Testim (testosterone gel) for Low T: Side Effects & Warnings

Generic drug: testosterone

Brand name: Testim

What is Testim 1% (testosterone gel), and how does it work?

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 are using 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.

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

What are the side effects of Testim?

WARNING

SECONDARY EXPOSURE TO TESTOSTERONE

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

Testim can cause serious side effects including:

• 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 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 includeleg pain, swelling or redness. Signs and symptoms of a blood clotin 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.

What is the dosage for Testim?

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, predose 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. 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.
• 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.
• The patient should avoid swimming or showering or washing the administration site for a minimum of 2 hours after application.

Strict adherence to the following precautions is advised in order tominimize the potential for secondary exposure to testosterone fromTestim-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.

What drugs interact with Testim?

Insulin

• Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens.
• In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of anti-diabetic medication.

Oral Anticoagulants

• Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking warfarin, especially at the initiation and termination of androgen therapy.

Corticosteroids

• The concurrent use of testosterone with corticosteroids may result in increased fluid retention and requires careful monitoring particularly in patients with cardiac, renal or hepatic disease.

Does Testim cause addiction or withdrawal symptoms?

Drug Abuse And Dependence

Controlled Substance

Testim contains testosterone, a Schedule III controlled substance in the Controlled Substances Act.

Abuse

• Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects.
• Abuse and misuse of testosterone are seen in male and female adults and adolescents.
• Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders.
• There have been reports of misuse of men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice.

Abuse-Related Adverse Reactions

Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids, and include

•  cardiac arrest,
• myocardial infarction,
• hypertrophic cardiomyopathy,
•  congestive heart failure,
• cerebrovascular accident,
• hepatotoxicity, and
• serious psychiatric manifestations, including
  • major depression,
  • mania,
  • paranoia,
  • psychosis,
  • delusions,
  • hallucinations,
  • hostility, and
  • aggression.

The following adverse reactions have also been reported in men:

•  transient ischemic attacks,
• convulsions,
• hypomania,
• irritability,
• dyslipidemias,
• testicular atrophy,
• subfertility, and
• infertility.

The following additional adverse reactions have been reported in women:

• hirsutism,
• virilization,
• deepening of voice,
• clitoral enlargement,
• breast atrophy,
• male-pattern baldness, and
• menstrual irregularities.

The following adverse reactions have been reported in male and female adolescents:

• premature closure of bony epiphyses with termination of growth, and
• precocious puberty.

Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Dependence

Behaviors Associated with Addiction

Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors:

• Taking greater dosages than prescribed
• Continued drug use despite medical and social problems due to drug use
• Spending significant time to obtain the drug when supplies of the drug are interrupted
• Giving a higher priority to drug use than other obligations
• Having difficulty in discontinuing the drug despite desires and attempts to do so
• Experiencing withdrawal symptoms upon abrupt discontinuation of use

Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug.

Individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months, which include

• depressed mood,
• major depression,
• fatigue,
• craving,
• restlessness,
• irritability,
• anorexia,
• insomnia,
• decreased libido and
• hypogonadotropic hypogonadism.

Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

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Is Testim safe to use while pregnant or breastfeeding?

• Due to lack of controlled evaluations in women and potential virilizing effects,
  Testim is not indicated for use in women.
• Testim is contraindicated in pregnant women. Testosterone is teratogenic and may cause fetal harm based on data from animal studies and its mechanism of action.
• Exposure of a female fetus to androgens may result in varying degrees of virilization.
• There is no information on Testim use in breastfeeding women, as Testim is not indicated for use in females.