HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useJATENZO®
safely and effectively. See full prescribing information forJATENZO.
JATENZO(testosterone undecanoate)capsules, for oral use CIII
Initial U.S. Approval: 1953
WARNING: INCREASES IN BLOOD PRESSURE
See full prescribing information for complete boxed warning JATENZO can cause blood pressure (BP) increases that canincrease the risk of major adverse cardiovascular events(MACE), including non-fatal myocardial infarction, non-fatalstroke and cardiovascular death.
Before initiating JATENZO, consider the patient’s baselinecardiovascular risk and ensure blood pressure is adequatelycontrolled.
Periodically monitor for and treat new-onset hypertension orexacerbations of pre-existing hypertension and re-eva luatewhether the benefits of JATENZO outweigh its risks in patientswho develop cardiovascular risk factors or cardiovascular diseaseon treatment.
Due to this risk, use JATENZO only for the treatment of menwith hypogonadal conditions associated with structural or geneticetiologies.
INDICATIONS AND USAGE
JATENZO (testosterone undecanoate) is an androgen indicated fortestosterone replacement therapy in adult males for conditions associated witha deficiency or absence of endogenous testosterone.
Limitations of use:
• Safety and efficacy of JATENZO in males less than 18 years old have notbeen established.
DOSAGE AND ADMINISTRATION
• Prior to initiating JATENZO, confirm the diagnosis of hypogonadism byensuring that serum testosterone concentrations have been measured in themorning on at least two separate days and that these concentrations arebelow the normal range.
• Take JATENZO with food.
• Starting dose: 237 mg orally once in the morning and once in the evening.
• Adjust the dose to a minimum of 158 mg twice daily and a maximum of396 mg twice daily based on serum testosterone drawn 6 hours after themorning dose at least 7 days after starting treatment or following doseadjustment and periodically thereafter.
DOSAGE FORMS AND STRENGTHS
JATENZO (testosterone undecanoate) capsules for oral use are available inthe following strengths: 158mg, 198mg, 237mg.
CONTRAINDICATIONS
• Men with breast cancer or known or suspected prostate cancer.
• Women who are pregnant. Testosterone may cause fetal harm, Known hypersensitivity to JATENZO or any of its ingredients.
• Men with hypogonadal conditions not associated with structural or geneticetiologies.
WARNINGS AND PRECAUTIONS
• Monitor hematocrit approximately every 3 months to detect increased redblood cell mass and polycythemia.
• Monitor patients with benign prostatic hyperplasia (BPH) for worsening ofsigns and symptoms of BPH.
• Venous thromboembolism (VTE), including deep vein thrombosis (DVT)and pulmonary embolism (PE) have been reported in patients usingtestosterone. eva luate patients with signs or symptoms consistent withDVT or PE.
• Testosterone has been subject to abuse, typically at doses higher thanrecommended for the approved indication and in combination with otheranabolic androgenicsteroids.
• Exogenous administration of androgens may lead to azoospermia.
• Edema, with or without congestive heart failure, may occur in patientswith pre-existing cardiac, renal, or hep