study were >65. There were insufficient long-term safety data to assess a potential incremental risk of cardiovascular disease and prostate cancer.

ADVERSE REACTIONS

Most common adverse reactions included application site irritation (7%), application site erythema (5%), headache (5%), increased hematocrit (4%), diarrhea (3%), vomiting (3%), and increased PSA (1%).

TS HCP ISI 15MAY2015

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

Reference: 1. Axiron [package insert]. Indianapolis, IN: Eli Lilly and Company; 2015.