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ANDRODERM- testosterone patch


  1. Patient Information
  2. Patients Should Be Informed Of The Following Information:
  3. Patients Should Be Informed That Treatment With Androgens May Lead To Adverse Reactions That Include:

Patient 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
  • Potential Adverse Reactions with Androgens

Men with known or suspected prostate or breast cancer should not use ANDRODERM[seeContraindications (4)andWarnings and Precautions (5.1)].

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[seeDosage and Administration (2)andClinical Pharmacology (12.3)].

For all medical inquiries contact:
Allergan
Medical Communications
1-800-678-1605

Distributed by:
Allergan USA, Inc.
Madison, NJ 07940

2018 Allergan. All rights reserved.

ANDRODERMis a registered trademark of Allergan Sales, LLC.

Allerganand its design are trademarks of Allergan, Inc.

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