Indications for JATENZO:
Testosterone replacement therapy in adult males with congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism.
Limitations of Use:
Safety and efficacy have not been established in males <18yrs.
Prior to treatment, confirm diagnosis by ensuring serum testosterone has been measured in the AM on at least 2 separate days and that these concentrations are below normal range. Individualize. Take with food. ≥18yrs: initially 237mg twice daily (AM + PM); max 396mg twice daily. Dose adjustments based on serum testosterone (see full labeling).
<18yrs: not established.
Male breast or prostate cancer. Age-related hypogonadism. Pregnancy.
Increases in blood pressure (BP).
Not for use in women. Increases in BP can increase risk of major adverse cardiovascular events (MACE), including non-fatal MI, stroke, CV death. Prior to treatment, consider baseline CV risk and ensure BP adequately controlled. Monitor BP approx. 3 weeks after initiation or dose increase and periodically thereafter; treat new-onset hypertension or exacerbations of preexisting hypertension. Re-evaluate for continued treatment if CV risk factors or disease develops. Monitor hematocrit prior to initiation and approx. every 3 months during treatment; if elevation occurs, withhold until acceptable level. Increased risk of worsening BPH; monitor. Evaluate for prostate cancer prior to and during treatment. Monitor for venous thromboembolism; discontinue if suspected. Preexisting cardiac, renal or hepatic disease (discontinue if edema occurs). Discontinue and evaluate if signs/symptoms of hepatic dysfunction (eg, jaundice) occur. Possible sleep apnea in patients with obesity or chronic lung disease. Testosterone and/or other anabolic androgenic steroid abuse. Monitor serum testosterone, PSA, liver function, lipid profile, serum calcium (in cancer patients at risk for hypercalcemia/hypercalciuria) periodically. Risk of depression, suicidal ideation. Elderly.
May alter insulin sensitivity and glycemic control; reduce dose of antidiabetic agents if needed. Increased fluid retention with concomitant corticosteroids; monitor. Monitor INR and PT with concomitant oral anticoagulants. Concomitant prescription or OTC analgesic and cold medications may lead to additional BP increases. May alter serum lipids; adjust dose of lipid-lowering drugs or discontinue testosterone. May affect thyroid levels.
Polycythemia, diarrhea, dyspepsia, eructation, peripheral edema, nausea, increased hematocrit, headache, prostatomegaly, hypertension; gynecomastia, possible azoospermia (w. large doses).