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AVEED- testosterone undecanoate injection

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

Patient Information 

See FDA-Approved Medication Guide.

Advise Patients Of The Following: 

17.1 Risks of Serious Pulmonary Oil Microembolism (POME) and Anaphylaxis

  • Serious pulmonary oil microembolism (POME) reactions, involving cough, urge to cough, shortness of breath, sweating, throat tightening, chest pain, dizziness, and syncope, have been reported to occur during or immediately after the injection of intramuscular testosterone undecanoate. The majority of these events lasted a few minutes and resolved with supportive measures; however, some lasted up to several hours and some required emergency care and/or hospitalization.
  • Episodes of anaphylaxis, including life-threatening reactions, have also been reported to occur following the injection of intramuscular testosterone undecanoate.
  • Both serious POME reactions and anaphylaxis can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose.
  • Advise the patient to read the Aveed REMS information sheet titled "What You Need to Know About AVEEDTreatment: A Patient Guide.
  • Instruct patients to remain at the healthcare setting for 30 minutes after each Aveed injection.

17.2 Men with Known or Suspected Carcinoma of the Prostate or Breast

Men with known or suspected prostate or breast cancer should not use Aveed[see Contraindications (4)].

17.3 Potential Adverse Reactions to Androgens

Patients Should Be Informed That Treatment With Androgens May Lead To Adverse Reactions Which Include: 

  • Changes in urinary habits, such as increased urination at night, trouble starting the urine stream, passing urine many times during the day, having an urge to go the bathroom right away, having a urine accident, or being unable to pass urine or 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

17.4 Patients Should be Advised of the Following Instructions for Use

  • Read the Medication Guide before starting Aveed therapy and reread the Guide before each injection.
  • Adhere to all recommended monitoring.
  • Report any changes in their state of health, such as changes in urinary habits, breathing, sleep, and mood.

Distributed by:
Endo Pharmaceuticals Inc.
Malvern, PA 19355

AVEED is a registered trademark of Endo Pharmaceuticals Inc. or one of its affiliates

2019 Endo Pharmaceuticals Inc. All rights reserved.

Revised: 10/2019

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