JATENZO- testosterone undecanoate capsule, liquid filled
Clarus Therapeutics, Inc.
WARNING: BLOOD PRESSURE INCREASES These highlights do not include all the information needed to use. See full prescribing information for details. Initial U.S. Approval
These highlights do not include all the information needed to use. See full prescribing information for details. Initial U.S. Approval
- JATENZO can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death, with greater risk for MACE in patients with cardiovascular risk factors or established cardiovascular disease [ see Warnings and Precautions ( 5.1, 5.3) and Adverse Reactions ( 6.1) ].
- Before initiating JATENZO, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled.
- Starting approximately 3 weeks after initiating therapy or changing the dose, periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension in patients on JATENZO.
- Re-evaluate whether the benefits of JATENZO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease while on treatment.
- Due to this risk, use JATENZO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies [see Indications and Usage ( 1) and Contraindications ( 4)].
JATENZO (testosterone undecanoate) is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
- 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 have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
- Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.
Limitations of use:
- Safety and efficacy of JATENZO in males less than 18 years old have not been established [ see Use in Specific Populations ( 8.4) ].
Prior to initiating JATENZO, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these testosterone concentrations are below the normal range.
Individualize the dosage of JATENZO based on the patient’s serum testosterone concentration response to the drug. The recommended starting dose is 237 mg taken orally twice daily, once in the morning and once in the evening. Take JATENZO with food.
To ensure proper dose adjustment, measure serum testosterone concentrations 6 hours after the morning 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 serum testosterone 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 158 mg twice daily. The maximum recommended dose is 396 mg (two 198 mg capsules) twice daily.
|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|
|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|
JATENZO capsules 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 imprinted with “198” in red ink.
- The 237 mg testosterone undecanoate capsules are opaque orange and imprinted with “237” in white ink.
JATENZO is contraindicated in:
- Men with carcinoma of the breast or known or suspected carcinoma of the prostate [ see Warnings and Precautions ( 5.4) ].
- Women who are pregnant. Testosterone can cause virilization of the female fetus when administered 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 not associated with structural or genetic etiologies. The efficacy of JATENZO has not been established for these conditions, and JATENZO can increase BP which can increase the risk of MACE [see Boxed Warning and Warning and Precautions ( 5.1)].
In a clinical trial, JATENZO increased systolic BP during 4 months of treatment by an average of 4.9 mmHg based on ambulatory blood pressure monitoring (ABPM) and by an average of 2.8 mmHg 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 JATENZO-treated patients were started on antihypertensive medications or required intensification of their antihypertensive medication regimen during the 4-month trial.
These BP increases can increase the risk of MACE, with greater risk in patients with established cardiovascular 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 blood pressure is adequately controlled. Check BP approximately 3 weeks after initiating JATENZO or increasing the dose and periodically thereafter. Treat new-onset hypertension or exacerbations of pre-existing hypertension. Re-evaluate whether the benefits of continued treatment with JATENZO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease.
JATENZO is contraindicated in men with hypogonadal conditions such as “age-related hypogonadism,” because the efficacy of JATENZO has not been established for these conditions and the increases in BP can increase the risk of MACE [ see Contraindications ( 4) ].
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