FDA Approves Oral Testosterone Replacement Therapy Kyzatrex
The FDA has approved Kyzatrex (testosterone undecanoate) for the treatment of primary and secondary hypogonadism in adult males.
The FDA has approved Kyzatrex (testosterone undecanoate) for the treatment of primary and secondary hypogonadism in adult males.
No evidence of increase seen for short- to medium-term cardiovascular risk, but data lacking regarding long-term safety
Tlando is supplied as 112.5mg of testosterone undecanoate capsules.
The approval was based on data from a phase 3 study that evaluated the efficacy and safety of Tlando in 95 adult hypogonadal male patients.
Risk for myocardial infarction or stroke lower with testosterone therapy among men with hypogonadism and other cardiovascular risk factors
Study reveals that almost 90% of men have hypogonadism at the time of hospital admission for COVID-19.
Kyzatrex is an investigational, oral testosterone undecanoate softgel that utilizes lymphatic absorption and phytosterols to increase bioavailability and provide a favorable pharmacokinetic profile.
This slideshow shows drug information for Jatenzo. Click here for the complete Jatenzo monograph.
This week on the Pod we cover an insulin pump recall; Pharmacies running out of supplies in light of Covid-19 fears; Investigational Alzheimer disease treatments not meeting trial end points; A new cardiac ultrasound device; and a new oral testosterone replacement therapy.