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U.S. FDA Approves AVEED(TM) (Testosterone Undecanoate) Injectable Testosterone Replacement Therapy For Men Living With Hypogonadism, Or Low-T - WSJ.com
AVEED is available as a single-use vial. Dosage titration is not necessary. Following the first intramuscular injection of 3 mL of AVEED (750 mg), a second 3 mL dose is injected 4 weeks later, and then 3 mL is injected every 10 weeks thereafter. AVEED is prescribed and administered by trained healthcare providers in a doctor's office, clinic, or hospital.
Sorry if this has already been posted. I have to admit, I never thought it would happen. In fact, I've said as much on here, so color me very surprised. Of note, is the large volume of 3mL, and the requirement of a 90 second push. Also, it won't be available in a pharmacy, it must be injected by a healthcare provider in a clinic setting. All HCPs must be 'certified' on its proper administration techniques.
Seems like a good TRT option for busy people. But, it certainly doesn't fit well with the new men's health clinic business model, where the financial drivers are weekly visits.
Also, we finally see the safety issues that have delayed approval for these seven years: anaphylaxis and pulmonary oil microembolism (POME). Apparently branded commercial testosterone solutions have the same warning on anaphylaxis, but none have ever included wording on POME.
The FDA considered not just Endo's lone, rather small research study (N=141), but also post-marketing adverse event data from Europe, where Aveed (Nebido) has been approved for a number of years:
http://www.internalmedicinenews.com/index.php?id=2049&type=98&tx_ttnews[tt_news]=142661&cHash=da03e20e36
An FDA review of 199 postmarketing cases of POME, between November 2003 and April 2012, determined that 84 were severe, with severe dyspnea, loss of consciousness, circulatory collapse, or loss of bowel function. Many cases started as the medication was being injected. Although no deaths were reported, the long-term cardiopulmonary effects of severe cases or chronic effects of repeated less-severe episodes are not known, according to the FDA. During 2003-2011, there were 53 postmarketing cases of anaphylaxis reported, using a conservative definition.
Aveed's Black Box Warning:
WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS
--Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, including life-threatening reactions, have been reported to occur during or immediately after the administration of testosterone undecanoate injection. These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose.
--Following each injection of AVEED (testosterone undecanoate) injection, for intramuscular use CIII, observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis.
--Because of the risks of serious POME reactions and anaphylaxis, AVEED is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the AVEED REMS Program.
AVEED is available as a single-use vial. Dosage titration is not necessary. Following the first intramuscular injection of 3 mL of AVEED (750 mg), a second 3 mL dose is injected 4 weeks later, and then 3 mL is injected every 10 weeks thereafter. AVEED is prescribed and administered by trained healthcare providers in a doctor's office, clinic, or hospital.
Sorry if this has already been posted. I have to admit, I never thought it would happen. In fact, I've said as much on here, so color me very surprised. Of note, is the large volume of 3mL, and the requirement of a 90 second push. Also, it won't be available in a pharmacy, it must be injected by a healthcare provider in a clinic setting. All HCPs must be 'certified' on its proper administration techniques.
Seems like a good TRT option for busy people. But, it certainly doesn't fit well with the new men's health clinic business model, where the financial drivers are weekly visits.
Also, we finally see the safety issues that have delayed approval for these seven years: anaphylaxis and pulmonary oil microembolism (POME). Apparently branded commercial testosterone solutions have the same warning on anaphylaxis, but none have ever included wording on POME.
The FDA considered not just Endo's lone, rather small research study (N=141), but also post-marketing adverse event data from Europe, where Aveed (Nebido) has been approved for a number of years:
http://www.internalmedicinenews.com/index.php?id=2049&type=98&tx_ttnews[tt_news]=142661&cHash=da03e20e36
An FDA review of 199 postmarketing cases of POME, between November 2003 and April 2012, determined that 84 were severe, with severe dyspnea, loss of consciousness, circulatory collapse, or loss of bowel function. Many cases started as the medication was being injected. Although no deaths were reported, the long-term cardiopulmonary effects of severe cases or chronic effects of repeated less-severe episodes are not known, according to the FDA. During 2003-2011, there were 53 postmarketing cases of anaphylaxis reported, using a conservative definition.
Aveed's Black Box Warning:
WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS
--Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, including life-threatening reactions, have been reported to occur during or immediately after the administration of testosterone undecanoate injection. These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose.
--Following each injection of AVEED (testosterone undecanoate) injection, for intramuscular use CIII, observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis.
--Because of the risks of serious POME reactions and anaphylaxis, AVEED is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the AVEED REMS Program.
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