Jatenzo, an Oral Testosterone Replacement Therapy

[madman]

Clarus Therapeutics Announces Commercial Launch and Availability of JATENZO® (testosterone undecanoate) capsules, CIII for the Treatment of Hypogonadism


Clarus Therapeutics Announces Commercial Launch and Availability of JATENZO® (testosterone undecanoate) capsules, CIII for the Treatment of Hypogonadism | BioSpace


NORTHBROOK, Ill., Feb. 10, 2020 (GLOBE NEWSWIRE) -- Clarus Therapeutics Inc. today announced that JATENZO® (testosterone undecanoate) capsules, CIII is now available by prescription in the U.S. for the treatment of appropriate men with testosterone deficiency (hypogonadism). JATENZO is the first and only oral softgel testosterone undecanoate, and the first oral testosterone medicine approved by the U.S. FDA in more than 60 years.1,2,3 JATENZO is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).1 JATENZO is not for use in men with hypogonadal conditions—such as “age-related hypogonadism”—that are not associated with structural or genetic etiologies.1

“JATENZO is finally available to healthcare providers and their hypogonadal patients. This FDA-approved oral testosterone replacement option is an important addition to the treatment landscape for men with testosterone deficiency,” said Dr. Robert Dudley, Chief Executive Officer of Clarus Therapeutics, Inc. “We believe a significant number of appropriate hypogonadal men will prefer an oral therapy that will help them restore their testosterone levels.”

“The launch of JATENZO means that healthcare providers, and their patients with indicated forms of hypogonadism, finally have an oral option, where liver toxicity was not observed in trials,” said Dr. Ronald S. Swerdloff, who was the lead investigator in the pivotal inTUne (investigational testosterone undecanoate) clinical trial and is also a Distinguished Professor of Medicine, David Geffen School of Medicine at UCLA; Chief, Division of Endocrinology at Harbor-UCLA Medical Center; and Senior Investigator at The Lundquist Institute.4 “JATENZO offers patients a convenient softgel formulation, and eliminates the worry of gel transference, skin irritation from patches, or pain from injections that other testosterone treatments carry.”




Jatenzo, an Oral Testosterone Replacement Therapy, Now Available


Jatenzo, an Oral Testosterone Replacement Therapy, Now Available - MPR


Jatenzo® (testosterone undecanoate; Clarus Therapeutics), an oral testosterone replacement therapy, is now available for the treatment of hypogonadism.

 

[madman]

 

[madman]

2.2 Dosing and Dose Adjustment Information

Individualize the dosage of JATENZO based on the patient’s serum testosterone concentration response to the drug. The recommended starting dose is 237 mg taken orally twice daily, once in the morning and once in the evening. Take JATENZO with food.

Dose Adjustment

To ensure proper dose adjustment, measure serum testosterone concentrations 6 hours after the morning dose in plain tubes, clotted at room temperature for 30 minutes prior to centrifugation. Adjust the JATENZO dose based on this serum testosterone measurement as shown in Table 1. Wait seven days after starting treatment or adjusting the dose before checking the serum testosterone concentration. Thereafter, periodically monitor serum testosterone concentrations 6 hours after the morning dose.

Administer the same dose in the morning and evening. The minimum recommended dose is 158 mg twice daily. The maximum recommended dose is 396 mg (two 198 mg capsules) twice daily.

 

[madman]

 

[madman]

JATENZO capsules are available in three strengths of 158 mg, 198 mg, and 237 mg.

The 158 mg strength is an opaque red capsule that contains 158 mg of testosterone undecanoate and is imprinted with “158” in white ink. The 198 mg strength is an opaque white capsule that contains 198 mg of testosterone undecanoate and is imprinted with “198” in red ink. The 237 mg strength is an opaque orange capsule that contains 237 mg of testosterone undecanoate and is printed with “237” in white ink. All capsule strengths also contain oleic acid, polyoxyl 40 hydrogenated castor oil (Cremophor RH 40), borage seed oil, peppermint oil, and butylated hydroxytoluene as inactive ingredients. Gelatin capsule shells are composed of the following inactive ingredients: Gelatin, sorbitol, glycerin, purified water, iron oxide red, FD&C Yellow #6, and titanium dioxide.

 

[madman]

12.3 Pharmacokinetics

Absorption

JATENZO delivers physiologic amounts of testosterone, producing testosterone concentrations that approximate normal concentrations seen in healthy men.

JATENZO was taken orally at a starting dose of 237 mg twice per day with meals in a multicenter, open-label, randomized, 2-arm, active-controlled trial in hypogonadal males. The dose was adjusted, as needed, on Days 14 and 56 between a minimum of 158 mg twice per day and a maximum of 396 mg twice per day based on the average plasma testosterone concentration obtained over 24 hours after the morning dose. The average daily NaF-EDTA plasma testosterone concentration was 403 (± 128) ng/dL at the end of treatment, where the normal eugonadal range in NaF-EDTA plasma was 252-907 ng/dL in this study. Note that the titration scheme for use in clinical practice is based on serum total testosterone [see Dosage and Administration (2.2)].

Table 3 summarizes the pharmacokinetic (PK) parameters for plasma total testosterone in patients completing at least 105 days of JATENZO treatment administered twice daily.

 

[madman]

Figure 2 summarizes the mean plasma total testosterone profile for the patients at the final PK visit.




Figure 2: Mean (±SEM) Concentration-Time Profile for NaF-EDTA Plasma Total Testosterone in JATENZO Treated Subjects at Final PK Visit

SEM = standard error of the mean; T = testosterone

When JATENZO was dosed with different breakfasts containing various amounts of fat, the bioavailability with the 30 g fat, 45 g fat, and high-calorie high-fat breakfasts was comparable, but there was a food effect with the 15 g fat breakfast compared to the 30 g fat breakfast. The 15 g fat breakfast had a 25% decrease in testosterone exposure compared to the 30 g fat breakfast.

 

[madman]

What are the ingredients in JATENZO? Active ingredient: testosterone undecanoate Inactive ingredients: oleic acid, polyoxyl 40 hydrogenated castor oil (Cremophor RH 40), borage seed oil, peppermint oil, and butylated hydroxytoluene. The ingredients of the soft gelatin capsule shells are gelatin, sorbitol, glycerin, purified water, iron oxide red, FD&C Yellow #6, and titanium dioxide.

 

[Stpfan]

I tried a similar oral testosterone undecanoate pill about 2 years ago. Just a very mild dose every 12 hours. Within 3 days I had superior constipation. I can't even describe how it screws up your stomach and digestive system. Perhaps we all react differently to it? But just giving everyone the heads up.

 

[Nelson Vergel]

FDA approves new oral testosterone capsule called Jatenzo

 

[Nelson Vergel]

WEBINAR: Jatenzo - the new oral testosterone - this Thursday May 14, 2020 at 830PM eastern/730 PM central. By Dr Jason Kovac

Register and tune-in.
This is the link: Registration

 

[jonro]

Oral is good, but twice a day and its effectiveness varies with your diet. It's great news, but I'm wondering how well it will work in practice.

 

[Pursuit_Sanus]

Did anybody tune into the webinar? The doctor giving the presentation is a urologist not far from me.

 

[kassad]

Jatenzo presentation: https://www.fda.gov/media/110642/download

 

[madman]

Clarus Announces JATENZO® (Testosterone Undecanoate) Capsules, CIII Now Covered by Express Scripts

JATENZO is the first and only FDA-approved oral testosterone replacement therapy of its kind Coverage effective December 1, 2020 on the Express Scripts...

www.globenewswire.com

Clarus Announces JATENZO® (Testosterone Undecanoate) Capsules, CIII Now Covered by Express Scripts


NORTHBROOK, Ill., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Clarus Therapeutics, Inc. today announced that Express Scripts, Inc, one of the leading pharmacy benefit managers (PBMs) in the United States will now cover JATENZO® (testosterone undecanoate) capsules, CIII. JATENZO is the first and only FDA-approved oral testosterone undecanoate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).1,2 Important Safety Information, including Boxed Warning, is provided below. Limitations of use: Safety and efficacy of JATENZO in males less than 18 years old have not been established.

“This partnership with Express Scripts meaningfully enhances the coverage of JATENZO for patients, and provides appropriate hypogonadal men additional access to an oral testosterone replacement therapy option,” said Dr. Robert Dudley, Chief Executive Officer of Clarus Therapeutics, Inc. “We believe this improved access to JATENZO will give physicians, and their appropriate patients, a convenient oral option for testosterone replacement therapy, and an alternative, not only for new patients but for those patients who are dissatisfied with their current treatment options.”

As of December 1, 2020, nearly 99 million commercial lives, or 61.4% of lives in the U.S., now have access to JATENZO with the addition of Express Scripts. Clarus is committed to working with payers to further broaden JATENZO access for patients and to support patients and providers who desire an oral testosterone replacement therapy option. Clarus also offers patients financial assistance through its JATENZO GO program, where eligible patients with commercial insurance may pay as little as $0 for their monthly prescription of JATENZO. For eligible patients with commercial coverage for JATENZO, their first prescription is free while waiting for insurance verification and prior authorization appeals. Patients can find out more by calling 1-844-269-2795 or visiting the JATENZO website at www.Jatenzo.com for all eligibility requirements.

 

[Nelson Vergel]

Oral TRT without Dose Titration Requirement

Introduction: Most marketed testosterone replacement therapy (TRT) products require multiple dose adjustment visits to achieve desired eugonadal testosterone (T) levels. For the majority of patients, typical titration of TRT takes 3-6 months with multiple bloods draws and titrations (mostly up...

www.excelmale.com

 

[madman]

Dr. Swerdloff discusses the oral testosterone capsule Jatenzo

Jatenzo is approved by the FDA as a testosterone replacement therapy for men with certain forms of hypogonadism.

www.urologytimes.com

Ronald S. Swerdloff, MD, MACP, discusses the approved indication and efficacy of Jatenzo (testosterone undecanoate), an oral testosterone capsule. Jatenzo is approved by the FDA as a testosterone replacement therapy for men with certain forms of hypogonadism. It is indicated for patients with low testosterone levels as a result of certain medical conditions, such as genetic disorders or cancer-related damage to their pituitary gland.

Swerdloff is a senior investigator at the Lundquist Institute, chief, Division of Endocrinology, Harbor-UCLA Medical Center, and professor of Medicine, David Geffen School of Medicine at UCLA.

 

[DS3]

 

[madman]

 

[Nelson Vergel]

JATENZO ORAL TESTOSTERONE: ANDROGEN AND METABOLIC THERAPIES FOR BETTER HEALTH

www.excelmale.com