y lipoprotein decreased 5 (3.0)
Nausea 4 (2.4)
Among the 569 patients who received JATENZO in all Phase 2 and 3 trials combined, thefollowing adverse reactions were reported in >2% of patients: polycythemia, diarrhea, dyspepsia,eructation, peripheral edema, nausea, increased hematocrit, headache, prostatomegaly, andhypertension.
Three of the 166 patients (1.8%) in the 4-month study experienced adverse reactions that led topremature discontinuation from the study, including rash (n=1) and headache (n=2).
BP Increases
In the 4-month clinical study, 24-hour ABPM was conducted on 166 patients. ABPM wasconducted at baseline and at Day 139 of JATENZO therapy. A total of 135 patients had
acceptable ABPM recordings at both time periods. In that group, the mean change in 24-hoursystolic BP and diastolic BP from baseline to final on-treatment visit on Day 139 (n=135) was4.9 mmHg (95% CI 3.5, 6.4) and 2.5 mmHg (95% CI 1.5, 3.6), respectively.
The ABPM systolic and diastolic increases were larger in patients with a history of hypertensionwho were being treated with antihypertensive therapy (5.4 mmHg [95% CI 3.3, 7.6] and 3.2mmHg [95% CI 1.7, 4.7], respectively [n=67]) compared to patients with no history ofhypertension at baseline (4.4 mmHg [95% CI 2.3, 6.4] and 1.8 mmHg [95% CI 0.2, 3.3],respectively [n=63]).
The BP measured in a clinic setting using BP cuff measurements rose during the course oftreatment with a mean systolic increase of 2.8 mmHg (95% CI 1.0, 4.6) and a mean diastolicincrease of 0.6 mmHg (95% CI -0.7, 1.9) at the final on-treatment visit (Day 139).
Twelve (7.2%) patients on JATENZO started antihypertensive or had their antihypertensiveregimen increased during the course of the study. A total of 6 patients were reported to have anadverse reaction of hypertension (2 patients with hypertension and 4 patients with worseninghypertension), and 3 were reported to have an adverse reaction of increased blood pressure.
HR Increases
JATENZO increased mean heart rate by an average of 2.2 beats per minute (bpm) [95% CI (1.0,3.3), N=135] during the study. Patients without a history of hypertension had a greater averageincrease in mean heart rate (2.7 bpm [95% CI (0.8, 4.6), N=63]) compared to patients withtreated hypertension (1.9 bpm [95% CI (0.3, 3.5), N=67)]).
Increases in Hematocrit
Increases in hematocrit were reported in 8 of the 166 (4.8%) patients, which occurred in thesecond half of the study. None of these increases led to premature discontinuation of JATENZO.
Headaches
Headaches were reported in 8 of the 166 patients (4.8%) of which three required treatment withanalgesics or non-steroidal anti-inflammatory drugs and 2 led to premature discontinuation fromthe study. Five of these 8 patients had headache events that resolved within 1 to 2 days.
Depression and suicidal ideation
Two of the 166 patients (1.2%) reported either worsening depression (n=1) or new-onsetdepression (n=1). One of the 569 patients (0.2%) in clinical trials had suicidal ideation.
Eachpatient completed the study.
Increases in Serum PSA
The mean increase from baseline in PSA was 0.2 ng/mL (n=161). Increases in serum PSAconcentrations, defined as an increase from baseline of at least 1.4 ng/mL or PSA greater than4 ng/mL, occurred in 3 (1.9%) of the patients at the final visit.
6.2 Postmarketing Experience
The following adverse reactions have been identified during post-approval use of testosterone.
Because these reaction |
