Jatenzo Generic Name & Formulations
Legal Class
CIII
General Description
Testosterone undecanoate 158mg, 198mg, 237mg; gel caps; contains castor oil.
Pharmacological Class
Androgen.
How Supplied
Caps—120
Manufacturer
Generic Availability
NO
Jatenzo Indications
Indications
Testosterone replacement therapy in adult males with congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism.
Limitations of Use
Safety and efficacy have not been established in males <18yrs.
Jatenzo Dosage and Administration
Adult
Prior to treatment, confirm diagnosis by ensuring serum testosterone has been measured in the AM on at least 2 separate days and that these concentrations are below normal range. Individualize. Take with food. ≥18yrs: initially 237mg twice daily (AM + PM); max 396mg twice daily. Dose adjustments based on serum testosterone (see full labeling).
Children
<18yrs: not established.
Jatenzo Contraindications
Contraindications
Male breast or prostate cancer. Age-related hypogonadism. Pregnancy.
Jatenzo Boxed Warnings
Boxed Warning
Increases in blood pressure (BP).
Jatenzo Warnings/Precautions
Warnings/Precautions
Not for use in women. Increases in BP can increase risk of major adverse cardiovascular events (MACE), including non-fatal MI, non-fatal stroke, CV death. Prior to treatment, consider baseline CV risk and ensure BP adequately controlled. Monitor BP approx. 3 weeks after initiation or dose increase and periodically thereafter; treat new-onset hypertension or exacerbations of preexisting hypertension. Reevaluate for continued treatment if CV risk factors or disease develops. Monitor hematocrit prior to initiation and approx. every 3 months during treatment; if elevation occurs, withhold until acceptable level. Increased risk of worsening BPH; monitor. Evaluate for prostate cancer prior to and during treatment. Monitor for venous thromboembolism; discontinue if suspected. Preexisting cardiac, renal or hepatic disease (discontinue if edema occurs). Discontinue and evaluate if signs/symptoms of hepatic dysfunction (eg, jaundice) occur. Possible sleep apnea in patients with obesity or chronic lung disease. Testosterone and/or other anabolic androgenic steroid abuse. Monitor serum testosterone, PSA, liver function, lipid profile, serum calcium (in cancer patients at risk for hypercalcemia/hypercalciuria) periodically. Risk of depression, suicidal ideation. Elderly.
Jatenzo Pharmacokinetics
See Literature
Jatenzo Interactions
Interactions
May alter insulin sensitivity and glycemic control; reduce dose of antidiabetic agents if needed. Increased fluid retention with concomitant corticosteroids; monitor. Monitor INR and PT with concomitant oral anticoagulants. Concomitant prescription or OTC analgesic and cold medications may lead to additional BP increases. May alter serum lipids; adjust dose of lipid-lowering drugs or discontinue testosterone. May affect thyroid levels.
Jatenzo Adverse Reactions
Adverse Reactions
Polycythemia, diarrhea, dyspepsia, eructation, peripheral edema, nausea, increased hematocrit, headache, prostatomegaly, hypertension; gynecomastia, possible azoospermia (w. large doses).
Jatenzo Clinical Trials
See Literature
Jatenzo Note
Not Applicable
Jatenzo Patient Counseling
See Literature