Indications for: KYZATREX
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. Take with food. Individualize. ≥18yrs: 200mg twice daily (AM + PM); max 400mg twice daily. Treatment continuation based on serum testosterone (see full labeling).
<18yrs: not established.
Male breast or prostate cancer. Age-related hypogonadism. Pregnancy.
Blood pressure (BP) increases.
Not substitutable with other oral testosterone undecanoate products. Not for use in women. Increases in BP can increase risk of major adverse cardiovascular events (MACE), including non-fatal MI, non-fatal stroke, CV death; use only for hypogonadal conditions associated with structural or genetic etiologies. Prior to treatment, consider baseline CV risk and ensure BP adequately controlled. Monitor BP after initiation or dose increase, and periodically thereafter; treat new-onset hypertension or exacerbations of preexisting hypertension. Reevaluate for continued treatment if CV risk factors or disease develops. Monitor hematocrit prior to initiation and approx. every 3 months; 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. 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 (eg, warfarin). 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.
Hypertension; headache, arthralgia, diarrhea, increased hemoglobin, anxiety, constipation, peripheral edema, increased PSA, increased heart rate, gynecomastia, spermatogenesis (w. large doses).
Generic Drug Availability: