XYOSTED SIDE EFFECTS
- Generic Name: testosterone enanthate injection
- Brand Name: Xyosted
- Drug Class: ANDROGENS
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of XYOSTED was evaluated in 2 clinical studies in a total of 283 men who received weekly subcutaneous doses for up to one year. All patients were started on 75 mg weekly, then the dose was titrated to 50 mg or 100 mg weekly, as needed, to achieve pre-dose total testosterone concentrations of ≥350 ng/dL and <650 ng/dL.
Table 1 summarizes adverse reactions (≥2%) reported in a one-year study with XYOSTED.
Table 1: Number (%) of Patients with Adverse Reactions ≥2% in a 1 Year study with XYOSTED
| Preferred Term | Overall (N=150) n (%) |
| Hematocrit increased | 21 (14.0) |
| Hypertension | 19 (12.7) |
| Prostatic specific antigen (PSA) increased | 18 (12.0) |
| Injection site bruising | 10 (6.7) |
| Headache | 8 (5.3) |
| Back pain | 5 (3.3) |
| Blood creatine phosphokinase increased | 5 (3.3) |
| Injection site hemorrhage | 5 (3.3) |
| Acne | 4 (2.7) |
| Blood testosterone increased | 4 (2.7) |
| Cough | 4 (2.7) |
| Edema peripheral | 4 (2.7) |
| Injection site erythema | 4 (2.7) |
| Prostatitis | 4 (2.7) |
| Urinary tract infection | 4 (2.7) |
| Abdominal pain | 3 (2.0) |
| Arthralgia | 3 (2.0) |
| Fatigue | 3 (2.0) |
| Hematuria | 3 (2.0) |
| Polycythemia | 3 (2.0) |
| Sleep apnea syndrome | 3 (2.0) |
| Note: Includes events that started on or after the first dosing, or existed prior to the first dose and worsened in severity or relatedness after dosing. Percentage was calculated using the number of patients in the column heading as the denominator. | |
Table 2 summarizes the adverse reactions (≥2%) reported in a 6-month study with XYOSTED.
Table 2: Number (%) of Patients with Adverse Reactions ≥2% in a 6-Month Study with XYOSTED
| Preferred Term | Overall (N = 133) n (%) |
| Hematocrit increased | 11 (8.3) |
| Injection site hemorrhage | 8 (6.0) |
| Blood creatine phosphokinase increased | 5 (3.8) |
| Injection site bruising | 5 (3.8) |
| Prostatitis | 4 (3.0) |
| Prostatic specific antigen (PSA) increased | 4 (3.0) |
| Urinary tract infection | 4 (3.0) |
| Fatigue | 3 (2.3) |
| Hypertension | 3 (2.3) |
| Insomnia | 3 (2.3) |
| Nausea | 3 (2.3) |
| Note: Includes events that started on or after the first dosing, or existed prior to the first dose and worsened in severity or relatedness after dosing. Percentage was calculated using the number of patients in the column heading as the denominator. | |
BP Increases In The 6-Month Clinical Study
In the 6-month clinical study, 24-hour ambulatory blood pressure monitoring (ABPM) was conducted in 133 patients, 113 of whom completed the study. ABPM was conducted at 3 distinct 24-hour time periods: at Baseline and following 6 and 12 weeks of XYOSTED therapy. A total of 62 patients had acceptable ABPM recordings at baseline and Week 12. In that group, the mean change in systolic BP from baseline to Week 12 was + 3.9 mmHg (95% CI 1.4-6.4) and the mean change in diastolic BP was + 1.5 mmHg (95% CI 0.4-2.6).
Increases In Hematocrit
Increases in hematocrit to ≥55% were reported for 12 of the 283 patients in the 2 clinical studies, representing 4.2% of patients who received XYOSTED for up to one year. While the studies did not pre-define clinical adverse events related to increased hematocrit, polycythemia was reported as a medically significant adverse event in the investigator’s clinical judgment in 1.8% of treated patients. XYOSTED dosing resulted in mean hemoglobin increases of 1.0 ± 1.1 g/dL at 6 months and 1.1 ± 1.4 g/dL at 1 year and mean hematocrit increases of 3.8 ± 3.4% at 6 months and 5.4 ± 3.4% at 1 year.
Injection Site Reactions
Injection site reactions, including injection site bruising, injection site hemorrhage, injection site erythema and injection site induration were reported in 36 of the 283 patients in the 2 clinical studies, representing 12.7% of patients who received XYOSTED for up to one year. No patients discontinued XYOSTED because of injection site reactions.
Depression And Suicide Attempts
Depression requiring discontinuation was reported in 2 of the 283 patients in the two clinical studies and suicide attempts (one complete and one incomplete) were reported in 2 additional patients, comprising a total of 4 patients, representing 1.4% of patients who received XYOSTED for up to one year.
Increases In Serum PSA
Increases in serum PSA concentrations, defined as an increase from baseline of at least 1.4 ng/mL, or PSA greater than 4 ng/mL, led to discontinuation in 4.6% of the 283 patients in the 2 clinical studies.
SRC: NLM .