Manufacturer:

Lilly, Eli and Company

Pharmacological Class:

Androgen.

Active Ingredient(s):

Testosterone 30mg/1.5mL pump actuation; solution; contains alcohol; latex-free.

Indication(s):

Testosterone replacement therapy.

Pharmacology:

Endogenous androgens, including testosterone and dihydrotestosterone, are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics.

Male hypogonadism results from insufficient secretion of testosterone and is characterized by low serum testosterone concentrations. Signs/symptoms associated with male hypogonadism include erectile dysfunction and decreased ­sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis. Male hypogonadism has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter’s Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).

Axiron is a clear, colorless, single phase solution containing 30mg of testosterone in 1.5mL of solution for topical administration through the axilla. In general, steady-state serum concentrations are achieved by approximately 14 days of daily dosing.

Legal Classification:

CIII

Adults:

Advise patients to strictly adhere to recommended instructions. Apply to clean, dry intact skin of the axilla; do not apply to the scrotum, penis, abdomen, shoulders or upper arms. ≥18yrs: Initially apply 60mg (30mg per axilla) once daily in the AM; measure serum testosterone levels to ensure response. May adjust dose based on serum testosterone concentration 2 to 8 hours after applying and at least 14 days after starting therapy or following dose adjustment. May increase dose in 30mg increments if serum testosterone <300ng/dL up to 120mg; reduce dose to 30mg if levels >1050ng/dL, discontinue if serum testosterone remains >1050ng/dL. Wash hands after application. Allow soln to dry before it touches clothing. Not interchangeable with other topical testosterone products.

Children:

<18yrs: not recommended.

Contraindication(s):

Male breast or prostate cancer. Use in women. Pregnancy (Cat.X). Nursing mothers.

Warnings/Precautions:

Other persons (esp. children) must avoid contact with application site. Secondary exposure to testosterone; promptly discontinue if signs of virilization in children and women occurs, until cause is identified. Increased risk for worsening BPH. Evaluate for prostate cancer before starting therapy (esp. elderly). Cardiac, renal, or hepatic disease (discontinue if edema occurs). Sleep apnea. Monitor hemoglobin, hematocrit, liver function, PSA, thyroid function, cholesterol, HDL-C, and serum testosterone. Risk of hypercalcemia; monitor. Men with BMI >35kg/m²: not studied. Avoid showering or swimming for at least 2 hours after application.

Interaction(s):

Monitor INR and PT with anticoagulants. May affect insulin requirements. Increased risk of edema with ACTH, corticosteroids.

Adverse Reaction(s):

Local reactions, increased hematocrit, headache, diarrhea, vomiting, increased serum PSA; gynecomastia, virilization in children.

How Supplied:

Pump—90mL (60 metered doses) (w. applicator)