doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone)has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms,cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatalcomplication. Long-term therapy with intramuscular testosterone enanthate has producedmultiple hepatic adenomas. JATENZO is not known to cause these adverse effects.
Nonetheless, patients should be instructed to report any signs or symptoms of hepaticdysfunction (e.g. jaundice). If these occur, promptly discontinue JATENZO while the cause iseva luated.
5.10 Edema
Androgens, including JATENZO, may promote retention of sodium and water. Edema, with orwithout congestive heart failure, may be a serious complication in patients with pre-existingcardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy maybe required.
5.11 Gynecomastia
Gynecomastia may develop and persist in patients being treated for hypogonadism.
5.12 Sleep Apnea
The treatment of hypogonadal men with testosterone may potentiate sleep apnea in somepatients, especially those with risk factors such as obesity or chronic lung disease.
5.13 Lipids
Changes in the serum lipid profile may require dose adjustment of lipid lowering drugs ordiscontinuation of testosterone therapy. Monitor the lipid profile periodically, particularly afterstarting testosterone therapy.
5.14 Hypercalcemia
Androgens, including JATENZO, should be used with caution in cancer patients at risk ofhypercalcemia (and associated hypercalciuria). Monitor serum calcium concentrations regularlyduring treatment with JATENZO in these patients.
5.15 Decreased Thyroxine-binding Globulin
Androgens, including JATENZO, may decrease concentrations of thyroxin-binding globulin,resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4.
Free thyroid hormone concentrations remain unchanged, however, and there is no clinicalevidence of thyroid dysfunction.
5.16 Risk of Depression and Suicide
Depression and suicidal ideation has been reported in patients treated with JATENZO in clinicaltrials. Advise patients and caregivers to seek medical attention for manifestations of new onsetor worsening depression, suicidal ideation or behavior, anxiety, or other mood changes [seeAdverse Events (6.1)].
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction ratesobserved in the clinical trials of a drug cannot be directly compared to rates in the clinical trialsof another drug and may not reflect the rates observed in practice.
The safety of JATENZO was eva luated in a randomized, controlled clinical study with 166patients treated with JATENZO twice daily with morning and evening meals for approximately 4months. All patients were started on 237 mg twice daily, then the dose was titrated to 158 mg,198 mg, 316 mg, or 396 mg twice daily to achieve testosterone concentrations in the eugonadalrange.
Table 2 summarizes adverse reactions (≥2%) reported in this 4-month study.
Table 2: Number (%) of Patients with Adverse Reactions ≥ 2% in a 4-Month Study withJATENZO
Preferred Term
Overall (N = 166)
n (%)
Headache 8 (4.8)
Hematocrit increased 8 (4.8)
Hypertension 6 (3.6)
High-densit |
