FDA approves new oral testosterone capsule called Jatenzo

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Nelson Vergel

Founder, ExcelMale.com
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.

Jatenzo oral testosterone.jpg


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
 
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Nelson Vergel

Founder, ExcelMale.com
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

Active Member
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
 
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tmaxey1

Member
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

Member
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!
 
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Voltz

New Member
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

Member
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.
 
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Voltz

New Member
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.
 
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