Androgel

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

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 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.

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. 

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.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• There may be a higher chance of prostate cancer. Talk with the doctor.
• If you have an enlarged prostate, your signs can get worse while you use AndroGel. Call your doctor if this happens to you.
• High blood pressure has happened with this medicine. Have your blood pressure checked as you have been told by your doctor.
• Treatment with AndroGel may lead to higher cholesterol and triglycerides. The effect of these changes on heart health is not known. Talk with the doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
• This medicine is an anabolic steroid. Anabolic steroid drugs have been abused and misused before. Anabolic steroid abuse can lead to dependence and very bad health problems. These health problems include heart or blood vessel problems, stroke, liver problems, and mental or mood problems. Talk with the doctor.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• This medicine is not approved for treating low testosterone levels caused by getting older. Talk with your doctor.
• This medicine may affect sperm in men. This may affect being able to father a child. Talk with the doctor.
• Tell the doctor right away if a child or woman touches the gel or solution and has any bad effects. In children, these are forceful actions, enlarged sex organs, and early growth of pubic hair. In women, these are a deep voice, change in body hair, or pimples.
• If a pregnant woman touches the gel or solution, call the doctor right away.

Clinical Trials in Adult Hypogonadal Males

AndroGel 1% was evaluated in a multi-center, randomized, parallel-group, active-controlled, 180-day trial in 227 hypogonadal men. The study was conducted in 2 phases. During the Initial Treatment Period (Days 1-90), 73 patients were randomized to AndroGel 1% 50 mg daily, 78 patients to AndroGel 1% 100 mg daily, and 76 patients to a non-scrotal testosterone transdermal system. The study was double-blind for dose of AndroGel 1% but open-label for active control. Patients who were originally randomized to AndroGel 1% and who had single-sample serum testosterone concentrations above or below the normal range on Day 60 were titrated to 75 mg daily on Day 91. During the Extended Treatment Period (Days 91-180), 51 patients continued on AndroGel 1% 50 mg daily, 52 patients continued on AndroGel 1% 100 mg daily, 41 patients continued on a non-scrotal testosterone transdermal system (5 mg daily), and 40 patients received AndroGel 1% 75 mg daily. Upon completion of the initial study, 163 enrolled and 162 patients received treatment in an open-label extension study of AndroGel 1% for an additional period of up to 3 years.

Mean peak, trough and average serum testosterone concentrations within the normal range (298-1043 ng/dL) were achieved on the first day of treatment with doses of 50 mg and 100 mg of AndroGel 1%. In patients continuing on AndroGel 1% 50 mg and 100 mg, these mean testosterone concentrations were maintained within the normal range for the 180-day duration of the original study. Figure 2 summarizes the 24-hour pharmacokinetic profiles of testosterone administered as AndroGel 1% for 30, 90 and 180 days. Testosterone concentrations were maintained as long as the patient continued to properly apply the prescribed AndroGel 1% treatment.

Figure 2: Mean Steady-State Testosterone Concentrations in Patients with Once-Daily AndroGel 1% Therapy

Table 4 summarizes the mean testosterone concentrations on Treatment Day 180 for patients receiving 50 mg, 75 mg, or 100 mg of AndroGel 1%. The 75 mg dose produced mean concentrations intermediate to those produced by 50 mg and 100 mg of AndroGel 1%.

Of 129 hypogonadal men who were appropriately titrated with AndroGel 1% and who had sufficient data for analysis, 87% achieved an average serum testosterone concentration within the normal range on Treatment Day 180.

In patients treated with AndroGel 1%, there were no observed differences in the average daily serum testosterone concentrations at steady-state based on age, cause of hypogonadism, or body mass index.

DHT concentrations increased in parallel with testosterone concentrations at AndroGel 1% doses of 50 mg/day and 100 mg/day, but the DHT/T ratio stayed within the normal range, indicating enhanced availability of the major physiologically active androgen. Serum estradiol (E2) concentrations increased significantly within 30 days of starting treatment with AndroGel 1% 50 or 100 mg/day and remained elevated throughout the treatment period but remained within the normal range for eugonadal men. Serum levels of SHBG decreased very slightly (1 to 11%) during AndroGel 1% treatment. In men with hypergonadotropic hypogonadism, serum levels of LH and FSH fell in a dose- and time-dependent manner during treatment with AndroGel 1%.

Phototoxicity in Humans

The phototoxic potential of AndroGel 1% was evaluated in a double-blind, single-dose study in 27 subjects with photosensitive skin types. The Minimal Erythema Dose (MED) of ultraviolet radiation was determined for each subject. A single 24 (+1) hour application of duplicate patches containing test articles (placebo gel, testosterone gel, or saline) was made to naive skin sites on Day 1. On Day 2, each subject received five exposure times of ultraviolet radiation, each exposure being 25% greater than the previous one. Skin evaluations were made on Days 2 to 5. Exposure of test and control article application sites to ultraviolet light did not produce increased inflammation relative to non-irradiated sites, indicating no phototoxic effect.

AndroGel 1% is supplied in unit-dose aluminum foil packets in cartons of 30. Each packet of 2.5 g or 5 g gel contains 25 mg or 50 mg testosterone, respectively.

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Disposal

Used AndroGel 1% packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

See FDA-Approved Patient Labeling (Medication Guide)

Patients should be informed of the following:

Use in Men with Known or Suspected Prostate or Breast Cancer

Men with known or suspected prostate or breast cancer should not use AndroGel 1% [see Contraindications (4) and Warnings and Precautions (5.1)].

Potential for Secondary Exposure to Testosterone and Steps to Prevent Secondary Exposure

Secondary exposure to testosterone in children and women can occur with the use of testosterone gel in men. Cases of secondary exposure to testosterone have been reported in children.

Physicians should advise patients of the reported signs and symptoms of secondary exposure which may include the following:

• In children; unexpected sexual development including inappropriate enlargement of the penis or clitoris, premature development of pubic hair, increased erections, and aggressive behavior
• In women; changes in hair distribution, increase in acne, or other signs of testosterone effects
• The possibility of secondary exposure to testosterone gel should be brought to the attention of a healthcare provider
• AndroGel 1% should be promptly discontinued 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 testosterone gel in men [see Medication Guide]:

• Children and women should avoid contact with unwashed or unclothed application site(s) of men using testosterone gel
• Patients using AndroGel 1% should apply the product as directed and strictly adhere to the following:
  • Wash hands with soap and water after application
  • Cover the application site(s) with clothing after the gel has dried
  • Wash the application site(s) thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated
  • In the event that unwashed or unclothed skin to which AndroGel 1% 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 [see Dosage and Administration (2.2), Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].

Potential Adverse Reactions with Androgens

Patients should be informed that treatment with androgens may lead to adverse reactions which include:

• Changes in urinary habits such as increased urination at night, trouble starting your urine stream, passing 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 and weak urine flow.
• Breathing disturbances, including those associated with sleep, or excessive daytime sleepiness.
• Too frequent or persistent erections of the penis.
• Nausea, vomiting, changes in skin color, or ankle swelling.

Patients Should Be Advised of the Following Instructions for Use:

• Read the Medication Guide before starting AndroGel 1% therapy and to reread it each time the prescription is renewed
• AndroGel 1% should be applied and used appropriately to maximize the benefits and to minimize the risk of secondary exposure in children and women
• Keep AndroGel 1% out of the reach of children
• AndroGel 1% is an alcohol based product and is flammable; therefore avoid fire, flame or smoking until the gel has dried
• It is important to adhere to all recommended monitoring
• Report any changes in their state of health, such as changes in urinary habits, breathing, sleep, and mood
• AndroGel 1% is prescribed to meet the patient’s specific needs; therefore, the patient should never share AndroGel 1% with anyone.
• Wait 5 hours before swimming or washing following application of AndroGel 1%. This will ensure that the greatest amount of AndroGel 1% is absorbed into their system.

Marketed by:

AbbVie Inc.
North Chicago, IL 60064, USA

© 2016 AbbVie Inc.

5036330-Revised October, 2016

Medication Guide

AndroGel® (AN DROW JEL) CIII

(testosterone gel) 1%

Read this Medication Guide that comes with AndroGel 1% before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about AndroGel 1%?

1. Early signs and symptoms of puberty have happened in young children who were accidentally exposed to testosterone through contact with men using AndroGel 1%.
   
   Signs and symptoms of early puberty in a child may include:
   • enlarged penis or clitoris
   • early development of pubic hair
   • increased erections or sex drive
   • aggressive behavior
   
   AndroGel 1% can transfer from your body to others.
2. Women and children should avoid contact with the unwashed or unclothed area where AndroGel 1% has been applied to your skin.
   
   Stop using AndroGel 1% 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 AndroGel 1%.
   
   Signs and symptoms of exposure to AndroGel 1% in children may include:
   • enlarged penis or clitoris
   • early development of pubic hair
   • increased erections or sex drive
   • aggressive behavior
   
   Signs and symptoms of exposure to AndroGel 1% in women may include:
   • changes in body hair
   • a large increase in acne

• To lower the risk of transfer of AndroGel 1% from your body to others, you should follow these important instructions:
  • Apply AndroGel 1% only to areas that will be covered by a short sleeve T-shirt. These areas are your shoulders and upper arms, or stomach area (abdomen), or shoulders, upper arms and stomach area.
  • Wash your hands right away with soap and water after applying AndroGel 1%.
  • After the gel has dried, cover the application area with clothing. Keep the area covered until you have washed the application area well or have showered.
  • If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.
  • If a woman or child makes contact with the AndroGel 1% application area, that area on the woman or child should be washed well with soap and water right away.

What is AndroGel 1%?

AndroGel 1% is a prescription medicine that contains testosterone. AndroGel 1% is used to treat adult males who have low or no testosterone due to certain medical conditions.

Your healthcare provider will test your blood before you start and while you are taking AndroGel 1%.

It is not known if AndroGel 1% is safe or effective to treat men who have low testosterone due to aging.

It is not known if AndroGel 1% is safe or effective in children younger than 18 years old. Improper use of AndroGel 1% may affect bone growth in children.

AndroGel 1% is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your AndroGel 1% in a safe place to protect it. Never give your AndroGel 1% 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.

AndroGel 1% is not meant for use in women.

Who should not use AndroGel 1%?

Do not use AndroGel 1% if you:

• have breast cancer
• have or might have prostate cancer
• are pregnant or may become pregnant or breast-feeding. AndroGel 1% 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 AndroGel 1% has been applied.

Talk to your healthcare provider before taking this medicine if you have any of the above conditions.

What should I tell my healthcare provider before using AndroGel 1%?

Before you use AndroGel 1%, tell your healthcare provider if you:

• have breast cancer
• have or might have prostate cancer
• have urinary problems due to an enlarged prostate
• have heart problems
• have liver or kidney problems
• have problems breathing while you sleep (sleep apnea)
• have 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 AndroGel 1% with certain other medicines can affect each other.

Especially, tell your healthcare provider if you take:

• insulin
• corticosteroids
• medicines that decrease blood clotting

Know the medicines you take. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use AndroGel 1%?

• It is important that you apply AndroGel 1% exactly as your healthcare provider tells you to.
• Your healthcare provider will tell you how much AndroGel 1% to apply and when to apply it.
• Your healthcare provider may change your AndroGel 1% dose. Do not change your AndroGel 1% dose without talking to your healthcare provider.
• AndroGel 1% is to be applied to the area of your shoulders, upper arms, or abdomen that will be covered by a short sleeve t-shirt. Do not apply AndroGel 1% to any other parts of your body such as your penis, scrotum, chest, armpits (axillae), knees, or back.
• Apply AndroGel 1% at the same time each morning. AndroGel 1% should be applied after showering or bathing.
• Wash your hands right away with soap and water after applying AndroGel 1%.
• Avoid showering, swimming, or bathing for at least 5 hours after you apply AndroGel 1%.
• AndroGel 1% is flammable until dry. Let AndroGel 1% dry before smoking or going near an open flame.
• Let the application areas dry completely before putting on a t-shirt.

Applying AndroGel 1%:

AndroGel 1% comes in packets.

• Before applying AndroGel 1%, make sure that your shoulders, upper arms, and abdomen are clean, dry, and there is no broken skin.
• The application sites for AndroGel 1% are the shoulders, upper arms, or abdomen that will be covered by a short sleeve t-shirt (See Figure A).

(Figure A)

When using AndroGel 1% packets:

• Tear open the packet completely at the dotted line. Squeeze from the bottom of the packet to the top.
• Squeeze all of the AndroGel 1% out of the packet into the palm of your hand. Apply AndroGel 1% to the application site. You may also apply AndroGel 1% from the packet directly to the application site.
• AndroGel 1% should be applied right away.
• Wash your hands with soap and water right away.

What are the possible side effects of AndroGel 1%?

See “What is the most important information I should know about AndroGel 1%?”

AndroGel 1% can cause serious side effects including:

• If you already have enlargement of your prostate gland your signs and symptoms can get worse while using AndroGel 1%. 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 you for prostate cancer or any other prostate problems before you start and while you use AndroGel 1%.
• 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 AndroGel 1% may lower your sperm count.
• Swelling of your ankles, feet, or body, with or without heart failure.
• Enlarged or painful breasts.
• Have problems breathing while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effects of AndroGel 1% include:

• acne
• skin irritation where AndroGel 1% is applied
• lab test changes
• increased 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.

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

These are not all the possible side effects of AndroGel 1%. For more information, ask your healthcare provider or pharmacist.

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

How should I store AndroGel 1%?

• Store AndroGel 1% between 59ºF to 86ºF (15ºC to 30ºC).
• Safely throw away used AndroGel 1% in household trash. Be careful to prevent accidental exposure of children or pets.
• Keep AndroGel 1% away from fire.

Keep AndroGel 1% and all medicines out of the reach of children.

General information about the safe and effective use of AndroGel 1%

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AndroGel 1% for a condition for which it was not prescribed. Do not give AndroGel 1% to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about AndroGel 1%. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about AndroGel 1% that is written for health professionals.

For more information, go to www.AndroGel.com or call 1-800-633-9110.

What are the ingredients in AndroGel 1%?

Active ingredient: testosterone

Inactive ingredients: carbomer 980, ethyl alcohol 67.0%, isopropyl myristate, purified water and sodium hydroxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Marketed by:

AbbVie Inc.
North Chicago, IL 60064, USA

© 2016 AbbVie Inc.

5036330-Revised October, 2016

NDC 0051–8425–30

CIII

AndroGel®(testosterone gel) 1%

30 Unit-dose Packets

Contains 25 mg of testosterone in 2.5 Grams of gel per unit dose

Clear, colorless gel provides transdermal delivery of testosterone through the skin of the shoulders, upper arms, or abdomen.*

Rx Only

For Topical Use Only

Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure.

Dispense the enclosed Medication Guide to each patient.

*See accompanying package insert.

abbvie

NDC 0051–8450–30

CIII

AndroGel® (testosterone gel) 1%

30 Unit-dose Packets

Contains 50 mg of testosterone in 5 Grams of gel per unit dose

Clear, colorless gel provides transdermal delivery of testosterone through the skin of the shoulders, upper arms, or abdomen.*

Rx Only

For Topical Use Only

Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure.

Dispense the enclosed Medication Guide to each patient.

*See accompanying package insert.

abbvie

NDC 0051–8488–88

Get emergency medical help if you have any signs of an allergic reaction to Androgel: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using AndroGel and call your doctor at once if you have:

• increased urination (many times per day), loss of bladder control;

• painful or difficult urination;

• breast pain or swelling;

• painful or bothersome erections;

• swelling, rapid weight gain, shortness of breath during sleep;

• chest pain or pressure, pain spreading to your jaw or shoulder;

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs.

Topical testosterone is absorbed through the skin and can cause symptoms of male features in a woman or child who comes into contact with the medication. Call your doctor if your female partner has male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any other signs of male characteristics.

Common Androgel side effects may include:

• redness, itching, burning, hardened skin or other irritation where the medicine was applied;

• headache, mood changes;

• increased red blood cells (may cause dizziness, itching, redness in your face, or muscle pain);

• vomiting, diarrhea;

• strange dreams;

• frequent or prolonged erections; or

• high blood pressure - severe headache, blurred vision, pounding in your neck or ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.