Pronunciation:

tes-TOS-ter-one

Brand Names:

• Androgel
• Axiron
• First-Testosterone
• First-Testosterone MC
• Fortesta
• Testim
• Vogelxo

Dosage Forms:

• Gel/Jelly
• Solution

Warnings:

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

Virilization has been reported in children who were secondarily exposed to topical testosterone solution. Healthcare providers should advise patients to strictly adhere to instructions for use. Children should avoid contact with unwashed or unclothed testosterone application sites .

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Androgen

Uses of This Medicine:

Testosterone topical gel is used for the treatment of males whose bodies do not make enough natural testosterone, a condition called hypogonadism. Testosterone is a male hormone responsible for the growth and development of the male sex organs and maintenance of secondary sex characteristics.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of testosterone topical gel in children. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of testosterone topical gel in the elderly. However, elderly patients may be at an increased risk for developing heart and blood vessel problems, or prostate problems (including prostate cancer), which may require caution in patients receiving this medicine.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Anisindione
• Bupropion
• Dicumarol
• Levoketoconazole
• Methotrexate
• Paclitaxel
• Paclitaxel Protein-Bound
• Phenprocoumon
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Licorice

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to alcohol or soy products or
• Breast cancer (males) or
• Prostate cancer, known or suspected—Should not be used in patients with these conditions.

• Blood clotting problems (eg, deep vein thrombosis, pulmonary embolism) or
• Diabetes or
• Enlarged prostate or
• Heart attack, history of or
• Hypercalcemia (high calcium in the blood) or
• Hyperlipidemia (high lipid or cholesterol in the blood) or
• Lung disease or breathing problems (eg, sleep apnea) or
• Problems with passing urine or
• Stroke, history of—Use with caution. May make these conditions worse.

• Heart disease (eg, congestive heart failure) or
• Kidney disease or
• Liver disease—Use with caution. Testosterone may cause edema (fluid retention) in patients with these conditions.

Proper Use of This Medicine:

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Androgel® or Fortesta® is available in two forms: individual packets or multi-dose pump. Vogelxo™ is available in three forms: individual packets, multi-dose pump, or tube. If you are using the pump gel for the first time, prime the pump before measuring out your first dose. Hold the pump over a sink and press the pump all the way down at least 3 times (Androgel® or Vogelxo™) or 8 times (Fortesta®) or until the gel begins to flow freely. Rinse the medicine discarded into the sink down the drain. Place the palm of your hand under the pump and press the pump the proper number of times to measure out your correct dose.

If you are using the gel in foil packets, tear the packet completely open along the perforation. Squeeze the entire contents directly onto the skin where you will apply the gel. You may also empty the packet into the palm of your hand and then apply the medicine. Throw away the empty foil packet in a place where children and pets cannot reach it.

Axiron® is available in two forms:

• Pump actuated metered dose bottle—For first time use, prime it before measuring out your first dose. Hold the bottle over a sink and press the pump all the way down at least 3 times. Rinse the medicine discarded into the sink down the drain. Place the palm of your hand under the pump and press the pump the proper number of times to measure out your correct dose.
• Twist actuated metered dose bottle—For first time use, prime it before measuring out your first dose. Hold the bottle over a sink and twist the dose dial on the bottle. Rinse the medicine discarded into the sink down the drain. Repeat this two more times. Completely twist (180° turn) the dose dial one time after priming to get your correct dose.

AndroGel® is available in two dosage strengths: AndroGel® 1% and AndroGel® 1.62%. AndroGel® 1% is used differently than AndroGel® 1.62%, even though they are both applied to the skin. Do not change your dose unless your doctor tells you to.

To use the gel:

• Make sure that you wash your hands with soap and water before and after applying the gel.
• Apply AndroGel® 1% to a clean, dry, intact skin of the shoulders, upper arms, or abdomen (stomach), unless your doctor tells you to use it on another part of your body. AndroGel® 1.62% should only be applied to a clean, dry intact skin of the shoulders and upper arms. Fortesta® should be applied to a clean, dry, intact skin of the front or inner thighs. Vogelxo™ should be applied to a clean, dry, intact skin of the shoulders or upper arms. Do not apply Vogelxo™ to your abdomen or stomach. Do not apply this medicine to your scrotum or your penis. Do not use the medicine on skin that has a cut, scrape, or other type of injury.
• Allow the gel to dry on your skin before you cover it with clothing (eg, shorts, pants, t-shirt).
• Wait for at least 2 hours (for AndroGel® 1.62%, Fortesta®, and Vogelxo™) or 5 hours (for AndroGel® 1%) after applying this medicine before showering or swimming.

To use the topical solution:

• Apply an antiperspirant or deodorant spray at least 2 minutes before you apply this medicine.
• Apply Axiron® to each clean, dry, intact skin of your underarm using an applicator. Do not apply this medicine to your stomach, penis, scrotum, shoulders, or upper arms. Do not use the medicine on skin that has a cut, scrape, or other type of injury. Do not drink this medicine.
• Wipe any medicine that drips or runs with an applicator. Do not rub the solution with your fingers or hand.
• Pump actuated metered dose bottle: Rinse the applicator cup with water and pat it dry with a tissue. Put the cup and cap back onto the bottle.
• Twist actuated metered dose bottle: Rinse the applicator with water and pat it dry with a tissue. Put the lid back on the bottle.
• Allow the solution to dry for at least 3 minutes before you cover the area with clothing. Do not shower or swim for least 2 hours.
• If any medicine gets in your eyes, rinse them right away with water and call your doctor. Do not drink the medicine.

The gel or solution form can be transferred to another person if they touch or rub the skin where the medicine was placed or if some of it remains on your hands. To keep this from happening, wash your hands again after applying the medicine. Also, wash the area where you applied the gel with soap and water if you expect to have a skin-to-skin contact with another person.

This medicine is flammable until it dries on the skin. Do not use it near heat, an open flame, or while smoking.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For hormone replacement:
  • For topical dosage form (gel):
    • Adults—
      • AndroGel® 1%: At first, apply 50 milligrams (mg) (two 25 mg packets or a single 50 mg packet) to a clean, dry, intact skin once a day (usually in the morning). Your doctor may increase your dose as needed. However, the dose is usually not more than 100 mg per day.
      • AndroGel® 1.62%: At first, apply 40.5 milligrams (mg) (2 pumps or a single 40.5 mg packet) to a clean, dry, intact skin once a day (usually in the morning). Your doctor may adjust your dose as needed. However, the dose is usually not more than 81 mg per day.
      • Fortesta®: At first, apply 40 milligrams (mg) (4 pumps) to a clean, dry, intact skin once a day (usually in the morning). Your doctor may adjust your dose as needed. However, the dose is usually not more than 70 mg per day.
      • Vogelxo™: At first, apply 50 milligrams (mg) (1 tube, 1 packet, or 4 pumps) to a clean, dry, intact skin once a day (usually in the morning). Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg once a day.
    • Children—Use and dose must be determined by your doctor.
  • For topical dosage form (solution):
    • Adults—At first, apply 60 milligrams (mg) (1 pump or 1 twist actuation of 30 mg) to each clean, dry, intact skin of your underarm once a day (usually in the morning). Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the medicine in a safe place. Do not give it to anyone else, even if you have the same symptoms. Throw away the empty pump, tube, or packet in a place where children and pets cannot reach it.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly. Blood tests may be needed to check for any problems or unwanted effects.

This medicine should not be used by women. Testosterone may cause birth defects if a pregnant woman comes in contact with the medicine. Make sure your doctor knows if your sexual partner is pregnant. If a pregnancy occurs while you are using this medicine, tell your doctor right away.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Children and women should avoid contact with the unwashed or unclothed area where the testosterone gel has been applied. If another person does accidentally get this medicine on the skin, wash the area with soap and water as soon as possible.

Tell your doctor if your female partner or child starts to have male-like body changes while you are using this medicine. Such changes may include hair growth on the face, a deeper voice, or a significant increase in acne. The changes may also include an enlarged penis or clitoris, early development of pubic hair, increased erections or sexual desire, aggressive behavior, and bone problems.

This medicine may cause blood clotting problems. Check with your doctor right away if you have a chest pain, trouble breathing, coughing up blood, numbness or weakness in your arm or leg, or on one side of your body, or pain in your lower leg (calf) while using this medicine.

This medicine may increase your risk of having heart or blood vessel problems, including a heart attack or stroke. Tell your doctor right away if you have chest pain that may spread to your arms, jaw, back, or neck, faintness, headache, nausea, vomiting, trouble breathing, trouble seeing or speaking, or unusual sweating.

In some cases, this medicine may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause fluid retention (edema) in some patients. Tell your doctor right away if you have bloating or swelling of the face, arms, hands, lower legs, or feet, tingling of the hands or feet, or unusual weight gain or loss.

This medicine may affect the results of the prostate specific antigen (PSA) test, which may be used to detect prostate cancer. Make sure you tell all of your doctors that you are using this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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:

More common

Blood in the urine

difficulty urinating

frequent urination

Less common

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

Incidence not known

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:

More common

Blemishes on the skin

burning, itching, redness, skin rash, swelling, or soreness at the application site

pimples

Less common

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

Incidence not known

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.