Kyzatrex — Medica
Hypogonadism (primary or secondary) in males (testicular hypofunction/low testosterone with symptoms)
Initial criteria
- age ≥ 18 years (adult males)
- Pretreatment signs and symptoms of androgen deficiency (e.g., depressed mood, decreased energy, progressive decrease in muscle mass, osteoporosis, loss of libido)
- Two pretreatment serum testosterone (total or bioavailable) measurements taken in the morning on two separate days
- Both serum testosterone values are low according to normal laboratory reference values
Reauthorization criteria
- Patient has had persistent pretreatment signs and symptoms of androgen deficiency
- At least one pretreatment serum testosterone (total or bioavailable) level was low according to normal laboratory reference value
Approval duration
1 year