"The US Food and Drug Administration (FDA) has approved class-wide labeling changes for all prescription testosterone products, the agency announced today.
New safety information from published literature and case reports on the risks "...
Worsening of Benign Prostatic Hyperplasia and Potential Risk of Prostate Cancer
- Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH.
- Patients treated with androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating treatment. It is appropriate to re-evaluate patients 3 to 6 months after initiation of treatment, and then in accordance with prostate cancer screening practices [see CONTRAINDICATIONS].
Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. Check hematocrit prior to initiating testosterone treatment. It is appropriate to re-evaluate the hematocrit 3 to 6 months after starting testosterone treatment, and then monitor annually. Discontinue testosterone therapy if the hematocrit becomes elevated. Testosterone therapy may be restarted when the hematocrit decreases to an acceptable level. An increase in red blood cell mass may increase the risk of thromboembolic events.
Use in Women and Children
Women and children should not use ANDRODERM. Use in women and children has not been studied with ANDRODERM.
Due to lack of controlled studies in women and potential virilizing effects, ANDRODERM is not indicated for use in women and children [see CONTRAINDICATIONS and Use In Specific Populations].
Potential for Adverse Effects on Spermatogenesis
At large doses of exogenous androgens, including ANDRODERM, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) that could lead to adverse effects on semen parameters including reduction of sperm count.
Hepatic Adverse Effects
Prolonged use of high doses of orally active 17-alpha-alkyl androgens (methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. ANDRODERM is not known to cause these adverse effects.
Androgens, including ANDRODERM, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease [see ADVERSE REACTIONS].
Gynecomastia may develop and persist in patients being treated with androgens, including ANDRODERM, for hypogonadism.
Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy.
Androgens, including ANDRODERM, should be used 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 ANDRODERM, may decrease concentrations of thyroxine-binding globulins, resulting in decreased total T4 serum concentration and increased resin uptake of T3 and T4. Free thyroid hormone concentration remains unchanged and there is no clinical evidence of thyroid dysfunction.
Magnetic Resonance Imaging (MRI)
Skin burns have been reported at the application site in patients wearing an aluminized transdermal system during a magnetic resonance imaging scan (MRI). Because ANDRODERM contains aluminum, it is recommended to remove the system before undergoing an MRI.
Patient Counseling Information
See “FDA-approved patient labeling (PATIENT INFORMATION)”. Patients should be informed of the following information:
Use in Men with Known or Suspected Prostate or Breast Cancer
Men with known or suspected prostate or breast cancer should not use ANDRODERM [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].
Potential Adverse Reactions with Androgens
Patients should be informed that treatment with androgens may lead to adverse reactions that include:
- Changes in urinary habits such as increased urination at night, trouble starting your urine stream, passing 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 and having a weak urine flow
- Breathing disturbances, including those associated with sleep, or excessive daytime sleepiness
- Too frequent or persistent erections of the penis
- Nausea, vomiting, changes in skin color, or ankle swelling
Patients Should be Advised of these Application Instructions
- ANDRODERM should not be applied to the scrotum.
- ANDRODERM should not be applied over a bony prominence or on a part of the body that could be subject to prolonged pressure during sleep or sitting. Application to these sites has been associated with burn-like blister reactions.
- ANDRODERM does not have to be removed during sexual intercourse, nor while taking a shower or bath.
- ANDRODERM systems should be applied nightly. The site of application should be rotated, with an interval of 7 days between applications to the same site.
- If the ANDRODERM system becomes loose, smooth it down again by rubbing your finger firmly around the edges. If a patch falls off before noon, replace it with a fresh patch and wear it until you apply a fresh patch(es) that evening. If it falls off later in the day, do not replace it until you apply a fresh patch(es) that evening. If it falls off do not tape ANDRODERM to skin.
- If patients or caregivers experience difficulty separating the patch from the release liner or observe transfer of adhesive to the liner, tearing and/or other damage to the patch during removal from the liner, the patch should be discarded, and a new patch should be applied.
- ANDRODERM should be applied immediately after opening the individual pouch and removing the protective liner. Do not use if the individual pouch seal is broken or if the patch appears to be damaged. Do not cut patches. Only intact patches should be applied.
- Strenuous exercise or excessive perspiration may loosen a patch or cause it to fall off.
- Skin burns have been reported at the application site in patients wearing an aluminized transdermal system during a magnetic resonance imaging scan (MRI). Because ANDRODERM contains aluminum, it is recommended to remove the system before undergoing an MRI.
- Avoid swimming or showering until 3 hours following application of ANDRODERM [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].
For all medical inquiries contact: WATSON Medical Communications Parsippany, NJ 07054 800-272-5525
Carcinogenesis, Mutagenesis, Impairment of Fertility
Testosterone has been tested by subcutaneous injection and implantation in mice and rats. In mice, the implant induced cervical-uterine tumors, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats. Testosterone was negative in the in vitro Ames and in the in vivo mouse micronucleus assays. The administration of exogenous testosterone has been reported to suppress spermatogenesis in the rat, dog and non-human primates, which was reversible on cessation of the treatment.
Use In Specific Populations
Pregnancy Category X [see CONTRAINDICATIONS] — ANDRODERM is contraindicated during pregnancy or in women who may become pregnant. Testosterone is teratogenic and may cause fetal harm. Exposure of a female fetus to androgens may result in varying degrees of virilization. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
Although it is not known how much testosterone transfers into human milk, ANDRODERM is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants. Testosterone and other androgens may adversely affect lactation [see CONTRAINDICATIONS].
Safety and efficacy of ANDRODERM have not been established in males less than18 years of age. Improper use may result in acceleration of bone age and premature closure of epiphyses.
There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing ANDRODERM to determine whether efficacy in those over 65 years of age differs from younger patients. Additionally, there are insufficient long-term safety data in geriatric patients utilizing ANDRODERM to assess a potential incremental risk of cardiovascular disease and prostate cancer.
No studies were conducted in patients with renal impairment.
No studies were conducted in patients with hepatic impairment.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/7/2016
Additional Androderm Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.