Is Aveed (Nebido outside the US) Long Acting Testosterone Injection The Answer For Men's Low T?

[Keith Willse]

http://www.multivu.com/mnr/65167-u-s-fda-approves-endo-aveed-for-men-with-hypogonadism-low-t

Dublin, Ireland, March 6, 2014 / PRNewswire / — Endo International plc (NASDAQ: ENDP) (TSX: ENL) announced today that its operating company Endo Pharmaceuticals Inc. received U.S. Food and Drug Administration (FDA) approval of AVEED™ (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone. AVEED is a new prescription medicine indicated to produce serum testosterone levels in the normal range by administration of a single 3-mL (750 mg) intramuscular injection given once at initiation of therapy, at 4 weeks, and then every 10 weeks thereafter. It is expected to be available in early March.

 

[Nelson Vergel]

Endo International announced today that its operating company Endo Pharmaceuticals Inc. received U.S. Food and Drug Administration (FDA) approval of AVEED™ (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone. AVEED is a new prescription medicine indicated to produce serum testosterone levels in the normal range by administration of a single 3-mL (750 mg) intramuscular injection given once at initiation of therapy, at 4 weeks, and then every 10 weeks thereafter. It is expected to be available in early March.

More on Aveed (known as Nebido outside the United States) here: https://www.excelmale.com/forum/thr...g-acting-testosterone)?highlight=aveed+nebido

 

[jsmma]

I came on today specifically to see if this had been posted here.

As of now I have been on 200/100 Test Cyp (100 mg/week divided up into EOD doses) for about 5 solid months. It has been a breeze. Sometimes I forgot my shot and just up it 50% the next day but always sticking to the 100 mg/week dose.

I saw this the other day and it really got my attention. Where do things go from here? How long will it be before I can go to my doc and say HEY, I WANT TO TRY THIS?

Should I try it right away?

I keep seeing Anaphylaxis as a possible side. Is the risk greater with this more so than IM with other Test ethers?

The thought of only 6 shots or so per year is pretty intriguing if I can somehow get the same results as I have thus far.

Just hoping for a wider discussion on this. I don't want to mess up a good thing. Just want to know from the experts if in their opinion it would be a solid decision.

 

[Nelson Vergel]

You will probably have to wait 4 months until the product is available and we know pricing. I will be posting several guides on it soon.

It is a game changer in TRT!!

Here is the product website (with copay card)

http://www.aveedusa.com/

Have your doctor apply to become a provider by giving him this link: https://www.aveedrems.com/AveedUI/rems/slhpc.action



The US will not allow injecting 1000 mg of Aveed (testosterone undecanoate, called Nebido around the world) like they do it all over the world. These are the instructions here:

"For intramuscular use only (2.1).

3 mL (750 mg) is to be injected intramuscularly at initiation, at 4 weeks, and every 10 weeks thereafter (2.1).

Following each injection of Aveed, 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 (2.3).

Inject Aveed deeply into the gluteal muscle following the usual precautions for intramuscular administration of oily solutions (2.3)."

Here is the main transcript from Aveed's FDA review process:

http://www.fda.gov/downloads/adviso...ivehealthdrugsadvisorycommittee/ucm348092.pdf

Here is prescribing information: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022219s000lbl.pdf



PATIENT SAVINGS PROGRAM:

If you have been prescribed AVEED™, you may be eligible for savings with the Patient Savings Program.

Eligible patients: Pay $0 copay on your first 2 injections with the AVEED Rebate Program.[SUP]*[/SUP] The program will pay up to a maximum reimbursement of $165 for each of your first 2 AVEED injections—PLUS, up to a maximum reimbursement of $135 for each injection thereafter. If your total out of pocket expense exceeds these amounts you are responsible for the additional amounts.

http://aveedusa.com/patient/aveed-patient-savings.aspx

 

[Eli1947]

Just want to cool your expectations guys. It is far from being "a new area in treatment".
I have been on Nebido for a while. Can't state what would happen if stayed longer with it.
Aveed is actually the same formulation of Nebido sold in the US at a reduce volume capacity (3/4 unit volume).
The good news is that Aveed seems to be supplied in multi-dose vial vs other places in the world as single unit 4 ml glass ampoule. See nelson's post. This may help in practice dividing the dose into small doses as with the experience with other ester formulations in the US for better control of testosterone uniformity.
This of course is in contrary to the main advantage presented by manufacturer of long acting and fewer injections/year.

 

[Kelly]

I'm curious. It seems the dosing protocol is the same for everyone. That seems problematic to me. Anyone have any knowledge of the latitude the prescribing physician will be given with this?

 

[Nelson Vergel]

We will see. I doubt that TT levels will be above 500 ng/dL if you inject every 10 weeks only 750 mg of Aveed. I bet that injection frequency was based on keeping TT levels above 350 ng/dL, which is the level used by insurance companies as the "cut-off" for hypogonadism. Endo will learn a hard lesson when men start wanting to inject more frequently than that. Most insurers will not want to pay for "early" refills. Only time will tell.

 

[Nelson Vergel]

Pharmacokinetics and Safety of Long-Acting Testosterone Undecanoate (Aveed in the US, Nebido in all other countries) Injections in Hypogonadal Men: An 84-Week Phase III Clinical Trial


ABSTRACT:

Currently available testosterone (T) injections in the United States are administered at 2&#8211;3 weekly intervals. Less frequent injections with favorable serum T pharmacokinetics would benefit hypogonadal men. The objective of this study is to assess the pharmacokinetics of long-acting testosterone undecanoate (TU) intramuscular (IM) injection in hypogonadal men. An unblinded, multicenter phase 3 clinical trial was conducted in 31 academic centers and contract research organizations. Males (130) more than 18 years of age with serum total T < 300 ng/dL were enrolled and received 750-mg injections of TU at weeks 0 and 4 and every 10 weeks thereafter for 9 injections over 84 weeks. The main outcome variables were serum total T, free T, dihydrotestosterone (DHT), estradiol (E2) levels, and safety parameters. After the first injection, patients maintained average trough T concentrations in the adult male range (300&#8211;1000 ng/dL or 10.4&#8211;34.7 nmol/L) before each injection and at multiple time points measured after the third and fourth injections. Serum free T, DHT, and E2 levels and their ratios to serum T remained relatively consistent once steady state was attained. TU injections were generally well tolerated, with safety profiles similar to other T replacement. We conclude that hypogonadal patients treated for 84 weeks with a 750-mg IM injection of TU every 10 weeks demonstrated average concentrations of T, its metabolites (DHT and E2), and ratios—DHT:T and E2: T—within the adult male reference range at all time points measured. TU injections would be an acceptable alternative to the currently available 2&#8211;3 weekly injectables.

**************

This was a multicenter, open-label, US-based study of the efficacy and safety of treatment with 750 mg TU in 3 mL of castor oil (250 mg/mL) by deep IM injections administered to the gluteus muscle at week 0 (baseline), week 4, and every 10 weeks thereafter through 9 injections.


Serum free T, DHT, E2, and SHBG concentrations for 10 weeks after the third TU injection are provided in the next graph. Serum free T, DHT, and E2 concentrations after the third 750-mg TU injection followed the same pattern as serum T, with peaks at about 7 days and troughs before the next injection. Serum SHBG showed steady levels, which was not changed throughout the 10 weeks after the TU injection.






The following graph provides the mean concentrations of serum T in 117 men over the 10-week interval after the third and fourth injection of 750 mg TU. The serum T levels peaked at about 7 days after each injection. Then serum T levels gradually decreased to reach a mean serum T level just above 300 ng/dL (10.4 nmol/L) 10 weeks after the injection. The serum T profiles were identical after the third and fourth injections.




Comment from Nelson Vergel:

The current approved injection protocol for Aveed in the US (3 mL (750 mg) to be injected intramuscularly at initiation, at 4 weeks, and every 10 weeks thereafter) does not keep total testosterone blood levels above 500 ng/dl. The cut off used was 300 ng/dL in the studies that got the product approved in the United States. Many men do not feel the benefits of testosterone replacement when their total T blood levels are under 500 ng/dL. So, this protocol may not be successful for many men in the United States.

 

[Nelson Vergel]

Total Testosterone Blood Levels When Using Aveed (Nebido) injections

For more details on how testosterone blood levels behave when using Aveed (Nebido in the rest of the world), read this document from a FDA meeting that reviewed the product:

JOINT MEETING FOR REPRODUCTIVE HEALTH DRUGS AND
THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY
COMMITTEE
APRIL 18, 2013
NDA 022219: testosterone undecanoate (proposed trade name, Aveed)
for intramuscular injection sponsored by Endo Pharmaceuticals
Solutions, Inc., for the replacement therapy in adult males for
conditions associated with a deficiency or absence of endogenous
testosterone

 

[Eli1947]

Hi nelson, do you know if the packaging of aveed is a multidose type ?
Nebido is supplied in Europ in a glass ampule .

 

[MCBeastX]

I would like to add to this as well,

I have been on Nebido for over 3 years now in Asia where the dosage is 1000mg/4ml vials. For me the injection lasts about 2.5 months. For others I assume it may be different as everyone has different requirements and levels of converting to estrogen and SHGB and whatnot. I have never been on any other injection dosage such as you boys do in the states but I would imagine it might be a bit easier to stay balanced with more injections due to the rate of conversion.

I was initially diagnosed as extremely low, way below even the lowest benchmark so pretty well well anything is better than what I was experiencing then. I guess it is all up to the individual user and their needs. I know when I get back to the US soon if I was to be on this dosage of Aveed, it definitely would not last me 10 weeks!

 

[Eli1947]

MCBeastX , thanks for sharing! of course you will be better at any treatment than without it. It would be nice if you can elaborate on how did you feel and managed while at high and at the time of low just before next injection. How were you monitored during that period by your doctor for the parameters of T , SHBG estrogen etc and what were your results. I managed just 3 shots of Nebido , the priming shots after the gel stopped working . so I cant say I had the treatment as should be in order to evaluate it real benefit.

 

[MCBeastX]

MCBeastX , thanks for sharing! of course you will be better at any treatment than without it. It would be nice if you can elaborate on how did you feel and managed while at high and at the time of low just before next injection. How were you monitored during that period by your doctor for the parameters of T , SHBG estrogen etc and what were your results. I managed just 3 shots of Nebido , the priming shots after the gel stopped working . so I cant say I had the treatment as should be in order to evaluate it real benefit.

I have attached a small spreadsheet I was doing recently to track the levels , unfortunately I no longer have medical coverage here and really don't feel like paying the high costs of the full blood tests. I am in a bit of a pickle here at the moment as I recently finished a contract at my last job and my medical coverage was from them.
I had a severe accident a couple of years back that shattered both my elbows and left me semi handicapped with regards to full use of my arms.
Due to this I am having alot of trouble getting proper coverage here as the nature of the accident was an explosion of a large water vessel that put me in the hospital for a couple of weeks. So, you can imagine the exclusions on any coverage ....they basically exclude anything to do with my arms ,back, neck , head...etc!

Anyway, back to the real question!

When I get the injection for a couple of days after it is a mix of feelings, sometimes good sometimes bad. I assume this is my body dealing with a spike in T and the conversion that may be happening at the same time. After a couple of days everything seems to stabilize and I feel strong and balanced. this usually lasts for about 2 months after the injection and then I can start to feel the decline. I know when I am due for another injection when i start feeling overly emotional. I have gone through bouts of depression before where I have not even considered that the hormones could be the cause because of the timing only to go and get a blood test and realize that I am in fact very low on T or very high in E2 as you can see by the attached.

As i said , I was very low when i initially discovered the cause of all my depression and mood swings. Initially I went to hospital with depression and was put on anti depressants which only made things worse. I was doing my own research at this time and came across Andropause and thought maybe this was the cause so I went and asked for bloodless for T...I still remember the look on the nurses face!....you want what? Well, 2 hours later it was confirmed....I was at 1.54 ng/ml on a range of 2.8 - 8.0!

I got on TRT and my life was back! started working out and bulked up, felt much better!

I actually thank my lucky stars that I was in much better shape when I had my accident in May of 2012 because if not I may be dead, the nature of the accident was so extreme that I am extremely lucky to have escaped with only the injuries I had and what I have now.

I truly believe that being on this therapy may have saved my life and enabled me to recover as I have. My surgeon initially told me that I probably would not get the use of my right arm back but I have managed to get my elbow to bend to at least 90 deg. His prognoses was max 30 deg!

If I was still feeling the way I felt before TRT I dont think I could have managed as well.

Again, I believe it could be better with proper management and knowledgeable doctor looking at all aspects. The endos here just don't know enough about this yet... and most I have seen tell me I know more than they do about this subject.

I am really looking forward to getting back to the US and getting some real answers instead of doing this all on my own so to speak!

 

[Nelson Vergel]

McBeatX

I am glad you joined us and that you not only survived your accident but also overcame the limitations caused by it. A true fighter!
Let me know when you get back to the US to see if we can help get you good care.

Nelson

 

[Eli1947]

MCBeastX , Thanks a lot again for sharing . I am very sorry about all the trouble you went through.
Your story pretty much is the "same" story as of mine and others guys telling their story all around the globe. Though, details are different. Unfortunately, open mind MD to look at the big picture seem to be rare animals on the planet. Same as for any profession. Your story, mine and as well of many others just prove the rule a great Jewish scholar over 2000 y ago put it so precisely, and in such few words: " If I am not for myself, who is for me? And if I am only for myself, what am I? And if not now, when?"
I hope that when you will be back to the US you will find the right medical help to continue what you already achieved, yes by yourself though with the help of the medical personnel. From the stories of other Americans even in the US it is not simple to get a proper endocrinologist that know how to deal with TRT when it is not just write you a prescription give you the shot and forget about the details for the outcome. I don't mean to insult MD, there are very good professional MD all over the world, much less than what we need.
My case is also a bit complicated as it results from an accident of exposure to chemical resulting in Leukemia and probably also Prostate cancer. Treatment caused me to become hypo-gonadal. though I demanded T check and result showed low T MD claimed it OK. So I was treated with SSRI. Then PC is contraindicated with TRT as a general rule. I lost my bone density and felt bad for 8 years till 2 MD agreed to treat and see what happen. My feel , mood changed and felt very soon blast of energy , PSA went down. But it is not so easy going all time. The anticancer treatment is there and has it own interactions with other medication prescribed and cut the trouble maker short or out. So as you did and the scholar put it I had to care for myself learning about metabolic drugs interactions and drug delivery interactions trying to look for the right MDs in the fields that will agree to cooperate among them and with me. a on going projet now 11 years of fight. Not an easy task.

 

[MCBeastX]

Nelson, thanks again!

Eli1947, so sorry for your struggle, this thing that we face is such a personal thing and still so much in its infancy as far the general medical field goes, I for one am very glad that modern medicine is finally realizing that homeopathic and ancient medicines and practices are not so much hocus pocus as previously thought. It's seems that people are starting to open up their minds and accept things that are out of the norm. Future will hold a much more open minded view of these situations and more understanding I am sure. At the moment ,I am still having trouble convincing my own wife about the benefits of HRT not only for men but women as well!


Stay strong!

 

[Eli1947]

Thank you MCBeastX . I join Nelson statement welcoming you and salute you for your fight! Nelson suggestion to help, make me feel sure that you will get proper medical attention when you will be back home.
I just want to point out that openness like yours, like Nelson's and others forming that forum and that on ********, help and ease the struggle. TRT is not new, it started back in the forties of the previous century. T en Tcyp and even Nebido are old drugs. Mostly used not for treatment of hypogonadals. The fear of abuse usage, is a lot to do with not giving proper treatment to a known medical condition.

 

[Jay Ara]

Hi guys, I'm back on Nebido after 1 year off, due to fertility issues, now after my first shot my doc asked me to take a new blood work in 7 weeks and in 8 weeks we will talk again to decide the interval, last blood work my test was low. Anyway, I feel great right after the shot, placebo effect or not I feel good again. Normally I feel the decrease of my test 1 month after my shot, I guess that is normal until I find steady levels.

 

[Rain27]

You achieved fertility?

 

[Jay Ara]

Hi Rain27,

After many tests I got ok sperm and I decided to freeze it and keep it ready for the right moment. Like that allowed me to go back to my therapy.

I did not try the Insemination yet, so I'm not sure if that works or not, according to the sperm count I have stored fertil samples.

Are you having problems?

Regards,
Jay