• Jatenzo is a brand (trade) name for testosterone undecanoate which may be used to replace missing testosterone in males.
• Jatenzo works by directly replacing missing testosterone that is not being made naturally by a man's body. Testosterone is called an endogenous androgen (a male sex hormone made naturally by the body), and together with dihydrotestosterone (DHT) is responsible for the normal growth and development of the male sex organs (the prostate, seminal vesicles, penis, and scrotum) and maintenance of secondary sex characteristics, including male hair growth, laryngeal enlargement, vocal cord thickening, muscle mass, and fat distribution.
• Jatenzo belongs to the class of medications known as androgens and anabolic steroids.

• Approved for the treatment of male hypogonadism, a condition in which the body doesn't produce enough testosterone. Male hypogonadism may be congenital (present from birth) or acquired (from injury or infection). It is not approved for “age-related hypogonadism”, (low testosterone levels caused by aging) because of heart safety risks.
• May be used to treat primary hypogonadism due to testicular failure due to cryptorchidism (undescended testes), orchiectomy, genetic disorders, such as Klinefelter syndrome, low testosterone levels caused by chemotherapy or toxic damage from alcohol or heavy metals, and some other conditions. These men usually have low testosterone levels and FSH and LH levels above the normal range.
• Also treats hypogonadotropic hypogonadism (congenital or acquired), such as gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men usually have low testosterone levels but FSH and LH levels are in the low to normal range.
• Available as an oral capsule that is taken twice a day.
• Starts working with the first dose.
• The usual starting dose is 237mg taken twice a day. Measure serum testosterone levels 6 hours after the morning dose and adjust dosage based on product information guidelines. Wait 7 days after starting treatment or when changing the dose before measuring levels. The minimum recommended dose is 158mg twice a day and the maximum is 396mg twice a day. The same dose should be taken morning and night.
• Available as 158mg, 198mg, and 237mg capsules.
• Not known to cause liver problems, although patients should still be monitored for the development of liver toxicity.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• A headache, an increase in hematocrit (red blood cell count), a decrease in high-density lipoprotein cholesterol (“good” cholesterol), high blood pressure, and nausea are the most common side effects reported. May worsen symptoms of benign prostatic hyperplasia and increase the risk of prostate cancer. May also exacerbate sleep apnea, particularly in those who are obese or who have preexisting lung conditions. May increase the risk of blood clots and affect moods.
• Jatenzo contains a boxed warning about an increased risk of high blood pressure that can increase the risk of major cardiovascular adverse events, such as a heart attack, stroke, or heart-related death. Men with preexisting cardiovascular disease or cardiovascular disease risk factors are more at risk. Starting 3 weeks after dose initiation or dose changes monitor for new-onset high blood pressure or exacerbations of pre-existing hypertension.
• Because of the risk of high blood pressure, Jatenzo is only indicated for those men with hypogonadal conditions associated with structural or genetic causes.
• Not suitable for men with breast cancer or known or suspected prostate cancer, those with allergies to Jatenzo or any of its ingredients, or men with age-related hypogonadism.
• May adversely affect serum lipid levels, including lowering HDL and elevating LDL levels. These changes can be marked and significantly impact the risk of atherosclerosis and coronary artery disease. Monitor and consider adjustments to the dosage of cholesterol-lowering medications.
• Jatenzo is an expensive medication and costs from $850 to over $1,000 per month for a supply of 60 capsules if you are paying cash and using an online discount. But many patients do not have to pay these high prices. Insurance may cover a portion of the cost of Jatenzo and there may be a copay. In addition, Clarus Therapeutics, the manufacturer of Jatenzo offers a Savings Card through the Jatenzo Go program. Eligible patients with private, commercial insurance may be able to pay as little as $0 for their prescription with this card. The Jatenzo Go program offers a yearly benefit with a $2,000 maximum. These programs are not valid for patients with government-funded insurance such as Medicaid, Medicare, or Tricare. Call the Jatenzo Go program for more details at 1-844-269-2795.
• Testosterone is a Schedule III controlled substance in the Controlled Substances Act. Always store in a safe place to prevent misuse.
• Not approved for use in women. Jatenzo can cause virilization of the female fetus. May affect sperm levels and decrease fertility in men. May cause gynecomastia (breast enlargement in men)

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Take Jatenzo with food. Take one dose in the morning and one dose at night.
• Jatenzo can cause high blood pressure and increase your risk of having a heart attack or stroke or a blood clot. Report any symptoms such as a headache, shortness of breath, chest pain, numbness down one side of your body, or sleep disturbances to your doctor.
• You will need regular blood pressure monitoring and hematocrit monitoring while you are taking Jatenzo. Always keep your appointments with your healthcare provider.
• Jatenzo may be sought after by anabolic steroid misusers. Keep your Jatenzo tablets in a safe place and never share them with anyone. Overuse of Jatenzo can cause serious cardiovascular and psychiatric adverse events.
• Jatenzo may cause you to retain fluid which may exacerbate the symptoms of heart failure and kidney disease. Tell your doctor if you notice any signs of edema, such as ankle swelling.
• Although Jatenzo is not known to cause liver problems, you should report any signs of liver dysfunction, such as yellow skin or eyes, abdominal pain, or dark urine, to your healthcare provider immediately.
• Tell your doctor about any other worrying side effects you may be experiencing, such as a persistent headache, depression, or suicidal thoughts, irritability, weight loss, persistent erections, or sleep disturbances. When it comes time to stop taking Jatenzo your doctor should discontinue it slowly.
• Can cause dependence which may lead to withdrawal symptoms on discontinuation, such as depressed mood, fatigue, cravings

• Starts working with the first dose.
• In a 4-month study of 166 men with hypogonadism, 87% of Jatenzo-treated men reached testosterone levels within the normal range, which was the main endpoint of the study.
• The diagnosis of hypogonadism needs to be confirmed before initiating the first dose of Jatenzo by measuring serum testosterone levels in the morning on at least two separate days. These must be below the normal range.

Medicines that interact with Jatenzo may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Jatenzo. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Jatenzo include:

• anti-androgens, such as apalutamide
• antifungals, such as fluconazole
• aprepitant
• berotralstat
• calcitriol topical
• cannabidiol
• corticosteroids, such as budesonide or prednisone (may cause increased fluid retention, particularly in patients with heart, kidney, or liver disease)
• cyclosporine
• heart medications, such as diltiazem
• hepatitis C treatments, such as boceprevir
• HIV medications, such as darunavir, efavirenz, or ritonavir
• herbals, such as black cohosh
• insulin (may change the sensitivity to insulin and blood glucose control)
• leflunomide
• levothyroxine
• lomitapide
• medications for diabetes, such as glipizide or glyburide
• morphine
• nefazodone
• NSAIDs, such as diclofenac, ibuprofen, or naproxen
• oxcarbazepine
• peginterferon beta-1a
• warfarin (Jatenzo may increase the risk of blood clotting and more frequent monitoring of INR and PT may be required).

Androgens may decrease blood glucose levels in people with diabetes and the dosage of some diabetes medications may need to be decreased.

Medications that have the potential to increase blood pressure, either by fluid retention, such as NSAIDs (eg, ibuprofen, naproxen, or indomethacin), or by a direct effect, such as pseudoephedrine, phenylephrine, caffeine, herbal supplements, other hormones, biologics, stimulants, immunosuppressants, or antidepressants can also interact with Jatenzo.

Note that this list is not all-inclusive and includes only common medications that may interact with Jatenzo. You should refer to the prescribing information for Jatenzo for a complete list of interactions.