Exam Flashcards
What percentage of men achieved the primary endpoint?
87%
Is Jatenzo known to cause serious hepatic adverse effects?
No
Was there a food effect on T exposure that depended on dietary fat content?
The bioavailability w/ the 30g fat, 45g fat and high calorie high fat breakfasts were comparable. The 15g fat bfast had a 25% decrease in testosterone exposure comparitively.
What were the primary endpoints of the inTUne study?
% of patients w/ mean plasma total T concentration (Cavg) over 24 hours w/in the normal range on the final visit of the study.
What are the potential AE’s on fertility?
Spermatogenesis may be suppressed through feedback inhibition of pituitary FSH possibly leading to AE’s on semen parameters including sperm count.
What were the secondary endpoints of the inTUne study?
% of patients with a maximum total T concentration (Cmax) above <1500 ng/dL, between 1800 and 2500 ng/dL and >2500 ng/dL.
For which patients is Jatenzo contraindicated?
Men with known hypersensitivity, Men with carcinoma of the breast, Men with known, or suspected carcinoma of the prostate, women who are pregnant, men with hypogonodal conditions such as age related HG.
What are specific conditions that fall under primary HG and hypogonadotropic hypogonadism?
cryptorchidism, Klinefelter syndrome and orchitis
What are the recommended starting, minimum and maximum doses (twice daily)?
237mg, 158mg, 396mg
What are 5 AE’s reported from the clinical study in >2% of patients?
headache, hematocrit increased, hypertension, high density lipoprotein, nausea
How many patients had increased PSA at the final study visit?
1.9% (3)
Due to the black box warning, what should be done before and after initiating Jatenzo?
Consider the patient’s baseline cardiovascular risk and ensure BP is adequately controlled. Starting approximately 3 weeks after first dose of Jatenzo, or changing the dose, periodically monitor for and treat new-onset hypertension, or exacerbations od pre-existing hypertension.
In which section of the PI are cardiovascular risk and BP addressed?
Boxed Warning- 5.1 Increase in BP, 5.3 Cardiovascular risk, 6 Adverse Events
For which patients is Jatenzo contraindicated?
Men with known hypersensitivity to Jatenzo, or any of the ingredients.
Men with carcinoma of the breast
Men with known, or suspected carcinoma of the prostate
Women who are pregnant
Men with a hypogonadal condition, such as “age related” HG.
There is a black box warning for Jatenzo. What is the main concern?
BP increases that could increase the risk of MACE.
