• Hypogonadism

Aveed Generic Name & Formulations

General Description

Testosterone undecanoate 250mg/mL; soln for IM inj; contains castor oil, benzyl benzoate.

Pharmacological Class


How Supplied

Single-use vial (3mL)—1


Aveed Indications


Testosterone replacement therapy in adult males with congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism.

Limitations of Use

Not established in men with age-related hypogonadism.

Aveed 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. Give by deep IM inj into gluteal muscle. ≥18yrs: 3mL (750mg) once at initiation, followed by 3mL (750mg) at 4 weeks, then 3mL (750mg) every 10 weeks thereafter.


<18yrs: not established.

Aveed Contraindications


Male breast or prostate cancer. Pregnancy. Nursing mothers.

Aveed Boxed Warnings

Boxed Warning

Serious pulmonary oil microembolism (POME) reactions and anaphylaxis.

Aveed Warnings/Precautions


Not for use in women. Risk of serious pulmonary oil microembolism reactions and anaphylaxis; observe for 30mins after each inj. Avoid intravascular inj. Increased risk of worsening BPH; monitor. Evaluate for prostate cancer prior to and during treatment. Monitor hematocrit prior to initiation, at 3–6 months after starting therapy, then annually; if elevation occurs, withhold until acceptable level. 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 diseases. Testosterone and/or other anabolic androgenic steroid abuse. Monitor serum testosterone, PSA, liver function, cholesterol, lipid profile, serum calcium (in cancer patients at risk for hypercalcemia/hypercalciuria) periodically. Monitor for venous thromboembolism; discontinue if suspected. Inform patients of possible increased risk of MI, stroke. Elderly.



Aveed Pharmacokinetics

See Literature

Aveed 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. May alter serum lipids; adjust dose of lipid-lowering drugs or discontinue testosterone. May affect thyroid levels.

Aveed Adverse Reactions

Adverse Reactions

Acne, inj site pain, hypogonadism, fatigue, irritability, insomnia, mood swings, increased PSA, estradiol, or hemoglobin; edema, gynecomastia, possible azoospermia (w. large doses).

Aveed Clinical Trials

See Literature

Aveed Note


Available only through the Aveed REMS program. For more information call (855) 755-0494 or visit www.AveedREMS.com.

Aveed Patient Counseling

See Literature