FDA-Approved Oral Testosterone: Jatenzo (Testosterone Undecanoate)

[Nelson Vergel]

The U.S. Food and Drug Administration today approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism. These men have low testosterone levels due to specific medical conditions, such as genetic disorders like Klinefelter syndrome or tumors that have damaged the pituitary gland. Jatenzo should not be used to treat men with “age-related hypogonadism,” in which testosterone levels decline due to aging, even if these men have symptoms that appear to be related to low testosterone. Jatenzo’s benefits do not outweigh its risks for that use.

This oral version of testosterone undecanoate has been available in Canada for years. It has a short half-life.
https://www.fda.gov/downloads/Advis...iveHealthDrugsAdvisoryCommittee/UCM591416.pdf

 

[Nelson Vergel]

This is the same medication approved in Canada years ago under the name Andriol.

"The dose of testosterone undecanoate is adjusted according to the response of the person taking the medication. For the first 2 to 3 weeks of treatment, a daily dose of 120 mg to 160 mg in two divided doses is used. After this, the dose of testosterone undecanoate usually ranges from 40 mg to 120 mg daily. Take capsules with a meal and swallow them whole without chewing them."

https://www.merck.ca/static/pdf/ANDRIOL-PM_E.pdf

 

[Rabbit91476]

Interesting. Following. They don’t specify why only certain kinds. It said mice trials had no damage to live if I read it correct but didn’t see human results. Curious as the reason. Any word on cost

 

[tmaxey1]

Interesting. Following. They don’t specify why only certain kinds. It said mice trials had no damage to live if I read it correct but didn’t see human results. Curious as the reason. Any word on cost

Seems they have concerns over the amount of DHT conversion and E2. It seems the way the medicine is digested based on what you eat with it can cause the blood levels to vary.

I can't help but be concerned with this line in.

Cardiovascular Risk: Class labeling for all approved testosterone replacement therapies states that some studies, but not all, have reported an increased risk of major adverse cardiovascular events in association with use of testosterone replacement therapy in men. FDA has required testosterone manufacturers to conduct a postmarketing randomized, double-blind, placebo-controlled trial to definitively determine whether these therapies increase major adverse cardiovascular events, such as myocardial infarction and stroke.

I may be off base but I won't be suprised to see the FDA do a favor for some of their pharmaceutical friends and come after TRT. Once the profits of some SSRI's ect take a hit watch out.

 

[Systemlord]

It looks like I'll be the first forum member to report of my experience on Jatenzo. My doctor gave a medical exception since I've had treatment failure for four years now putting my copay at $4 for a 90 day supply.

I was prescribed 158mg twice daily.

Also a steady state is reached in 7 days!

 

[Voltz]

It looks like I'll be the first forum member to report of my experience on Jatenzo. My doctor gave a medical exception since I've had treatment failure for four years now putting my copay at $4 for a 90 day supply.

I was prescribed 158mg twice daily.

Also a steady state is reached in 7 days!

What did you struggle with regarding treatment failures? Have you seen an improvement since making the switch?

 

[Systemlord]

What did you struggle with regarding treatment failures?

I only felt good after dosing changes on injections, but never felt good after reaching a steady state, I've felt good on Jatenzo the entire time even when not at a steady state.

My body doesn't like super steady hormones levels, I respond to frequently changing hormones, frequent peaks and troughs injections just can't mimic.

Have you seen an improvement since making the switch

A massive improvement in how I feel, my diabetes management and body comp changes in a short period of time (2 weeks).

My veins went from not being visible to ballooning at the start of Jatenzo.

 

[Voltz]

I only felt good after dosing changes on injections, but never felt good after reaching a steady state, I've felt good on Jatenzo the entire time even when not at a steady state.

My body doesn't like super steady hormones levels, I respond to frequently changing hormones, frequent peaks and troughs injections just can't mimic.

A massive improvement in how I feel, my diabetes management and body comp changes in a short period of time (2 weeks).

My veins went from not being visible to ballooning at the start of Jatenzo.

Interesting, I'm going to have to look into this more. It sounds like from my limited knowledge that Jatenzo may mimick to a certain degree the same peaks and valleys of normally functioning endocrine system... So to speak.

 

[goga]

Is Jatenzo considered to be safe for liver? As I know, there were some issues with Andriol.

 

[Nelson Vergel]

Is Jatenzo considered to be safe for liver? As I know, there were some issues with Andriol.

A few guys on here have tried it

My Experience On Jatenzo (Oral TRT) Log

I wanted to start a thread detailing my personal experience with Jatenzo (oral TRT) which is remarkable in how quickly it has shown results when compared with injections. The first week on Jatenzo was very pleasant unlike my experience after dosing changes on injections, all with minimal swings...

www.excelmale.com

But this is happening as we speak

Clarus files for bankruptcy, eyes auction of testosterone therapy Jatenzo

Clarus Therapeutics (CRXT) filed voluntary petitions under Chapter 11 in the U.S

seekingalpha.com

 

[madman]

Is Jatenzo considered to be safe for liver? As I know, there were some issues with Andriol.

Yes.

post #4

thoughts on a gel for me

I have tried testosterone on and off over the years but I never stick with it. I first tried the self injections but a couple times hit a muscle and was sore for a week so I gave up on them. Then I tried the under the tongue trocees (or however you spell it) they took forever to dissolve that...

www.excelmale.com

SAFETY ANALYSIS OF AN ORAL TESTOSTERONE UNDECANOATE (TU) FORMULATION FOLLOWING 2 YEARS OF ADMINISTRATION IN HYPOGONADAL MEN (2021)

CONCLUSIONS: This oral TU formulation is an option for hypogonadal men and has a safety profile consistent with other approved T products. Notably, no evidence of liver toxicity was observed. The long-term efficacy and safety profile of oral TU may provide a treatment option that avoids issues associated with other TRTs, such as injection site pain or transference to partners and children.

Study finds oral testosterone therapy undecanoate is effective, with no liver toxicity

An industry-supported study of an oral testosterone replacement therapy (TRT), testosterone undecanoate (TU, Jatenzo) finds it is an effective, long-term treatment for men with low testosterone levels, with no evidence of liver toxicity. The findings are being presented virtually at ENDO 2021...

www.endocrine.org

JATENZO®: Challenges in the development of oral testosterone

Testosterone therapy (TT) for the treatment of testosterone deficiency (TD) can be administered via several routes of administration. Due to a variety of concerns such as hepatotoxicity, an oral formulation has long been absent in the United States. Recently, JATENZO® (testosterone undecanoate)...

www.excelmale.com

 

[goga]

Is it different from Andriol? Fast results are great. Injections work very slowly...

 

[Nelson Vergel]

My Experience On Jatenzo (Oral TRT) Log

I wanted to start a thread detailing my personal experience with Jatenzo (oral TRT) which is remarkable in how quickly it has shown results when compared with injections. The first week on Jatenzo was very pleasant unlike my experience after dosing changes on injections, all with minimal swings...

www.excelmale.com

 

[Systemlord]

Here is where Dr. Mohit Khera MD says oral testosterone, Kyzatrex/Orlando/Jatenzo has a good side effects profile versus other formulations/delivery systems.