Axiron

Axiron comes in a pump bottle.

Use this medicine exactly as your doctor prescribes. Don't apply more or less Axiron than is recommended.

Before using Axiron, take a bath or shower so your armpit area is clean. Don't apply the medicine to broken skin.

Apply Axiron only to your armpits. Never use this medicine on other areas of your body.

Use the special applicator to apply the medicine. Don't use your fingers or hands.

After the solution has dried, cover the application area with clothing and keep it covered until you've washed the area well.

If you're using an antiperspirant or deodorant, apply it at least two minutes before applying Axiron.

Try to use this medicine around the same time each morning.

Wash your hands immediately with soap and water after applying Axiron. Also, rinse and dry the applicator after each use.

Avoid swimming or bathing for at least two hours after applying the medicine.

Axiron Overdose

If you suspect an overdose, contact a poison control center or emergency room immediately.

You can get in touch with a poison control center at 800-222-1222.

Missed Dose of Axiron

If you miss a dose of Axiron, apply it as soon as you remember.

But skip the missed dose if it's almost time for your next scheduled dose.

Don't use extra Axiron to make up for a missed dose.

Axiron is part of the drug class:

• 3 oxoandrosten 4 derivatives

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

Apply the gel or skin patch as soon as you remember. Skip the missed dose if it is almost time to apply your next dose. Do not use extra patches or gel to make up the missed dose.

If a skin patch falls off in the morning, reapply it. If it does not stick well, apply a new patch. If the patch falls off in the afternoon and cannot be reapplied, wait until your regular patch replacement time in the evening before putting on a new patch.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blood in the urine
• difficulty urinating
• frequent urination

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• feeling faint, dizzy, or lightheaded
• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck
• frequent strong or increased urge to urinate
• headache
• nervousness
• pain, redness, or swelling in the arm or leg
• pounding in the ears
• slow or fast heartbeat
• sweating
• swelling of the breasts or breast soreness in both females and males
• tingling of the hands or feet
• unusual weight gain or loss
• waking to urinate at night

• Aggressive behavior
• anxiety
• bluish lips or skin
• chest pain
• cough
• decrease in testicle size
• development of pubic hair
• difficult or labored breathing
• dizziness or lightheadedness
• enlargement of the clitoris or penis
• fainting
• fast heartbeat
• not breathing
• pain, redness, or swelling in the arm or leg
• painful or prolonged erection of the penis
• tightness in the chest
• troubled breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Blemishes on the skin
• burning, itching, redness, skin rash, swelling, or soreness at the application site
• pimples

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• crying
• decreased interest in sexual intercourse
• depression
• discoloration of the hair
• dry skin
• false or unusual sense of well-being
• hair loss
• inability to have or keep an erection
• lack or loss of strength
• loss in sexual ability, desire, drive, or performance
• loss of memory
• paranoia
• problems with memory
• quick to react or overreact emotionally
• rapidly changing moods
• thinning of the hair

• Increased in sexual ability, desire, drive, or performance
• trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Axiron.
• If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this medicine.
• Wash your hands before and after use.
• Follow how to use as you have been told by the doctor or read the package insert.
• Do not take Axiron by mouth. Use on your skin only.
• Use this medicine at the same time of day.
• Not all products are the same strength. Read and follow label carefully.
• Do not get Axiron (testosterone topical solution) on other parts of your body or on other people.
• Do not put on the genitals.
• Keep out of your eyes.
• Some products come in pumps. Some products come in packets. If you are using a pump, you will need to prime it before you use it the first time. Prime the pump as you are told in the package insert.
• After putting this medicine on, you will need to wait some time before you bathe, shower, or swim. Be sure you know how long you need to wait. Read the package insert for more details.
• Let dry before covering with clothing.
• Avoid fire, flames, or smoking until dry.
• Put on clean, dry, healthy skin using the applicator under the arm.
• Do not use your fingers or hand to rub Axiron into the skin.
• Change armpits with each dose.
• Allow skin to dry between uses.
• If you use an antiperspirant or deodorant, put on at least 2 minutes before you put on this medicine.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

• Store at room temperature. Do not freeze.
• Store in a dry place. Do not store in a bathroom.
• Protect from heat or open flame.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Prior to initiating Axiron, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.

Dosing and Dose Adjustment

The recommended starting dose of Axiron (testosterone) topical solution is 60 mg of testosterone (2 pump or 2 twist actuations) applied once daily.

To ensure proper dosing, serum testosterone concentrations should be measured after initiation of therapy to ensure that the desired concentrations (300 ng/dL-1050 ng/dL) are achieved. The Axiron dose can be adjusted based on the serum testosterone concentration from a single blood draw 2 – 8 hours after applying Axiron and at least 14 days after starting treatment or following dose adjustment.

If the measured serum testosterone concentration is below 300 ng/dL, the daily testosterone dose may be increased from 60 mg (2 pump or 2 twist actuations) to 90 mg (3 pump or 3 twist actuations) or from 90 mg to 120 mg (4 pump or 4 twist actuations). If the serum testosterone concentration exceeds 1050 ng/dL, the daily testosterone dose should be decreased from 60 mg (2 pump or 2 twist actuations) to 30 mg (1 pump or 1 twist actuation) as instructed by a physician. If the serum testosterone concentration consistently exceeds 1050 ng/dL at the lowest daily dose of 30 mg (1 pump or 1 twist actuation), Axiron therapy should be discontinued.

The application site and dose of Axiron are not interchangeable with other topical testosterone products.

Administration Instructions

Axiron is applied to the axilla, preferably at the same time each morning, to clean, dry, intact skin. Do not apply Axiron to other parts of the body including to the scrotum, penis, abdomen, shoulders or upper arms. After applying the solution, the application site should be allowed to dry completely prior to dressing. Avoid fire, flames or smoking until the solution has dried since alcohol based products, including Axiron, are flammable.

When deodorants or antiperspirants are used as part of a regular program for personal hygiene, they should not interfere with the efficacy of Axiron in treating hypogonadism. If patients use an antiperspirant or deodorant (stick or roll-on) then it should be applied at least 2 minutes prior to the application of Axiron to avoid contamination of the stick or roll-on product.

Patients should be advised to avoid swimming or washing the application site until two hours following application of Axiron [see Clinical Pharmacology (12.3)].

To reduce the likelihood of interpersonal transfer of testosterone, the application site should always be washed prior to any skin-to-skin contact regardless of the length of time since application. [See Warnings and Precautions (5.2)].

Axiron is available in two presentations (i.e., pump actuated or twist actuated metered-dose pump).

Pump Actuated Metered-Dose Pump

Axiron is applied to the axilla using an applicator. When using Axiron for the first time, patients should be instructed to prime the pump by depressing the pump three times, discard any product dispensed directly into a basin, sink, or toilet and then wash the liquid away thoroughly. This priming should be done only prior to the first use of each pump. After priming, patients should completely depress the pump one time (1 pump actuation) to dispense 30 mg of testosterone. Ensure that the liquid is directed into the cup. The cup should be filled with no more than 30 mg (1 pump actuation) of testosterone. Dosing that requires greater than one pump actuation must be applied in increments of 30 mg as is shown in Table 1.

Keeping the applicator upright, patients should place it up into the axilla and wipe steadily down and up into the axilla. If the solution drips or runs, it can be wiped back up with the applicator cup. The solution should not be rubbed into the skin with fingers or hand. The process is then repeated with application of 30 mg of testosterone (1 pump actuation) to the other axilla to achieve a total of 60 mg of testosterone applied. For patients prescribed the 90 mg dose of testosterone, the procedure is the same, but three applications are required. To dose 120 mg of testosterone, four applications are required alternating left and right for each application as shown in Table 1. When repeat application to the same axilla is required, the axilla should be allowed to dry completely before more Axiron is applied.

After use, the applicator should be rinsed under room temperature, running water and then patted dry with a tissue. The applicator and cap are then replaced on the bottle for storage.

Twist Actuated Metered-Dose Pump

Axiron is applied to the axilla using an applicator. When using Axiron for the first time, patients should be instructed to prime the pump by twisting the dose dial and discarding any product dispensed directly into a basin, sink, or toilet, and then washing the liquid away thoroughly. This should be repeated two additional times. This priming should be done only prior to the first use of each bottle. After priming, patients should completely twist (180° turn) the dose dial one time (1 twist actuation) to dispense 30 mg of testosterone. The applicator should be filled with no more than 30 mg (1 twist actuation) of testosterone. Dosing that requires greater than one twist actuation must be applied in increments of 30 mg as is shown in Table 1.

Keeping the applicator upright, patients should place it up into the axilla and wipe steadily down and up into the axilla. If the solution drips or runs, it can be wiped back up with the applicator. The solution should not be rubbed into the skin with fingers or hand. The process is then repeated with application of 30 mg of testosterone (1 twist actuation) to the other axilla to achieve a total of 60 mg of testosterone applied. For patients prescribed the 90 mg dose of testosterone, the procedure is the same, but three applications are required. To dose 120 mg of testosterone, four applications are required alternating left and right for each application as shown in Table 1. When repeat application to the same axilla is required, the axilla should be allowed to dry completely before more Axiron is applied.

After use, the applicator should be wiped with a disposable tissue. The lid is then replaced on the bottle for storage.

Hands should be washed thoroughly with soap and water after Axiron has been applied [see Warnings and Precautions (5.2)].

Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from Axiron treated 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 application of Axiron.
• 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 direct 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 transfer 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.

• Axiron is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precaution (5.1)].
• Axiron is contraindicated in women who are, or who may become pregnant, or who are breastfeeding. Axiron may cause fetal harm when administered to a pregnant woman. Axiron 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. [See Use in Specific Populations (8.1, 8.3)].

Carcinogenesis, Mutagenesis, Impairment of Fertility

Testosterone has been tested by subcutaneous injection and implantation in mice and rats. In mice, the implant induced cervical-uterine tumors, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats. Testosterone was negative in the in vitro Ames and in the in vivo mouse micronucleus assays. The administration of exogenous testosterone has been reported to suppress spermatogenesis in the rat, dog and non-human primates, which was reversible on cessation of the treatment.

Axiron topical solution is an underarm testosterone treatment.

Testosterone is a naturally occurring male hormone necessary for many processes in the body.

Axiron is used to treat adult males who have low or no testosterone.

Axiron will not enhance athletic performance and should not be used for this purpose.

Do not use Axiron if you are allergic to testosterone, or if you have prostate cancer or male breast cancer.

To make sure Axiron is safe for you, tell your doctor if you have ever day:

• cancer;

• enlarged prostate, urination problems;

• sleep apnea (breathing stops during sleep);

• heart disease, heart attack, or stroke;

• a blood clot;

• diabetes; or

• liver disease or kidney disease.

Axiron should not be used by a woman. Testosterone can cause birth defects in an unborn baby. A pregnant woman should avoid coming into contact with Axiron solution, or with a man's skin areas where the solution has been applied. If contact does occur, wash with soap and water right away.

Older men who use Axiron may have an increased risk of prostate enlargement or cancer. If you are over 65, talk with your doctor about your specific risk. Axiron solution should not be used on anyone younger than 18 years old. Improper use of this medicine may affect bone growth in children.

Use Axiron exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than prescribed. Follow the directions on your prescription label.

Misuse of testosterone can cause dangerous or irreversible effects, such as enlarged breasts, small testicles, infertility, high blood pressure, heart attack, stroke, liver disease, bone growth problems, addiction, and mental effects such as aggression and violence.

Do not share this medicine with another person.

Axiron comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Before using a new bottle of Axiron for the first time, you will need to prime the pump. To prime the pump gently push down on the pump 3 times. Do not use any solution that comes out while priming. Wash it down the sink to avoid accidental exposure to others. Your pump is now ready to use.

Axiron is to be applied to the armpits only. Before applying, make sure that your armpit is clean, dry and that there is no broken skin. Do not apply Axiron to any other parts of your body such as your stomach area (abdomen), penis, scrotum, shoulders or upper arms.

Apply Axiron at about the same time each morning. This medicine should be applied after showering or bathing. You can use an antiperspirant or deodorant before applying this medicine. If you use antiperspirant or deodorant, then it should be applied at least 2 minutes before you apply this medicine.

To be sure Axiron is helping your condition, your blood will need to be tested often. Your prostate or liver function may also need to be tested. Visit your doctor regularly.

Use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store this medicine at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.