Aveed Generic Name & Formulations
Legal Class
CIII
General Description
Testosterone undecanoate 250mg/mL; soln for IM inj; contains castor oil, benzyl benzoate.
Pharmacological Class
Androgen.
How Supplied
Single-use vial (3mL)—1
Manufacturer
Aveed Indications
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
Adult
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.
Children
<18yrs: not established.
Aveed Contraindications
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
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.
REMS
Aveed Pharmacokinetics
See Literature
Aveed Interactions
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
Notes
Available only through the Aveed REMS program. For more information call (855) 755-0494 or visit www.AveedREMS.com.
Aveed Patient Counseling
See Literature
Images
