Questions?

Call the AXIRON support line at 1-877-9-AXIRON (1-877-929-4766)

Indication

AXIRON is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

  • Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above the normal range
  • Hypogonadotropic hypogonadism (congenital or acquired): idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range

Important limitations of use — Safety and efficacy of AXIRON in males <18 years old have not been established.

Important Safety
Information for AXIRON

Important Safety Information for AXIRON (testosterone) topical solution

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE

  • Virilization has been reported in children who were secondarily exposed to topical testosterone products.
  • Children should avoid contact with unwashed or unclothed application sites in men using AXIRON.
  • Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

CONTRAINDICATIONS

AXIRON is contraindicated in:

  • men with breast cancer or known or suspected prostate cancer
  • women that are or may become pregnant, or are breastfeeding. AXIRON may cause fetal harm if administered to a pregnant woman and may cause serious adverse reactions in nursing infants. If a pregnant woman is exposed to AXIRON, she should be apprised of the potential hazard to the fetus.

WARNINGS AND PRECAUTIONS

  • Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer: Monitor patients with BPH for worsening of signs and symptoms. Patients treated with androgens may be at increased risk for prostate cancer. Evaluate for prostate cancer before initiating treatment, re-evaluate 3 to 6 months after initiation of treatment, then in accordance with prostate cancer screening practices.
  • Secondary Exposure to Testosterone: Cases of secondary exposure in children and women have been reported with topical testosterone products, including cases resulting in virilization of children. Signs and symptoms included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases, these regressed with removal of testosterone exposure. In a few cases, enlarged genitalia did not fully return to age-appropriate size, and bone age remained modestly greater than chronological age. Risk of transfer was increased in some cases by not adhering to precautions for appropriate use of the product. Children and women should avoid contact with unwashed or unclothed application sites in men using AXIRON. Inappropriate changes in genital size or development of pubic hair or libido in children; or changes in body hair distribution, significant increase in acne, or other signs of virilization in adult women and the possibility of secondary exposure should be brought to the attention of a physician. Therapy should be promptly discontinued at least until the cause of virilization is identified.

Strict adherence to the following precautions is advised to minimize the potential for secondary exposure to testosterone from the skin:

  • Children and women should avoid contact with the unclothed or unwashed application sites on the skin of men using AXIRON.
  • Patients should wash their hands immediately with soap and water after AXIRON application.
  • Patients should cover the application site(s) with clothing (e.g., a T-shirt) after the solution has dried.
  • Prior to any situation in which direct skin-to-skin contact is anticipated, patients should wash the application site thoroughly with soap and water to remove any testosterone residue. In the event that unwashed or unclothed skin to which AXIRON has been applied comes in contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible.

While interpersonal testosterone transfer can occur with a T-shirt on, it has been shown that it can be substantially reduced by wearing a T-shirt and the majority of residual testosterone is removed from the skin surface by washing with soap and water.

  • Polycythemia: Increases in hematocrit may require lowering or discontinuation of testosterone treatment. Check hematocrit prior to initiating treatment; re-evaluate 3 to 6 months after starting treatment, then annually. If hematocrit becomes elevated, stop therapy until it decreases to an acceptable level. An increase in hematocrit may increase the risk of thromboembolic events.
  • Venous Thromboembolism: There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as AXIRON. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with AXIRON and initiate appropriate workup and management.
  • Spermatogenesis: At large doses, spermatogenesis may be suppressed which could possibly lead to adverse effects on semen parameters including, sperm count.
  • Edema: Androgens, including AXIRON, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease.
  • Gynecomastia: Gynecomastia may develop and may persist in patients being treated with androgens, including AXIRON.
  • Sleep Apnea: Testosterone treatment may potentiate sleep apnea in some patients, especially those with risk factors (e.g. obesity, chronic lung disease).
  • Lipids: Changes in serum lipid profile may require dose adjustment or discontinuation of therapy.
  • Hypercalcemia: Use androgens, including AXIRON with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.
  • Decreased Thyroxine-binding Globulin: Androgens, including AXIRON, may decrease thyroxin-binding globulin concentrations resulting in decreased total T4 serum concentration and increased resin uptake of T3 and T4. Free thyroid hormone concentration remain unchanged, however there is no clinical evidence of thyroid dysfunction.
  • Flammability: Patients should be advised to avoid smoking, fire, or flame until the AXIRON dose applied has dried.

DRUG INTERACTIONS

  • Insulin: Changes in insulin sensitivity or glycemic control may occur. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.
  • Oral anti-coagulants: Changes in anticoagulant activity may occur. More frequent monitoring of INR and prothrombin time is recommended in patients taking anticoagulants, especially at initiation and termination of androgen therapy.
  • Corticosteroids: Use of testosterone with ACTH or corticosteroids may result in increased fluid retention and should be monitored cautiously, particularly in patients with cardiac, renal, or hepatic disease.

USE IN SPECIFIC POPULATIONS

  • Geriatric Use: There were insufficient numbers of geriatric patients in AXIRON studies to determine if efficacy in those >65 years of age differs from younger patients. 21 of 155 patients in the pivotal clinical study were >65. There were insufficient long-term safety data to assess a potential incremental risk of cardiovascular disease and prostate cancer.

ADVERSE REACTIONS

  • Most common adverse reactions included application site irritation (7%), application site erythema (5%), headache (5%), increased hematocrit (4%), diarrhea (3%), vomiting (3%), and increased PSA (1%).

For more information, please see full Prescribing Information, including Boxed Warning regarding the risk of secondary exposure, and Medication Guide.

TS HCP ISI 10JUL2014