Generic Name and Formulations:
Testosterone 1%; gel.
Auxilium Pharmaceuticals, Inc.
Testosterone replacement therapy.
Advise patients to strictly adhere to recommended instructions. Apply to clean, dry intact skin of the shoulders and/or upper arms; do not apply to genitals or abdomen. ≥18 years: initially apply 5g (1 tube) once daily in the AM; measure serum testosterone level to ensure response; may increase to 10g after 2 weeks. Do not wash site for at least 2 hours after application.
<18 years: not recommended.
Male breast or prostate cancer. Not for use in women. Pregnant and nursing women must avoid skin contact with application sites on men. Pregnancy (Cat.X). Nursing mothers.
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, cholesterol, HDL-C, and serum testosterone. Avoid showering or swimming for at least 2 hours after application. Elderly (may increase risk of prostatic hyperplasia and prostatic carcinoma).
May potentiate oral anticoagulants, oxyphenbutazone. May alter insulin effects. Increased risk of edema with corticosteroids or ACTH.
Local reactions, headache, increased hemoglobin/hematocrit or BP, depression, hot flushes, insomnia, mood swings, gynecomastia, dysgeusia; virilization in children.