Testosterone undecanoate

Testosterone undecanoate is a long-acting form of testosterone used in hormone replacement therapy for adult males with hypogonadism, the medical term for low testosterone that causes symptoms. This treatment aims to restore healthy testosterone levels and ease symptoms of testosterone deficiency, such as fatigue, low libido, depression, and reduced muscle mass and bone density.

This form of testosterone doesn’t have to be injected as often as shorter-acting forms, such as testosterone cypionate or testosterone enanthate. When it’s given as an intramuscular injection, patients can get a shot every 10 to 14 weeks.

An oral version of testosterone undecanoate also exists, though its absorption is variable and can be influenced by dietary food intake. The oral form may pose additional risks to the heart and liver, and it needs to be taken twice daily.

Some common side effects across both the injectable and oral versions include acne, increased red blood cell count, mood changes, and potential prostate effects.

Aveed (testosterone undecanoate) injection is indicated for:

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

  • Primary hypogonadism (congenital or acquired)

  • Hypogonadotropic hypogonadism (congenital or acquired)

Androgen

The most commonly reported adverse reactions (≥2%) are:

• Acne

• Injection site pain

• Prostatic specific antigen (PSA) increased

• Estradiol increased

• Hypogonadism

• Fatigue

• Irritability

• Hemoglobin increased

• Insomnia

• Mood swings

The price of testosterone undecanoate may vary depending on the form, dosage, quantity, where you buy it, and your insurance plan. 

The average retail price of testosterone undecanoate injections (sold under the brand name Aveed^®) is about $2,000 per injection, but eligible people with health insurance may pay $0 for the medication using the Aveed Copay Assistance Program.

The average retail price of oral testosterone undecanoate (sold under the brand names Jatenzo and Kyzatrex) is between $400 and $1,700 for a month’s supply, but coupons and discount cards may be available to bring down the price. Jatenzo’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 are currently no lower-cost generic versions of these medications available.

• Men with carcinoma of the breast or known or suspected carcinoma of the prostate

• Women who are pregnant. Testosterone may cause fetal harm

• Known hypersensitivity to Aveed or its ingredients (testosterone undecanoate, refined castor oil, benzyl benzoate)

• Drug interactions: Androgens may decrease blood glucose, changes in anticoagulant activity may be seen with androgens, Use of testosterone with corticosteroids may result in increased fluid retention

• 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 products

• Some postmarketing studies have shown an increased risk of heart attack and stroke associated with use of testosterone replacement therapy

• Exogenous administration of androgens may lead to azoospermia

• Edema with or without congestive heart failure may be a complication in patients with preexisting cardiac, renal, or hepatic disease

• Sleep apnea may occur in those with risk factors

• Monitor prostatic specific antigen (PSA), hemoglobin, hematocrit, and lipid concentrations periodically

WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS

Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, including life-threatening reactions, have been reported to occur during or immediately after the administration of testosterone undecanoate injection.  These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose.

Following each injection of Aveed, observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis.

Aveed is available only through a restricted program called the Aveed REMS Program.

*This information is from the label for brand name Aveed^®. See the Full Prescribing Information for more complete information. Testosterone undecanoate, the active ingredient in Aveed, 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.