• Hypogonadism

Jatenzo Generic Name & Formulations

General Description

Testosterone undecanoate 158mg, 198mg, 237mg; gel caps; contains castor oil.

Pharmacological Class


How Supplied


Generic Availability


Jatenzo 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


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).


<18yrs: not established.

Jatenzo Contraindications


Male breast or prostate cancer. Age-related hypogonadism. Pregnancy.

Jatenzo Boxed Warnings

Boxed Warning

Increases in blood pressure (BP).

Jatenzo 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


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