Testim

Name: Testim

Testim Interactions

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

Testim Food Interactions

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 testosterone, there are no specific foods that you must exclude from your diet when receiving this medication.

Testim and Pregnancy

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.

Testosterone 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. Testosterone should never be used by pregnant women.

Testim Overdose

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

If testosterone 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.

Other Requirements

Store testosterone at room temperature.

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

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

How should I use Testim (testosterone topical)?

Follow all directions on your prescription label. Never use testosterone topical in larger amounts, or for longer than prescribed.

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.

Different brands of testosterone topical have different instructions for use. Not every brand of this medicine is used on the same skin areas. Some brands are applied to the shoulder, upper arm, or stomach. Other brands are applied to the thighs or to the underarms. Carefully follow the patient instructions provided with your medicine.

Do not apply testosterone topical to your penis or scrotum. Some brands of this medicine should also not be applied to the back, chest, or stomach areas. Apply this medicine only to the skin areas recommended for your specific brand of testosterone topical.

Apply testosterone gel to dry skin after showering or bathing. Allow the medicine to dry for at least 5 minutes before you dress.

Wash your hands with soap and water after applying the gel.

Cover treated skin areas with clothing to keep from getting this medicine on other people. If someone else does come into contact with a treated skin area, they must wash the contact area right away with soap and water.

Apply the transdermal skin patch to a flat, clean, dry, and undamaged area of skin on your back, stomach, upper arm, or thigh. Wear the patch for 24 hours and then replace it with a new patch. Choose a different skin area each time you put on a new patch. Do not use the same skin area twice in a 7-day period.

While using testosterone topical, you may need frequent blood tests.

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

Store at room temperature away from moisture and heat.

Keep each skin patch in the foil pouch until you are ready to use it. Do not use a skin patch that has been cut or damaged After removing a skin patch, fold it closed with the sticky side in, and throw it away in a place where pets and children cannot reach it.

Commonly used brand name(s)

In the U.S.

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

Available Dosage Forms:

  • Gel/Jelly
  • Cream
  • Solution
  • Kit

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Androgen

Dosage and administration

Prior to initiating, Testim 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 Testim® is 50 mg of testosterone (one tube) applied once daily (preferably in the morning) to clean, dry intact skin of the shoulders and/or upper arms.

Dose Adjustment

To ensure proper dosing, serum testosterone concentrations should be measured. Morning, pre-dose serum testosterone concentrations should be measured approximately 14 days after initiation of therapy to ensure proper serum testosterone concentrations are achieved.  If the serum testosterone concentration is below the normal range (300 ng/dL to 1,000 ng/dL), the daily Testim dose may be increased from 50 mg testosterone (one tube) to 100 mg testosterone (two tubes) once daily.

The maximum recommended dose of Testim is 100 mg once daily.

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

Administration Instructions

Upon opening the tube the entire contents should be squeezed into the palm of the hand and immediately applied to the shoulders and/or upper arms (area of application should be limited to the area that will be covered by the patient’s short sleeve T-shirt (see figure below). Do not apply Testim to the genitals or to the abdomen.

Application sites should be allowed to dry for a few minutes prior to dressing.  Hands should be washed thoroughly with soap and water after Testim has been applied. Avoid fire, flame or smoking during the application of Testim until the Testim has dried [see Warnings and Precautions (5.2), (5.16)].

In order to prevent transfer to another person, wear clothing to cover the application sites. If direct skin-to-skin contact with another person is anticipated, the application sites must be washed thoroughly with soap and water [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].

The patient should avoid swimming or showering or washing the administration site for a minimum of 2 hours after application [see Clinical Pharmacology (12.3)].

Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from Testim-treated skin:


  • Children and women should avoid contact with unwashed or unclothed application site(s) of men using Testim.
  • Testim should only be applied to the upper arms and shoulders. The area of application should be limited to the area that will be covered by a short sleeve T-shirt.
  • Patients should wash their hands with soap and water immediately after applying Testim.
  • Patients should cover the application site(s) with clothing (e.g., a T-shirt) after the gel has dried.
  • Prior to situations in which direct skin-to-skin contact is anticipated, patients should wash the application site(s) thoroughly with soap and water to remove any testosterone residue.
  • In the event that unwashed or unclothed skin to which Testim 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.

Contraindications


  • Testim is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions (5.1)].
  • Testim is contraindicated in women who are or may become pregnant, or who are breastfeeding. Testim may cause fetal harm when administered to a pregnant woman. Testim may cause serious adverse reactions in nursing infants. Exposure of a fetus or nursing infant to androgens may result in varying degrees of virilization. Pregnant women or those who may become pregnant need to be aware of the potential for transfer of testosterone from men treated with Testim. If a pregnant woman is exposed to Testim, she should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5.2) and Use in Specific Populations (8.1, 8.3)].

Warnings and precautions

Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer


  • Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms.
  • Patients treated with androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating and during treatment with androgens [see Contraindications (4)].

Potential for Secondary Exposure to Testosterone

Cases of secondary exposure resulting in virilization of children have been reported in postmarketing surveillance. Signs and symptoms have included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases, these signs and symptoms regressed with removal of the exposure to testosterone gel. In a few cases, however, enlarged genitalia did not fully return to age-appropriate normal size, and bone age remained modestly greater than chronological age. The risk of transfer was increased in some of these cases by not adhering to precautions for the appropriate use of the topical testosterone product. Children and women should avoid contact with unwashed or unclothed application sites in men using Testim [see Dosage and Administration (2.2), Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)].

Inappropriate changes in genital size or development of pubic hair or libido in children, or changes in body hair distribution, significant increase in acne, or other signs of virilization in adult women should be brought to the attention of a physician and the possibility of secondary exposure to testosterone gel should also be brought to the attention of a physician. Testosterone gel should be promptly discontinued until the cause of virilization has been identified.

Polycythemia

Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. Check hematocrit prior to initiating treatment. It would also be appropriate to re-evaluate the hematocrit 3 to 6 months after starting treatment, and then annually. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable concentration. An increase in red blood cell mass may increase the risk of thromboembolic events.

Venous Thromboembolism

There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as Testim. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with Testim and initiate appropriate workup and management [see Adverse Reactions (6.2)].

Cardiovascular Risk

Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use Testim.

Abuse of Testosterone and Monitoring of Serum Testosterone Concentrations

Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions [see Drug Abuse and Dependence (9)].

If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.

Use in Women

Due to lack of controlled evaluations in women and potential virilizing effects, Testim is not indicated for use in women [see Contraindications (4) and Use in Specific Populations (8.1, 8.3)].

Potential for Adverse Effects on Spermatogenesis

With large doses of exogenous androgens, including Testim, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) which could possibly lead to adverse effects on semen parameters including sperm count.

Hepatic Adverse Effects

Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice).  Peliosis hepatis can be a life-threatening or fatal complication.  Long-term therapy with intramuscular testosterone enanthate, which elevates blood levels for prolonged periods, has produced multiple hepatic adenomas.  Testim is not known to cause these adverse effects.  Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice).  If these occur, promptly discontinue Testim while the cause is evaluated.

Edema

Androgens, including Testim, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease.  In addition to discontinuation of the drug, diuretic therapy may be required.

Gynecomastia

Gynecomastia occasionally develops and occasionally persists in patients being treated for hypogonadism [see Adverse Reactions (6.1)].

Sleep Apnea

The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.

Lipids

Changes in the serum lipid profile may occur. Monitor the lipid profile periodically, particularly after starting testosterone therapy and after dose increases.

Hypercalcemia

Androgens, including Testim, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.

Decreased Thyroxine-binding Globulin

Androgens, including Testim, may decrease concentrations of thyroxine-binding globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Flammability

Alcohol-based products, including Testim, are flammable; therefore, patients should be advised to avoid fire, flame or smoking until the Testim has dried.

Description

Testim® (testosterone gel) is a clear to translucent hydroalcoholic topical gel containing testosterone, an androgen.  Testim provides continuous transdermal delivery of testosterone for 24 hours, following a single application to intact, clean, dry skin of the shoulders and/or upper arms.

One 5-g or two 5-g tubes of Testim contains 50 mg or 100 mg of testosterone, respectively, to be applied daily to the skin’s surface.  Approximately 10% of the applied testosterone dose is absorbed across skin of average permeability during a 24-hour period.

The active pharmacological ingredient in Testim is testosterone. Testosterone USP is a white to practically white crystalline powder chemically described as 17-β hydroxyandrost-4-en-3-one. The structural formula is shown in the following figure:

Inactive ingredients in Testim are purified water, pentadecalactone, carbopol, acrylates, propylene glycol, glycerin, polyethylene glycol, ethanol (74%), and tromethamine.

Patient counseling information

See FDA-approved patient labeling (Medication Guide).

Advise patients of the following:

 Men with Known or Suspected Carcinoma of the Breast or Prostate

Men with known or suspected prostate or breast cancer should not use Testim® [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
  • Testim 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 Testim should apply the product as directed and strictly adhere to the following:
    • Wash hands with soap and water immediately 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 Testim 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 the urine stream, passing urine many times during the day, having an urge to go the bathroom right away, having a urine accident, or being unable to pass urine or 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 Testim therapy and reread it each time the prescription is renewed
  • Testim should be applied and used appropriately to maximize the benefits and to minimize the risk of secondary exposure in children and women
  • Keep Testim out of the reach of children. The package is not child resistant.
  • Testim 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
  • Testim is prescribed to meet the patient’s specific needs; therefore, the patient should never share Testim with anyone.
  • Testim should be applied once daily at approximately the same time each day to clean dry skin of the shoulders and/or upper arms.
  • Testim should not be applied to the scrotum, penis, or abdomen.
  • Wait 2 hours before swimming or washing following application of Testim. This will ensure that the greatest amount of Testim is absorbed into their system.

Distributed by:
Endo Pharmaceuticals Inc.
Malvern, PA 19355   USA

Manufactured by:
DPT Laboratories, Ltd.
San Antonio, TX 78215

US Patent Nos. 7,320,968; 7,608,605; 7,608,606; 7,608,607; 7,608,608; 7,608,609; 7,608,610; 7,935,690; 8,063,029; 8,178,518

140721

Medication Guide

Testim® (TĔS tim) CIII

(testosterone gel)

Read this Medication Guide that comes with Testim before you start using 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 Testim?

  • Early signs and symptoms of puberty have happened in young children who were accidentally exposed to testosterone through contact with men using Testim.

    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

    Testim can transfer from your body to others.

  • Women and children should avoid contact with the unwashed or unclothed area where Testim has been applied to your skin.

    Stop using Testim 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 Testim.

    Signs and symptoms of exposure to Testim 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 Testim in women may include:
    • changes in body hair
    • a large increase in acne

To lower the risk of transfer of Testim from your body to others, you should follow these important instructions:

  • Apply Testim only to the areas of your shoulders and upper arms that will be covered by a short sleeve T-shirt.
  • Wash your hands right away with soap and water after applying Testim.
  • 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 Testim application area, that area on the woman or child should be washed well with soap and water right away.

What is Testim?

Testim is a prescription medicine that contains testosterone.  Testim 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 use Testim.

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

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

Testim is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines.  Keep your Testim in a safe place to protect it.  Never give your Testim to anyone else, even if they have the same symptoms you have.  Selling or giving away this medicine may harm others and it is against the law.

Testim is not meant for use in women.

Who should not use Testim?

Do not use Testim if you:

  • have breast cancer
  • have or might have prostate cancer
  • are pregnant or may become pregnant or are breastfeeding. Testim may harm your unborn or breastfeeding baby.
    Women who are pregnant or who may become pregnant should avoid contact with the area of skin where Testim 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 Testim?
Before you use Testim, 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 Testim with certain other medicines can affect each other.

Especially, tell your healthcare provider if you take:

  • insulin
  • medicines that decrease blood clotting
  • corticosteroids

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 Testim?

  • It is important that you apply Testim exactly as your healthcare provider tells you to.
  • Your healthcare provider will tell you how much Testim to apply and when to apply it.  
  • Your healthcare provider may change your Testim dose.  Do not change your Testim dose without talking to your healthcare provider.
  • Testim is to be applied to the areas of your shoulders and upper arms that will be covered by a short sleeve T-shirt. Do not apply Testim to any other parts of your body such as your stomach area (abdomen), penis, or scrotum.
  • Apply Testim at the same time each morning. Testim should be applied after showering or bathing.
  • Wash your hands with soap and water right away after applying Testim.
  • Avoid showering, swimming, or bathing for at least 2 hours after you apply Testim.
  • Testim is flammable until dry.  Let the Testim dry before smoking or going near an open flame.
  • Let the application areas dry for a few minutes before putting on a T-shirt.

Applying Testim:

  • Before applying Testim, make sure that your shoulders and upper arms are clean, dry, and there is no broken skin.
  • The application sites for Testim are the shoulders and upper arms that will be covered by a short sleeve T-shirt (see Figure A).
  • Remove the cap from the tube and use the top of the cap to pierce the metal seal on the top of the tube by pushing or screwing the cap in.
  • Squeeze all of the Testim out of the tube into the palm of your hand.  Squeeze from the bottom of the tube to the top.
  • Apply all of the Testim to the application sites. Rub the gel onto your skin for several seconds. Let the application site dry for a few minutes before putting on a T-shirt.
  • Wash your hands with soap and water right away after applying Testim.

What are the possible side effects of Testim?

Testim can cause serious side effects including:

  • See “What is the most important information I should know about Testim?”
  • If you already have enlargement of your prostate gland your signs and symptoms can get worse while using Testim.  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 Testim.
  • 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 Testim may lower your sperm count.
  • Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney or liver disease.
  • Enlarged or painful breasts.
  • Having 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 Testim include:

  • skin irritation where Testim is applied
  • increased red blood cell count
  • headache
  • increased blood pressure

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 Testim.  For more information, ask your healthcare provider or pharmacist.

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

How should I store Testim?

  • Store Testim between 59°F to 86°F (15°C to 30°C).
  • Safely throw away used Testim in household trash.  Be careful to prevent accidental exposure of children or pets.
  • Keep Testim away from fire.

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

General information about the safe and effective use of Testim.

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

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

For more information, go to www.Testim.com or call 1-800-462-3636.

What are the ingredients in Testim?

Active ingredient: testosterone

Inactive ingredients: purified water, pentadecalactone, carbopol, acrylates, propylene glycol, glycerin, polyethylene glycol, ethanol (74%), and tromethamine.

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

Distributed by:
Endo Pharmaceuticals Inc.
Malvern, PA 19355

By:  DPT Laboratories, Ltd.
San Antonio, TX 78215

Revised: 10/2016

140716

Package Label - Principal Display Panel – 5 g Tube Label - NDC 66887-001-01

Package Label - Principal Display Panel – 30 Unit-dose Tubes Carton - NDC 66887-001-05

Testim 
testosterone gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66887-001
Route of Administration TRANSDERMAL DEA Schedule CIII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TESTOSTERONE (TESTOSTERONE) TESTOSTERONE 50 mg  in 5 g
Packaging
# Item Code Package Description
1 NDC:66887-001-05 30 TUBE in 1 CARTON
1 5 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021454 10/31/2002
Labeler - Endo Pharmaceuticals, Inc. (007746469)
Establishment
Name Address ID/FEI Operations
Contract Pharmaceuticals Limited Canada 248761249 MANUFACTURE(66887-001)
Establishment
Name Address ID/FEI Operations
DPT Laboratories, Ltd 832224526 MANUFACTURE(66887-001)
Revised: 10/2016   Endo Pharmaceuticals, Inc.

For the Consumer

Applies to testosterone: buccal patch extended release

Other dosage forms:

  • intramuscular injectable, intramuscular oil, intramuscular solution, intramuscular suspension
  • nasal gel/jelly
  • transdermal patch extended release

Along with its needed effects, testosterone (the active ingredient contained in Testim) 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 while taking testosterone:

Incidence not known
  • Pain, redness, or swelling in the arm or leg
  • trouble breathing

Get emergency help immediately if any of the following symptoms of overdose occur while taking testosterone:

Symptoms of overdose
  • Blurred vision
  • headache
  • seizures
  • slurred speech
  • sudden and severe inability to speak
  • temporary blindness
  • weakness in the arm or leg on one side of the body, sudden and severe

Some side effects of testosterone 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
  • Gum or mouth irritation
Less common
  • Bad, unusual, or unpleasant (after) taste
  • bleeding gums
  • blemishes on the skin
  • breast pain
  • change in taste
  • cough
  • crying
  • depersonalization
  • diarrhea
  • discouragement
  • dizziness
  • dry mouth
  • dysphoria
  • enlarged breasts
  • euphoria
  • fear or nervousness
  • feeling sad or empty
  • gum pain or blisters
  • hoarseness
  • indigestion
  • irritability
  • itching skin
  • loss of appetite
  • loss of interest or pleasure
  • lower back or side pain
  • mouth ulcers
  • nausea
  • noisy breathing
  • painful or difficult urination
  • paranoia
  • passing of gas
  • pounding in the ears
  • quick to react or overreact emotionally
  • rapidly changing moods
  • redness and swelling of the gums
  • slow or fast heartbeat
  • stinging of the lips
  • stomach cramps, pain, fullness, or discomfort
  • swelling of the gums
  • swelling of the nose
  • tiredness
  • toothache
  • trouble concentrating
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting

(web3)