The most common adverse reaction of KYZATREX (incidence ≥ 2%) is hypertension (2.6%).
Venous Thromboembolism (VTE)
VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone. Discontinue KYZATREX if VTE is suspected and initiate appropriate workup and management.
Abuse of Testosterone and Monitoring of Testosterone Concentrations
Testosterone has been subject to abuse, typically at doses higher than indicated and in combination with other anabolic androgenic steroids. If abuse is suspected, check testosterone levels to ensure they are within therapeutic range. Counsel patients concerning the serious adverse reactions associated with abuse and consider the possibility of abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.
Potential for Adverse Effects on Spermatogenesis
Large doses of androgens can suppress spermatogenesis. Inform patients of this risk before prescribing KYZATREX.
Edema
Edema may occur in patients with pre-existing cardiac, renal, or hepatic disease. In addition to discontinuing KYZATREX, diuretic therapy may be required.
Sleep Apnea
KYZATREX may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung disease.
Lipid Changes
KYZATREX may affect serum lipid profiles. Monitor patient lipid concentrations periodically; if necessary, adjust dosage of lipid lowering drug(s) or discontinue KYZATREX.
Other warnings include:
Hepatic adverse effects from prolonged use of high doses of methyltestosterone; gynecomastia; hypercalcemia in cancer patients; and decreased thyroxine-binding globulin.
