cular Risk
Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes oftestosterone replacement therapy in men. To date, epidemiologic studies and randomizedcontrolled trials have been inconclusive for determining the risk of MACE, such as non-fatalmyocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosteronecompared to non-use. Some studies, but not all, have reported an increased risk of MACE inassociation with use of testosterone replacement therapy in men.
JATENZO can cause BP increases that can increase the risk of MACE [see Boxed Warning andWarnings and Precautions (5.1)]. Patients should be informed of this possible risk whendeciding whether to use or to continue to use JATENZO.
5.4 Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate
Cancer
Patients with BPH treated with androgens are at an increased risk for worsening of signs andsymptoms of BPH. Monitor patients with BPH for worsening signs and symptoms.
Patients treated with androgens may be at increased risk for prostate cancer. eva luate patientsfor prostate cancer prior to initiating and during treatment with androgens [see Contraindications(4)].
5.5 Venous Thromboembolism
There have been postmarketing reports of venous thromboembolic events, including deep veinthrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone replacementproducts such as JATENZO. eva luate patients who report symptoms of pain, edema, warmthand erythema in the lower extremity for DVT and those who present with acute shortness ofbreath for PE. If a venous thromboembolic event is suspected, discontinue treatment withJATENZO and initiate appropriate workup and management [see Adverse Reactions (6.2)].
5.6 Abuse of Testosterone and Monitoring of Testosterone Concentrations
Testosterone has been subject to abuse, typically at doses higher than recommended for theapproved indication and in combination with other anabolic androgenic steroids. Anabolicandrogenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions[see Drug Abuse and Dependence (9)].
If testosterone abuse is suspected, check testosterone concentrations to ensure they are withintherapeutic range [see Dose and Administration (2)]. However, testosterone levels may be in thenormal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patientsconcerning the serious adverse reactions associated with abuse of testosterone and anabolicandrogenic steroids. Conversely, consider the possibility of testosterone and anabolicandrogenic steroid abuse in suspected patients who present with serious cardiovascular or
sychiatric adverse events.
5.7 Not for Use in Women
Due to lack of controlled studies in women and potential virilizing effects, JATENZO is notindicated for use in women [see Contraindications (4) and Use in Specific Populations (8.1,8.2)].
5.8 Potential for Adverse Effects on Spermatogenesis
With large doses of exogenous androgens, including JATENZO, spermatogenesis may besuppressed through feedback inhibition of pituitary FSH possibly leading to adverse effects onsemen parameters including sperm count [see Use in Specific Populations (8.3)]. Patients shouldbe informed of this possible risk when deciding whether to use or to continue to use JATENZO.
5.9 Hepatic Adverse Effects
Prolonged use of high |
