Module 2- Package Insert

Question 1

Why is oral Methyl-T not recommended for use?

Answer 1

Associated with abnormal liver function. Associated with liver toxicity.

Question 2

What kind of drug is Testosterone Undecanoate?

Answer 2

Testosterone Prodrug, anabolic androgenic steroid

Question 3

After food is digested and absorbed, from the small intestine, components either-

Answer 3

enter the liver portal circulation, enter the lymphatic circulation.

Question 4

What is SEDDS?

Answer 4

Self Emulsifying delivery system.

Question 5

SEDDS allows testosterone undecanoate to form lipoprotein particles that are what?

Answer 5

Absorbed into the lymphatic circulation and bypass the liver.

Question 6

How should Jatenzo be dosed?

Answer 6

237mg BiD with food

Question 7

What is the recommended dose to start Jatenzo?

Answer 7

237mg

Question 8

How many patients were randomized to the TU arm of the trial?

Answer 8

166

Question 9

What is the primary endpoint of the inTUne trial?

Answer 9

% of patients with total plasma testosterone Cavg in the normal eugonadal range @ final PK visit.

Question 10

How many patients taking TU achieved the primary endpoint?

Answer 10

87.3%Ho

Question 11

How many patients taking TU had a treatment emergent AE that led to discountinuation of the study?

Answer 11

3

Question 12

Patients taking TU had a mean increase of ____ in systolic BP?

Answer 12

4.9 mmHg

Question 13

TU increased PSA levels by____? How many patients experienced it?

Answer 13

.2 ng/mL, 3 patients

Question 14

Who is Jatenzo indicated for?

Answer 14

TRT indicated for the treatment of adult males for conditions associated with a defiency, or absence of endogenous testosterone.

Question 15

Jatenzo has a half life of?

Answer 15

2-4 hours

Question 16

Which oral TU products bypass 1st pass liver metabolism?

Answer 16

Kyzatrex, Tlando, Jatenzo

Question 17

What % of patients maintained normal hematocrit levels?

Answer 17

97%

Question 18

How many patients saw increases in hematocrit?

Answer 18

8 of 166

Question 19

How often should hematocrit be monitored to detect increased red blood cells and polycythemia?

Answer 19

Every 3 months

Question 20

Does Jatenzo have a pediatric indication?

Answer 20

No

Question 21

How does Jatenzo impact hematocrit levels?

Answer 21

Increases production of red blood cells, potentially raising hematocrit levels.

Question 22

How do you explain the plasma testosterone level of 403 ng/dL in the inTUne study @ final PK visit?

Answer 22

Patient’s average T level over 24 hours was 403 ng/dL @ final PK visit.