Names and pronunciation
Androderm, AndroGel, Fortesta, Testim, Vogelxo Aveed, Jatenzo
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Drug reference
Androderm, AndroGel, Fortesta, Testim, Vogelxo Aveed, Jatenzo
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Func. class.: Androgenic anabolic steroid
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Chem. class.: Halogenated testoster- one derivative Controlled Substance Schedule III
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Do not confuse: Testoderm/Testoderm TTS
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ACTION: Increases weight by building body tissue; increases potassium, phosphorus, chloride, nitrogen levels, bone development
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USES: Female breast cancer, hypogonadism, eunuchoidism, male climacteric, oligospermia, impotence, vulvar dystrophies, low testosterone levels, delayed male puberty (inj)
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CONTRAINDICATIONS: Preg- nancy, breastfeeding, severe cardiac/ renal/hepatic disease, hypersensitivity, genital bleeding (rare), male breast/ prostate cancer Precautions: Diabetes mellitus, CV dis- ease, MI, urinary tract disorders, pros- tate cancer, hypercalcemia
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Black Box Warning: Children, accidental exposure, pulmonary oil microembolism, risk of serious hypersensitivity reactions or anaphylaxis Black Box Warning: Anaphylaxis: usually with testosterone undecanoate (Aveed) oil for injection; may occur after any injection, observe for 30 min after each use; this product is contrain- dicated in those with castor oil, benzyl alcohol, benzoic acid hypersensitivity Black Box Warning: Accidental expo- sure in children has occurred with topi- cal product after contact with application site, with clothing; wash hands with soap, water Black Box Warning: Pulmonary oil microembolism: occurs immediately after 1000 mg IM injected of testosterone undecanoate; symptoms include cough, dyspnea, chest pain, dizziness, throat tightening; some events resolve with supportive measures after a few minutes, some require emergency measures • Mental status: affect, mood, behav- ioral changes, aggression • Signs of masculinization in female: increased libido, deepening of voice, de- creased breast tissue, enlarged clitoris, menstrual irregularities; male: gyneco- mastia, impotence, testicular atrophy • Hypercalcemia: lethargy, polyuria, polydipsia, nausea, vomiting, constipa- tion; product may have to be decreased • Hypoglycemia in diabetic patients; oral antidiabetic action is increased • Diet with increased calories, protein; decrease sodium if edema occurs • Beers: avoid in older adults unless indi- cated for confirmed hypogonadism with clinical symptoms; potential for cardiac problems; do not use in prostate cancer • Pregnancy/breastfeeding: do not use in pregnancy, breastfeeding
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SIDE EFFECTS CNS: Dizziness, headache, fatigue, trem- ors, paresthesias, flushing, sweating, anxiety, lability, insomnia, carpal tunnel syndrome CV: Increased B/P EENT: Conjunctival edema, nasal congestion ENDO: Abnormal glucose tolerance test GI: Nausea, vomiting, constipation, weight gain, cholestatic jaundice GU: Hematuria, amenorrhea, vaginitis, decreased libido, decreased breast size, clitoral hypertrophy, testicular atrophy, gynecomastia, large prostate HEMA: Polycythemia INTEG: Rash, acneiform lesions, oily hair/skin, flushing, sweating, acne vul- garis, alopecia, hirsutism MS: Cramps, spasms
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INTERACTIONS • Edema: ACTH, adrenal steroids, bu- PROPion Increase: effects of oxyphenbutazone Increase: PT—anticoagulants Decrease: glucose levels—may alter need for oral antidiabetics, insulin Drug/Lab Test Increase: serum cholesterol, blood glu- cose, urine glucose, Hct, Hgb, WBC Decrease: serum calcium, serum potas- sium, T4, T3, thyroid 131I uptake test, urine 17-OHCS, 17-KS, PBI
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DOSAGE AND ROUTES Replacement • Adult: IM (enanthate or cypionate) 50-400 mg q2-4wk; TOPICAL SOL (Ax- iron) 60 mg (2 pump actuations); apply each AM • Adult (male)/child: SUBCUT (pel- lets) 150-450 mg (2-6 pellets) inserted q3-6mo • Adult: TRANSDERMAL (Testo- derm, Androderm) 4-6 mg applied q24hr; GEL (AndroGel) 1% 5 mg ap- plied q24hr, once daily; 1.62% 40.5 mg (2 pump actuations) every AM; topical sol (Axiron) 30 mg/actuation; NASAL GEL 1 pump actuation in each nostril tid Breast cancer, palliative • Adult: IM 200-400 mg q2-4wk (cypi- onate or enanthate) Delayed male puberty • Adolescent males: 50-200 mg q2- 4wk for a limited period (cypionate or enathate)
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Available forms: Enanthate: inj 200 mg/mL; cypionate: inj 100, 200 mg/mL; pellets 75 mg; transdermal 2, 4 mg/24 hr; gel 1%, 1.62%, 10 mg/actuation; topical sol 30 mg/actuation; nasal gel 5.5 mg/actuation
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Administer: • Titrated dose; use lowest effective dose • IM inj deep into upper outer quadrant of gluteal muscle • Transdermal patches: Testoderm to skin of scrotum; Androderm to skin of back, upper arms, thighs, abdomen; area must be dry shaved; may be reapplied after bathing, swimming • Gel: products are not interchange- able; dosage and administration for AndroGel 1% differs from that of An- droGel 1.62%; apply daily to clean, dry area on shoulders, upper arms, or ab- domen; women, children should not touch treated skin Topical solution route • Use the applicator, apply to clean, dry intact skin of the axilla at the same time each AM; do not apply to any other part of the body; allow to dry; if deodorant is used, apply at least 2 min before using; prime pump 3×; discard any solution that is released; to dispense, position the nozzle over the applicator cup and depress the pump once fully; with the applicator upright, place it up into the axilla and wipe steadily down and up into the axilla; do not use fingers or hand to rub the solution; if multiple applications are necessary for the re- quired dose, alternate application be- tween the left and right axilla; when repeat application to the same axilla is necessary, allow the solution to dry completely before the next applica- tion; after use, rinse the applicator under running water and pat dry with tissue; wash hands with soap and water • Following application, allow the site to dry before putting on clothing • Direct contact of the medicated skin with the skin of another person can re- sult in the transfer of residual testoster- one and absorption by the other per- son; to reduce accidental transfer, the patient should cover the application site(s) with clothing after the solution has dried; wash with soap and water before any skin-to-skin contact in the case of direct contact, the other person should wash the area of contact with soap and water • Topical solution is flammable; fire, flame, and smoking should be avoided T during use • Avoid swimming or washing the appli- cation site until 2 hr after application
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Assess: • CV status: B/P q4hr, HB/HCT; weight daily; notify prescriber if weekly weight gain >5 lb • Fluid volume: I&O ratio; be alert for decreasing urinary output, increasing edema • Growth rate, bone age in children; growth rate may be uneven (linear/bone growth) with extended use • Electrolytes: potassium, sodium, chlo- rine, calcium; cholesterol • Hepatic studies: ALT, AST, bilirubin • Edema, hypertension, cardiac symp- toms, jaundice
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Evaluate: • Therapeutic response: 4-6 wk in os- teoporosis
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • That product must be combined with complete health plan: diet, rest, exercise • To notify prescriber if therapeutic re- sponse decreases, if edema occurs • About changes in sex characteristics: priapism, gynecomastia, increased libido • That women should report menstrual irregularities, voice changes, acne, facial hair growth; if pregnancy is planned or suspected, or if breastfeeding • That course of 1-3 mo is necessary for response with breast cancer • About the proper application of patches and how to use gel, IM injection, buccal system, intranasal gel; about SUB- CUT implant complications • Nasal: Teach patient to report nasal bleeding, irritation, pain • Topical: Teach patient to avoid contact with area that has been treated, to wash area before contact • Buccal: Teach patient how to adminis- ter buccal tab to gum • Transdermal: Advise patient to notify provider of virilization in females See Appendix B See Appendix B
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PHARMACOKINETICS PO: Metabolized in liver; excreted in urine, breast milk; crosses placenta
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• Adult (male)/child: SUBCUT (pel- lets) 150-450 mg (2-6 pellets) inserted q3-6mo
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