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Androgens (Methyltestosterone, Testosterone Enanthenate, Fluoxymesterone)

(an-druh-jens, meth-ull-tes-TOSS-ter-own, tes-toss-ter-own en-an-thin-ate, flew-oks-ee-MESS-tuh-rohn)

Trade/other name(s): Android, Androderm, Androgel, Androxy, Axiron, Delatestryl, Fortesta, Halotestin, Striant, Testim, Testopel, Testred, and others

Why would this drug be used?

Androgens belong to the group of drugs known as hormones or hormone antagonists. They are used to treat several types of cancer that are sensitive to hormones, including breast cancer in women. Androgens are also used to replace normal hormones in men who have had both testicles removed or who have low testosterone levels due to childhood cancer treatment. They are also used for other conditions.

How does this drug work?

Androgens seem to change the hormonal environment in the cancer cell. For certain cancers, this takes away what makes them grow, and the cancer cell does not divide. The exact mechanism is still unknown.

In healthy men, androgens are needed to maintain muscle mass and bone strength.

Before taking this medicine

Tell your doctor…

  • If you are allergic to anything, including medicines, dyes, additives, or foods.
  • If you have any medical conditions such as kidney disease, liver disease (including hepatitis), heart disease, congestive heart failure, diabetes, gout, or infections. These conditions may require that your medicine dose, regimen, or timing be changed.
  • If you have an enlarged prostate. Androgens may worsen this condition.
  • If you are a man with breast cancer or prostate cancer. This drug can worsen these problems in men.
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. This drug may cause birth defects if either the male or female is taking it at the time of conception or during pregnancy. Men and women who are taking this drug need to use some kind of birth control. It is important to check with your doctor about what kinds of birth control can be used with this medicine.
  • If you are breast-feeding. It is not known how much of this drug passes into breast milk. It could harm the baby.
  • If you think you might want to have children in the future. This drug may reduce fertility. Talk with your doctor about the possible risk with this drug and the options that may preserve your ability to have children.
  • If you have diabetes. This drug may affect blood sugar levels. You and your doctor will need to watch your sugar levels closely while you are getting this drug.
  • About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

Androgens may boost the effect of anticoagulants (blood thinners). This can lead to bleeding problems in some. Your doctor may want to check your blood more often if you take blood thinners.

If you take insulin for diabetes, your blood sugar levels and insulin requirements may change.

Corticosteroids such as prednisone and dexamethasone can increase the risk of retaining fluids and swelling. This is more of a problem for people with heart or liver disease.

Check with your doctor, nurse, or pharmacist about other medicines, vitamins, herbs, and supplements, and whether alcohol can cause problems with this medicine.

Interactions with foods

No serious interactions with food are known at this time. Check with your doctor, nurse, or pharmacist about whether foods may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Pills or injections: Androgens for breast cancer treatment can be given as pills by mouth or by an injection in the muscle. Depending on your diagnosis and the type of androgen you take, you may take pills once a day or as often as 4 times a day. Injections may be given as often as 3 times a week, or as infrequently as every 4 weeks. Your doctor will decide the type of androgen, dose, and frequency.

Other routes

Men who need androgens to raise testosterone levels to normal can usually take the drug once a day in the form of a liquid, gel, or patch that allows the drug to be absorbed through the skin. It can also be given as a tablet-like system that is absorbed through the mucous membranes of the mouth (given twice a day), as an injection, or as a pellet that is implanted under the skin every 3 months.

Gel and liquid testosterone: If you use androgen liquid or gel, pay close attention to the instructions. They require that the medicine be applied to certain parts of the body. Some are applied to the skin of the chest, shoulders, upper arms, or abdomen, while others are put under the arms or on the thighs. Do not apply to the scrotum or penis. Use exactly the amount your doctor prescribes.

Wash your hands right away after you apply gel or liquid. Do not put clothes over the skin where you have applied the liquid or gel until it dries. The liquid and gel contain alcohol, so stay away from fire or flames until it is dry. If you splash any into your eyes, flush them with water and call the doctor if they are irritated.

To get the best effect, most manufacturers say that you should not swim or shower for 2 hours after applying androgen liquids or gels to the skin. Some (such as Androgel) recommend waiting longer, at least 5 hours before bathing or swimming.

Avoid letting women or children touch any area where you have put gel or liquid even after it dries. Keep the area covered if possible. If not, shower or wash the area before allowing skin contact with women or children. If they come in contact with the area where you have applied liquid or gel, they should immediately wash their skin that touched the androgen-covered area with soap and water.

Testosterone patch: The patch can be applied to clean, dry, intact skin (skin that is not broken, blistered, scraped, or scratched) on the upper arms, thighs, abdomen, or back. Do not put it on any area that gets a lot of pressure when lying down or sitting. It can be left in place during bathing, swimming, and sex.

Buccal testosterone: One type of testosterone (Striant) is absorbed through the gum and lip. This system is placed between the gum and upper lip (above the incisor tooth) every 12 hours. The rounded edge faces toward the gum. Put it against the gum, and hold it there with a finger for 30 seconds until it sticks firmly. Switch sides with each dose. Be careful not to dislodge it during eating, drinking, or brushing teeth. When taking it out, gently slide it downward toward the tooth to avoid scratching the gum.

Testosterone pellets: Testosterone also comes in pellets (Testopel) that can be implanted under the skin by your doctor every 3 months or so.

Safe usage, handling, and disposal of all types of testosterone

Take this drug exactly as your doctor tells you to. If you do not understand the instructions, your doctor or nurse can explain them to you.

Do not allow children or women to come in contact with your androgen gels or liquids. If a pregnant woman gets it on her skin, it can harm the fetus. Contact with topical androgens can cause women to grow facial hair and other man-like features, and cause problems for children as well.

Any gel or liquid that you don’t use should be thrown away in a covered trash can or plastic bag. When you remove a skin patch or buccal system, dispose of it where no one, especially children or pets, will find and pick it up. Keep unused medicine in a tightly closed container and away from children and pets.

Precautions

Androgens may make you retain salt and water. To keep this from happening, your doctor may prescribe a diuretic ("water pill"). Tell your doctor or nurse if you gain weight or notice your feet or ankles swelling.

Increased blood calcium may occur when you start the drug if you have cancer in the bones or are bedridden. Your doctor will watch your blood calcium levels. Tell your doctor or nurse if you start becoming drowsy, confused, thirsty, constipated, and have to pass urine frequently. Keep all your appointments for blood tests.

Women receiving androgens will notice their voice getting deeper over time. If you take the drug for more than 3 months, you may also notice less interest in sex, more body hair, acne, and an enlarging clitoris. Though these symptoms often go away after the drug is stopped, they can become permanent if you keep taking the drug. Talk to your doctor or nurse about this.

Call your doctor if you have nausea or vomiting.

Androgens can cause prostate enlargement in men. Talk with your doctor if you have to pass urine more often, have a slow urine stream, or have trouble passing urine.

Androgens can make sleep apnea worse. If you or your partner notice problems with your breathing, especially during sleep, talk with your doctor.

Your doctor may check your blood count to be sure that you are not making too many red blood cells. Sometimes androgens can cause this problem and increase the risk of blood clots (such as blood clots in the legs, strokes, heart attacks.)

Androgens may cause liver problems, and rarely have even caused tumors or liver cancer if taken for a long time. Let your doctor or nurse know right away if you have belly (abdominal) pain or yellowing of skin or eyes.

The androgen patch can cause burn-like reactions if it is used in an area that gets a lot of pressure when sitting or lying down. Avoid the bony parts of the hips, shoulders, and upper arms when choosing patch sites. See your doctor if you notice blisters or pain.

Do not allow anyone else to take, borrow, or use this medicine.

Possible side effects

You will probably not have most of the following side effects, but if you have any talk to your doctor or nurse. They can help you understand the side effects and cope with them.

Common

  • fluid retention*
  • deepening of voice in women *
  • increased body hair and acne in women (men can also have acne)*
  • increased size of clitoris*
  • stopping of menstrual periods in women
  • reduced sperm production in men
  • itching where patch is placed

Less common

  • increased blood calcium level*
  • nausea
  • increased appetite
  • increase in red blood cell counts*
  • older men may have trouble passing urine due to prostate enlargement*
  • burning, blisters, or rash where patch is placed*
  • masculine features in women who come in contact with androgen gels or liquids
  • premature stopping of bone growth and early puberty in children who come in contact with androgen gels or liquids

Rare

  • painful, prolonged, or frequent erections in men
  • worsening of sleep apnea (problems breathing during sleep)*
  • worsening of pattern baldness in men
  • worsening of heart failure due to retaining fluids*
  • liver problems, including tumors or cancers*
  • increased risk of blood clots due to high red blood cell counts*
  • severe allergic reactions with skin welts, rash, trouble breathing, dizziness

*See "Precautions" section for more detailed information.

There are some other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – the first of these drugs were approved before 1984 (FDA cannot verify dates of drugs approved before 1984).

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.


Last Medical Review: 04/25/2011
Last Revised: 04/25/2011