Aveed

Aveed^® is a long-acting injectable form of testosterone used in testosterone replacement therapy (TRT) for adult men with hypogonadism, a condition in which the body does not produce enough testosterone. Unlike shorter-acting testosterone injections that require weekly or biweekly shots, Aveed is given every 10 weeks after an initial loading phase.

Aveed helps restore normal testosterone levels, which can improve energy levels, libido, muscle mass, mood stability, and bone density in men with low testosterone.

The medication has similar risks and side effects to other forms of TRT, but a significant concern with Aveed is the risk of pulmonary oil microembolism, a rare but serious reaction that can cause shortness of breath, coughing, chest pain, or dizziness immediately after injection. Because of this risk, Aveed must be administered in a certified healthcare setting where patients can be monitored for at least 30 minutes post-injection.

Regular check-ups are also essential to ensure testosterone levels remain within a safe range and to monitor for any adverse 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 Aveed may vary depending on your insurance plan and whether you use a copay assistance program. 

The average retail price of 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.

• 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.