apsules for oral use are available in three strengths:
The 158 mg testosterone undecanoate capsules are opaque red and imprinted with“158” in white ink.
The 198 mg testosterone undecanoate capsules are opaque white and imprintedwith “198” in red ink.
The 237 mg testosterone undecanoate capsules are opaque orange and imprintedwith “237” in white ink.
4 CONTRAINDICATIONS
JATENZO is contraindicated in:
Men with carcinoma of the breast or known or suspected carcinoma of the prostate [seeWarnings and Precautions (5.4)].
Women who are pregnant. Testosterone can cause virilization of the female fetus whenadministered to a pregnant woman [see Use in Specific Populations (8.1)].
Men with known hypersensitivity to JATENZO or any of its ingredients [see Description(11)].
Men with hypogonadal conditions, such as “age-related hypogonadism”, that are notassociated with structural or genetic etiologies. The efficacy of JATENZO has not beenestablished for these conditions, and JATENZO can increase BP which can increase therisk of MACE [see Boxed Warning and Warning and Precautions (5.1)].
5 WARNINGS AND PRECAUTIONS
5.1 Increase in Blood Pressure
In a clinical trial, JATENZO increased systolic BP during 4 months of treatment by an averageof 4.9 mmHg based on ambulatory blood pressure monitoring (ABPM) and by an average of 2.8mmHg from baseline based on blood pressure cuff measurements [see Adverse Reactions (6.1)].
Average blood pressures had not plateaued at the end of the trial. Seven percent of JATENZOtreatedpatients were started on antihypertensive medications or required intensification of theirantihypertensive medication regimen during the 4-month trial.
These BP increases can increase the risk of MACE, with greater risk in patients with establishedcardiovascular disease or risk factors for cardiovascular disease [see Boxed Warning].
In some patients, the increase in BP with JATENZO may be too small to detect, but can still
increase the risk for MACE.
Before initiating JATENZO, consider the patient’s baseline cardiovascular risk and ensure bloodpressure is adequately controlled. Check BP approximately 3 weeks after initiating JATENZOor increasing the dose and periodically thereafter. Treat new-onset hypertension orexacerbations of pre-existing hypertension. Re-eva luate whether the benefits of continuedtreatment with JATENZO outweigh its risks in patients who develop cardiovascular risk factorsor cardiovascular disease.
JATENZO is contraindicated in men with hypogonadal conditions such as “age-relatedhypogonadism,” because the efficacy of JATENZO has not been established for these conditionsand the increases in BP can increase the risk of MACE [see Contraindications (4)].
5.2 Polycythemia
Increases in hematocrit reflective of increases in red blood cell mass, may require lowering thedose or discontinuation of JATENZO. Check that hematocrit is not elevated prior to initiatingJATENZO. eva luate hematocrit approximately every 3 months while the patient is onJATENZO. If hematocrit becomes elevated, stop JATENZO until the hematocrit decreases to anacceptable concentration. If JATENZO is restarted and again causes hematocrit to becomeelevated, stop JATENZO permanently. An increase in red blood cell mass may increase the riskof thromboembolic events [see Warnings and Precautions (5.5)].
5.3 Cardiovas |
