August 25, 2014

Do You Need Aveed?

AveedWhat is Aveed?

Aveed is a long-acting injectable testosterone. It’s generic name is testosterone undecanoate and has been available in Europe for years, but did not receive FDA approval in the United States until early 2014. Aveed’s presumed advantage is that it doesn’t have to be injected weekly like most current testosterone injectables.

After an initial injection, followed by a second injection in 4 weeks, Aveed is then injected every 10 weeks beginning with the third injection. Thus, it is felt it will be more convenient for men over the more commonly used injectable testosterones.

Aveed contains 750 mg of testosterone undecanoate in 3 mls. So Aveed provides an average weekly dose of testosterone of 75 mg. It is suspended in castor oil and benzyl benzoate.

Aveed and FDA Approval

Aveed did not receive FDA approval without some controversy or struggles. The FDA is requiring that it carry a box-warning regarding the risk of pulmonary oil microembolism (POME) and anaphylaxis.

It is only distributed through a program called risk evaluation and mitagation strategy (REMS) which requires that patients be observed for 30 minutes following an injection to rule out POME. In addition, healthcare facilities and physicians must be specifically certified to prescribe and dispense Aveed.

What is Pulmonary Oil Microembolism?

An embolus can be any substance that enters the bloodstream that blocks or obstructs blood flow. The most common form of emboli are blood clots. But, fat (usually from a fracture bone as bone marrow contains fat) can become emboli and so can any medication suspended in oil. An embolus that affects the blood flow to the lungs is called a pulmonary embolus.

The signs and symptoms of POME include cough, dyspnea (shortness of breath), hot flush, increased sweating, difficulty speaking, and hyperventilation. POME requires prompt medical attention.

Despite box-warning requirement the incidence of POME following Aveed is still rare, in the neighborhood of 1.5 cases per 10,000 or 0.015%. POME is not peculiar to Aveed and has been reported with the use of other oil-based testosterone formulations.

Aveed: Advantages and Disadvantages

I don’t see the potential for POME to be a major drawback directly, but I suspect the REMS requirement will deter physicians from participating in the program.  A potential drawback for me is the dose. Most of my patients receiving testosterone injections require 100 mg of testosterone a week. So I think some men may be left inadequately treated using Aveed.

As a physician inadequate testosteorne levels and clinical response are concerning. In Europe, testosterone undecanoate is available in 1,000 mg syringes equal to 100 mg of testosterone a week.

Testosterone levels are relatively stable using Aveed and that is felt to be another advantage, but that’s theoretical. Testosterone levels are supposed to fluctuate throughout the day – at least that’s what nature intended as that is how the body works. That fluctuation keeps testosterone receptors from constantly being stimulated and keeps them from being desensitized to testosterone.

I’m not convinced that stable testosterone levels hour after hour and day after day is ideal. It seems it might lead to tolerance to the drug, but that’s just speculation on my part. Time will tell as they say.

We’ll keep you posted as we learn more about Aveed!

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Dr. Joe Jacko

Dr. Joe is board certified in internal medicine and sports medicine with additional training in hormone replacement therapy and regenerative medicine. He has trained or practiced at leading institutions including the Hughston Clinic, Cooper Clinic, Steadman-Hawkins Clinic of the Carolinas, and Cenegenics. He currently practices in Columbus, Ohio at Grandview Primary Care. Read more about Dr. Joe Jacko

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