Data from FDA - Curated by EPG Health - Last updated 01 June 2018

Indication(s)

1 INDICATIONS AND USAGE Testim is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Limitations of use: Safety and efficacy of Testim in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. Safety and efficacy of Testim in males less than 18 years old have not been established [see Use in Specific Populations (8.4)]. Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure [see Dosage and Administration (2) and Clinical Pharmacology (12.3)]. Testim is an androgen indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary Hypogonadism (Congenital or Acquired) (1) Hypogonadotropic Hypogonadism (1) Limitations of Use: Safety and efficacy of Testim in men with “age-related hypogonadism” have not been established. (1) Safety and efficacy of Testim in males less than 18 years old have not been established. (8.4) Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure. (1, 12.3)

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Advisory information

contraindications
4 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)]. Men with known carcinoma of the breast or known or suspected carcinoma of the prostate. (4, 5.1) Pregnant or breastfeeding women. Testosterone may cause fetal harm. (4, 8.1, 8.3)
Adverse reactions
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥ 2% of the Testim patients and greater than placebo) are application site reaction and increased hematocrit. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Endo Pharmaceuticals, Inc. at 1-800-462-3636 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a controlled clinical study, 304 patients were treated with Testim 50 mg or 100 mg or placebo gel for up to 90 days. Two hundred five (205) patients received Testim 50 mg or 100 mg daily and 99 patients received placebo. Subjects could be counted in both Testim treatment groups if they received both 50 mg and 100 mg at different points in the study and experienced an adverse reaction at both dose levels. Adverse reactions reported by ≥1% of the Testim patients and greater than placebo are listed in Table 1. Table 1: Incidence of Adverse Reactions (Reported by ≥1% of the Testim Patients and Greater than Placebo) in the Controlled Clinical Trial Through 90 Days Event Testim 50 mg (n=103) Testim 100 mg (n=149) Placebo (n=99) Application Site Reactions 2% 4% 3% Blood Pressure Increased 1% 1% 0% Gynecomastia 1% 0% 0% Headache 1% 1% 0% Hematocrit/hemoglobin Increased 1% 2% 0% Hot Flushes 1% 0% 0% Insomnia 1% 0% 0% Mood Swings 1% 0% 0% Smell Disorder 1% 0% 0% Spontaneous Penile Erection 1% 0% 0% Taste Disorder 1% 1% 0% The following adverse reactions occurred in fewer than 1% of patients but were greater in Testim groups compared to the placebo group: activated partial thromboplastin time prolonged, blood creatinine increased, prothrombin time prolonged, appetite increased, sensitive nipples, and acne. In this clinical trial of Testim, six patients had adverse reactions that led to their discontinuation. These events included: depression with suicidal ideation, urinary tract infection, mood swings and hypertension. No Testim patients discontinued due to skin reaction. In one foreign Phase 3 trial, one subject discontinued due to a skin-related adverse reaction. In the pivotal U.S. and European Phase 3 trials combined, at the 50 mg dosage strength, the percentage of subjects reporting clinically notable increases in hematocrit or hemoglobin were similar to placebo. However, in the 100 mg dose group, 2.3% and 2.8% of patients had a clinically notable increase in hemoglobin (≥ 19 g/dL) or hematocrit (≥ 58%), respectively, compared to 1.0% and 1.5% of patients in the placebo group, respectively. In the combined US and European open label extension studies, approximately 140 patients received Testim for at least 6 months. The results from these studies are consistent with those reported for the US controlled clinical trial. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of testosterone gel products. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Secondary Exposure to Testosterone in Children Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarketing surveillance of testosterone gel products. Signs and symptoms of these reported cases have included enlargement of the clitoris (with surgical intervention) or of the penis, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases with a reported outcome, these signs and symptoms were reported to have regressed with removal of the testosterone gel exposure. 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. In some of the cases, direct contact with the sites of application on the skin of men using testosterone gel was reported. In at least one reported case, the reporter considered the possibility of secondary exposure from items such as the testosterone gel user’s shirts and/or other fabrics, such as towels and sheets [see Warnings and Precautions (5.2)]. Vascular Disorders Venous thromboembolism [see Warnings and Precautions (5.4)] Cardiovascular Disorders Myocardial infarction, stroke [see Warnings and Precautions (5.5)]

Usage information

Dosing and administration
2 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. Prior to initiating Testim, confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range. (2) Recommended starting dose for adult males: 50 mg of testosterone (one tube) applied topically once daily. (2.1) Apply to clean, dry, intact skin of the shoulders and/or upper arms. Do NOT apply Testim to the genitals or abdomen. (2.1, 2.2) If morning pre-dose serum testosterone concentration is below normal range, increase dose to 100 mg. (2.1) Pre-dose serum testosterone concentration should be assessed periodically. (2.1) Patients should wash hands with soap and water immediately after applying Testim and cover application site(s) with clothing after gel has dried. Wash the application site thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated. (2.2) Testim is not interchangeable with other topical testosterone products. (2.1) 2.1 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. 2.2 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. Figure A
Use in special populations
8 USE IN SPECIFIC POPULATIONS Geriatric Patients: There are insufficient long-term safety data to assess the potential risks of cardiovascular disease and prostate cancer. (8.5) 8.1 Pregnancy Pregnancy Category X [see Contraindications (4)]: Testim is contraindicated in pregnant women or in women who may become pregnant. Testosterone is teratogenic and may cause fetal harm. Exposure of a fetus to androgens, such as testosterone, may result in varying degrees of virilization. If Testim is used during pregnancy or if the patient becomes pregnant while taking Testim, the patient should be made aware of the potential hazard to the fetus. 8.3 Nursing Mothers Although it is not known how much testosterone transfers into human milk, Testim is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants [see Contraindications (4)]. 8.4 Pediatric Use The safety and effectiveness of Testim in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses. 8.5 Geriatric Use There is insufficient long-term safety data in geriatric patients to assess the potentially increased risks of cardiovascular disease and prostate cancer [see Warnings and Precautions (5.1)]. 8.6 Renal Impairment No studies were conducted in patients with renal impairment. 8.7 Hepatic Impairment No studies were conducted in patients with hepatic impairment.
Pregnancy and lactation
8.3 Nursing Mothers Although it is not known how much testosterone transfers into human milk, Testim is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants [see Contraindications (4)].

Interactions

7 DRUG INTERACTIONS Androgens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients. (7.1) Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of International Normalized Ratio (INR) and prothrombin time is recommended in patients taking warfarin. (7.2) Use of testosterone with corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease. (7.3) 7.1 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. 7.2 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. 7.3 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.

More information

Category Value
Authorisation number NDA021454
Agency product number 3XMK78S47O
Orphan designation No
Product NDC 66887-001
Date Last Revised 30-04-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 1597132
Storage and handling Store at 20°C to 25°C (68°F - 77°F). Excursions permitted to 15°C to 30°C (59°F - 86°F) [See USP Controlled Room Temperature]. Discard used Testim tubes in household trash in a manner that prevents accidental exposure of women, children, or pets [see Boxed Warning and Warnings and Precautions (5.2)]. Contents are flammable [see Warnings and Precautions (5.16)].
Marketing authorisation holder Endo Pharmaceuticals, Inc.
Warnings WARNING: SECONDARY EXPOSURE TO TESTOSTERONE Virilization has been reported in children who were secondarily exposed to testosterone gel [see Warnings and Precautions (5.2) and Adverse Reactions (6.2)]. Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel [see Dosage and Administration (2.2) and Warnings and Precautions (5.2)] Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see Dosage and Administration (2.2), Warnings and Precautions (5.2) and Patient Counseling Information (17)]. WARNING: SECONDARY EXPOSURE TO TESTOSTERONE See full prescribing information for complete boxed warning Virilization has been reported in children who were secondarily exposed to testosterone gel (5.2, 6.2) Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel (2.2, 5.2) Healthcare providers should advise patients to strictly adhere to recommended instructions for use (2.2, 5.2, 17)