Jatenzo

Jatenzo^® is an oral testosterone medication that contains the androgen testosterone undecanoate. It’s used for testosterone replacement therapy (TRT) and is designed to help restore normal testosterone levels in adult men with confirmed testosterone deficiency due to medical conditions such as hypogonadism, which happens when the body does not produce enough testosterone on its own. It is not approved for age-related declines in testosterone.

Unlike injectable testosterone, Jatenzo is taken as a capsule, offering a convenient alternative for patients who prefer oral therapy. The typical starting dose of Jatenzo is 237 mg taken twice daily with food, but the dosage may be adjusted based on blood testosterone levels. The prescribed dose usually ranges between 158 mg and 396 mg twice daily. 

Side effects of Jatenzo may include increased blood pressure, headaches, nausea, diarrhea, and changes in mood, such as irritability or aggression. More serious risks include cardiovascular complications like heart attack, stroke, and worsening of pre-existing hypertension (high blood pressure). Jatenzo can also increase red blood cell count, which may raise the risk of blood clots.

Jatenzo (testosterone undecanoate) is indicated for:

• Testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone

Androgen

Most common adverse reactions (incidence >2%):

• Polycythemia

• Diarrhea

• Indigestion

• Belching

• Peripheral swelling

• Nausea

• Increased hematocrit

• Headache

• Prostatomegaly

• High blood pressure

The price of Jatenzo may vary depending on the dosage, quantity, where you buy it, and your insurance plan. The average retail price of Jatenzo is about $1,700 for a month’s supply of 237 mg capsules, but coupons and discount cards may be available to bring down the price. The drug’s manufacturer offers a copay card that allows eligible people with commercial insurance to pay as little as $0 per month for Jatenzo and those without insurance to pay $185 for a month’s supply.

There is currently no lower-cost generic version of Jatenzo available.

Jatenzo is only available by prescription from a healthcare provider. If you’re interested in taking this medication, make an appointment with your provider. They can assess your testosterone levels and discuss with you whether testosterone replacement therapy is appropriate based on factors like your health status, medical history, and symptoms.

• Men with breast cancer or known or suspected prostate cancer

• Women who are pregnant. Testosterone may cause fetal harm

• Known hypersensitivity to Jatenzo or any of its ingredients

• Men with hypogonadal conditions not associated with structural or genetic etiologies

• Drug interactions: Androgens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients, changes in anticoagulant activity may be seen with androgens, use of testosterone with corticosteroids may result in increased fluid retention, concomitant administration of medications that are known to increase blood pressure may lead to additional increases in blood pressure when used with Jatenzo

• Monitor hematocrit approximately every 3 months to detect increased red blood cell mass and polycythemia

• Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH

• Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone

• Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids

• Exogenous administration of androgens may lead to azoospermia

• Edema, with or without congestive heart failure, may occur in patients with pre-existing cardiac, renal, or hepatic disease

• Sleep apnea may occur in those with risk factors

• Monitor prostate specific antigen (PSA) and lipid concentrations periodically

• Depression and suicidal ideation have occurred during clinical trials in patients treated with Jatenzo

WARNING: INCREASES IN BLOOD PRESSURE

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.

Before initiating Jatenzo, consider the patient's baseline cardiovascular risk and ensure blood pressure is adequately controlled.

Periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension and re-evaluate whether the benefits of Jatenzo outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment.

Due to this risk, use Jatenzo only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.

There are other treatments for low testosterone or hypogonadism. Some treatments may be better suited to you than others. If you’re interested in trying an alternative to Jatenzo, consider connecting with a healthcare provider who can help you evaluate your options.

Other types of testosterone replacement therapy (sometimes called androgen replacement) include:

• Injectable testosterone, such as Aveed^®, Depo^®-Testosterone, or Azmiro^®

• Implantable testosterone pellets, such as Testopel^®

• Other oral testosterone therapy medications, including Kyzatrex^® and Tlando^®

• Topical testosterone, such as Androderm^® (testosterone patch) and Testim^® (testosterone gel)

Alternatives to TRT that may help manage low testosterone in men include the following, which can signal the body to have or make more testosterone:

• Aromatase inhibitors like Arimidex^® (anastrozole)

• Human chorionic gonadotropin (hCG) or Ovidrel^®, a lab-made version of hCG

• Selective estrogen receptor modulators like Clomid (clomiphene)

Your healthcare provider may also prescribe non-medication alternatives that can support healthy testosterone levels, including:

• Exercise

• Stress management

• Dietary improvements

• Getting enough sleep

• Weight loss

*This information is from the label for brand name Jatenzo^®. See the Full Prescribing Information for more complete information. Testosterone undecanoate, the active ingredient in Jatenzo, may also be the active ingredient in other medications, and this information may not be accurate for all medications that include the active ingredient testosterone undecanoate.