AndroGel

AndroGel is a prescription medication used to treat low testosterone levels (hypogonadism) in men who do not produce enough natural testosterone. It may also be used to treat delayed puberty in adolescent males. AndroGel may also be administered to women to treat certain types of cancer.

AndroGel is a hormone that is usually produced by the body. It controls the growth, development, and function of male sexual organs and characteristics.

This medication comes in a gel and is applied to the skin of the shoulders, upper arms, or abdomen (stomach) depending on the strength of Androgel and is applied typically once a day.

Common side effects of AndroGel include irritation and redness at the site of application, headache, acne, stomach pain, nervousness, hair loss, changes in mood and behavior, and changes in the ability to taste or smell.

AndroGel is a prescription medication used to treat low testosterone levels in men who do not produce enough natural testosterone.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• AbbVie Inc.

• AbbVie US LLC

Serious side effects have been reported with AndroGel. See the “AndroGel Precautions” section.

Common side effects of AndroGel include the following:

• Breast enlargement
• Decreased sexual desire
• Acne
• Hair loss
• Hot flashes
• Depression
• Changes in mood
• Nervousness
• Headache
• Weakness
• Insomnia
• Dry skin
• Changes in the ability to taste or smell
• Skin irritation at the site of application

This is not a complete list of AndroGel side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

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 AndroGel drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Androgel 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

Serious side effects have been reported with injectable testosterone including the following:

• Virilization in women, which includes amenorrhea or menstrual irregularities, deepening of the voice, clitoral enlargement
• Sexual changes or dysfunction in males, which includes breast enlargement and excessive frequency or duration of penile erections

Do not use Androgel if you:

• are allergic to Androgel or to any of its ingredients
• are a male with breast or prostate cancer
• are a woman who is or may become pregnant

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of AndroGel, there are no specific foods that you must exclude from your diet when receiving this medication.

Before using AndroGel, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to AndroGel or to any of its ingredients
• have or have had prostate cancer or an enlarged prostate
• have or have had breast cancer
• have sleep apnea
• have heart problems
• have diabetes
• have kidney disease
• have lung disease
• have liver disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

AndroGel falls into category X. It has been shown that women taking testosterone during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. AndroGel should never be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if AndroGel crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using AndroGel.

Use AndroGel exactly as prescribed.

This medication comes in a gel and is applied to the skin of the shoulders, upper arms, or stomach (Androgel 1% gel only) depending on the strength of Androgel and is applied typically once a day.

IIf you miss a dose, apply the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not apply two doses of AndroGel at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age
• your gender

The recommended dose of Androgel (testosterone) for the treatment of hypogonadism in males is 50 to 100 mg daily applied to the skin. 

If you take use much Androgel, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Androgel is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Store Androgel at room temperature.

Keep this and all medicines out of the reach of children.

Used pumps or packets for this medication should be disposed of in household trash in a manner that prevents accidental application or ingestion by children or pets.

WARNING: SECONDARY EXPOSURE TO ANDROGEL 

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