one concentration obtained over 24hours post-morning dose.
The primary endpoint was the percentage of patients with mean plasma total testosteroneconcentration (Cavg) over 24-hours within the normal eugonadal range on the final PK visit of thestudy.
Secondary endpoints were the percentage of patients with a maximum total testosteroneconcentration (Cmax) above three predetermined limits: less than or equal to 1500 ng/dL, between1800 and 2500 ng/dL, and greater than 2500 ng/dL.
One hundred and forty-five (87%) of the 166 hypogonadal men who received JATENZO had amean total testosterone concentration (Cavg) within the normal eugonadal range at the end oftreatment.
The percentage of patients who received JATENZO and had Cmax less than or equal to 1500ng/dL, between 1800 and 2500 ng/dL, and greater than 2500 ng/dL at the final PK visit were83%, 3%, and 3%, respectively. Note that the testosterone concentrations were not measured inserum but the effects of different sample preparation conditions were accounted for in dataanalysis of the results shown here. The titration scheme for use in clinical practice is based onserum total testosterone [see Dosage and Administration (2.2)].
16 HOW SUPPLIED/STORAGE AND HANDLING
JATENZO (testosterone undecanoate) capsules are available in three strengths of 158 mg, 198mg, and 237 mg. Capsules are packaged as 120 units in wide-mouth, round, white HDPE bottlesith white, polypropylene, child resistant caps and induction-sealed liner.
158 mg capsules are opaque red capsules imprinted with “158” in white ink and are supplied inbottles: NDC 69087-158-12.
198 mg capsules are opaque white capsules imprinted with “198” in red ink and are supplied inbottles: NDC 69087-198-12.
237 mg capsules are opaque orange capsules imprinted with “237” in white ink and are suppliedin bottles: NDC 69087-237-12.
Keep JATENZO out of reach of children.
Store at 20°C to 25ºC (68°F to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF).
Avoid exposing the capsules to moisture (store in a dry place).
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Increased Blood Pressure and Risk for Major Adverse Cardiovascular Events (MACE)Inform patients that JATENZO can increase BP that can increase the risk for MACE,including myocardial infarction, stroke, and cardiovascular death.
Instruct patients about the importance of monitoring BP periodically while on JATENZO.
If BP increases while on JATENZO, antihypertensive medications may need to bestarted, added, or adjusted to control BP, or JATENZO may need to be discontinued.
Other Adverse Reactions
Inform patients that treatment with androgens may lead to adverse reactions which include:Changes in urinary habits related to effects on prostate size, such as increased urination atnight, hesitancy, frequency, urinary urgency, having a urine accident, being unable topass urine and weak urine flowBreathing disturbances that may reflect obstructive sleep apnea, including thoseassociated with sleep, or excessive daytime sleepinessToo frequent or persistent erections of the penis
Ankle swelling that may reflect peripheral edema
Red blood cell count increase
PSA increase
Nausea and vomiting
Instruct patients to report any changes in their state of health, such as changes in urinary ha |
