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N O V A - G R A P S K A 15 godina | GRAPSKA | NOVOSTI IZ GRAPSKE
Autor FDA approves oral testosterone capsule for men with hypogonadism
happer
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Komentari: 124
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Registrovan: 26.04.18
Upisano u 20-07-2019 15:28
FDA approves oral testosterone capsule for men with hypogonadism


The FDA on Wednesday approved testosterone undecanoate in an oral capsule to treat men with certain forms of hypogonadism, the agency announced in a press release.

The approval marks the first new oral testosterone replacement product in more than 60 years. The indication is for men with low testosterone levels due to specific medical conditions, such as Klinefelter syndrome or tumors that have damaged the pituitary gland. This oral testosterone undecanoate (Jatenzo, Clarus Therapeutics) 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, according to the FDA, which stated that the drug’s benefits do not outweigh its risks for that use.Testosterone decanoate Uses
Jatenzo’s oral route of administration provides an important addition to current treatment options available for men with certain hypogonadal conditions who up until now have most commonly been treated with testosterone products that are applied to the skin or injected,” Hylton V. Joffe, MD, MMSc, director of the division of bone, reproductive and urologic products in the FDA’s Center for Drug Evaluation and Research, said in the release. “But it’s important to emphasize that this drug should not, like other testosterone treatments, be used to treat older men with ‘age-related hypogonadism.’ The benefits of testosterone therapy, including Jatenzo, have not been established for this use, and Jatenzo’s effects on raising blood pressure can increase the risks of heart attack, stroke and cardiovascular death in this population.”

The efficacy of Jatenzo was demonstrated in a 4-month clinical trial involving 166 men with hypogonadism. Study participants initially were given Jatenzo at a dose of 237 mg twice per day, and the dose was adjusted downward or upward to a maximum of 396 mg twice per day on the basis of testosterone levels. At the end of the study, 87% of men treated with the oral testosterone undecanoate achieved an average testosterone level within the normal range, which was the primary study endpoint.

In an interview conducted before a presentation on oral testosterone undecanoate at the Androgen Society annual meeting in New Orleans this month, Ronald Swerdloff, MD, professor of medicine, endocrinology, metabolism and nutrition at the David Geffen School of Medicine at UCLA and chief of the division of endocrinology at Harbor UCLA Medical Center, told Endocrine Today that the agent has “excellent pharmacokinetics” and, when taken with meals, has few unanticipated adverse effects. Development of the drug, he said, has been complex due to challenges associated with oral dosing. The formulation of testosterone undecanoate, however, reduces a dietary fat effect and the variability of testosterone response, he said.

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bullet halil40Pogledaj sve porukice od ovoga posjetioca 
21/05/2016 00:19
Zdravo. Jal aktivna ova stranica

bullet administratorPogledaj sve porukice od ovoga posjetioca 
02/08/2015 20:53
Stranica je bila komplet zapustena, zahvaljujuci nekome. Uskoro ponovo i u novom ruhu, kao i sa novim sadrzajem.

bullet bbPogledaj sve porukice od ovoga posjetioca 
25/10/2013 19:29
sellam,malo si zapustio stranicu Jasko

bullet zlatanPogledaj sve porukice od ovoga posjetioca 
17/10/2013 02:19
kako mu je zena

bullet zlatanPogledaj sve porukice od ovoga posjetioca 
17/10/2013 02:19
sta je bilo sa mesudom ribom

bullet zlatanPogledaj sve porukice od ovoga posjetioca 
17/10/2013 02:17
doni sto se ne javljas sa novim vijestima

bullet zlatanPogledaj sve porukice od ovoga posjetioca 
17/10/2013 02:16
sta ima novoga u grapskoj

bullet dzoniPogledaj sve porukice od ovoga posjetioca 
27/08/2013 07:21
selam iz oblacne grapske..svi su na broju hvala bogu..svako dobro bosno i hercegovino...

Bullet Bullet

bullet alemkamenPogledaj sve porukice od ovoga posjetioca 
11/07/2013 12:12
Nek mirisu avlije

bullet dzoniPogledaj sve porukice od ovoga posjetioca 
11/07/2013 09:45
selam iz suncane i tople grapske..svi su na broju hvala bogu..svako dobro bosno i hercegovino..PS.11.07.2013..18 GODINA OD STRADANJA SREBRENICE..NEKA IM JE VJECNI RAHMET...

bullet dzoniPogledaj sve porukice od ovoga posjetioca 
30/06/2013 07:28
selam iz suncane grapske..danas su dzenaze HURTIC MEHMEDU I MURATOVIC OSMANU poslije ikindije namaza..rahmet im dusi..svako dobro bosno i hercegovino..

bullet dzoniPogledaj sve porukice od ovoga posjetioca 
21/06/2013 10:22
selam iz vrele i suncane grapske..svi su na broju hvala bogu,,svako dobro bosno i hercegovino..

bullet dzoniPogledaj sve porukice od ovoga posjetioca 
13/06/2013 07:24
selam iz oblacne grapske..svi su na broju hvala bogu..svako dobro bosno i hercegovino..

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