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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
JATENZO (testosterone undecanoate) is an androgen indicated for testosterone replacementtherapy in adult males for conditions associated with a deficiency or absence of endogenoustestosterone:
Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism,bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome,chemotherapy, or toxic damage from alcohol or heavy metals. These men usually havelow serum testosterone concentrations and gonadotropins (follicle-stimulating hormone[FSH], luteinizing hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizinghormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from
tumors, trauma, or radiation. These men have low testosterone serum concentrations buthave gonadotropins in the normal or low range.Limitations of use:
Safety and efficacy of JATENZO in males less than 18 years old have not beenestablished [see Use in Specific Populations (8.4)].

2 DOSAGE AND ADMINISTRATION
2.1 Confirmation of Hypogonadism Before Initiation of JATENZO
Prior to initiating JATENZO, confirm the diagnosis of hypogonadism by ensuring that serumtestosterone concentrations have been measured in the morning on at least two separate days andthat these testosterone concentrations are below the normal range.
2.2 Dosing and Dose Adjustment Information
Individualize the dosage of JATENZO based on the patient’s serum testosterone concentrationresponse to the drug. The recommended starting dose is 237 mg taken orally twice daily, once inthe morning and once in the evening. Take JATENZO with food.
Dose Adjustment
To ensure proper dose adjustment, measure serum testosterone concentrations 6 hours after themorning dose in plain tubes, clotted at room temperature for 30 minutes prior to centrifugation.
Adjust the JATENZO dose based on this serum testosterone measurement as shown in Table 1.
Wait seven days after starting treatment or adjusting the dose before checking the serumtestosterone concentration. Thereafter, periodically monitor serum testosterone concentrations 6
hours after the morning dose.
Administer the same dose in the morning and evening. The minimum recommended dose is 158mg twice daily. The maximum recommended dose is 396 mg (two 198 mg capsules) twice daily.
Table 1: JATENZO Dose Adjustment Scheme
Testosterone Concentration in
Serum From Plain Tube Drawn
6 hours After Morning Dose
Current JATENZO Dose
(mg, twice daily)
New JATENZO Dose
(mg, twice daily)
Less than 425 ng/dL
158 198
198 237
237 316 (two 158 mg capsules)
316 (two 158 mg capsules) 396 (two 198 mg capsules)
425 ng/dL – 970 ng/dL No Dose Change
More than 970 ng/dL
396 (two 198 mg capsules) 316 (two 158 mg capsules)
316 (two 158 mg capsules) 237
237 198
198 158
158 Discontinue Treatment
3 DOSAGE FORMS AND STRENGTHS
JATENZO c