II. Precautions

  1. Cardiovascular disease risk with Androgen Replacement is still unclear
  2. Androgen Replacement is not recommended for asymptomatic men or those with normal range Serum Testosterone
  3. Discontinue Testosterone Supplementation if no improvement after 3-6 months

III. Indications: Men

  1. Depression, Fatigue, muscle wasting in HIV or AIDS
  2. Symptomatic Testicular Failure AND low morning Serum Testosterone levels<300 ng/dl (two levels are recommended)
    1. See Male Menopause
    2. See Hypogonadism
    3. FDA approved for low testosterone due to underlying cause (e.g. pituitary disorder, testicular infection)
      1. Not FDA approved for normal testosterone decline with routine aging
    4. Symptoms
      1. Decreased libido
      2. Impotence

IV. Contraindications

V. Effects: Positive

  1. Increases bone density or decreases bone loss
  2. Increase Lean Body Mass and Muscle Strength
  3. Decrease body fat
  4. Increase serum Hematocrit
  5. Increases sense of well-being, mood and cognition (variable effects)
  6. Increases libido

VI. Effects: Disproved Risks for physiologic Androgen Replacement

VII. Adverse Effects: Cardiovascular Disease Risk (mixed results)

  1. Increased mortality, CVA and MI may be associated with Testosterone Replacement
    1. Vigen (2013) JAMA 310(17):1829-36 [PubMed]
  2. Older studies suggested no increased cardiovascular disease risk
    1. Zmuda (1997) Am J Epidemiol 146:609-14 [PubMed]

VIII. Adverse Effects (decreased if testosterone level stable)

  1. HDL Cholesterol declines
  2. Increased Prostate Cancer growth
  3. Polycythemia, Thromboembolism and cerebral vascular accident risk
  4. May exacerbate Sleep Apnea
  5. Hepatotoxicity (especially oral preparations)
  6. Behavior and mood changes
    1. Moodiness or irritability
    2. Aggressive behavior
  7. Virilization (Hirsutism, Alopecia, Acne)
  8. Lethargy (low Serum Testosterone fluctuations)
  9. Edema
  10. Gynecomastia

IX. Labs: Monitoring while on Testosterone

  1. See Androgen Replacement in Women for monitoring women
  2. Baseline Labs
    1. Prostate Specific Antigen (PSA)
    2. Digital Rectal Exam and Prostate examination
    3. Morning Serum Testosterone level
      1. Confirm low testosterone on 2 different morning Serum Testosterone levels
    4. Hematocrit
    5. Liver Function Tests
  3. Monitoring for Establishing Injection Dose
    1. Serum Testosterone at one week post injection
      1. Level above normal: decrease subsequent doses
    2. Serum Testosterone at two weeks post injection
      1. Level below normal: increase injection frequency
  4. Monitoring every 6 months
    1. Prostate (Consider annual screening instead)
      1. Prostate Specific Antigen (PSA)
      2. Digital Rectal Exam
    2. Hematocrit (discontinue testosterone if >54%)
    3. Liver Function Tests (indicated in oral testosterone)
    4. Re-evaluate testosterone efficacy

X. Dosing: Testosterone Injection (Intramuscular)

  1. Transdermal delivery is preferred over intramuscular
    1. Cardiovascular risks may be higher with injectable
  2. Preparations: Every 2 weeks
    1. Testosterone cypionate (Depo-Testosterone)
    2. Testosterone enanthate (Delatestryl)
    3. Typical Dose: 200 mg IM every 2 weeks ($4 per month)
    4. Range: 50 to 400 mg IM every 2-4 weeks
  3. Preparations: Every 10 weeks
    1. Testosterone undecanoate (Aveed) injectable
    2. Dose: 3-mL (750 mg) Intramuscular Injection
      1. Give once at starting protocol THEN
      2. Give again in 4 weeks THEN
      3. Give every 10 weeks
    3. Adverse effects
      1. Pulmonary-Oil Microembolism (POME) and Anaphylaxis
    4. Precautions
      1. Carries black box warning (regarding POME, Anaphylaxis) and certification for prescribers

XI. Dosing: Testosterone Transdermal (preferred, physiologic)

  1. Background
    1. Serum Testosterone peaks 2 hours post-patch application
    2. Risk of skin-to-skin transmission of testosterone
  2. Testoderm one 4 or 6 mg patch ($72 per month)
    1. Apply to shaved Scrotum every 24 hours
    2. Much less irritating than Androderm
  3. Androderm ($98 per month)
    1. Typical dose: 4 mg patch daily
      1. Manufacturer changed dose in 2011
      2. Androderm 2 mg patch (instead of 2.5 mg)
      3. Androderm 4 mg patch (instead of 5 mg)
    2. May cause rash (8% of patients)
    3. Apply to skin every 24 hours
      1. Abdomen
      2. Thigh
      3. Between Shoulder blades
  4. Androgel
    1. Very expensive ($300/month)
    2. Testosterone 1% gel four pumps (5 grams) topically daily
      1. May cause local skin reaction
      2. Apply to upper arms, Shoulders and Abdomen
      3. Avoid bathing for 5 hours after application
    3. Testosterone 1.62% gel two pumps topically daily
      1. Newer preparation released in 2011
      2. Equivalent to 4 pumps of the 1%
      3. Apply to upper arms, Shoulders, but NOT to Abdomen (due to less absorption)
      4. Avoid bathing for 2 hours after application

XII. Dosing: Other forms

  1. Testosterone buccal (Striant) 30 mg to gums twice daily
    1. May cause oral irritation
    2. New option less studied than other forms
  2. Testosterone implanted pellets (Testopel)
    1. 150 to 450 mg implanted SQ q3-6 months
    2. Used for Delayed Puberty in males
  3. Oral testosterone (not recommended)
    1. Listed for completeness
    2. Not recommended due to hepatotoxicity and less effect
    3. Agents
      1. Methyltestosterone (Android)
      2. Fluoxymesterone (Halotestin)

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Cost: Medications

androderm (on 8/17/2016 at Medicaid.Gov Survey of pharmacy drug pricing)
ANDRODERM 2 MG/24HR PATCH $7.67 each
ANDRODERM 4 MG/24HR PATCH $15.16 each

Ontology: Androderm (C0718531)

Concepts Pharmacologic Substance (T121) , Hormone (T125) , Steroid (T110)
MSH D013739
French Androderm
Italian Testosterone, CEPA, Testosterone, Faulding, Testosterone, Paladin, Androderm, Testosterone, Watson, Testosterone, AstraZeneca
English androderm, Androderm, AstraZeneca Brand of Testosterone, CEPA Brand of Testosterone, Faulding Brand of Testosterone, Paladin Brand of Testosterone, Watson Brand of Testosterone
Norwegian Androderm

Ontology: Testoderm (C0723655)

Concepts Pharmacologic Substance (T121) , Steroid (T110) , Hormone (T125)
MSH D013739
French Testoderm
Italian Testosterone, Ferring, Testosterone, Ortho, Testoderm
English testoderm, Testoderm, Ferring Brand of Testosterone, Ortho Brand of Testosterone
Norwegian Testoderm