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Dispensing AndroGel 1%

Dosing for AndroGel 1%

  • Each actuation of the metered-dose pump delivers 1.25 g of gel (12.5 mg of testosterone).2
  • The recommended starting dose of AndroGel 1% is 5 g of gel (50 mg of testosterone) once daily.2
    • Doses may be adjusted in 2.5 g of gel (25 mg of testosterone) increments.2
  • Dose is applied once daily to the shoulders, upper arms, and/or abdomen.2
  • AndroGel 1% can be applied by hand or directly to the application site.2
  • After application, patients should wash their hands with soap and water.2

Safety Considerations2

Signs of virilization in children and women and the possibility of secondary exposure to testosterone gel should be brought to the attention of the healthcare provider. Testosterone gel should be promptly discontinued until the cause of the virilization is identified. AndroGel 1% is not indicated for use in women. AndroGel 1% must not be applied to the genitals.

Administration

Provide the following instructions to your patients. For more information, direct patients to www.androgel.com.

Provide the following instructions to your patients:

Preparing the Pump: Before using the pump for the first time, you'll need to press down firmly on the pump 3 times. Do not use any AndroGel 1% that came out while priming. Wash it down the sink or throw it in the trash to avoid accidental exposure to others. You do not have to prime your pump every day, only the first day you use it.

AndroGel 1% pump

Your healthcare provider will tell you how much AndroGel 1% to apply. You can also check the label on your bottle to see how many times to press the pump for the dose your doctor has prescribed.

AndroGel 1% Packet: In addition to the pump, AndroGel 1% comes in packets [in 2.5 g of gel (25 mg of testosterone) and 5 g of gel (50 mg of testosterone) dosing options]. After use, throw away the packet in the trash out of the reach of children to avoid accidental exposure.

AndroGel® 1% (testosterone gel)

Directions for use:
Make your application part of your daily routine.

  1. Apply AndroGel 1% at the same time every day, preferably every morning, to clean, dry, intact skin. Do not apply to genitals.
  2. If using the pump, press down firmly on the pump one time. AndroGel 1% also comes in 2.5 g of gel (25 mg of testosterone) and 5 g of gel (50 mg of testosterone) packets. If using the packets, you can open them by tearing along the dotted line. Squeeze the contents into the palm of your hand. Squeeze from the bottom of the packet up.
  3. Apply the gel to one or more of the application sites (see illustration above). These areas are your shoulders and upper arms, or stomach area, or shoulders, upper arms and stomach area. Do not apply to your penis or scrotum.
  4. Repeat steps 2 and 3 until you have applied the dose your doctor has prescribed for you.

AndroGel 1% is not meant for use in women.

After you apply AndroGel 1%:

  1. Wash your hands right away with soap and water.
  2. Let the application sites dry.
  3. Cover the application sites with a shirt.
  4. AndroGel 1% is flammable until dry. Let the gel dry before smoking or going near an open flame.

If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water. If a woman or child comes in contact with the AndroGel 1% application area, that area on the woman or child should be washed well with soap and water right away. Stop using AndroGel 1% and call your healthcare provider right away if you see any signs or symptoms of puberty in a child, or changes in body hair or increased acne in a woman, that may have occurred though accidental exposure to AndroGel 1%.

Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from AndroGel 1%-treated skin:

  • Children and women should avoid contact with unwashed or unclothed application site(s) of men using testosterone gel.
  • AndroGel 1% should only be applied to the shoulders, upper arms, and/or abdomen (area of application should be limited to the area that will be covered by the patient’s short sleeve t-shirt).
  • Patients should wash their hands immediately with soap and water after applying AndroGel 1%.
  • Patients should cover the application site(s) with clothing (e.g., a shirt) after the gel has dried.
  • Prior to any situation in which skin-to-skin contact with the application site is anticipated, patients should wash the application site(s) thoroughly with soap and water to remove any testosterone residue.
  • In the event that unwashed or unclothed skin to which AndroGel 1% has been applied comes in direct 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. Studies show that residual testosterone is removed from the skin surface by washing with soap and water.
 
 

Indication2,3

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 Information2,3

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. IMS Health, National Prescription Audit, June 2000-February 2011. 2. AndroGel 1% [package insert]. North Chicago, IL: Abbott Laboratories. 3. AndroGel 1.62% [package insert]. North Chicago, IL: Abbott Laboratories.