AndroGel 1.62%: Familiar application sites of shoulders and upper arms
An application process designed with the patient in mind
- AndroGel 1.62% is applied to the shoulders and upper arms in the morning.1
- aDose can be adjusted between 20.25 mg (1 pump press) and 81 mg (4 pump presses).1
- AndroGel 1.62% is a clear, odorless, quick-drying gel that can be applied by hand or directly on the application site.1
- After application, patients should wash their hands with soap and water.1
- For better absorption, patients should wait at least 2 hours after applying AndroGel 1.62% before showering or swimming.1
Dosage and administration for AndroGel 1.62% differs from AndroGel 1%. AndroGel is not interchangeable with other topical testosterone products.
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Safety Considerations1
Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from AndroGel 1.62%–treated skin:
- Children and women should avoid contact with unwashed or unclothed application site(s) of men using AndroGel 1.62%.
- Apply AndroGel 1.62% only to the upper arms and shoulders. The application area should be limited to the area that will be covered by a t-shirt.
- Patients should wash their hands with soap and water after application.
- Cover the application site with clothing after the gel has dried.
- Wash the application site(s) thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated.
- In the event that AndroGel 1.62% comes in direct contact with the skin of another person, the general area of contact should be washed with soap and water as soon as possible.
Flexible dosing in a low-volume formulation
- The starting dose of AndroGel 1.62% is 40.5 mg of testosterone (2 pump presses).1
- Flexibility to titrate up or down in 20.25-mg increments (1 pump press).1
- Monitor serum testosterone concentration 14 and 28 days after starting treatment, following dose adjustment and periodically thereafter, and titrate based on patient’s response to therapy.1
Indication1,2
AndroGel® (testosterone gel) 1% and 1.62% CIII are androgens indicated for replacement therapy in adult 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.
- Hypogonadotropic hypogonadism (congenital or acquired): idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.
Important limitations of use: Safety and efficacy of AndroGel in males <18 years old have not been established.
Important Safety Information1,2
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
- Virilization has been reported in children who were secondarily exposed to testosterone gel.
- Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel.
- Healthcare providers should advise patients to strictly adhere to recommended instructions for use.
- AndroGel is contraindicated in men with breast cancer or known or suspected prostate cancer, and in women who are pregnant, may become pregnant, or are breastfeeding, as testosterone may cause fetal harm; or in men with known hypersensitivity to any of the ingredients in AndroGel.
- Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens due to an increased risk for worsening signs and symptoms of BPH.
- Patients treated with androgens may be at increased risk for prostate cancer and should be evaluated prior to initiating and during treatment with androgens as appropriate. Monitor prostate specific antigen (PSA) levels periodically.
- Avoid unintentional exposure of women or children to AndroGel. Secondary exposure to testosterone can produce signs of virilization and should be brought to the attention of the healthcare provider. Exposure of a pregnant woman to AndroGel may result in potential hazard to the fetus. AndroGel should be promptly discontinued until the cause of virilization is identified.
- Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. Monitor hematocrit prior to and periodically during treatment. Monitor hemoglobin periodically.
- AndroGel is not indicated for use in women.
- Treatment with AndroGel may lead to azoospermia; edema which may be serious in patients with preexisting cardiac, renal, or hepatic disease, or in patients taking adrenocorticotropic hormone (ACTH) or corticosteroids; gynecomastia; sleep apnea, especially in those with risk factors; changes in insulin sensitivity or glycemic control; and changes in anticoagulant activity.
- Treatment with androgens may lead to serious hepatic effects. AndroGel is not known to cause these adverse effects. Monitor liver function tests (LFTs) periodically.
- Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy. Monitor lipid levels periodically.
- Androgens 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.
- Most common adverse reaction of AndroGel 1.62% (incidence ≥5%) is an increase in prostate specific antigen (PSA). Most common adverse reactions for AndroGel 1% (incidence ≥5%) are acne, application site reactions, abnormal lab tests, and prostatic disorders.
- Dosage and administration for AndroGel 1.62% differs from AndroGel 1%. AndroGel is not interchangeable with other topical testosterone products.
Please see full Prescribing Information including BOXED WARNING and Medication Guide.
References: 1. AndroGel 1.62% [package insert]. North Chicago, IL: Abbott Laboratories. 2. AndroGel 1% [package insert]. North Chicago, IL: Abbott Laboratories.