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This information has been developed and provided by an independent third-party source. Merck & Co., Inc. does not endorse and is not responsible for the accuracy of the content, or for practices or
standards of non-Merck sources.
ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.
Pronunciation
(tes TOS ter one)
Generic Available (U.S.)
Yes: Injection, powder
Index Terms
Controlled Substance
C-III
Medication Guide
An FDA-approved patient medication guide, which is available with the product and as follows, must be dispensed with this medication:
AndroGel® 1%: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM188474.pdf
AndroGel® 1.62%: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM255313.pdf
Axiron®: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM249396.pdf
Fortesta™: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM239932.pdf
Testim®: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM188475.pdf
Testosterone Gel: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM294248.pdf
REMS Components
AndroGel® 1%, AndroGel® 1.62%, Axiron®, Fortesta™, Testim®: Medication Guide
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Use: Labeled Indications
Injection: Androgen replacement therapy in the treatment of delayed male puberty; male hypogonadism (primary or hypogonadotropic); inoperable metastatic female breast cancer (enanthate only)
Pellet: Androgen replacement therapy in the treatment of delayed male puberty; male hypogonadism (primary or hypogonadotropic)
Buccal system, topical gel, topical solution, transdermal system: Male hypogonadism (primary or hypogonadotropic)
Capsule (not available in U.S.): Conditions associated with a deficiency or absence of endogenous testosterone
Use: Unlabeled
Androgen deficiency in men with AIDS wasting; postmenopausal women (short-term use in select cases)
Pregnancy Risk Factor
X
Pregnancy Considerations
Testosterone may cause adverse effects, including masculinization of the female fetus, if used during pregnancy. Females who are or may become pregnant should also avoid skin-to-skin contact to areas where testosterone has been applied topically on another person.
Lactation
Enters breast milk/contraindicated
Breast-Feeding Considerations
High levels of endogenous maternal testosterone, such as those caused by certain ovarian cysts, suppress milk production. Maternal serum testosterone levels generally fall following pregnancy and return to normal once breast-feeding is stopped. The amount of testosterone present in breast milk or the effect to the nursing infant following maternal supplementation is not known. Some products are contraindicated while breast-feeding. Females who are nursing should avoid skin-to-skin contact to areas where testosterone has been applied topically on another person.
Contraindications
Hypersensitivity to testosterone or any component of the formulation; males with known or suspected carcinoma of the breast or prostate; specific products are contraindicated in women
Depo®-Testosterone: Also contraindicated in serious hepatic, renal, or cardiac disease
Warnings/Precautions
Boxed warnings:
• Secondary exposure: See “Other warnings/precautions” below.
Concerns related to adverse effects:
• Gynecomastia: May cause gynecomastia.
• Hepatic effects: Prolonged use of high doses of androgens has been associated with serious hepatic effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, jaundice).
• Hypercalcemia: May cause hypercalcemia in patients with prolonged immobilization or cancer.
• Hypercholesterolemia: May alter serum cholesterol; use caution with history of MI or coronary artery disease.
• Hypoglycemia: Has both androgenic and anabolic activity, the anabolic action may enhance hypoglycemia.
• Polycythemia: May increase hematocrit requiring dose adjustment or discontinuation
• Prostate cancer: May increase the risk of prostate cancer.
• Spermatogenesis: Large doses may suppress spermatogenesis.
Disease-related concerns:
• Benign prostatic hyperplasia (BPH): Urethral obstruction may develop in patients with BPH; treatment should be discontinued if this should occur (use lower dose if restarted). Withhold treatment pending urological evaluation in patients with palpable prostate nodule or induration, PSA >4 ng/mL, or PSA >3 ng/mL in men at high risk of prostate cancer (Bhasin, 2010).
• Edematous conditions: Use with caution in patients with conditions influenced by edema (eg, cardiovascular disease, migraine, seizure disorder, renal or hepatic impairment) or medications that enhance edema formation (eg, corticosteroids); testosterone may cause fluid retention.
• Sleep apnea: May potentiate sleep apnea in some male patients (obesity or chronic lung disease).
Special populations:
• Elderly: Use with caution in elderly patients, they may be at greater risk for prostatic hyperplasia, prostate cancer, fluid retention, and transaminase elevations.
• Pediatrics: May accelerate bone maturation without producing compensatory gain in linear growth in children; in prepubertal children perform radiographic examination of the hand and wrist every 6 months to determine the rate of bone maturation and to assess the effect of treatment on the epiphyseal centers. Gels, solution, transdermal, and buccal system have not been evaluated in males <18 years of age; safety and efficacy of injection have not been established in males <12 years of age.
• Women: During treatment for metastatic breast cancer, women should be monitored for signs of virilization; discontinue if mild virilization is present to prevent irreversible symptoms.
Dosage form specific issues:
• Benzyl alcohol: Some dosage forms may contain benzyl alcohol which has been associated with "gasping syndrome" in neonates.
• Gel: Fortesta™ is not interchangeable with other topical testosterone products. AndroGel® 1% and AndroGel® 1.62% are not interchangeable.
• Solution: Axiron® is not interchangeable with other topical testosterone products. Use in males with BMI >35 kg/m2 has not been established.
• Soy: Some testosterone products may be chemically synthesized from soy.
• Transdermal patch: May contain conducting metal (eg, aluminum); remove patch prior to MRI.
Other warnings/precautions:
• Secondary exposure: Testosterone may be transferred to another person following skin-to-skin contact with the application site. [U.S. Boxed Warning]: Virilization in children has been reported following contact with unwashed or unclothed application sites of men using topical testosterone. Patients should strictly adhere to instructions for use in order to prevent secondary exposure. Virilization of female sexual partners has also been reported with male use of topical testosterone. Symptoms of virilization generally regress following removal of exposure; however, in some children, enlarged genitalia and bone age did not fully return to age appropriate normal. Signs of inappropriate virilization in women or children following secondary exposure to topical testosterone should be brought to the attention of a healthcare provider.
Adverse Reactions
Frequency not always defined.
Cardiovascular: Deep venous thrombosis, edema, hypertension, vasodilation
Central nervous system: Abnormal dreams, aggressive behavior, anger, amnesia, anxiety, blood pressure increased/decreased, chills, depression, dizziness, emotional lability, excitation, fatigue, headache, hostility, insomnia, malaise, memory loss, mood swings, nervousness, seizure, sleep apnea, sleeplessness
Dermatologic: Acne, alopecia, contact dermatitis, dry skin, erythema, folliculitis, hair discoloration, hirsutism (increase in pubic hair growth), pruritus, rash, seborrhea
Endocrine & metabolic: Breast pain/soreness, gonadotropin secretion decreased, growth acceleration, gynecomastia, hot flashes, hypercalcemia, hyperchloremia, hypercholesterolemia, hyper-/hypoglycemia, hyper-/hypokalemia, hyperlipidemia, hypernatremia, inorganic phosphate retention, libido changes, menstrual problems (including amenorrhea), virilism, water retention
Gastrointestinal: Appetite increased, diarrhea, gastroesophageal reflux, GI bleeding, GI irritation, nausea, taste disorder, vomiting, weight gain
Following buccal administration (most common): Bitter taste, gum edema, gum or mouth irritation, gum pain, gum tenderness, taste perversion
Genitourinary: Bladder irritability, impotence, oligospermia, penile erections (spontaneous), priapism, prostatic carcinoma, prostatic hyperplasia, prostatitis, PSA increased, testicular atrophy, urination impaired
Hepatic: Bilirubin increased, cholestatic hepatitis, cholestatic jaundice, hepatic dysfunction, hepatic necrosis, hepatocellular neoplasms, liver function test changes, peliosis hepatis
Hematologic: Anemia, bleeding, hematocrit/hemoglobin increased, leukopenia, polycythemia, suppression of clotting factors
Local: Application site reaction (gel, solution), injection site inflammation/pain
Transdermal system: Pruritus at application site (17% to 37%), burn-like blisters under system (12%), erythema at application site (≤7%), vesicles at application site (6%), allergic contact dermatitis to system (4%), burning at application site (3%), induration at application site (3%), exfoliation at application site (<3%)
Neuromuscular & skeletal: Back pain, hemarthrosis, hyperkinesias, paresthesia, weakness
Ocular: Lacrimation increased
Renal: Creatinine increased, hematuria, polyuria
Respiratory: Dyspnea, nasopharyngitis
Miscellaneous: Anaphylactoid reactions, diaphoresis, hypersensitivity reactions, smell disorder
Postmarketing and/or case reports: Injection: Cough, coughing fits, respiratory distress; migraine; virilization of children following secondary exposure to topical gel (advanced bone age, aggressive behavior, enlargement of clitoris requiring surgery, enlargement of penis, erections increased, libido increased, pubic hair development); vitreous detachment
Metabolism/Transport Effects
Substrate of CYP2B6 (minor), CYP2C19 (minor), CYP2C9 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Drug Interactions
Conivaptan: May increase the serum concentration of CYP3A4 Substrates (Low risk). Risk C: Monitor therapy
CycloSPORINE: Androgens may enhance the hepatotoxic effect of CycloSPORINE. Androgens may increase the serum concentration of CycloSPORINE. Risk D: Consider therapy modification
CycloSPORINE (Systemic): Androgens may enhance the hepatotoxic effect of CycloSPORINE (Systemic). Androgens may increase the serum concentration of CycloSPORINE (Systemic). Risk D: Consider therapy modification
Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Androgens may enhance the anticoagulant effect of Vitamin K Antagonists. Risk D: Consider therapy modification
Ethanol/Nutrition/Herb Interactions
Herb/Nutraceutical: St John's wort may decrease testosterone levels.
Storage
Androderm®: Store at room temperature. Do not store outside of pouch. Excessive heat may cause system to burst.
AndroGel® 1%, AndroGel® 1.62%, Axiron®, Delatestryl®, Striant®, Testim®: Store at room temperature.
Depo® Testosterone: Store at room temperature. Protect from light.
Fortesta™: Store at room temperature; do not freeze
Testopel®: Store in a cool location.
Mechanism of Action
Principal endogenous androgen responsible for promoting the growth and development of the male sex organs and maintaining secondary sex characteristics in androgen-deficient males
Pharmacodynamics/Kinetics
Duration (route and ester dependent): I.M.: Cypionate and enanthate esters have longest duration, ≤2-4 weeks; gel: 24-48 hours
Absorption: Transdermal gel: ~10% of applied dose
Protein binding: 98%; bound to sex hormone-binding globulin (40%) and albumin
Metabolism: Hepatic; forms metabolites, including dihydrotestosterone (DHT) and estradiol (both active)
Half-life elimination: Variable: 10-100 minutes
Excretion: Urine (90%); feces (6%)
Dosage
Adolescents and Adults: Males:
I.M.:
Primary hypogonadism or hypogonadotropic hypogonadism: Testosterone enanthate or testosterone cypionate: 50-400 mg every 2-4 weeks (FDA-approved dosing range); 75-100 mg/week or 150-200 mg every 2 weeks (Bhasin, 2010)
Delayed puberty: Testosterone enanthate: 50-200 mg every 2-4 weeks for a limited duration
Pellet (for subcutaneous implantation): Delayed puberty, primary hypogonadism or hypogonadotropic hypogonadism: 150-450 mg every 3-6 months
Adults:
I.M.: Females: Inoperable metastatic breast cancer: Testosterone enanthate: 200-400 mg every 2-4 weeks
Oral: Males: Conditions associated with a deficiency or absence of endogenous testosterone: Capsule (Andriol®; not available in U.S.): Initial: 120-160 mg/day in 2 divided doses for 2-3 weeks; adjust according to individual response; usual maintenance dose: 40-120 mg/day (in divided doses)
Topical: Primary male hypogonadism or hypogonadotropic hypogonadism:
Buccal: 30 mg twice daily (every 12 hours) applied to the gum region above the incisor tooth
Gel: Apply to clean, dry, intact skin. Do not apply testosterone gel to the genitals.
AndroGel® 1%, Testim®: 5 g (to deliver 50 mg of testosterone with 5 mg systemically absorbed) applied once daily (preferably in the morning) to the shoulder and upper arms. AndroGel® 1% may also be applied to the abdomen. Dosage may be increased to a maximum of 10 g (100 mg).
Dose adjustment based on testosterone levels:
Less than normal range: Increase dose from 5 g to 7.5 g to 10 g
Greater than normal range: Decrease dose. Discontinue if consistently above normal at 5 g/day
AndroGel® 1.62%: 40.5 mg applied once daily in the morning to the shoulder and upper arms. Dosage may be increased to a maximum of 81 mg.
Dose adjustment based on testosterone levels:
>750 ng/dL: Decrease dose by 20.25 mg/day
≥350 ng/dL to ≤750 ng/dL: Maintain current dose
<350 ng/dL: Increase dose by 20.25 mg/day
Fortesta™: 40 mg once daily in the morning. Apply to the thighs. Dosing range: 10-70 mg/day
Dose adjustment based on serum testosterone levels:
≥2500 ng/dL: Decrease dose by 20 mg/day
≥1250 to <2500 ng/dL: Decrease dose by 10 mg/day
≥500 and <1250 ng/dL: Maintain current dose
<500 ng/dL: Increase dose by 10 mg/day
Solution: Axiron®: 60 mg once daily. (Dosage range 30-120 mg/day). Apply to the axilla at the same time each morning; do not apply to other parts of the body. Apply to clean, dry, intact skin. Do not apply testosterone solution to the genitals.
Dose adjustment based on serum testosterone levels:
>1050 ng/dL: Decrease 60 mg/day dose to 30 mg/day; if levels >1050 ng/dL persist after dose reduction discontinue therapy
<300 ng/dL: Increase 60 mg/day dose to 90 mg/day, or increase 90 mg/day dose to 120 mg/day
Transdermal system (Androderm®): Note: Patches are available in 2 mg, 2.5 mg, 4 mg, and 5 mg strengths. Initial dose is either 4 mg/day or 5 mg/day and dose adjustment varies as follows:
Initial: 4 mg/day (as one 4 mg/day patch; do not use two 2 mg/day patches)
Dose adjustment based on testosterone levels:
>930 ng/dL: Decrease dose to 2 mg/day
400-930 ng/dL: Continue 4 mg/day
<400 ng/dL: Increase dose to 6 mg/day (as one 4 mg/day and one 2 mg/day patch)
Initial: 5 mg/day (as one 5 mg/day or two 2.5 mg/day patches)
Dose adjustment based on testosterone levels:
>1030 ng/dL: Decrease dose to 2.5 mg/day
300-1030 ng/dL: Continue 5 mg/day
<300 ng/dL: Increase dose to 7.5 mg/day (as one 5 mg/day and one 2.5 mg/day patch)
Dosing conversion: If needed, patients may be switched from the 2.5 mg/day, 5 mg/day, and 7.5 mg/day patches as follows. Patch change should occur at their next scheduled dosing. Measure early morning testosterone concentrations ~2 weeks after switching therapy:
From 2.5 mg/day patch to 2 mg/day patch
From 5 mg/day patch to 4 mg/day patch
From 7.5 mg/day patch to 6 mg/day patch (one 2 mg/day and one 4 mg/day patch)
Dosing adjustment in renal impairment: No dosage adjustment provided in manufacturer's labeling (has not been studied). Use with caution; may enhance edema formation.
Dosing adjustment in hepatic impairment: No dosage adjustment provided in manufacturer's labeling (has not been studied). Use with caution; may enhance edema formation.
Administration: Oral
Oral, buccal application (Striant®): One mucoadhesive for buccal application (buccal system) should be applied to a comfortable area above the incisor tooth. Apply flat side of system to gum. Rotate to alternate sides of mouth with each application. Hold buccal system firmly in place for 30 seconds to ensure adhesion. The buccal system should adhere to gum for 12 hours. If the buccal system falls out, replace with a new system. If the system falls out within 4 hours of next dose, the new buccal system should remain in place until the time of the following scheduled dose. System will soften and mold to shape of gum as it absorbs moisture from mouth. Do not chew or swallow the buccal system. The buccal system will not dissolve; gently remove by sliding downwards from gum; avoid scratching gum.
Oral, capsule (Andriol®; not available in the U.S.): Should be administered with meals. Should be swallowed whole; do not crush or chew.
Administration: I.M.
Warm injection to room temperature and shaking vial will help redissolve crystals that have formed after storage. Administer by deep I.M. injection into the upper outer quadrant of the gluteus maximus.
Administration: Other
Transdermal patch (Androderm®): Apply patch to clean, dry area of skin on the back, abdomen, upper arms, or thigh. Do not apply to bony areas or parts of the body that are subject to prolonged pressure while sleeping or sitting. Do not apply to the scrotum. Avoid showering, washing the site, or swimming for 3 hours after application. Following patch removal, mild skin irritation may be treated with OTC hydrocortisone cream. A small amount of triamcinolone acetonide 0.1% cream may be applied under the system to decrease irritation; do not use ointment. Patch should be applied nightly. Rotate administration sites, allowing 7 days between applying to the same site.
Topical gel and solution: Apply to clean, dry, intact skin. Application sites should be allowed to dry for a few minutes prior to dressing. Hands should be washed with soap and water after application. Do not apply testosterone gel or solution to the genitals. Alcohol-based gels and solutions are flammable; avoid fire or smoking until dry. Testosterone may be transferred to another person following skin-to-skin contact with the application site. Strict adherence to application instructions is needed in order to decrease secondary exposure. Thoroughly wash hands after application and cover application site with clothing (ie, shirt) once gel or solution has dried, or clean application site thoroughly with soap and water prior to contact in order to minimize transfer. In addition to skin-to-skin contact, secondary exposure has also been reported following exposure to secondary items (eg, towel, shirt, sheets). If secondary exposure occurs, the other person should thoroughly wash the skin with soap and water as soon as possible.
AndroGel® 1%, AndroGel® 1.62%, Testim®: Apply (preferably in the morning) to clean, dry, intact skin of the shoulder and upper arms. AndroGel® 1% may also be applied to the abdomen; do not apply AndroGel® 1.62% or Testim® to the abdomen. Area of application should be limited to what will be covered by a short sleeve t-shirt. Apply at the same time each day. Upon opening the packet(s), the entire contents should be squeezed into the palm of the hand and immediately applied to the application site(s). Alternatively, a portion may be squeezed onto palm of hand and applied, repeating the process until entire packet has been applied. Application site should not be washed for ≥2 hours following application of AndroGel® 1.62% or Testim®, or >5 hours for AndroGel® 1%.
AndroGel® 1% multidose pump: Prime pump 3 times (and discard this portion of product) prior to initial use. Each actuation delivers 1.25 g of gel (4 actuations = 5 g; 6 actuations = 7.5 g; 8 actuations = 10 g); each actuation may be applied individually or all at the same time.
AndroGel® 1.62% multidose pump: Prime pump 3 times (and discard this portion of product) prior to initial use. Each actuation delivers 20.25 mg of gel (2 actuations = 40.5 mg; 3 actuations = 60.75 mg; 4 actuations = 81 mg); each actuation may be applied individually or all at the same time.
Axiron®: Apply using the applicator to the axilla at the same time each morning. Do not apply to other parts of the body (eg, abdomen, genitals, shoulders, upper arms). Avoid washing the site or swimming for 2 hours after application. Prior to first use, prime the applicator pump by depressing it 3 times (discard this portion of the product). After priming, position the nozzle over the applicator cup and depress pump fully one time; ensure liquid enters cup. Each pump actuation delivers testosterone 30 mg. No more than 30 mg (one pump) should be added to the cup at one time. The total dose should be divided between axilla (example, 30 mg/day: apply to one axilla only; 60 mg/day: apply 30 mg to each axilla; 90 mg/day: apply 30 mg to each axilla, allow to dry, then apply an additional 30 mg to one axilla; etc). To apply dose, keep applicator upright and wipe into the axilla; if solution runs or drips, use cup to wipe. Do not rub into skin with fingers or hand. If more than one 30 mg dose is needed, repeat process. Apply roll-on or stick antiperspirants or deodorants prior to testosterone. Once application site is dry, cover with clothing. After use, rinse applicator under running water and pat dry with a tissue. The application site and dose of this product are not interchangeable with other topical testosterone products.
Fortesta™: Apply to skin of front and inner thighs. Do not apply to other parts of the body. Use one finger to rub gel evenly onto skin of each thigh. Avoid showering, washing the site, or swimming for 2 hours after application. Prior to first dose, prime the pump by holding canister upright and fully depressing the pump 8 times (discard this portion of the product). Each pump actuation delivers testosterone 10 mg. The total dose should be divided between thighs (example, 10 mg/day: apply 10 mg to one thigh only; 20 mg/day: apply 10 mg to each thigh; 30 mg/day: apply 20 mg to one thigh and 10 mg to the other thigh; etc). Once application site is dry, cover with clothing. The application site and dose of this product are not interchangeable with other topical testosterone products.
Monitoring Parameters
Periodic liver function tests, cholesterol, hemoglobin and hematocrit (prior to therapy, at 3-6 months, then annually); radiologic examination of wrist and hand every 6 months (when using in prepubertal children). Withhold initial treatment with hematocrit >50%, hyperviscosity, untreated obstructive sleep apnea, or uncontrolled severe heart failure. Monitor urine and serum calcium and signs of virilization in women treated for breast cancer. Serum glucose (may be decreased by testosterone, monitor patients with diabetes). Evaluate males for response to treatment and adverse events 3-6 months after initiation and then annually.
Bone mineral density: Monitor after 1-2 years of therapy in hypogonadal men with osteoporosis or low trauma fracture (Bhasin, 2010)
PSA: In men >40 years of age with baseline PSA >0.6 ng/mL, PSA and prostate exam (prior to therapy, at 3-6 months, then as based on current guidelines). Withhold treatment pending urological evaluation in patients with palpable prostate nodule or induration or PSA >4 ng/mL or if PSA >3 ng/mL in men at high risk of prostate cancer (Bhasin, 2010).
Do not treat with severe untreated BPH with IPSS symptom score >19.
Serum testosterone: After initial dose titration (if applicable), monitor 3-6 months after initiating treatment, then annually.
Injection: Measure midway between injections. Adjust dose or frequency if testosterone concentration is <400 ng/dL or >700 ng/dL (Bhasin, 2010).
AndroGel® 1%, Testim®: Morning serum testosterone levels ~14 days after start of therapy or dose adjustments
AndroGel® 1.62%: Morning serum testosterone levels after 14 and 28 days of starting therapy or dose adjustments and periodically thereafter
Androderm®: Morning serum testosterone levels (following application the previous evening) ~14 days after start of therapy or dose adjustments
Axiron®: Serum testosterone levels can be measured 2-8 hours after application and after 14 days of starting therapy or dose adjustments
Fortesta™: Serum testosterone levels can be measured 2 hours after application and after 14 and 35 days of starting therapy or dose adjustments
Striant®: Application area of gums; total serum testosterone 4-12 weeks after initiating treatment, prior to morning dose
Testopel®: Measure at the end of the dosing interval (Bhasin, 2010)
Reference Range
Total testosterone, males:
12-13 years: <800 ng/dL
14 years: <1200 ng/dL
15-16 years: 100-1200ng/dL
17-18 years: 300-1200 ng/dL
19-40 years: 300-950 ng/dL
>40 years: 240-950 ng/dL
Free testosterone, males: 9-30 ng/dL
Test Interactions
Testosterone may decrease thyroxine-binding globulin, resulting in decreased total T4; free thyroid hormone levels are not changed.
Dietary Considerations
Testosterone USP may be synthesized from soy. Food and beverages have not been found to interfere with buccal system; ensure system is in place following eating, drinking, or brushing teeth.
Patient Education
Instruct patient that this drug is not to be used by women except in rare situations. Drug can cause male-like features in females or children, such as changes in sex drive, increased body hair, acne, aggressive behavior, or irregular periods. It should be applied to clean, dry skin and then covered with clothing. No swimming or showering should be allowed up to ≥2 hours (product-dependent) after topical application. Inform patients that testosterone may lower blood sugars and that symptoms of hypoglycemia, such as shaking, hunger, blurred vision, or rapid heartbeat, should be monitored. Inform prescriber if patient has history of diabetes or liver or kidney disease. Serious side effects which need to be reported include problems with urination, ankle swelling, nausea or stomach pains, or frequent or prolonged erections.
Geriatric Considerations
Elderly males treated with androgens may be at increased risk of developing prostatic hyperplasia and prostatic carcinoma. Increase in libido may occur.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Buccal administration: Bitter taste, gum edema, gum or mouth irritation, gum tenderness, and taste perversion.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause anxiety, insomnia, aggressive behavior, or depression
Mental Health: Effects on Psychiatric Treatment
May rarely cause neutropenia; use caution with clozapine and carbamazepine
Nursing: Physical Assessment/Monitoring
Instruct patients to apply to clean, dry skin and that area should be covered with clothing to prevent transmission.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, topical [compounding kit]:
First®-Testosterone MC: 2% (60 g) [contains benzyl alcohol, sesame oil]
Gel, topical:
AndroGel®: 1% [5 g gel/packet] (30s); 1% [2.5 g gel/packet] (30s); 1% [1.25 g gel/actuation] (75 g) [contains ethanol 67%; may be chemically synthesized from soy]
AndroGel®: 1.62% [1.25 g gel/actuation] (75 g) [contains ethanol]
Fortesta™: 10 mg/actuation (60 g) [contains ethanol; 0.5 g gel/actuation; 120 metered actuations]
Testim®: 1% [5 g gel/tube] (30s) [contains ethanol 74%; may be chemically synthesized from soy]
Implant, subcutaneous:
Testopel®: 75 mg (10s, 24s, 100s)
Injection, oil, as cypionate: 100 mg/mL (10 mL); 200 mg/mL (1 mL, 10 mL)
Depo®-Testosterone: 100 mg/mL (10 mL); 200 mg/mL (1 mL, 10 mL) [contains benzyl alcohol, benzyl benzoate, cottonseed oil]
Injection, oil, as enanthate: 200 mg/mL (5 mL)
Delatestryl®: 200 mg/mL (5 mL) [contains chlorobutanol, sesame oil]
Mucoadhesive, for buccal application [buccal system]:
Striant®: 30 mg (60s) [may be chemically synthesized from soy]
Ointment, topical [compounding kit]:
First®-Testosterone: 2% (60 g) [contains benzyl alcohol, sesame oil]
Patch, transdermal:
Androderm®: 2 mg/24 hours (60s); 2.5 mg/24 hours (60s [DSC]); 4 mg/24 hours (30s); 5 mg/24 hours (30s [DSC]) [contains ethanol, metal]
Powder, for prescription compounding [micronized]: USP: 100% (5 g, 25 g)
Powder, for prescription compounding, as propionate: USP: 100% (5 g, 25 g)
Solution, topical:
Axiron®: 30 mg/actuation (110 mL) [contains ethanol, isopropyl alcohol; 60 metered actuations]
Pricing: U.S. (www.drugstore.com)
Cream (First-Testosterone MC)
2% (60): $53.19
Gel (AndroGel)
50 mg/5 g (150): $368.97
Gel (AndroGel Pump)
1% (150): $360.97
20.25 MG/ACT(1.62%) (75): $348.98
Gel (Testim)
1% (150): $330.00
Misc (Striant)
30 mg (60): $357.90
Oil (Delatestryl)
200 mg/mL (5): $93.98
Oil (Depo-Testosterone)
100 mg/mL (10): $78.74
200 mg/mL (1): $27.99
200 mg/mL (10): $132.29
Oil (Testosterone Cypionate)
200 mg/mL (1): $32.99
200 mg/mL (10): $100.99
Oil (Testosterone Enanthate)
200 mg/mL (5): $83.99
Ointment (First-Testosterone)
2% (60): $51.99
Patch, 24-hour (Androderm)
2 mg/24 hrs (60): $329.99
4 mg/24 hrs (30): $309.99
References
Bhasin S, Cunningham GR, Hayes FJ, et al, “Testosterone Therapy In Men With Androgen Deficiency Syndromes: An Endocrine Society Clinical Practice Guideline,” J Clin Endocrinol Metab, 2010, 95(6):2536-59.
Petak SM, Nankin HR, Spark RF, et al, “American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Hypogonadism in Adult Male Patients − 2002 Update,” Endocr Pract, 2002, 8(6):440-56.
Wierman ME, Basson R, Davis SR, et al, “Androgen therapy in Women: An Endocrine Society Clinical Practice Guideline,” J Clin Endocrinol Metab, 2006, 91(10):3697-710.
International Brand Names
Lexi-Comp.com
Last full review/revision March 2012
Content last modified March 2012
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