AXIRON can transfer from your body to others. This can happen if other people come into contact with the area where the AXIRON was applied. Signs of puberty that are not expected (for example, pubic hair) have happened in young children who were accidentally exposed to testosterone through skin to skin contact with men using topical testosterone products like AXIRON. Women and children should avoid contact with the unwashed or unclothed area where AXIRON has been applied. If a woman or child makes contact with the application area, the contact area on the woman or child should be washed well with soap and water right away.To lower the risk of transfer of AXIRON from your body to others, follow these important instructions:
- Apply AXIRON only to your armpits.
- Wash your hands right away with soap and water after applying AXIRON.
- After the solution has dried, cover the application area with clothing. Keep area covered until you have washed the application area well or have showered.
- If you expect another person to have direct skin-to-skin contact with your armpits, first wash the application area well with soap and water.
Stop using AXIRON and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have occurred through accidental exposure to AXIRON. Signs and symptoms in children may include enlarged penis or clitoris; early development of pubic hair; increased erections or sex drive; aggressive behavior. Signs and symptoms in women may include changes in body hair and a large increase in acne.
Who should not use AXIRON?Do not use AXIRON if you:
- have or might have prostate cancer
- have breast cancer
- are pregnant or may become pregnant or are breast-feeding. AXIRON may harm your unborn or breast-feeding baby.
Women who are pregnant or who may become pregnant should avoid contact with the area of skin where AXIRON has been applied.
What should I tell my healthcare provider before using AXIRON?Before you use AXIRON, tell your healthcare provider if you have:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using AXIRON with other medicines can affect each other. Especially, tell your healthcare provider if you take:
- breast cancer
- or might have prostate cancer
- urinary problems due to an enlarged prostate
- heart problems
- kidney or liver problems
- problems breathing while you sleep (sleep apnea)
- any other medical conditions
- medicines that decrease blood clotting
What are the possible side effects of AXIRON?AXIRON can cause serious side effects. Call your healthcare provider right away if you have any of the following:
- If you already have enlargement of your prostate gland, your signs and symptoms can get worse while using AXIRON. This can include: increased urination at night, trouble starting your urine stream, having to pass urine many times during the day, having an urge that you have to go to the bathroom right away, having a urine accident, being unable to pass urine or weak urine flow.
- Possible increased risk of prostate cancer. Your healthcare provider should check for prostate cancer or any other prostate problems before you start and while you use AXIRON.
- Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
- Possible increased risk of heart attack or stroke.
- In large doses AXIRON may lower your sperm count.
- Swelling of your ankles, feet, or body.
- Enlarged or painful breasts.
- Problems breathing while you sleep (sleep apnea).
The most common adverse events include: skin redness or irritation where AXIRON is applied, increased red blood cell count, headache, diarrhea, vomiting, and increase in blood level of Prostate Specific Antigen (a test used to screen for prostate cancer). Other side effects include more erections than are normal for you or erections that last a long time.
AXIRON is flammable until dry. Let AXIRON dry before smoking or going near an open flame.
Axiron is available by prescription only
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.
TS CON ISI 15MAY2015
For more information, please see full , including Boxed Warning regarding the risk of transfer to others, and .
- 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): 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
Limitations of use
- Safety and efficacy of AXIRON in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.
- Safety and efficacy of AXIRON in males <18 years old have not been established.
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.
CONTRAINDICATIONSAXIRON 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.
- Cardiovascular Risk: Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use AXIRON.
- 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.
- 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.
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%).
TS HCP ISI 15MAY2015
For more information, please see full , including Boxed Warning regarding the risk of secondary exposure, and .
Reference: 1. Axiron [package insert]. Indianapolis, IN: Eli Lilly and Company; 2015.